Effective Date of Requirement for Premarket Approval for Blood Lancets, 11151-11160 [2016-04579]
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(2) For those devices intended for use
in the home, labeling must be written so
that it is understandable to lay users.
(vi) Labeling must also include the
following statements, prominently
placed:
(A) ‘‘For use only on a single patient.
Discard the entire device after use.’’
(B) ‘‘Warning: Not intended for more
than one use. Do not use on more than
one patient. Improper use of blood
lancets can increase the risk of
inadvertent transmission of bloodborne
pathogens, particularly in settings
where multiple patients are tested.’’
(b) Single use only blood lancet
without an integral sharps injury
prevention feature—(1) Identification. A
disposable blood lancet intended for a
single use that is comprised of a single
use blade attached to a solid, nonreusable base that is used to puncture
the skin to obtain a drop of blood for
diagnostic purposes.
(2) Classification. Class II (special
controls). The special controls are:
(i) The design characteristics of the
device must ensure that the structure
and material composition are consistent
with the intended use and address the
risk of sharp object injuries and
bloodborne pathogen transmissions;
(ii) Mechanical performance testing
must demonstrate that the device will
withstand forces encountered during
use;
(iii) The device must be demonstrated
to be biocompatible;
(iv) Sterility testing must demonstrate
the sterility of the device;
(v) Labeling must include:
(A) Detailed descriptions, with
illustrations, of the proper use of the
device.
(B) Handwashing instructions for the
user before and after use of the device.
(C) Instructions on cleaning and
disinfection of the skin to be pierced.
(D) Instructions for the safe disposal
of the device.
(E) Labeling must be appropriate for
the intended use environment.
(1) For those devices intended for
health care settings, labeling must
address the health care facility use of
these devices, including how these
lancets are to be used with personal
protective equipment, such as gloves.
(2) For those devices intended for use
in the home, labeling must be written so
that it is understandable to lay users.
(vi) Labeling must also include the
following statements, prominently
placed:
(A) ‘‘For use only on a single patient.
Discard the entire device after use.’’
(B) ‘‘Warning: Not intended for more
than one use. Do not use on more than
one patient. Improper use of blood
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lancets can increase the risk of
inadvertent transmission of bloodborne
pathogens, particularly in settings
where multiple patients are tested.’’
(c) Multiple use blood lancet for single
patient use only—(1) Identification. A
multiple use capable blood lancet
intended for use on a single patient that
is comprised of a single use blade
attached to a solid, reusable base that is
used to puncture the skin to obtain a
drop of blood for diagnostic purposes.
(2) Classification. Class II (special
controls). The special controls are:
(i) The design characteristics of the
device must ensure that:
(A) The lancet blade can be changed
with every use, either manually or by
triggering a blade storage unit to discard
the used blade and reload an unused
blade into the reusable base; and
(B) The structure and material
composition are consistent with the
intended use and address the risk of
sharp object injuries and bloodborne
pathogen transmissions; and allow for
validated cleaning and disinfection;
(ii) Mechanical performance testing
must demonstrate that the device will
withstand forces encountered during
use;
(iii) The device must be demonstrated
to be biocompatible;
(iv) Sterility testing must demonstrate
the sterility of the device;
(v) Validation testing must
demonstrate that the cleaning and
disinfection instructions are adequate to
ensure that the reusable lancet base can
be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with
illustrations, of the proper use of the
device.
(B) The Environmental Protection
Agency (EPA) registered disinfectant’s
contact time for disinfectant use.
(C) Handwashing instructions for the
user before and after use of the device.
(D) Instructions on cleaning and
disinfection of the skin to be pierced.
(E) Instructions on the cleaning and
disinfection of the device.
(F) Instructions for the safe disposal of
the device.
(G) Instructions for use must address
the safe storage of the reusable blood
lancet base between uses to minimize
contamination or damage and the safe
storage and disposal of the refill lancet
blades.
(H) Labeling must be appropriate for
the intended use environment.
(1) For those devices intended for
health care settings, labeling must
address the health care facility use of
these devices, including how these
lancets are to be used with personal
protective equipment, such as gloves.
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11151
(2) For those devices intended for use
in the home, labeling must be written so
that it is understandable to lay users.
(vii) Labeling must also include the
following statements, prominently
placed:
(A) ‘‘For use only on a single patient.
Disinfect reusable components
according to manufacturer’s instructions
between each use.’’
(B) ‘‘Used lancet blades must be safely
discarded after a single use.’’
(C) ‘‘Warning: Do not use on more
than one patient. Improper use of blood
lancets can increase the risk of
inadvertent transmission of bloodborne
pathogens, particularly in settings
where multiple patients are tested. The
cleaning and disinfection instructions
for this device are intended only to
reduce the risk of local use site
infection; they cannot render this device
safe for use for more than one patient.’’
(d) Multiple use blood lancet for
multiple patient use—(1) Identification.
A multiple use capable blood lancet
intended for use on multiple patients
that is comprised of a single use blade
attached to a solid, reusable base that is
used to puncture the skin to obtain a
drop of blood for diagnostic purposes.
(2) Classification. Class III (premarket
approval).
Dated: February 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–04578 Filed 3–2–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA–2016–M–0035]
Effective Date of Requirement for
Premarket Approval for Blood Lancets
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed order.
The Food and Drug
Administration (FDA) is issuing a
proposed administrative order to require
the filing of a premarket approval
application (PMA) following the
reclassification of multiple use blood
lancets for multiple patient use from
class I to class III. FDA is summarizing
its proposed findings regarding the
degree of risk of illness or injury
designed to be eliminated or reduced by
requiring this device to meet the PMA
requirements of the Federal Food, Drug,
SUMMARY:
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Federal Register / Vol. 81, No. 42 / Thursday, March 3, 2016 / Proposed Rules
and Cosmetic Act (the FD&C Act) and
the benefits to the public from the use
of the device.
DATES: Submit either electronic or
written comments on this proposed
order by June 1, 2016. See section X of
the SUPPLEMENTARY INFORMATION section
of this document for the proposed
effective date of any final order that may
publish based on this proposal.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–M–0035 for ‘‘Effective Date of
Requirement for Premarket Approval for
Blood Lancets.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
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Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on http:/
/www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G422, Silver Spring,
MD 20993–0002, 301–796–6524,
joshua.nipper@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background—Regulatory Authorities
The FD&C Act, as amended,
establishes a comprehensive system for
the regulation of medical devices
intended for human use. Section 513 of
the FD&C Act (21 U.S.C. 360c)
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established three categories (classes) of
devices, reflecting the regulatory
controls needed to provide reasonable
assurance of their safety and
effectiveness. The three categories of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval).
Under section 513(d)(1) of the FD&C
Act, devices that were in commercial
distribution before the enactment of the
1976 amendments, May 28, 1976
(generally referred to as
‘‘preamendments devices’’), are
classified after FDA: (1) Receives a
recommendation from a device
classification panel (an FDA advisory
committee); (2) publishes the panel’s
recommendation for comment, along
with a proposed regulation classifying
the device; and (3) publishes a final
regulation classifying the device. FDA
has classified most preamendments
devices under these procedures.
Devices that were not in commercial
distribution prior to May 28, 1976
(generally referred to as
‘‘postamendments devices’’), are
classified automatically by section
513(f) of the FD&C Act into class III
without any FDA rulemaking process.
Those devices remain in class III and
require premarket approval unless, and
until, FDA reclassifies the device into
class I or II, or FDA issues an order
finding the device to be substantially
equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate
device that does not require premarket
approval. The Agency determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
procedures in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part
807 of the regulations (21 CFR part 807).
A person may market a
preamendments device that has been
classified into class III through
premarket notification procedures, and
devices found substantially equivalent
by means of premarket notification
(510(k)) procedures to such a
preamendments device or to a device
within that type (both the
preamendments and substantially
equivalent devices are referred to as
preamendments class III devices) may
be marketed without submission of a
PMA until FDA issues a final order
under section 515(b) of the FD&C Act
(21 U.S.C. 360e(b)) requiring premarket
approval. Section 515(b)(1) of the FD&C
Act directs FDA to issue an order
requiring premarket approval for a
preamendments class III device.
Section 515(f) of the FD&C Act
provides an alternative pathway for
meeting the premarket approval
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requirement. Under section 515(f),
manufacturers may meet the premarket
approval requirement if they file a
notice of completion of a product
development protocol (PDP) approved
under section 515(f)(4) of the FD&C Act
and FDA declares the PDP completed
under section 515(f)(6)(B) of the FD&C
Act. Accordingly, the manufacturer of a
class III preamendments device may
comply with a call for PMAs by filing
a PMA or a notice of completion of a
PDP. In practice, however, the option of
filing a notice of completion of a PDP
has rarely been used. For simplicity,
although the PDP option remains
available to manufacturers in response
to a final order under section 515(b) of
the FD&C Act, this document will refer
only to the requirement for the filing
and obtaining approval of a PMA.
On July 9, 2012, Congress enacted the
Food and Drug Administration Safety
and Innovation Act (FDASIA). Section
608(b) of FDASIA (126 Stat. 1056)
amended section 515(b) of the FD&C
Act, changing the process for requiring
premarket approval for a
preamendments class III device from
rulemaking to an administrative order.
Section 515(b)(1) of the FD&C Act sets
forth the process for issuing a final
order. Specifically, prior to the issuance
of a final order requiring premarket
approval for a preamendments class III
device, the following must occur:
Publication of a proposed order in the
Federal Register, a meeting of a device
classification panel described in section
513(b) of the FD&C Act, and
consideration of comments to a public
docket.
In June 2013, FDA held a meeting of
a device classification panel described
in section 513(b) of the FD&C Act to
discuss the classification of multiple use
blood lancets for multiple patient use.
Although, to FDA’s knowledge, no
device is currently being marketed for
this use, one device has been cleared for
this use. As explained further in section
V.A of this document, this device
classification panel meeting discussed
whether multiple use blood lancets for
multiple patient use should be
reclassified into class III or remain in
class I, and the discussion included
whether PMAs should be required for
these devices. The panel recommended
that, because multiple use blood lancets
for multiple patient use present a
potential unreasonable risk of illness or
injury and insufficient information
exists to establish special controls for
multiple use blood lancets for multiple
patient use, the device should be
reclassified into class III. FDA is not
aware of new information that would
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provide a basis for a different
recommendation or findings.
Section 515(b)(2) of the FD&C Act
provides that a proposed order to
require premarket approval shall
contain: (1) The proposed order, (2)
proposed findings with respect to the
degree of risk of illness or injury
designed to be eliminated or reduced by
requiring the device to have an
approved PMA and the benefit to the
public from the use of the device, (3) an
opportunity for the submission of
comments on the proposed order and
the proposed findings, and (4) an
opportunity to request a change in the
classification of the device based on
new information relevant to the
classification of the device.
Section 515(b)(3) of the FD&C Act
provides that FDA shall, after the close
of the comment period on the proposed
order, consideration of any comments
received, and a meeting of a device
classification panel described in section
513(b) of the FD&C Act, issue a final
order to require premarket approval or
publish a document terminating the
proceeding together with the reasons for
such termination. If FDA terminates the
proceeding, FDA is required to initiate
reclassification of the device under
section 513(e) of the FD&C Act, unless
the reason for termination is that the
device is a banned device under section
516 of the FD&C Act (21 U.S.C. 360f).
A preamendments class III device
may be commercially distributed
without a PMA until 90 days after FDA
issues a final order requiring premarket
approval for the device, or 30 months
after final classification of the device
under section 513 of the FD&C Act
becomes effective, whichever is later
(section 501(f) of the FD&C Act (21
U.S.C. 351(f)). Elsewhere in this issue of
the Federal Register, FDA is issuing a
proposed order to reclassify multiple
use blood lancets for multiple patient
use from class I to class III. Therefore,
assuming both the reclassification order
and the order to require PMAs are
finalized at the same time, the date by
which a PMA for multiple use blood
lancets for multiple patient use must be
filed will be 30 months after the date
FDA issues the final order reclassifying
multiple use blood lancets for multiple
patients. If a PMA is not filed for such
device by the later of the two dates, as
specified in section 501(f)(2)(B) of the
FD&C Act, then the device would be
deemed adulterated under section 501(f)
of the FD&C Act unless the device is
distributed for investigational use under
an approved application for an
investigational device exemption (IDE).
In accordance with section 515(b) of
the FD&C Act, interested persons are
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11153
being offered the opportunity to request
reclassification of multiple use blood
lancets for multiple patient use.
II. Regulatory History of the Device
Elsewhere in this issue of the Federal
Register, FDA is proposing to reclassify
multiple use blood lancets for multiple
patient use into class III under section
513(e) of the FD&C Act.
Blood lancets were classified in part
878 (21 CFR part 878) by a final rule
published in the Federal Register on
June 24, 1988 (53 FR 23856) that
classified 51 general and plastic surgery
devices. This 1988 rule classified blood
lancets into class I (general controls).
These devices were grouped with other
devices under ‘‘Manual surgical
instrument for general use,’’ 21 CFR
878.4800. At the time, blood lancets had
been in common use in medical practice
for many years, and FDA believed that
general controls were sufficient to
provide reasonable assurance of the
safety and effectiveness of those
devices. This rule was amended on
April 5, 1989 (54 FR 13826) to clarify
that manual surgical instruments for
general use made of the same materials
as used in preamendment devices were
exempt from premarket notification
510(k) review.
On December 7, 1994, FDA further
amended the classification when it
published a final rule in the Federal
Register (59 FR 63005) that exempted
148 class I devices from premarket
notification, with limitations. Blood
lancets were one of those devices. FDA
determined that manufacturers’
submissions of premarket notifications
were unnecessary for the protection of
the public health and that FDA’s review
of such submissions would not advance
its public health mission.
On August 26, 2010, FDA and the
Centers for Disease Control and
Prevention (CDC) issued joint initial
communications warning that the use of
fingerstick devices (blood lancets) to
obtain blood from more than one patient
posed a risk of transmitting bloodborne
pathogens. The communication was
updated on November 29, 2010 (Ref. 1).
FDA’s communication update, ‘‘Use of
Fingerstick Devices on More Than One
Person Poses Risk for Transmitting
Bloodborne Pathogens: Initial
Communication: Update 11/29/2010’’,
stated that ‘‘[o]ver the past 10–15 years,
the CDC and the FDA have noted a
progressive increase in reports of
bloodborne infection transmission
(primarily hepatitis B virus) resulting
from the shared use of fingerstick and
POC [or ‘Point of Care’] blood testing
devices.’’ FDA and CDC recommended,
among other things, that health care
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professionals and patients never use a
blood lancet for more than one person.
On November 29, 2010, FDA
published a guidance entitled
‘‘Guidance for Industry and Food and
Drug Administration Staff; Blood Lancet
Labeling’’ (75 FR 73107) (Ref. 2). This
guidance includes labeling
recommendations to address concerns
that both health care providers and
patients may be unaware of the serious
adverse health risks associated with
using the same blood lancet for assisted
withdrawal of blood from more than one
patient, even when the blood lancet
blade is changed for each blood draw.
FDA recommends in the guidance that
all blood lancets be labeled for use only
on a single patient. FDA recommends in
the guidance that a statement limiting
use to a single patient should also
appear on the label attached to the
device, if possible. The guidance was for
immediate implementation. When final,
this order will supersede this labeling
guidance.
On June 26, 2013, FDA held a meeting
of the General and Plastic Surgery
Devices Panel of the Medical Devices
Advisory Committee (the Panel) to
discuss the potential reclassification of
blood lancets (Ref. 3). The Panel
discussed new scientific information,
the risks to health from blood lancets,
whether blood lancets should be
reclassified or remain in class I, and
possible special controls for these
devices if reclassified into class II. The
Panel agreed that general controls were
not sufficient to provide a reasonable
assurance of safety and effectiveness of
blood lancets. The Panel believed that
because multiple use blood lancets for
multiple patient use presented a
potential unreasonable risk of illness or
injury, and insufficient information
existed to establish special controls for
these devices, they should be
reclassified into class III. The Panel
recommended that all other blood lancet
devices be reclassified into class II
(special controls). FDA is not aware of
new information since this Panel
meeting that would provide a basis for
a different recommendation or finding.
III. Dates New Requirements Apply
Assuming FDA finalizes the order
proposing reclassification of multiple
use blood lancets for multiple patient
use found elsewhere in this issue of the
Federal Register, this device will be
classified into class III. In accordance
with sections 501(f)(2)(B) and 515(b) of
the FD&C Act, FDA is proposing to
require that a PMA be filed with the
Agency for multiple use blood lancets
for multiple patient use devices and
accessories by the last day of the 30th
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calendar month beginning after the
month in which the classification of the
device in class III became effective, or
on the 90th day after the date of the
issuance of a final order under 515(b),
whichever is later. Assuming this order
is finalized at or near the same time the
final order to reclassify these devices
into class III, this requirement will take
effect 30 months after the
reclassification order issues. An
applicant whose device was legally in
commercial distribution before May 28,
1976, or whose device has been found
to be substantially equivalent to such a
device, will be permitted to continue
marketing such class III devices during
FDA’s review of the PMA provided that
a PMA is timely filed. FDA intends to
review any PMA for the device within
180 days. FDA cautions that under
section 515(d)(1)(B)(i) of the FD&C Act,
the Agency may not enter into an
agreement to extend the review period
for a PMA beyond 180 days unless the
Agency finds that ‘‘. . . the continued
availability of the device is necessary for
the public health.’’
Under the FD&C Act, if any multiple
use blood lancets for multiple patient
use are currently in distribution and no
PMA is submitted for these devices by
the last day of the 30th calendar month
beginning after the month in which the
classification of the device in class III
became effective or within 90 days of a
final order calling for PMAs, or a denial
is rendered on a filed PMA, these
devices would be considered
adulterated under section 501(f)(1) of
the FD&C Act. In addition, no new
devices will be permitted in interstate
commerce without approval of a PMA.
The device may be distributed for
investigational use only if the
requirements of the IDE regulations are
met. The requirements for significant
risk devices include submitting an IDE
application to FDA for review and
approval. An approved IDE is required
to be in effect before an investigation of
the device may be initiated or continued
under § 812.30 (21 CFR 812.30). FDA,
therefore, recommends that IDE
applications be submitted to FDA at
least 30 days before the end of the 30month period after the issuance of the
final order to avoid interrupting any
ongoing investigations.
FDA intends that under § 812.2(d), the
publication in the Federal Register of
any final order based on this proposal
will include a statement that, as of the
date on which the filing of a PMA is
required, the exemptions in § 812.2(c)(1)
and (2) from the requirements of the IDE
regulations for preamendments class III
devices will cease to apply to any
device that is: (1) Not legally on the
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market on or before that date, or (2)
legally on the market on or before that
date but for which a PMA is not filed
by that date, or for which PMA approval
has been denied or withdrawn.
IV. Device Subject to This Proposal
Multiple Use Blood Lancet for Multiple
Patient Use (21 CFR 878.4850(d))
Elsewhere in this issue of the Federal
Register, FDA is proposing to identify
multiple use blood lancet for multiple
patient use in a new 21 CFR 878.4850(d)
in the following way: A multiple use
capable blood lancet intended for use on
multiple patients that is comprised of a
single use blade attached to a solid,
reusable base that is used to puncture
the skin to obtain a drop of blood for
diagnostic purposes.
V. Proposed Findings With Respect to
Risks and Benefits Multiple Use Blood
Lancet for Multiple Patient Use
As required by section 515(b) of the
FD&C Act, FDA is publishing its
proposed findings regarding: (1) The
degree of risk of illness or injury
designed to be eliminated or reduced by
requiring that this device have an
approved PMA, and (2) the benefits to
the public from the use of the device.
These findings are based on the
reports and recommendations of the
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee (the Panel) from the meeting
on June 26, 2013 (Ref. 3) and any
additional information that FDA has
obtained. Additional information
regarding the risks as well as
classification associated with this
device type can be found in section V.C
as well as in the proposed order
published elsewhere in this issue of the
Federal Register proposing to reclassify
these devices into class III. The device
has the potential to benefit the public by
puncturing the skin to obtain small
blood specimens for testing blood
glucose, hemoglobin, and other blood
components. In addition, acute care
hospitals may consider reusing a single
device or using one device with
multiple blades to have benefits in that
doing so may expedite procedures. The
risks associated with the device include
bloodborne pathogen transmission,
sharp object injuries, local tissue
infections, and adverse tissue reaction
(not infection).
A. Summary of Data
FDA uses the bloodborne pathogens
definition in 29 CFR 1910.1030(b).
Bloodborne pathogens, such as HBV,
may be transmitted between patients by
blood and certain body fluids (Ref. 4).
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Since HBV-infected patients, who often
lack clinical symptoms of hepatitis,
have high concentrations of HBV in
their blood and HBV is stable at ambient
temperatures, transmission of HBV may
result from exposure to equipment that
has not been adequately disinfected or
by the misuse of ‘‘single use only’’
medical devices (e.g., needles and
syringes) (Ref. 5).
The history of recognized bloodborne
pathogen transmission by blood lancets
may have started in 1923 when an
outbreak of jaundice occurred in the
Goteborg Hospital diabetic clinic in
Sweden, which was described by
Schmid et al. (Ref. 6). All patients had
blood drawn for glucose testing from
their ear lobes by a spring-activated
‘‘Schnepper’’ device, which was cleaned
‘‘perfunctorily’’ between uses. As a
result, 26 clinic patients developed
jaundice. Outbreaks of hepatitis in
English diabetic patients were described
by Graham in 1938 (Ref. 7) and by
Droller in 1945 (Ref. 8). In both of these
outbreaks, venous blood for glucose
measurement was drawn using syringes
that were only chemically disinfected
between uses while the needles were
boiled; cleaning procedures were not
mentioned in the reports. Syringes and
needles are now single-use-only devices
because the procedures used to
reprocess these devices many years ago
have long been recognized to be
inadequate, resulting in outbreaks of
hepatitis transmission (Ref. 6). There
were also two case reports, in 1985 and
1997, of the transmission of HBV
infection due to sharing personal use
blood lancets for home glucose
monitoring with one other person who
already had HBV. One report was from
the United States and one was from
Hungary (Refs. 9 and 10). In addition,
Mendez et al. reported a 75-year-old
patient with diabetes who died of acute
hepatitis, whose only risk factor for
HBV infection appeared to be her
diabetic care at a local outpatient
facility where she had repeated
fingersticks for blood glucose
monitoring (Ref. 11).
During the 1990s, several bloodborne
transmission issues led to CDC and FDA
involvement. In 1990, CDC learned of a
nosocomial outbreak of HBV
transmission due to the use of a springloaded lancet device whose disposable
platform was not removed and
discarded after each use of the device
while it was used for the care of
multiple patients (Ref. 12).1 CDC
1 Hepatitis B and hepatitis C infections, as well
as other bloodborne infections such as HIV
infection, are reported to State health departments
and, by them, to CDC; FDA does not usually receive
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reported this outbreak to FDA; FDA
then issued a safety alert warning users
of the precautions needed for the safe
use of this device (Ref. 13). This was the
first reported outbreak of HBV
transmission associated with the use of
a blood lancet device in the United
States (Refs. 13 and 14).
CDC’s outbreak investigation revealed
that a patient who had diabetes and also
a chronic HBV infection caused by a
relatively rare viral subtype was
admitted to the outbreak ward in 1989.
Twelve of the 23 patients who acquired
hepatitis B after admission to the same
ward as the chronic HBV source patient
were serotyped, and all were found to
have the same viral subtype causing
their hepatitis B infections. The first
nosocomially infected patient had a
very long-term stay on the ward and so
served as a source of transmission to
other patients over a period of 12
months. Twenty of the 23 outbreak
patients had diabetes; they and the three
other case-patients all experienced
numerous POC fingerstick blood draws
with the same type of blood lancet
while hospitalized on the outbreak
ward. The implicated blood lancet
device included a disposable platform
to stabilize the patient’s finger; the
single use lancet blade penetrated a hole
in that platform to reach the patient’s
skin. Half the ward nursing staff who
performed fingersticks with this lancet
acknowledged not changing the device
platform with each use of the lancet. A
similar outbreak of hepatitis
transmission was reported in 1990 in
France in which a similar blood lancet
device was implicated. Douvin et al.
(Ref. 15) reported that examination of
the device implicated in the French
outbreak showed visible blood
contamination of the lancet platform in
24 percent of studied uses of that
device. Shier et al. (Ref. 16) reported in
1993 that the use of another springloaded lancet device in a volunteer
study of blood glucose levels resulted in
visible blood contamination on 29
percent of the device end caps. This
device was intended for ‘‘personal’’ use
only.
As a result of the 1990 outbreak of
HBV transmission due to blood lancet
use in the United States, FDA and CDC
recommended that spring-loaded blood
lancet devices should have only single
use only ‘‘platforms’’ as well as single
use only blades; the devices were to be
cleaned and disinfected per the
manufacturer’s instructions (Refs. 12
and 13). The 1990 FDA Safety Alert also
such reports directly from health care facilities or
personnel, even when a medical device has
transmitted the infection.
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advised ‘‘Devices (blood lancets)
without a removable platform should
only be used with one patient in the
hospital or outpatient setting. After the
patient is discharged, the device may be
reused only if it is disinfected according
to the manufacturer’s instructions. If
there are no instructions for
disinfection, the device should be
discarded.’’
Since 1990, the incidence of diabetes
mellitus has increased significantly in
the United States, especially in adults
aged 65–79 (Refs. 17 and 18). At the
same time, clinical practice in the care
of these patients increasingly
emphasized the need for improved
blood glucose level control, resulting in
the increased use of POC blood glucose
monitoring both in health care facilities
and at home (Refs. 19–21).
Unfortunately, along with the increased
incidence of diabetes has come a
progressive increase in the reports of
bloodborne infection transmission
(primarily HBV), resulting from the
shared use of fingerstick and POC blood
testing devices (Ref. 1). In 2011, the CDC
reported that 25 of 29 outbreaks of HBV
infection occurring in long-term care
facilities since 1996 involved adults
with diabetes receiving blood glucose
monitoring (Ref. 22).
In 1997, CDC reported two outbreaks
of HBV transmission, one in a nursing
home in Ohio and one in a hospital in
New York City (NYC) (Ref. 23). Two
different blood lancet devices were used
at the two sites. However, both lancet
devices included the use of an ‘‘end
cap’’ that came in contact with patient
skin. This was a separate, individual use
component of the lancet device used in
Ohio; the nursing home was reusing
both the lancet and the cap for multiple
patients. The end cap was a part of the
disposable, single use only lancet blade
assembly in the device used in NYC.
The exact mechanism of blood
transmission was not entirely clear in
the NYC setting; staff claimed they had
discarded the end cap after each use.
CDC postulated that either bloodcontaminated nurses gloves worn for the
care of multiple patients or the pen-like
lancet-holding device itself might have
been the source of the blood crosscontamination of the lancet. A similar
outbreak was reported by Quale et al. in
1998 from a hospital in New York (Ref.
24). The recognition of 3 cases of
nosocomially acquired HBV infection
resulted in an investigation that
uncovered another 11 cases. Reuse by
hospital staff of a disposable lancet end
cap with the lancet in multiple patients
was identified as the probable cause of
hepatitis cross-transmission to patients;
contamination of the lancet wound from
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blood on unchanged gloves worn by
nurses during collection of blood
samples from multiple patients may also
have contributed to the nosocomial
transmission of HBV in this outbreak.
CDC reviewed the incidence of
reported outbreaks of HBV and hepatitis
C infection in nonhospital health care
settings between 1998 and 2008 and
noted a significant increase in such
nosocomial transmission of bloodborne
pathogens (Refs. 25–28). N.D.
Thompson et al. identified 33 outbreaks
of nosocomial hepatitis transmission in
nonhospital health care settings (Ref.
25). Of these 33 outbreaks, 15 were
found to be due to blood glucose
monitoring in long-term care and
assisted living facilities. Only half of
these outbreak investigations were
published in the scientific literature; the
others were recognized by health
department investigations and reports to
CDC. In 9 of the 15 outbreaks of
nosocomial hepatitis in patients with
diabetes, blood lancet devices were
shared among multiple patients. In two
additional outbreaks, lancets were not
noted to be shared, but blood-soiled
glucose meters were stored together
with lancets without cleaning/
disinfection of the devices and gloves
were not regularly changed between
each patient. These failures of proper
infection control practice could have led
to blood contamination of individual
blood lancets in these two facilities.
N.D. Thompson et al. also
investigated blood glucose monitoring
practices in long-term care facilities in
Pinellas County, Florida, in 2007 and
found that 22 percent of the
participating facilities that used
reusable fingerstick devices used them
in multiple patients (Ref. 29). Patel et al.
reported in 2009 on the efforts of the
Virginia Department of Health to
improve blood glucose monitoring
practices in assisted living facilities
(ALFs) in Virginia (Ref. 30). This effort
followed two separate outbreaks of HBV
infections in two assisted living
facilities. In those outbreaks, one of the
three acutely symptomatic initial
patients died of HBV infection. Of 68
patients undergoing blood glucose
monitoring in these two facilities, a total
of 11 patients acquired HBV infection.
Both facilities used reusable blood
lancets to obtain blood from multiple
patients and did not clean or disinfect
the lancets between uses. The Virginia
Department of Health then mailed an
educational packet on safe blood
glucose monitoring practices to all ALFs
(640) in the State. A random sample of
ALFs was contacted after the
educational intervention and invited to
participate in a survey to evaluate the
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response to the educational packet. The
results found that 16 percent of the
facilities that used lancets to monitor
blood glucose levels were still using
these devices to obtain blood from
multiple patients.
Y.G. McIntosh et al. investigated
outbreaks of nosocomial HBV
transmission in four ALFs between 2009
and 2011 and found that in all four
facilities, pen-style lancets were used to
obtain blood for glucose monitoring
from multiple patients even though two
facilities provided each patient with
dedicated ‘‘single patient use only penstyle lancets’’ according to their policies
(Ref. 31). Z. Moore et al. reported
another outbreak of nosocomial HBV
transmission in an ALF in NC in 2010
in which blood lancet devices were
shared among multiple patients. Six of
the eight elderly patients who acquired
acute HBV in this outbreak died from
complications of hepatitis (Ref. 32).
M.K. Schaefer et al. surveyed a
stratified, random sample of ambulatory
surgery centers (ACS) in three volunteer
states in 2009 (Ref. 33). Of the 53 ACS
that performed blood glucose
monitoring, 11 (21 percent) reused penstyle blood lancets on multiple patients
and 17 (32 percent) also failed to clean
and disinfect blood glucose meters after
each use.
Thompson and Schaefer reported the
analysis of four outbreaks of nosocomial
HBV in ALFs in 2009–2010 (Ref. 34).
One was also reported separately by Z.
Moore et al. (Ref. 32). Two of the three
other outbreaks occurred in Virginia and
one in Florida; these 3 outbreaks
resulted in 21 new patients acquiring
acute hepatitis B. In two of the three
facilities, use of reusable blood lancets
to draw blood from multiple patients
was observed or reported. The third
facility denied that it permitted the
sharing of reusable lancets. However,
used lancets and glucose meters were
stored together, along with clean
supplies; visible blood contamination
was observed on several glucose meters
and one reusable lancet by the
investigator. Thompson and Schaefer
also reported in their paper on two
patient notification campaigns resulting
from the misuse of reusable blood
lancets with preloaded lancet cartridges,
intended and cleared only for single
patient use, which were used to obtain
blood from multiple patients. One
episode involved a community health
center and was reported when
personnel noted that the lancet blades
were not retracting properly, which
might have resulted in blade use for
more than one patient. The second
episode occurred at a community health
fair in which physician assistant
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students were offering diabetes
screening. During the fair, the students
realized that the lancet blades had not
been advanced properly so that each
patient received a new blade. The first
episode exposed 283 patients to a
contaminated lancet blade; the second
incident exposed approximately 60
patients. The results of the patient
notification studies were not reported.
As a result of this significant increase
in such nosocomial transmission of
bloodborne pathogens, on August 26,
2010, FDA and the CDC issued a Safety
Communication (Ref. 1) and a Clinical
Reminder (Ref. 35), respectively,
warning that the use of blood lancets to
obtain blood from more than one patient
risks the transmission of bloodborne
pathogen infections from one patient to
other patients. Both FDA and CDC
recommended that blood lancets should
never be used to obtain blood from more
than one patient. In addition, the
Centers for Medicare and Medicaid
Services issued a Survey and
Certification Memorandum for Point of
Care Devices and Infection Control in
Nursing Homes identifying the use of
blood lancet devices for more than one
patient as an infection control standards
deficiency (Ref. 36). On November 29,
2010, FDA issued ‘‘Guidance for
Industry and Food and Drug
Administration Staff: Blood Lancet
Labeling’’, which provided guidance for
lancet manufacturers on the labeling of
all blood lancets, including those
capable of reuse, as ‘‘single patient use
only’’ devices (Ref. 2).
In 2012, another outbreak of acute
HBV was reported in an ALF in Virginia
(Ref. 37). The source patient had been
recently transferred from another ALF
where she had acquired nosocomial
HBV infection from the shared use of
blood lancets for multiple patients (Ref.
31). This ALF also reused blood lancets
to obtain blood from multiple patients
for glucose monitoring. This dangerous
practice resulted in two new nosocomial
HBV infections in this ALF.
Outbreaks of hepatitis transmission
due to use of blood lancets to draw
blood from more than one patient for
blood glucose monitoring have not been
limited to the United States. In 2001,
Desenclos et al. described an outbreak of
nosocomial hepatitis C transmission in
an inpatient ward for children with
cystic fibrosis and diabetes in a French
hospital in 1994–1995 (Ref. 38). Blood
glucose monitoring was done by the
nursing staff for the patients with cystic
fibrosis as well as for the patients with
diabetes using a spring-loaded lancet
with a disposable platform to stabilize
the finger. These devices were shared
among patients between 1986 and 1992
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during repeated admissions to the
inpatient unit. After 1992, patients were
supposed to use only their own lancet
devices for blood glucose monitoring.
The retrospective prevalence of prior
hepatitis C infection was found to be 58
percent in patients with cystic fibrosis
and 17 percent in patients with diabetes
in 1994. At the time (1994), the
prevalence of antibody to hepatitis C in
the general public in France was 1.1
percent. The patients with cystic
fibrosis had more frequent and longer
admissions to the inpatient ward, and
more of the exposed cystic fibrosis
patients (66.7 percent) were screened for
hepatitis C infection than were the
patients with diabetes admitted to the
inpatient ward during the exposure
period (39.5 percent). These factors may
have influenced the apparent difference
in hepatitis C transmission in these two
groups of exposed patients.
In 2005, De Schrijver et al. described
an outbreak of acute HBV infection in a
nursing home in Antwerp (Ref. 39). The
initial report of a fulminant case of
acute HBV infection in an 83-year-old
resident of the home resulted in an
investigation that identified acute
hepatitis B infection in another four
patients there. Four of the five acutely
infected patients had diabetes and
received assisted blood glucose
sampling by the nursing home staff. The
two blood lancet models used in the
facility (one each in two sections) were
used to obtain blood from multiple
patients. The device platforms were not
disposable. The lancets were washed
only when blood was visible on the
device and were not disinfected. Nurses
did not routinely wash their hands or
wear gloves when obtaining blood. Two
of the five patients with acute
nosocomial hepatitis B died of their
infections.
In 2008, Gotz et al. reported the
investigation of two cases of acute HBV
infection among patients at a nursing
home in the Netherlands (Ref. 40). The
nursing home stay of these two patients
overlapped with that of a patient with
known chronic HBV infection. Early in
this time period, the nursing home
changed the lancet device used for
glucose monitoring from a spring-loaded
device with a disposable platform (used
for multiple patients) to a device with
a rotating drum dispensing new lancet
blades, which was also used to draw
blood from multiple patients, although
it was labeled for single patient use
only. This device was used for about a
month until the staff realized that active
rotation of the drum was occasionally
forgotten, resulting in the reuse of a
lancet blade on more than 1 patient. The
new device was then removed from the
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facility and the spring-loaded lancet was
returned to use. The two patients with
acute HBV received blood glucose
monitoring as did the source patient
with chronic HBV, sometimes on the
same day. Two other patients who also
received blood glucose monitoring
escaped infection. The investigators
stated that they believed the rotating
lancet drum device was likely the
means of transmission of HBV infection
between patients.
In 2011, Duffell et al. reported on the
investigations of five reports of HBV
transmission in community health care
settings in the United Kingdom (Ref. 4).
All of the nine initially reported
patients with HBV had diabetes and
were receiving blood glucose
monitoring. Further investigation
identified another 12 patients with
acute HBV infection. The care settings
in which hepatitis transmission
occurred were described as a ‘‘private
residential home’’ (1 patient), nursing
and residential home (1 patient),
‘‘private nursing and residential’’ (1
patient) and ‘‘local care home’’ (2
patients). Eleven of the 21 acutely
infected patients had symptomatic HBV;
seven of these patients died, five due to
the HBV infection. All of the care sites
in which acute HBV transmission
occurred were using blood lancets
designed intended for single patient use
only; these devices were either routinely
or occasionally used for multiple
patients. One facility also used a single
glucometer for multiple patients and did
not clean or disinfect it between
patients. The authors also noted that
information reported on patients found
to have acute HBV infection between
1990 and 2003 identified only four
patients with blood glucose monitoring
as a possible risk factor; one of these
patients was infected as a result of inhospital transmission from another
patient on the same ward, although
details were not provided. Between
2004 and 2006, the 9 patients described
previously in this document were
reported and investigation led to the
discovery of an additional 12 cases of
health care-related HBV transmission
due to the improper use of blood lancets
during patient blood glucose
monitoring.
B. Benefits of the Device
A blood lancet is used to puncture the
skin to obtain small blood specimens for
testing blood glucose, hemoglobin, and
other blood components. Some blood
lancets are used with POC blood testing
devices, such as blood glucose meters
and Prothrombin Time and
International Normalized Ratio (PT/INR)
anticoagulation meters. Today, probably
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the most common use for a blood lancet
is in diabetes monitoring. These devices
are used in both home and professional
health care settings. Only a small blood
sample is needed for testing of blood
glucose level. The blood sample is
dropped onto a test strip and inserted
into a blood glucose meter for results.
Some blood lancets are also used with
PT/INR anticoagulation meters. These
devices are used in both home and
professional health care settings. The PT
and INR are used to monitor the
effectiveness of the anticoagulant
warfarin. Warfarin helps inhibit the
formation of blood clots. The formation
of blood clots may be associated with
atrial fibrillation, the presence of
artificial heart valves, deep venous
thrombosis, and some cases of
pulmonary embolism. Because the use
of warfarin may cause excessive
bleeding, patients are monitored,
typically by PT/INR.
Because newborns have relatively
small amounts of blood compared to
adults, it is usually preferred to use as
small amount of blood as possible for
any screening or other laboratory tests
for newborns. Blood lancets may be
used to perform heel sticks in newborns.
Heel stick is a minimally invasive way
of obtaining capillary blood samples. In
newborns, heel sticks are the preferred
collection method for small volumes of
blood.
The possible benefit of multiple use
blood lancets for multiple patient use is
that acute care hospitals may consider
reusing a single device or using one
device with multiple blades to have
benefits, in that doing so may expedite
procedures.
C. Risks to Health
FDA has evaluated the risks to health
associated with use of multiple use
blood lancets for multiple patient use.
In doing so, FDA considered
information from the reports and
recommendations of the General and
Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee
from the meeting of June 26, 2013, the
adverse event reports for these devices
in FDA’s Manufacturer and User
Facility Device Experience (MAUDE)
database, and the published scientific
literature, which is discussed in FDA’s
executive summary for the June 26,
2013, panel. Based on this information,
FDA has determined the following risks:
1. Bloodborne Pathogen Transmission
Bloodborne pathogens such as HBV,
hepatitis C virus, and potentially any
other pathogen present in the
bloodstream of a patient can be
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transmitted from one patient to another
by the following mechanisms:
• Reuse of the same lancet blade to
draw blood from more than one patient
or
• Failure/inability to adequately
clean the base of a multiple use blood
lancet resulting in the blood
contamination of the next ‘‘new’’ lancet
blade when blood is drawn from more
than one patient.
2. Sharp Object Injuries
The blade of a lancet device is
designed to pierce the skin and draw
blood. Except when the used lancet
blade is immediately and automatically
covered by a sharps safety feature,
which renders the blade inaccessible,
the exposed sharp blade of a blood
lancet presents a puncture hazard to
anyone coming in contact with it. Blade
exposure can result due to either the
lack of a sharps safety feature or device
breakage.
3. Local Tissue Infections
Human skin always carries a
population of bacteria and often fungi
(normal skin flora), which causes no
problem for the host when skin is intact.
However, puncture injuries to the skin
by sharp objects such as lancet blades
can carry these microbes into the
normally sterile tissue below the skin.
Such injuries have the potential to cause
local skin/soft tissue infections.
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4. Adverse Tissue Reaction (Not
Infection)
Skin contact with some materials,
metals and material colorants can cause
skin inflammation, irritation or
exanthems (rashes). These reactions
may be due to either hypersensitivity to
a specific compound/metal or to a nonspecific reaction.
D. Summary of FDA Findings
FDA believes multiple use blood
lancets for multiple patient use should
be reclassified from class I to class III.
The Panel held on June 26, 2013,
discussed and made recommendations
regarding the regulatory classification of
blood lancets to reclassify multiple use
blood lancets for multiple patient use to
class III under 513(e) of the FD&C Act.
The Panel strongly agreed with FDA
that based on the available scientific
evidence, multiple use blood lancets for
multiple patient use should be
reclassified to class III because multiple
use blood lancets for multiple patient
use present a potential unreasonable
risk of illness or injury. They also
agreed that insufficient information
exists to establish special controls for
multiple use blood lancets for multiple
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patient use, because there is no
evidence that these devices can be
adequately cleaned and disinfected and
that there is no proven method of doing
so. Therefore, it is appropriate to
regulate them in class III.
FDA agrees with the Panel’s
recommendation that these devices
present a potential unreasonable risk of
illness or injury due to the inherent and
significantly increased risk of
bloodborne pathogen transmission risk
as compared to single use only or single
patient only blood lancets. FDA does
not believe existing valid scientific
evidence, as defined in § 860.7 (21 CFR
860.7), supports a reasonable assurance
that the device can be adequately
reprocessed between uses on different
patients. FDA also believes sufficient
information does not exist to establish
special controls for blood lancets
intended for multiple patient use. Given
the availability of safer single patient
use blood lancet devices, FDA further
believes that the probable benefits to
health from use of the device do not
outweigh the probable risks. Currently
FDA is unaware of technology or other
controls that would adequately mitigate
against the inherent and significantly
increased risk of blood borne pathogen
transmission in multiple use blood
lancets for use in multiple patients.
Therefore, the safety and effectiveness
of the multiple use blood lancets for
multiple patients, particularly the
effectiveness of their reprocessing
instructions/methods to render the
device safe for use on more than one
patient and the ability of health care
providers to follow these instructions
completely should be independently
demonstrated for each device of this
type via a PMA application. FDA is
proposing to require an individual
demonstration that a reasonable
assurance of safety and effectiveness
exists for each device within this type.
The manufacturer of each individual
device will have the opportunity to
demonstrate the safety and effectiveness
of the device for its intended use by
submitting a PMA.
document; (2) the effectiveness of the
device that is the subject of the
application; and (3) full reports of all
preclinical and clinical information
from investigations on the safety and
effectiveness of the device for which
premarket approval is sought.
A PMA must include valid scientific
evidence to demonstrate reasonable
assurance of the safety and effectiveness
of the device for its intended use
(§ 860.7(c)(2)). FDA defines valid
scientific evidence in § 860.7(c)(2)).
To present reasonable assurance of
safety and effectiveness of multiple use
blood lancets for multiple patient use,
FDA believes manufacturers should
submit performance testing, including
clinical trials of their device, in order to
support PMA approval. Existing
published clinical literature may also be
leveraged as part of the PMA
submission.
VI. PMA Requirements
A PMA for this device must include
the information required by section
515(c)(1) of the FD&C Act. Such a PMA
should also include a detailed
discussion of the risks identified
previously in this document, as well as
a discussion of the effectiveness of the
device for which premarket approval is
sought. In addition, a PMA must
include all data and information on: (1)
Any risks known, or that should be
reasonably known, to the applicant that
have not been identified in this
IX. Paperwork Reduction Act of 1995
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VII. Opportunity To Request a Change
in Classification
Before requiring the filing of a PMA,
FDA is required by section 515(b)(2)(D)
of the FD&C Act to provide an
opportunity for interested persons to
request a change in the classification of
the device based on new information
relevant to the classification. Any
proceeding to reclassify the device will
be under the authority of section 513(e)
of the FD&C Act.
A request for a change in the
classification of this device is to be in
the form of a reclassification petition
containing the information required by
21 CFR 860.123, including new
information relevant to the classification
of the device.
VIII. Analysis of Environmental Impact
We have determined under 21 CFR
25.34(b) that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
This proposed order refers to
collections of information that are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 814,
subparts B and E, have been approved
under OMB control number 0910–0231.
The collections of information in part
807, subpart E, have been approved
under OMB control number 0910–0120.
The collections of information under 21
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Federal Register / Vol. 81, No. 42 / Thursday, March 3, 2016 / Proposed Rules
CFR part 801 have been approved under
OMB control number 0910–0485.
X. Proposed Effective Date
FDA is proposing that any final order
based on this proposal become effective
on the date of its publication in the
Federal Register or at a later date if
stated in the final order.
XI. Codification of Orders
Prior to the amendments by FDASIA,
section 515(b) of the FD&C Act provided
for FDA to issue regulations to require
approval of an application for premarket
approval for preamendments devices or
devices found substantially equivalent
to preamendments devices. Section
515(b) of the FD&C Act, as amended by
FDASIA, provides for FDA to require
approval of an application for premarket
approval for such devices by issuing a
final order, following the issuance of a
proposed order in the Federal Register.
FDA will continue to codify the
requirement for an application for
premarket approval, resulting from
changes issued in a final order, in the
Code of Federal Regulations (CFR).
Therefore, under section 515(b)(1)(A) of
the FD&C Act, as amended by FDASIA,
in the proposed order, we are proposing
to require approval of an application for
premarket approval for multiple use
blood lancets for multiple patient use
and, if this proposed order is finalized,
we will make the language in 21 CFR
878.4850(d) consistent with the final
version of this proposed order.
XII. References
mstockstill on DSK4VPTVN1PROD with PROPOSALS
The following references are on
display in the Division of Dockets
Management (see ADDRESSES) and are
available for viewing by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday; they are also
available electronically at https://
www.regulations.gov. FDA has verified
the Web site addresses, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
1. U.S. Food and Drug Administration (FDA),
‘‘Use of Fingerstick Devices on More
Than One Person Poses Risk for
Transmitting Bloodborne Pathogens:
Initial Communication’’ (August 26,
2010) and ‘‘Update’’ (November 29,
2010), available at https://www.fda.gov/
MedicalDevices/Safety/Alertsand
Notices/ucm234889.htm and https://
www.fda.gov/MedicalDevices/Safety/
AlertsandNotices/ucm224025.htm.
2. U.S. Food and Drug Administration,
‘‘Guidance for Industry and Food and
Drug Administration Staff: Blood Lancet
Labeling’’ (November 29, 2010), available
at https://www.fda.gov/MedicalDevices/
VerDate Sep<11>2014
17:24 Mar 02, 2016
Jkt 238001
DeviceRegulationandGuidance/
GuidanceDocuments/ucm234577.htm.
3. FDA’s General and Plastic Surgery Devices
Panel transcript and other meeting
materials for the June 26, 2013, meeting,
available at https://www.fda.gov/Advisory
Committees/CommitteesMeeting
Materials/MedicalDevices/Medical
DevicesAdvisoryCommittee/Generaland
PlasticSurgeryDevicesPanel/
ucm349426.htm.
4. Duffell, E.F., L.M. Milne, C. Seng, et al.,
‘‘Five Hepatitis B Outbreaks in Care
Homes in the UK Associated With
Deficiencies in Infection Control Practice
in Blood Glucose Monitoring’’,
Epidemiology and Infection, 2011;
139:327–335.
5. Williams, I.T., J.F. Perz, and B.P. Bell,
‘‘Viral Hepatitis Transmission in
Ambulatory Health Care Settings’’,
Clinical Infectious Diseases, 2004;
38(11):1592–1598.
6. Schmid, R., ‘‘History of Viral Hepatitis: A
Tale of Dogmas and Misinterpretations’’,
Journal of Gastroenterology and
Hepatology, 2001; 16(7):718–722.
7. Graham, G., ‘‘Diabetes Mellitus: A Survey
of Changes in Treatment During the Last
Fifteen Years’’, The Lancet, 1938; 2:1–7.
8. Droller, H., ‘‘An Outbreak of Hepatitis in
a Diabetic Clinic’’, British Medical
Journal, 1945; 1(4400):623–625.
9. Stapleton, J. and S. Lemon, ‘‘Transmission
of Hepatitis B During Blood Glucose
Monitoring’’, Journal of the American
Medical Association, 1985; 253:3250.
10. Farkas, K. and G. Jermendy,
‘‘Transmission of Hepatitis B Infection
During Home Blood Glucose
Monitoring’’, Diabetic Medicine, 1997;
14:263.
11. Mendez, L., K.R. Reddy, R.A. Di Prima,
et al., ‘‘Fulminant Hepatic Failure Due to
Acute Hepatitis B and Delta Co-Infection:
Probable Bloodborne Transmission
Associated With a Spring-Loaded
Fingerstick Device’’, American Journal of
Gastroenterology, 1991; 86:895–897.
12. Centers for Disease Control and
Prevention (CDC), ‘‘Nosocomial
Transmission of Hepatitis B Virus
Associated With a Spring-Loaded
Fingerstick Device—California’’, MMWR
Morbidity and Mortality Weekly Report,
1990; 39 (35):610–613. (Available at:
https://www.cdc.gov/mmwr/preview/
mmwrhtml/00001743.htm.)
13. Food and Drug Administration (FDA),
‘‘Safety Alert Medical Devices; Hepatitis
B Transmission via Spring-Loaded
Lancet Devices’’ (August 28, 1990),
available at https://www.fda.gov/Medical
Devices/Safety/AlertsandNotices/Public
HealthNotifications/ucm241809.htm.
14. Polish, L., C.N. Shapiro, F. Bauer, et al.,
‘‘Nosocomial Transmission of Hepatitis
B Virus Associated With the Use of a
Spring-Loaded Fingerstick Device’’, New
England Journal of Medicine, 1992;
326(11):721–725.
15. Douvin, C., D. Simon, H. Zinelabidine, et
al., ‘‘An Outbreak of Hepatitis B in an
Endocrinology Unit Traced to a
Capillary-Blood-Sampling Device’’, New
England Journal of Medicine, 1990;
322:57–58.
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11159
16. Shier, N., J. Warren, M. Torabi, et al.,
‘‘Contamination of a Fingerstick Device’’,
New England Journal of Medicine, 1993;
328:969–997.
17. Centers for Disease Control and
Prevention (CDC), ‘‘Increasing
Prevalence of Diagnosed Diabetes—
United States and Puerto Rico, 1995–
2010’’, MMWR Morbidity and Mortality
Weekly Report, 2012; 61(45):918–921.
(Available at: https://www.cdc.gov/
mmwr/preview/mmwrhtml/mm6145a4.
htm?s_cid=mm6145a4_w.)
18. Centers for Disease Control and
Prevention (CDC), ‘‘Incidence of
Diagnosed Diabetes per 1,000 Population
Aged 18–79 Years, by Age, 1980–2014’’,
Atlanta, GA: U.S. Department of Health
and Human Services, CDC, National
Diabetes Surveillance System. Available
at www.cdc.gov/diabetes/statistics/
incidence/fig3.htm. Accessed October
19, 2014.
19. Clarke, S.F. and J.R. Foster, ‘‘A History of
Blood Glucose Meters and Their Role in
Self-Monitoring of Diabetes Mellitus’’,
British Journal of Biomedical Science,
2012; 69(2):83–93.
20. Yoo, E.-H. and S.-Y. Lee, ‘‘Glucose
Biosensors: An Overview of Use in
Clinical Practice’’, Sensors, 2010;
10(5):4558–4576.
21. Rajendran, R. and G. Rayman, ‘‘Point-ofCare Blood Glucose Testing for Diabetes
Care in Hospitalized Patients: An
Evidence-Based Review’’, Journal of
Diabetes Science and Technology, 2014;
8(6):1081–1090.
22. Centers for Disease Control and
Prevention (CDC), ‘‘Use of Hepatitis B
Vaccination for Adults With Diabetes
Mellitus: Recommendations of the
Advisory Committee on Immunization
Practices (ACIP)’’, MMWR Morbidity and
Mortality Weekly Report, 2011;
60(50):1709–1711. (Available at: https://
www.cdc.gov/mmwr/preview/
mmwrhtml/mm6050a4.htm?s_cid=
mm6050a4_w.)
23. Centers for Disease Control and
Prevention (CDC), ‘‘Nosocomial Hepatitis
B Virus Infection Associated With
Reusable Fingerstick Blood Sampling
Devices—Ohio and New York City,
1996’’, MMWR Morbidity and Mortality
Weekly Report, 1997; 46(10):217–221.
(Available at: https://www.cdc.gov/
mmwr/preview/mmwrhtml/
00046679.htm.)
24. Quale, J.M., D. Landman, B. Wallace, et
´ `
al., ‘‘Deja vu: Nosocomial Hepatitis B
Transmission and Fingerstick
Monitoring’’, The American Journal of
Medicine, 1998; 105;296–301.
25. Thompson, N.D., J. Perz, A. Moorman, et
al., ‘‘Nonhospital Health Care-Associated
Hepatitis B and C Virus Transmission:
United States, 1998–2008’’, Annals of
Internal Medicine, 2009; 150: 33–39.
26. Khan, A.J., S.M. Cotter, B. Schulz, et al.,
‘‘Nosocomial Transmission of Hepatitis
B Virus Infection Among Residents With
Diabetes in a Skilled Nursing Facility’’,
Infection Control and Hospital
Epidemiology, 2002; 23:313–318.
27. Centers for Disease Control and
Prevention (CDC), ‘‘Transmission of
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Federal Register / Vol. 81, No. 42 / Thursday, March 3, 2016 / Proposed Rules
Hepatitis B Virus Among Persons
Undergoing Blood Glucose Monitoring in
Long-Term-Care Facilities—Mississippi,
North Carolina, and Los Angeles County,
California, 2003–2004’’, MMWR
Morbidity and Mortality Weekly Report,
2005; 54(09):220–223. (Available at:
https://www.cdc.gov/mmwr/preview/
mmwrhtml/mm5409a2.htm.)
28. Thompson, N.D. and J.F. Perz,
‘‘Eliminating the Blood: Ongoing
Outbreaks of Hepatitis B Virus Infection
and the Need for Innovative Glucose
Monitoring Technologies’’, Journal of
Diabetes Science and Technology, 2009;
3(2):283–288.
29. Thompson, N.D., V. Barry, K. Alelis, et
al., ‘‘Evaluation of the Potential for
Bloodborne Pathogen Transmission
Associated With Diabetes Care Practices
in Nursing Homes and Assisted Living
Facilities, Pinellas County’’, Journal of
the American Geriatrics Society, 2010;
58:914–918.
30. Patel, A.S., M.B. White-Comstock, D.
Woolard, et al., ‘‘Infection Control
Practices in Assisted Living Facilities: A
Response to Hepatitis B Virus Infection
Outbreaks’’, Infection Control and
Hospital Epidemiology, 2009; 30:209–
214.
31. Centers for Disease Control and
Prevention (CDC), ‘‘Multiple Outbreaks
of Hepatitis B Virus Infection Related to
Assisted Monitoring of Blood Glucose
Among Residents of Assisted Living
Facilities—Virginia, 2009–2011’’, MMWR
Morbidity and Mortality Weekly Report,
2012; 61(19):339–343. (Available at:
https://www.cdc.gov/mmwr/preview/
mmwrhtml/mm6119a3.htm?s_cid=
mm6119a3_w.)
32. Centers for Disease Control and
Prevention (CDC), ‘‘Notes From the
Field: Deaths From Acute Hepatitis B
Virus Infection Associated With Assisted
Blood Glucose Monitoring in an
Assisted-Living Facility—North
Carolina, August–October, 2010,’’
MMWR Morbidity and Mortality Weekly
Report, 2011; 60(6):182. (Available at:
https://www.cdc.gov/mmwr/preview/
mmwrhtml/mm6006a5.htm?s_cid=
mm6006a5_w.)
33. Schaefer, M.K., M. Jhung, M. Dahl, et al.,
‘‘Infection Control Assessment of
Ambulatory Surgical Centers’’, Journal of
the American Medical Association, 2010;
303(22):2273–2279.
34. Thompson, N.D. and M.K. Schaefer,
‘‘‘Never Events’: Hepatitis B Outbreaks
and Patient Notifications Resulting From
Unsafe Practices During Assisted
Monitoring of Blood Glucose, 2009–
2010’’, Journal of Diabetes Science and
Technology, 2011; 5(6):1396–1402.
35. Centers for Disease Control and
Prevention (CDC), ‘‘CDC Clinical
Reminder: Use of Fingerstick Devices on
More Than One Person Poses Risk for
Transmitting Bloodborne Pathogens’’,
available at https://www.cdc.gov/injection
safety/Fingerstick-DevicesBGM.html.
36. Centers for Medical Services (CMS),
‘‘Survey and Certification
Memorandum’’ (August 27, 2010)
VerDate Sep<11>2014
17:24 Mar 02, 2016
Jkt 238001
available at https://www.cms.gov/survey
certificationgeninfo/downloads/
SCLetter10_28.pdf.
37. Centers for Disease Control and
Prevention (CDC), ‘‘Notes From the
Field: Transmission of HBV Among
Assisted-Living-Facility Residents—
Virginia, 2012’’, MMWR Morbidity and
Mortality Weekly Report, 2013;
62(19):389. (Available at: https://www.
cdc.gov/mmwr/preview/mmwrhtml/
mm6219a4.htm?s_cid=mm6219a4_w.)
38. Desenclos, J.C., M. Bourdiol-Razes, B.
Rolin, et al., ‘‘Hepatitis C in a Ward for
Cystic Fibrosis and Diabetic Patients:
Possible Transmission by Spring-Loaded
Finger-Stick Devices for Self-Monitoring
of Capillary Blood Glucose’’, Infection
Control and Hospital Epidemiology,
2001; 22(11):701–707.
39. De Schrijver, K., I. Maes, P. Van Damme,
et al., ‘‘An Outbreak of Nosocomial
Hepatitis B Virus Infection in a Nursing
Home for the Elderly in Antwerp
(Belgium)’’, Acta Clinica Belgica, 2005;
60(2):63–69.
40. Gotz, H.M., M. Schutten, G.J. Borsboom,
et al., ‘‘A Cluster of Hepatitis B
Infections Associated With Incorrect Use
of a Capillary Blood Sampling Device in
a Nursing Home in the Netherlands,
2007’’, Euro Surveillance, 2008; 13(7–
9):1–5.
List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act, and under
authority delegated to the Commissioner
of Food and Drugs, it is proposed that
21 CFR part 878, as proposed to be
amended elsewhere in this issue of the
Federal Register, be further amended as
follows:
PART 878—GENERAL AND PLASTIC
SURGERY DEVICES
1. The authority citation for 21 CFR
part 878 continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add paragraph (d)(3) to § 878.4850,
under subpart E, to read as follows:
■
§ 878.4850
Blood Lancets.
*
*
*
*
*
(d) * * *
(3) Date PMA or notice of completion
of a PDP is required: A PMA or a notice
of completion of a PDP is required to be
filed with the Food and Drug
Administration on or before [A DATE
WILL BE ADDED 90 DAYS AFTER
DATE OF PUBLICATION OF A
FUTURE FINAL ORDER CALLING FOR
PMAs IN THE FEDERAL REGISTER OR
30 MONTHS AFTER DATE OF
PUBLICATION OF A FUTURE FINAL
ORDER RECLASSSIFYING INTO
CLASS III, WHICHEVER IS LATER] for
any multiple use blood lancet for
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multiple patient use described in
paragraph (d)(1) of this section that was
in commercial distribution before May
28, 1976, or that has, on or before [A
DATE WILL BE ADDED 90 DAYS
AFTER DATE OF PUBLICATION OF A
FUTURE FINAL ORDER CALLING FOR
PMAs IN THE FEDERAL REGISTER OR
30 MONTHS AFTER DATE OF
PUBLICATION OF A FUTURE FINAL
ORDER RECLASSSIFYING INTO
CLASS III, WHICHEVER IS LATER],
been found to be substantially
equivalent to a multiple use blood
lancet for multiple patient use described
in paragraph (d)(1) of this section that
was in commercial distribution before
May 28, 1976. Any other multiple use
blood lancet for multiple patient use
shall have an approved PMA or a
declared completed PDP in effect before
being placed in commercial
distribution.
Dated: February 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–04579 Filed 3–2–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[REG–123867–14]
RIN 1545–BM28
Utility Allowances Submetering
Internal Revenue Service (IRS),
Treasury.
ACTION: Notice of proposed rulemaking
by cross-reference to temporary
regulations.
AGENCY:
This document contains
proposed regulations that amend the
utility allowance regulations concerning
the low-income housing credit. The
proposed regulations relate to the
circumstances in which utility costs
paid by a tenant based on actual
consumption in a submetered rentrestricted unit are treated as paid by the
tenant directly to the utility company.
The proposed regulations extend those
rules to situations in which a building
owner sells to tenants energy that is
produced from a renewable source and
that is not delivered by a local utility
company. The proposed regulations
affect owners of low-income housing
projects that claim the credit, the
tenants in those low-income housing
projects, and the State and local housing
credit agencies that administer the
SUMMARY:
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Agencies
[Federal Register Volume 81, Number 42 (Thursday, March 3, 2016)]
[Proposed Rules]
[Pages 11151-11160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04579]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2016-M-0035]
Effective Date of Requirement for Premarket Approval for Blood
Lancets
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed
administrative order to require the filing of a premarket approval
application (PMA) following the reclassification of multiple use blood
lancets for multiple patient use from class I to class III. FDA is
summarizing its proposed findings regarding the degree of risk of
illness or injury designed to be eliminated or reduced by requiring
this device to meet the PMA requirements of the Federal Food, Drug,
[[Page 11152]]
and Cosmetic Act (the FD&C Act) and the benefits to the public from the
use of the device.
DATES: Submit either electronic or written comments on this proposed
order by June 1, 2016. See section X of the SUPPLEMENTARY INFORMATION
section of this document for the proposed effective date of any final
order that may publish based on this proposal.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-M-0035 for ``Effective Date of Requirement for Premarket
Approval for Blood Lancets.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G422, Silver Spring, MD 20993-0002, 301-796-6524,
joshua.nipper@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background--Regulatory Authorities
The FD&C Act, as amended, establishes a comprehensive system for
the regulation of medical devices intended for human use. Section 513
of the FD&C Act (21 U.S.C. 360c) established three categories (classes)
of devices, reflecting the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness. The three
categories of devices are class I (general controls), class II (special
controls), and class III (premarket approval).
Under section 513(d)(1) of the FD&C Act, devices that were in
commercial distribution before the enactment of the 1976 amendments,
May 28, 1976 (generally referred to as ``preamendments devices''), are
classified after FDA: (1) Receives a recommendation from a device
classification panel (an FDA advisory committee); (2) publishes the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) publishes a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as ``postamendments devices''), are
classified automatically by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, FDA reclassifies
the device into class I or II, or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 of the regulations (21 CFR part 807).
A person may market a preamendments device that has been classified
into class III through premarket notification procedures, and devices
found substantially equivalent by means of premarket notification
(510(k)) procedures to such a preamendments device or to a device
within that type (both the preamendments and substantially equivalent
devices are referred to as preamendments class III devices) may be
marketed without submission of a PMA until FDA issues a final order
under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring
premarket approval. Section 515(b)(1) of the FD&C Act directs FDA to
issue an order requiring premarket approval for a preamendments class
III device.
Section 515(f) of the FD&C Act provides an alternative pathway for
meeting the premarket approval
[[Page 11153]]
requirement. Under section 515(f), manufacturers may meet the premarket
approval requirement if they file a notice of completion of a product
development protocol (PDP) approved under section 515(f)(4) of the FD&C
Act and FDA declares the PDP completed under section 515(f)(6)(B) of
the FD&C Act. Accordingly, the manufacturer of a class III
preamendments device may comply with a call for PMAs by filing a PMA or
a notice of completion of a PDP. In practice, however, the option of
filing a notice of completion of a PDP has rarely been used. For
simplicity, although the PDP option remains available to manufacturers
in response to a final order under section 515(b) of the FD&C Act, this
document will refer only to the requirement for the filing and
obtaining approval of a PMA.
On July 9, 2012, Congress enacted the Food and Drug Administration
Safety and Innovation Act (FDASIA). Section 608(b) of FDASIA (126 Stat.
1056) amended section 515(b) of the FD&C Act, changing the process for
requiring premarket approval for a preamendments class III device from
rulemaking to an administrative order.
Section 515(b)(1) of the FD&C Act sets forth the process for
issuing a final order. Specifically, prior to the issuance of a final
order requiring premarket approval for a preamendments class III
device, the following must occur: Publication of a proposed order in
the Federal Register, a meeting of a device classification panel
described in section 513(b) of the FD&C Act, and consideration of
comments to a public docket.
In June 2013, FDA held a meeting of a device classification panel
described in section 513(b) of the FD&C Act to discuss the
classification of multiple use blood lancets for multiple patient use.
Although, to FDA's knowledge, no device is currently being marketed for
this use, one device has been cleared for this use. As explained
further in section V.A of this document, this device classification
panel meeting discussed whether multiple use blood lancets for multiple
patient use should be reclassified into class III or remain in class I,
and the discussion included whether PMAs should be required for these
devices. The panel recommended that, because multiple use blood lancets
for multiple patient use present a potential unreasonable risk of
illness or injury and insufficient information exists to establish
special controls for multiple use blood lancets for multiple patient
use, the device should be reclassified into class III. FDA is not aware
of new information that would provide a basis for a different
recommendation or findings.
Section 515(b)(2) of the FD&C Act provides that a proposed order to
require premarket approval shall contain: (1) The proposed order, (2)
proposed findings with respect to the degree of risk of illness or
injury designed to be eliminated or reduced by requiring the device to
have an approved PMA and the benefit to the public from the use of the
device, (3) an opportunity for the submission of comments on the
proposed order and the proposed findings, and (4) an opportunity to
request a change in the classification of the device based on new
information relevant to the classification of the device.
Section 515(b)(3) of the FD&C Act provides that FDA shall, after
the close of the comment period on the proposed order, consideration of
any comments received, and a meeting of a device classification panel
described in section 513(b) of the FD&C Act, issue a final order to
require premarket approval or publish a document terminating the
proceeding together with the reasons for such termination. If FDA
terminates the proceeding, FDA is required to initiate reclassification
of the device under section 513(e) of the FD&C Act, unless the reason
for termination is that the device is a banned device under section 516
of the FD&C Act (21 U.S.C. 360f).
A preamendments class III device may be commercially distributed
without a PMA until 90 days after FDA issues a final order requiring
premarket approval for the device, or 30 months after final
classification of the device under section 513 of the FD&C Act becomes
effective, whichever is later (section 501(f) of the FD&C Act (21
U.S.C. 351(f)). Elsewhere in this issue of the Federal Register, FDA is
issuing a proposed order to reclassify multiple use blood lancets for
multiple patient use from class I to class III. Therefore, assuming
both the reclassification order and the order to require PMAs are
finalized at the same time, the date by which a PMA for multiple use
blood lancets for multiple patient use must be filed will be 30 months
after the date FDA issues the final order reclassifying multiple use
blood lancets for multiple patients. If a PMA is not filed for such
device by the later of the two dates, as specified in section
501(f)(2)(B) of the FD&C Act, then the device would be deemed
adulterated under section 501(f) of the FD&C Act unless the device is
distributed for investigational use under an approved application for
an investigational device exemption (IDE).
In accordance with section 515(b) of the FD&C Act, interested
persons are being offered the opportunity to request reclassification
of multiple use blood lancets for multiple patient use.
II. Regulatory History of the Device
Elsewhere in this issue of the Federal Register, FDA is proposing
to reclassify multiple use blood lancets for multiple patient use into
class III under section 513(e) of the FD&C Act.
Blood lancets were classified in part 878 (21 CFR part 878) by a
final rule published in the Federal Register on June 24, 1988 (53 FR
23856) that classified 51 general and plastic surgery devices. This
1988 rule classified blood lancets into class I (general controls).
These devices were grouped with other devices under ``Manual surgical
instrument for general use,'' 21 CFR 878.4800. At the time, blood
lancets had been in common use in medical practice for many years, and
FDA believed that general controls were sufficient to provide
reasonable assurance of the safety and effectiveness of those devices.
This rule was amended on April 5, 1989 (54 FR 13826) to clarify that
manual surgical instruments for general use made of the same materials
as used in preamendment devices were exempt from premarket notification
510(k) review.
On December 7, 1994, FDA further amended the classification when it
published a final rule in the Federal Register (59 FR 63005) that
exempted 148 class I devices from premarket notification, with
limitations. Blood lancets were one of those devices. FDA determined
that manufacturers' submissions of premarket notifications were
unnecessary for the protection of the public health and that FDA's
review of such submissions would not advance its public health mission.
On August 26, 2010, FDA and the Centers for Disease Control and
Prevention (CDC) issued joint initial communications warning that the
use of fingerstick devices (blood lancets) to obtain blood from more
than one patient posed a risk of transmitting bloodborne pathogens. The
communication was updated on November 29, 2010 (Ref. 1). FDA's
communication update, ``Use of Fingerstick Devices on More Than One
Person Poses Risk for Transmitting Bloodborne Pathogens: Initial
Communication: Update 11/29/2010'', stated that ``[o]ver the past 10-15
years, the CDC and the FDA have noted a progressive increase in reports
of bloodborne infection transmission (primarily hepatitis B virus)
resulting from the shared use of fingerstick and POC [or `Point of
Care'] blood testing devices.'' FDA and CDC recommended, among other
things, that health care
[[Page 11154]]
professionals and patients never use a blood lancet for more than one
person.
On November 29, 2010, FDA published a guidance entitled ``Guidance
for Industry and Food and Drug Administration Staff; Blood Lancet
Labeling'' (75 FR 73107) (Ref. 2). This guidance includes labeling
recommendations to address concerns that both health care providers and
patients may be unaware of the serious adverse health risks associated
with using the same blood lancet for assisted withdrawal of blood from
more than one patient, even when the blood lancet blade is changed for
each blood draw. FDA recommends in the guidance that all blood lancets
be labeled for use only on a single patient. FDA recommends in the
guidance that a statement limiting use to a single patient should also
appear on the label attached to the device, if possible. The guidance
was for immediate implementation. When final, this order will supersede
this labeling guidance.
On June 26, 2013, FDA held a meeting of the General and Plastic
Surgery Devices Panel of the Medical Devices Advisory Committee (the
Panel) to discuss the potential reclassification of blood lancets (Ref.
3). The Panel discussed new scientific information, the risks to health
from blood lancets, whether blood lancets should be reclassified or
remain in class I, and possible special controls for these devices if
reclassified into class II. The Panel agreed that general controls were
not sufficient to provide a reasonable assurance of safety and
effectiveness of blood lancets. The Panel believed that because
multiple use blood lancets for multiple patient use presented a
potential unreasonable risk of illness or injury, and insufficient
information existed to establish special controls for these devices,
they should be reclassified into class III. The Panel recommended that
all other blood lancet devices be reclassified into class II (special
controls). FDA is not aware of new information since this Panel meeting
that would provide a basis for a different recommendation or finding.
III. Dates New Requirements Apply
Assuming FDA finalizes the order proposing reclassification of
multiple use blood lancets for multiple patient use found elsewhere in
this issue of the Federal Register, this device will be classified into
class III. In accordance with sections 501(f)(2)(B) and 515(b) of the
FD&C Act, FDA is proposing to require that a PMA be filed with the
Agency for multiple use blood lancets for multiple patient use devices
and accessories by the last day of the 30th calendar month beginning
after the month in which the classification of the device in class III
became effective, or on the 90th day after the date of the issuance of
a final order under 515(b), whichever is later. Assuming this order is
finalized at or near the same time the final order to reclassify these
devices into class III, this requirement will take effect 30 months
after the reclassification order issues. An applicant whose device was
legally in commercial distribution before May 28, 1976, or whose device
has been found to be substantially equivalent to such a device, will be
permitted to continue marketing such class III devices during FDA's
review of the PMA provided that a PMA is timely filed. FDA intends to
review any PMA for the device within 180 days. FDA cautions that under
section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into
an agreement to extend the review period for a PMA beyond 180 days
unless the Agency finds that ``. . . the continued availability of the
device is necessary for the public health.''
Under the FD&C Act, if any multiple use blood lancets for multiple
patient use are currently in distribution and no PMA is submitted for
these devices by the last day of the 30th calendar month beginning
after the month in which the classification of the device in class III
became effective or within 90 days of a final order calling for PMAs,
or a denial is rendered on a filed PMA, these devices would be
considered adulterated under section 501(f)(1) of the FD&C Act. In
addition, no new devices will be permitted in interstate commerce
without approval of a PMA. The device may be distributed for
investigational use only if the requirements of the IDE regulations are
met. The requirements for significant risk devices include submitting
an IDE application to FDA for review and approval. An approved IDE is
required to be in effect before an investigation of the device may be
initiated or continued under Sec. 812.30 (21 CFR 812.30). FDA,
therefore, recommends that IDE applications be submitted to FDA at
least 30 days before the end of the 30-month period after the issuance
of the final order to avoid interrupting any ongoing investigations.
FDA intends that under Sec. 812.2(d), the publication in the
Federal Register of any final order based on this proposal will include
a statement that, as of the date on which the filing of a PMA is
required, the exemptions in Sec. 812.2(c)(1) and (2) from the
requirements of the IDE regulations for preamendments class III devices
will cease to apply to any device that is: (1) Not legally on the
market on or before that date, or (2) legally on the market on or
before that date but for which a PMA is not filed by that date, or for
which PMA approval has been denied or withdrawn.
IV. Device Subject to This Proposal
Multiple Use Blood Lancet for Multiple Patient Use (21 CFR 878.4850(d))
Elsewhere in this issue of the Federal Register, FDA is proposing
to identify multiple use blood lancet for multiple patient use in a new
21 CFR 878.4850(d) in the following way: A multiple use capable blood
lancet intended for use on multiple patients that is comprised of a
single use blade attached to a solid, reusable base that is used to
puncture the skin to obtain a drop of blood for diagnostic purposes.
V. Proposed Findings With Respect to Risks and Benefits Multiple Use
Blood Lancet for Multiple Patient Use
As required by section 515(b) of the FD&C Act, FDA is publishing
its proposed findings regarding: (1) The degree of risk of illness or
injury designed to be eliminated or reduced by requiring that this
device have an approved PMA, and (2) the benefits to the public from
the use of the device.
These findings are based on the reports and recommendations of the
General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee (the Panel) from the meeting on June 26, 2013 (Ref.
3) and any additional information that FDA has obtained. Additional
information regarding the risks as well as classification associated
with this device type can be found in section V.C as well as in the
proposed order published elsewhere in this issue of the Federal
Register proposing to reclassify these devices into class III. The
device has the potential to benefit the public by puncturing the skin
to obtain small blood specimens for testing blood glucose, hemoglobin,
and other blood components. In addition, acute care hospitals may
consider reusing a single device or using one device with multiple
blades to have benefits in that doing so may expedite procedures. The
risks associated with the device include bloodborne pathogen
transmission, sharp object injuries, local tissue infections, and
adverse tissue reaction (not infection).
A. Summary of Data
FDA uses the bloodborne pathogens definition in 29 CFR
1910.1030(b). Bloodborne pathogens, such as HBV, may be transmitted
between patients by blood and certain body fluids (Ref. 4).
[[Page 11155]]
Since HBV-infected patients, who often lack clinical symptoms of
hepatitis, have high concentrations of HBV in their blood and HBV is
stable at ambient temperatures, transmission of HBV may result from
exposure to equipment that has not been adequately disinfected or by
the misuse of ``single use only'' medical devices (e.g., needles and
syringes) (Ref. 5).
The history of recognized bloodborne pathogen transmission by blood
lancets may have started in 1923 when an outbreak of jaundice occurred
in the Goteborg Hospital diabetic clinic in Sweden, which was described
by Schmid et al. (Ref. 6). All patients had blood drawn for glucose
testing from their ear lobes by a spring-activated ``Schnepper''
device, which was cleaned ``perfunctorily'' between uses. As a result,
26 clinic patients developed jaundice. Outbreaks of hepatitis in
English diabetic patients were described by Graham in 1938 (Ref. 7) and
by Droller in 1945 (Ref. 8). In both of these outbreaks, venous blood
for glucose measurement was drawn using syringes that were only
chemically disinfected between uses while the needles were boiled;
cleaning procedures were not mentioned in the reports. Syringes and
needles are now single-use-only devices because the procedures used to
reprocess these devices many years ago have long been recognized to be
inadequate, resulting in outbreaks of hepatitis transmission (Ref. 6).
There were also two case reports, in 1985 and 1997, of the transmission
of HBV infection due to sharing personal use blood lancets for home
glucose monitoring with one other person who already had HBV. One
report was from the United States and one was from Hungary (Refs. 9 and
10). In addition, Mendez et al. reported a 75-year-old patient with
diabetes who died of acute hepatitis, whose only risk factor for HBV
infection appeared to be her diabetic care at a local outpatient
facility where she had repeated fingersticks for blood glucose
monitoring (Ref. 11).
During the 1990s, several bloodborne transmission issues led to CDC
and FDA involvement. In 1990, CDC learned of a nosocomial outbreak of
HBV transmission due to the use of a spring-loaded lancet device whose
disposable platform was not removed and discarded after each use of the
device while it was used for the care of multiple patients (Ref.
12).\1\ CDC reported this outbreak to FDA; FDA then issued a safety
alert warning users of the precautions needed for the safe use of this
device (Ref. 13). This was the first reported outbreak of HBV
transmission associated with the use of a blood lancet device in the
United States (Refs. 13 and 14).
---------------------------------------------------------------------------
\1\ Hepatitis B and hepatitis C infections, as well as other
bloodborne infections such as HIV infection, are reported to State
health departments and, by them, to CDC; FDA does not usually
receive such reports directly from health care facilities or
personnel, even when a medical device has transmitted the infection.
---------------------------------------------------------------------------
CDC's outbreak investigation revealed that a patient who had
diabetes and also a chronic HBV infection caused by a relatively rare
viral subtype was admitted to the outbreak ward in 1989. Twelve of the
23 patients who acquired hepatitis B after admission to the same ward
as the chronic HBV source patient were serotyped, and all were found to
have the same viral subtype causing their hepatitis B infections. The
first nosocomially infected patient had a very long-term stay on the
ward and so served as a source of transmission to other patients over a
period of 12 months. Twenty of the 23 outbreak patients had diabetes;
they and the three other case-patients all experienced numerous POC
fingerstick blood draws with the same type of blood lancet while
hospitalized on the outbreak ward. The implicated blood lancet device
included a disposable platform to stabilize the patient's finger; the
single use lancet blade penetrated a hole in that platform to reach the
patient's skin. Half the ward nursing staff who performed fingersticks
with this lancet acknowledged not changing the device platform with
each use of the lancet. A similar outbreak of hepatitis transmission
was reported in 1990 in France in which a similar blood lancet device
was implicated. Douvin et al. (Ref. 15) reported that examination of
the device implicated in the French outbreak showed visible blood
contamination of the lancet platform in 24 percent of studied uses of
that device. Shier et al. (Ref. 16) reported in 1993 that the use of
another spring-loaded lancet device in a volunteer study of blood
glucose levels resulted in visible blood contamination on 29 percent of
the device end caps. This device was intended for ``personal'' use
only.
As a result of the 1990 outbreak of HBV transmission due to blood
lancet use in the United States, FDA and CDC recommended that spring-
loaded blood lancet devices should have only single use only
``platforms'' as well as single use only blades; the devices were to be
cleaned and disinfected per the manufacturer's instructions (Refs. 12
and 13). The 1990 FDA Safety Alert also advised ``Devices (blood
lancets) without a removable platform should only be used with one
patient in the hospital or outpatient setting. After the patient is
discharged, the device may be reused only if it is disinfected
according to the manufacturer's instructions. If there are no
instructions for disinfection, the device should be discarded.''
Since 1990, the incidence of diabetes mellitus has increased
significantly in the United States, especially in adults aged 65-79
(Refs. 17 and 18). At the same time, clinical practice in the care of
these patients increasingly emphasized the need for improved blood
glucose level control, resulting in the increased use of POC blood
glucose monitoring both in health care facilities and at home (Refs.
19-21). Unfortunately, along with the increased incidence of diabetes
has come a progressive increase in the reports of bloodborne infection
transmission (primarily HBV), resulting from the shared use of
fingerstick and POC blood testing devices (Ref. 1). In 2011, the CDC
reported that 25 of 29 outbreaks of HBV infection occurring in long-
term care facilities since 1996 involved adults with diabetes receiving
blood glucose monitoring (Ref. 22).
In 1997, CDC reported two outbreaks of HBV transmission, one in a
nursing home in Ohio and one in a hospital in New York City (NYC) (Ref.
23). Two different blood lancet devices were used at the two sites.
However, both lancet devices included the use of an ``end cap'' that
came in contact with patient skin. This was a separate, individual use
component of the lancet device used in Ohio; the nursing home was
reusing both the lancet and the cap for multiple patients. The end cap
was a part of the disposable, single use only lancet blade assembly in
the device used in NYC. The exact mechanism of blood transmission was
not entirely clear in the NYC setting; staff claimed they had discarded
the end cap after each use. CDC postulated that either blood-
contaminated nurses gloves worn for the care of multiple patients or
the pen-like lancet-holding device itself might have been the source of
the blood cross-contamination of the lancet. A similar outbreak was
reported by Quale et al. in 1998 from a hospital in New York (Ref. 24).
The recognition of 3 cases of nosocomially acquired HBV infection
resulted in an investigation that uncovered another 11 cases. Reuse by
hospital staff of a disposable lancet end cap with the lancet in
multiple patients was identified as the probable cause of hepatitis
cross-transmission to patients; contamination of the lancet wound from
[[Page 11156]]
blood on unchanged gloves worn by nurses during collection of blood
samples from multiple patients may also have contributed to the
nosocomial transmission of HBV in this outbreak.
CDC reviewed the incidence of reported outbreaks of HBV and
hepatitis C infection in nonhospital health care settings between 1998
and 2008 and noted a significant increase in such nosocomial
transmission of bloodborne pathogens (Refs. 25-28). N.D. Thompson et
al. identified 33 outbreaks of nosocomial hepatitis transmission in
nonhospital health care settings (Ref. 25). Of these 33 outbreaks, 15
were found to be due to blood glucose monitoring in long-term care and
assisted living facilities. Only half of these outbreak investigations
were published in the scientific literature; the others were recognized
by health department investigations and reports to CDC. In 9 of the 15
outbreaks of nosocomial hepatitis in patients with diabetes, blood
lancet devices were shared among multiple patients. In two additional
outbreaks, lancets were not noted to be shared, but blood-soiled
glucose meters were stored together with lancets without cleaning/
disinfection of the devices and gloves were not regularly changed
between each patient. These failures of proper infection control
practice could have led to blood contamination of individual blood
lancets in these two facilities.
N.D. Thompson et al. also investigated blood glucose monitoring
practices in long-term care facilities in Pinellas County, Florida, in
2007 and found that 22 percent of the participating facilities that
used reusable fingerstick devices used them in multiple patients (Ref.
29). Patel et al. reported in 2009 on the efforts of the Virginia
Department of Health to improve blood glucose monitoring practices in
assisted living facilities (ALFs) in Virginia (Ref. 30). This effort
followed two separate outbreaks of HBV infections in two assisted
living facilities. In those outbreaks, one of the three acutely
symptomatic initial patients died of HBV infection. Of 68 patients
undergoing blood glucose monitoring in these two facilities, a total of
11 patients acquired HBV infection. Both facilities used reusable blood
lancets to obtain blood from multiple patients and did not clean or
disinfect the lancets between uses. The Virginia Department of Health
then mailed an educational packet on safe blood glucose monitoring
practices to all ALFs (640) in the State. A random sample of ALFs was
contacted after the educational intervention and invited to participate
in a survey to evaluate the response to the educational packet. The
results found that 16 percent of the facilities that used lancets to
monitor blood glucose levels were still using these devices to obtain
blood from multiple patients.
Y.G. McIntosh et al. investigated outbreaks of nosocomial HBV
transmission in four ALFs between 2009 and 2011 and found that in all
four facilities, pen-style lancets were used to obtain blood for
glucose monitoring from multiple patients even though two facilities
provided each patient with dedicated ``single patient use only pen-
style lancets'' according to their policies (Ref. 31). Z. Moore et al.
reported another outbreak of nosocomial HBV transmission in an ALF in
NC in 2010 in which blood lancet devices were shared among multiple
patients. Six of the eight elderly patients who acquired acute HBV in
this outbreak died from complications of hepatitis (Ref. 32). M.K.
Schaefer et al. surveyed a stratified, random sample of ambulatory
surgery centers (ACS) in three volunteer states in 2009 (Ref. 33). Of
the 53 ACS that performed blood glucose monitoring, 11 (21 percent)
reused pen-style blood lancets on multiple patients and 17 (32 percent)
also failed to clean and disinfect blood glucose meters after each use.
Thompson and Schaefer reported the analysis of four outbreaks of
nosocomial HBV in ALFs in 2009-2010 (Ref. 34). One was also reported
separately by Z. Moore et al. (Ref. 32). Two of the three other
outbreaks occurred in Virginia and one in Florida; these 3 outbreaks
resulted in 21 new patients acquiring acute hepatitis B. In two of the
three facilities, use of reusable blood lancets to draw blood from
multiple patients was observed or reported. The third facility denied
that it permitted the sharing of reusable lancets. However, used
lancets and glucose meters were stored together, along with clean
supplies; visible blood contamination was observed on several glucose
meters and one reusable lancet by the investigator. Thompson and
Schaefer also reported in their paper on two patient notification
campaigns resulting from the misuse of reusable blood lancets with
preloaded lancet cartridges, intended and cleared only for single
patient use, which were used to obtain blood from multiple patients.
One episode involved a community health center and was reported when
personnel noted that the lancet blades were not retracting properly,
which might have resulted in blade use for more than one patient. The
second episode occurred at a community health fair in which physician
assistant students were offering diabetes screening. During the fair,
the students realized that the lancet blades had not been advanced
properly so that each patient received a new blade. The first episode
exposed 283 patients to a contaminated lancet blade; the second
incident exposed approximately 60 patients. The results of the patient
notification studies were not reported.
As a result of this significant increase in such nosocomial
transmission of bloodborne pathogens, on August 26, 2010, FDA and the
CDC issued a Safety Communication (Ref. 1) and a Clinical Reminder
(Ref. 35), respectively, warning that the use of blood lancets to
obtain blood from more than one patient risks the transmission of
bloodborne pathogen infections from one patient to other patients. Both
FDA and CDC recommended that blood lancets should never be used to
obtain blood from more than one patient. In addition, the Centers for
Medicare and Medicaid Services issued a Survey and Certification
Memorandum for Point of Care Devices and Infection Control in Nursing
Homes identifying the use of blood lancet devices for more than one
patient as an infection control standards deficiency (Ref. 36). On
November 29, 2010, FDA issued ``Guidance for Industry and Food and Drug
Administration Staff: Blood Lancet Labeling'', which provided guidance
for lancet manufacturers on the labeling of all blood lancets,
including those capable of reuse, as ``single patient use only''
devices (Ref. 2).
In 2012, another outbreak of acute HBV was reported in an ALF in
Virginia (Ref. 37). The source patient had been recently transferred
from another ALF where she had acquired nosocomial HBV infection from
the shared use of blood lancets for multiple patients (Ref. 31). This
ALF also reused blood lancets to obtain blood from multiple patients
for glucose monitoring. This dangerous practice resulted in two new
nosocomial HBV infections in this ALF.
Outbreaks of hepatitis transmission due to use of blood lancets to
draw blood from more than one patient for blood glucose monitoring have
not been limited to the United States. In 2001, Desenclos et al.
described an outbreak of nosocomial hepatitis C transmission in an
inpatient ward for children with cystic fibrosis and diabetes in a
French hospital in 1994-1995 (Ref. 38). Blood glucose monitoring was
done by the nursing staff for the patients with cystic fibrosis as well
as for the patients with diabetes using a spring-loaded lancet with a
disposable platform to stabilize the finger. These devices were shared
among patients between 1986 and 1992
[[Page 11157]]
during repeated admissions to the inpatient unit. After 1992, patients
were supposed to use only their own lancet devices for blood glucose
monitoring. The retrospective prevalence of prior hepatitis C infection
was found to be 58 percent in patients with cystic fibrosis and 17
percent in patients with diabetes in 1994. At the time (1994), the
prevalence of antibody to hepatitis C in the general public in France
was 1.1 percent. The patients with cystic fibrosis had more frequent
and longer admissions to the inpatient ward, and more of the exposed
cystic fibrosis patients (66.7 percent) were screened for hepatitis C
infection than were the patients with diabetes admitted to the
inpatient ward during the exposure period (39.5 percent). These factors
may have influenced the apparent difference in hepatitis C transmission
in these two groups of exposed patients.
In 2005, De Schrijver et al. described an outbreak of acute HBV
infection in a nursing home in Antwerp (Ref. 39). The initial report of
a fulminant case of acute HBV infection in an 83-year-old resident of
the home resulted in an investigation that identified acute hepatitis B
infection in another four patients there. Four of the five acutely
infected patients had diabetes and received assisted blood glucose
sampling by the nursing home staff. The two blood lancet models used in
the facility (one each in two sections) were used to obtain blood from
multiple patients. The device platforms were not disposable. The
lancets were washed only when blood was visible on the device and were
not disinfected. Nurses did not routinely wash their hands or wear
gloves when obtaining blood. Two of the five patients with acute
nosocomial hepatitis B died of their infections.
In 2008, Gotz et al. reported the investigation of two cases of
acute HBV infection among patients at a nursing home in the Netherlands
(Ref. 40). The nursing home stay of these two patients overlapped with
that of a patient with known chronic HBV infection. Early in this time
period, the nursing home changed the lancet device used for glucose
monitoring from a spring-loaded device with a disposable platform (used
for multiple patients) to a device with a rotating drum dispensing new
lancet blades, which was also used to draw blood from multiple
patients, although it was labeled for single patient use only. This
device was used for about a month until the staff realized that active
rotation of the drum was occasionally forgotten, resulting in the reuse
of a lancet blade on more than 1 patient. The new device was then
removed from the facility and the spring-loaded lancet was returned to
use. The two patients with acute HBV received blood glucose monitoring
as did the source patient with chronic HBV, sometimes on the same day.
Two other patients who also received blood glucose monitoring escaped
infection. The investigators stated that they believed the rotating
lancet drum device was likely the means of transmission of HBV
infection between patients.
In 2011, Duffell et al. reported on the investigations of five
reports of HBV transmission in community health care settings in the
United Kingdom (Ref. 4). All of the nine initially reported patients
with HBV had diabetes and were receiving blood glucose monitoring.
Further investigation identified another 12 patients with acute HBV
infection. The care settings in which hepatitis transmission occurred
were described as a ``private residential home'' (1 patient), nursing
and residential home (1 patient), ``private nursing and residential''
(1 patient) and ``local care home'' (2 patients). Eleven of the 21
acutely infected patients had symptomatic HBV; seven of these patients
died, five due to the HBV infection. All of the care sites in which
acute HBV transmission occurred were using blood lancets designed
intended for single patient use only; these devices were either
routinely or occasionally used for multiple patients. One facility also
used a single glucometer for multiple patients and did not clean or
disinfect it between patients. The authors also noted that information
reported on patients found to have acute HBV infection between 1990 and
2003 identified only four patients with blood glucose monitoring as a
possible risk factor; one of these patients was infected as a result of
in-hospital transmission from another patient on the same ward,
although details were not provided. Between 2004 and 2006, the 9
patients described previously in this document were reported and
investigation led to the discovery of an additional 12 cases of health
care-related HBV transmission due to the improper use of blood lancets
during patient blood glucose monitoring.
B. Benefits of the Device
A blood lancet is used to puncture the skin to obtain small blood
specimens for testing blood glucose, hemoglobin, and other blood
components. Some blood lancets are used with POC blood testing devices,
such as blood glucose meters and Prothrombin Time and International
Normalized Ratio (PT/INR) anticoagulation meters. Today, probably the
most common use for a blood lancet is in diabetes monitoring. These
devices are used in both home and professional health care settings.
Only a small blood sample is needed for testing of blood glucose level.
The blood sample is dropped onto a test strip and inserted into a blood
glucose meter for results.
Some blood lancets are also used with PT/INR anticoagulation
meters. These devices are used in both home and professional health
care settings. The PT and INR are used to monitor the effectiveness of
the anticoagulant warfarin. Warfarin helps inhibit the formation of
blood clots. The formation of blood clots may be associated with atrial
fibrillation, the presence of artificial heart valves, deep venous
thrombosis, and some cases of pulmonary embolism. Because the use of
warfarin may cause excessive bleeding, patients are monitored,
typically by PT/INR.
Because newborns have relatively small amounts of blood compared to
adults, it is usually preferred to use as small amount of blood as
possible for any screening or other laboratory tests for newborns.
Blood lancets may be used to perform heel sticks in newborns. Heel
stick is a minimally invasive way of obtaining capillary blood samples.
In newborns, heel sticks are the preferred collection method for small
volumes of blood.
The possible benefit of multiple use blood lancets for multiple
patient use is that acute care hospitals may consider reusing a single
device or using one device with multiple blades to have benefits, in
that doing so may expedite procedures.
C. Risks to Health
FDA has evaluated the risks to health associated with use of
multiple use blood lancets for multiple patient use. In doing so, FDA
considered information from the reports and recommendations of the
General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee from the meeting of June 26, 2013, the adverse event
reports for these devices in FDA's Manufacturer and User Facility
Device Experience (MAUDE) database, and the published scientific
literature, which is discussed in FDA's executive summary for the June
26, 2013, panel. Based on this information, FDA has determined the
following risks:
1. Bloodborne Pathogen Transmission
Bloodborne pathogens such as HBV, hepatitis C virus, and
potentially any other pathogen present in the bloodstream of a patient
can be
[[Page 11158]]
transmitted from one patient to another by the following mechanisms:
Reuse of the same lancet blade to draw blood from more
than one patient or
Failure/inability to adequately clean the base of a
multiple use blood lancet resulting in the blood contamination of the
next ``new'' lancet blade when blood is drawn from more than one
patient.
2. Sharp Object Injuries
The blade of a lancet device is designed to pierce the skin and
draw blood. Except when the used lancet blade is immediately and
automatically covered by a sharps safety feature, which renders the
blade inaccessible, the exposed sharp blade of a blood lancet presents
a puncture hazard to anyone coming in contact with it. Blade exposure
can result due to either the lack of a sharps safety feature or device
breakage.
3. Local Tissue Infections
Human skin always carries a population of bacteria and often fungi
(normal skin flora), which causes no problem for the host when skin is
intact. However, puncture injuries to the skin by sharp objects such as
lancet blades can carry these microbes into the normally sterile tissue
below the skin. Such injuries have the potential to cause local skin/
soft tissue infections.
4. Adverse Tissue Reaction (Not Infection)
Skin contact with some materials, metals and material colorants can
cause skin inflammation, irritation or exanthems (rashes). These
reactions may be due to either hypersensitivity to a specific compound/
metal or to a non-specific reaction.
D. Summary of FDA Findings
FDA believes multiple use blood lancets for multiple patient use
should be reclassified from class I to class III. The Panel held on
June 26, 2013, discussed and made recommendations regarding the
regulatory classification of blood lancets to reclassify multiple use
blood lancets for multiple patient use to class III under 513(e) of the
FD&C Act. The Panel strongly agreed with FDA that based on the
available scientific evidence, multiple use blood lancets for multiple
patient use should be reclassified to class III because multiple use
blood lancets for multiple patient use present a potential unreasonable
risk of illness or injury. They also agreed that insufficient
information exists to establish special controls for multiple use blood
lancets for multiple patient use, because there is no evidence that
these devices can be adequately cleaned and disinfected and that there
is no proven method of doing so. Therefore, it is appropriate to
regulate them in class III.
FDA agrees with the Panel's recommendation that these devices
present a potential unreasonable risk of illness or injury due to the
inherent and significantly increased risk of bloodborne pathogen
transmission risk as compared to single use only or single patient only
blood lancets. FDA does not believe existing valid scientific evidence,
as defined in Sec. 860.7 (21 CFR 860.7), supports a reasonable
assurance that the device can be adequately reprocessed between uses on
different patients. FDA also believes sufficient information does not
exist to establish special controls for blood lancets intended for
multiple patient use. Given the availability of safer single patient
use blood lancet devices, FDA further believes that the probable
benefits to health from use of the device do not outweigh the probable
risks. Currently FDA is unaware of technology or other controls that
would adequately mitigate against the inherent and significantly
increased risk of blood borne pathogen transmission in multiple use
blood lancets for use in multiple patients. Therefore, the safety and
effectiveness of the multiple use blood lancets for multiple patients,
particularly the effectiveness of their reprocessing instructions/
methods to render the device safe for use on more than one patient and
the ability of health care providers to follow these instructions
completely should be independently demonstrated for each device of this
type via a PMA application. FDA is proposing to require an individual
demonstration that a reasonable assurance of safety and effectiveness
exists for each device within this type. The manufacturer of each
individual device will have the opportunity to demonstrate the safety
and effectiveness of the device for its intended use by submitting a
PMA.
VI. PMA Requirements
A PMA for this device must include the information required by
section 515(c)(1) of the FD&C Act. Such a PMA should also include a
detailed discussion of the risks identified previously in this
document, as well as a discussion of the effectiveness of the device
for which premarket approval is sought. In addition, a PMA must include
all data and information on: (1) Any risks known, or that should be
reasonably known, to the applicant that have not been identified in
this document; (2) the effectiveness of the device that is the subject
of the application; and (3) full reports of all preclinical and
clinical information from investigations on the safety and
effectiveness of the device for which premarket approval is sought.
A PMA must include valid scientific evidence to demonstrate
reasonable assurance of the safety and effectiveness of the device for
its intended use (Sec. 860.7(c)(2)). FDA defines valid scientific
evidence in Sec. 860.7(c)(2)).
To present reasonable assurance of safety and effectiveness of
multiple use blood lancets for multiple patient use, FDA believes
manufacturers should submit performance testing, including clinical
trials of their device, in order to support PMA approval. Existing
published clinical literature may also be leveraged as part of the PMA
submission.
VII. Opportunity To Request a Change in Classification
Before requiring the filing of a PMA, FDA is required by section
515(b)(2)(D) of the FD&C Act to provide an opportunity for interested
persons to request a change in the classification of the device based
on new information relevant to the classification. Any proceeding to
reclassify the device will be under the authority of section 513(e) of
the FD&C Act.
A request for a change in the classification of this device is to
be in the form of a reclassification petition containing the
information required by 21 CFR 860.123, including new information
relevant to the classification of the device.
VIII. Analysis of Environmental Impact
We have determined under 21 CFR 25.34(b) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IX. Paperwork Reduction Act of 1995
This proposed order refers to collections of information that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 814, subparts B and E, have
been approved under OMB control number 0910-0231. The collections of
information in part 807, subpart E, have been approved under OMB
control number 0910-0120. The collections of information under 21
[[Page 11159]]
CFR part 801 have been approved under OMB control number 0910-0485.
X. Proposed Effective Date
FDA is proposing that any final order based on this proposal become
effective on the date of its publication in the Federal Register or at
a later date if stated in the final order.
XI. Codification of Orders
Prior to the amendments by FDASIA, section 515(b) of the FD&C Act
provided for FDA to issue regulations to require approval of an
application for premarket approval for preamendments devices or devices
found substantially equivalent to preamendments devices. Section 515(b)
of the FD&C Act, as amended by FDASIA, provides for FDA to require
approval of an application for premarket approval for such devices by
issuing a final order, following the issuance of a proposed order in
the Federal Register. FDA will continue to codify the requirement for
an application for premarket approval, resulting from changes issued in
a final order, in the Code of Federal Regulations (CFR). Therefore,
under section 515(b)(1)(A) of the FD&C Act, as amended by FDASIA, in
the proposed order, we are proposing to require approval of an
application for premarket approval for multiple use blood lancets for
multiple patient use and, if this proposed order is finalized, we will
make the language in 21 CFR 878.4850(d) consistent with the final
version of this proposed order.
XII. References
The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. U.S. Food and Drug Administration (FDA), ``Use of Fingerstick
Devices on More Than One Person Poses Risk for Transmitting
Bloodborne Pathogens: Initial Communication'' (August 26, 2010) and
``Update'' (November 29, 2010), available at https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm234889.htm and https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
2. U.S. Food and Drug Administration, ``Guidance for Industry and
Food and Drug Administration Staff: Blood Lancet Labeling''
(November 29, 2010), available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm234577.htm.
3. FDA's General and Plastic Surgery Devices Panel transcript and
other meeting materials for the June 26, 2013, meeting, available at
https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm349426.htm.
4. Duffell, E.F., L.M. Milne, C. Seng, et al., ``Five Hepatitis B
Outbreaks in Care Homes in the UK Associated With Deficiencies in
Infection Control Practice in Blood Glucose Monitoring'',
Epidemiology and Infection, 2011; 139:327-335.
5. Williams, I.T., J.F. Perz, and B.P. Bell, ``Viral Hepatitis
Transmission in Ambulatory Health Care Settings'', Clinical
Infectious Diseases, 2004; 38(11):1592-1598.
6. Schmid, R., ``History of Viral Hepatitis: A Tale of Dogmas and
Misinterpretations'', Journal of Gastroenterology and Hepatology,
2001; 16(7):718-722.
7. Graham, G., ``Diabetes Mellitus: A Survey of Changes in Treatment
During the Last Fifteen Years'', The Lancet, 1938; 2:1-7.
8. Droller, H., ``An Outbreak of Hepatitis in a Diabetic Clinic'',
British Medical Journal, 1945; 1(4400):623-625.
9. Stapleton, J. and S. Lemon, ``Transmission of Hepatitis B During
Blood Glucose Monitoring'', Journal of the American Medical
Association, 1985; 253:3250.
10. Farkas, K. and G. Jermendy, ``Transmission of Hepatitis B
Infection During Home Blood Glucose Monitoring'', Diabetic Medicine,
1997; 14:263.
11. Mendez, L., K.R. Reddy, R.A. Di Prima, et al., ``Fulminant
Hepatic Failure Due to Acute Hepatitis B and Delta Co-Infection:
Probable Bloodborne Transmission Associated With a Spring-Loaded
Fingerstick Device'', American Journal of Gastroenterology, 1991;
86:895-897.
12. Centers for Disease Control and Prevention (CDC), ``Nosocomial
Transmission of Hepatitis B Virus Associated With a Spring-Loaded
Fingerstick Device--California'', MMWR Morbidity and Mortality
Weekly Report, 1990; 39 (35):610-613. (Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/00001743.htm.)
13. Food and Drug Administration (FDA), ``Safety Alert Medical
Devices; Hepatitis B Transmission via Spring-Loaded Lancet Devices''
(August 28, 1990), available at https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm241809.htm.
14. Polish, L., C.N. Shapiro, F. Bauer, et al., ``Nosocomial
Transmission of Hepatitis B Virus Associated With the Use of a
Spring-Loaded Fingerstick Device'', New England Journal of Medicine,
1992; 326(11):721-725.
15. Douvin, C., D. Simon, H. Zinelabidine, et al., ``An Outbreak of
Hepatitis B in an Endocrinology Unit Traced to a Capillary-Blood-
Sampling Device'', New England Journal of Medicine, 1990; 322:57-58.
16. Shier, N., J. Warren, M. Torabi, et al., ``Contamination of a
Fingerstick Device'', New England Journal of Medicine, 1993;
328:969-997.
17. Centers for Disease Control and Prevention (CDC), ``Increasing
Prevalence of Diagnosed Diabetes--United States and Puerto Rico,
1995-2010'', MMWR Morbidity and Mortality Weekly Report, 2012;
61(45):918-921. (Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6145a4.htm?s_cid=mm6145a4_w.)
18. Centers for Disease Control and Prevention (CDC), ``Incidence of
Diagnosed Diabetes per 1,000 Population Aged 18-79 Years, by Age,
1980-2014'', Atlanta, GA: U.S. Department of Health and Human
Services, CDC, National Diabetes Surveillance System. Available at
www.cdc.gov/diabetes/statistics/incidence/fig3.htm. Accessed October
19, 2014.
19. Clarke, S.F. and J.R. Foster, ``A History of Blood Glucose
Meters and Their Role in Self-Monitoring of Diabetes Mellitus'',
British Journal of Biomedical Science, 2012; 69(2):83-93.
20. Yoo, E.-H. and S.-Y. Lee, ``Glucose Biosensors: An Overview of
Use in Clinical Practice'', Sensors, 2010; 10(5):4558-4576.
21. Rajendran, R. and G. Rayman, ``Point-of-Care Blood Glucose
Testing for Diabetes Care in Hospitalized Patients: An Evidence-
Based Review'', Journal of Diabetes Science and Technology, 2014;
8(6):1081-1090.
22. Centers for Disease Control and Prevention (CDC), ``Use of
Hepatitis B Vaccination for Adults With Diabetes Mellitus:
Recommendations of the Advisory Committee on Immunization Practices
(ACIP)'', MMWR Morbidity and Mortality Weekly Report, 2011;
60(50):1709-1711. (Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6050a4.htm?s_cid=mm6050a4_w.)
23. Centers for Disease Control and Prevention (CDC), ``Nosocomial
Hepatitis B Virus Infection Associated With Reusable Fingerstick
Blood Sampling Devices--Ohio and New York City, 1996'', MMWR
Morbidity and Mortality Weekly Report, 1997; 46(10):217-221.
(Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/00046679.htm.)
24. Quale, J.M., D. Landman, B. Wallace, et al.,
``D[eacute]j[agrave] vu: Nosocomial Hepatitis B Transmission and
Fingerstick Monitoring'', The American Journal of Medicine, 1998;
105;296-301.
25. Thompson, N.D., J. Perz, A. Moorman, et al., ``Nonhospital
Health Care-Associated Hepatitis B and C Virus Transmission: United
States, 1998-2008'', Annals of Internal Medicine, 2009; 150: 33-39.
26. Khan, A.J., S.M. Cotter, B. Schulz, et al., ``Nosocomial
Transmission of Hepatitis B Virus Infection Among Residents With
Diabetes in a Skilled Nursing Facility'', Infection Control and
Hospital Epidemiology, 2002; 23:313-318.
27. Centers for Disease Control and Prevention (CDC), ``Transmission
of
[[Page 11160]]
Hepatitis B Virus Among Persons Undergoing Blood Glucose Monitoring
in Long-Term-Care Facilities--Mississippi, North Carolina, and Los
Angeles County, California, 2003-2004'', MMWR Morbidity and
Mortality Weekly Report, 2005; 54(09):220-223. (Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5409a2.htm.)
28. Thompson, N.D. and J.F. Perz, ``Eliminating the Blood: Ongoing
Outbreaks of Hepatitis B Virus Infection and the Need for Innovative
Glucose Monitoring Technologies'', Journal of Diabetes Science and
Technology, 2009; 3(2):283-288.
29. Thompson, N.D., V. Barry, K. Alelis, et al., ``Evaluation of the
Potential for Bloodborne Pathogen Transmission Associated With
Diabetes Care Practices in Nursing Homes and Assisted Living
Facilities, Pinellas County'', Journal of the American Geriatrics
Society, 2010; 58:914-918.
30. Patel, A.S., M.B. White-Comstock, D. Woolard, et al.,
``Infection Control Practices in Assisted Living Facilities: A
Response to Hepatitis B Virus Infection Outbreaks'', Infection
Control and Hospital Epidemiology, 2009; 30:209-214.
31. Centers for Disease Control and Prevention (CDC), ``Multiple
Outbreaks of Hepatitis B Virus Infection Related to Assisted
Monitoring of Blood Glucose Among Residents of Assisted Living
Facilities--Virginia, 2009-2011'', MMWR Morbidity and Mortality
Weekly Report, 2012; 61(19):339-343. (Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6119a3.htm?s_cid=mm6119a3_w.)
32. Centers for Disease Control and Prevention (CDC), ``Notes From
the Field: Deaths From Acute Hepatitis B Virus Infection Associated
With Assisted Blood Glucose Monitoring in an Assisted-Living
Facility--North Carolina, August-October, 2010,'' MMWR Morbidity and
Mortality Weekly Report, 2011; 60(6):182. (Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6006a5.htm?s_cid=mm6006a5_w.)
33. Schaefer, M.K., M. Jhung, M. Dahl, et al., ``Infection Control
Assessment of Ambulatory Surgical Centers'', Journal of the American
Medical Association, 2010; 303(22):2273-2279.
34. Thompson, N.D. and M.K. Schaefer, ```Never Events': Hepatitis B
Outbreaks and Patient Notifications Resulting From Unsafe Practices
During Assisted Monitoring of Blood Glucose, 2009-2010'', Journal of
Diabetes Science and Technology, 2011; 5(6):1396-1402.
35. Centers for Disease Control and Prevention (CDC), ``CDC Clinical
Reminder: Use of Fingerstick Devices on More Than One Person Poses
Risk for Transmitting Bloodborne Pathogens'', available at https://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html.
36. Centers for Medical Services (CMS), ``Survey and Certification
Memorandum'' (August 27, 2010) available at https://www.cms.gov/surveycertificationgeninfo/downloads/SCLetter10_28.pdf.
37. Centers for Disease Control and Prevention (CDC), ``Notes From
the Field: Transmission of HBV Among Assisted-Living-Facility
Residents--Virginia, 2012'', MMWR Morbidity and Mortality Weekly
Report, 2013; 62(19):389. (Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6219a4.htm?s_cid=mm6219a4_w.)
38. Desenclos, J.C., M. Bourdiol-Razes, B. Rolin, et al.,
``Hepatitis C in a Ward for Cystic Fibrosis and Diabetic Patients:
Possible Transmission by Spring-Loaded Finger-Stick Devices for
Self-Monitoring of Capillary Blood Glucose'', Infection Control and
Hospital Epidemiology, 2001; 22(11):701-707.
39. De Schrijver, K., I. Maes, P. Van Damme, et al., ``An Outbreak
of Nosocomial Hepatitis B Virus Infection in a Nursing Home for the
Elderly in Antwerp (Belgium)'', Acta Clinica Belgica, 2005;
60(2):63-69.
40. Gotz, H.M., M. Schutten, G.J. Borsboom, et al., ``A Cluster of
Hepatitis B Infections Associated With Incorrect Use of a Capillary
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Euro Surveillance, 2008; 13(7-9):1-5.
List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 878, as proposed to be amended elsewhere in
this issue of the Federal Register, be further amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
1. The authority citation for 21 CFR part 878 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add paragraph (d)(3) to Sec. 878.4850, under subpart E, to read as
follows:
Sec. 878.4850 Blood Lancets.
* * * * *
(d) * * *
(3) Date PMA or notice of completion of a PDP is required: A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before [A DATE WILL BE ADDED 90 DAYS
AFTER DATE OF PUBLICATION OF A FUTURE FINAL ORDER CALLING FOR PMAs IN
THE FEDERAL REGISTER OR 30 MONTHS AFTER DATE OF PUBLICATION OF A FUTURE
FINAL ORDER RECLASSSIFYING INTO CLASS III, WHICHEVER IS LATER] for any
multiple use blood lancet for multiple patient use described in
paragraph (d)(1) of this section that was in commercial distribution
before May 28, 1976, or that has, on or before [A DATE WILL BE ADDED 90
DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL ORDER CALLING FOR PMAs
IN THE FEDERAL REGISTER OR 30 MONTHS AFTER DATE OF PUBLICATION OF A
FUTURE FINAL ORDER RECLASSSIFYING INTO CLASS III, WHICHEVER IS LATER],
been found to be substantially equivalent to a multiple use blood
lancet for multiple patient use described in paragraph (d)(1) of this
section that was in commercial distribution before May 28, 1976. Any
other multiple use blood lancet for multiple patient use shall have an
approved PMA or a declared completed PDP in effect before being placed
in commercial distribution.
Dated: February 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04579 Filed 3-2-16; 8:45 am]
BILLING CODE 4164-01-P