Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 289 - RADIATION CONTROL
Subchapter G - REGISTRATION REGULATIONS
Section 289.301 - Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices
Universal Citation: 25 TX Admin Code § 289.301
Current through Reg. 49, No. 52; December 27, 2024
(a) Purpose.
(1) This section establishes requirements for
protection against all classes of laser radiation and intense-pulsed light
(IPL) device hazards. This section includes the responsibilities of the
registrant and the laser safety officer (LSO), laser and IPL device hazard
control methods, training requirements, and notification of injuries.
(2) For the purpose of this section, any
reference to a class of laser includes both International Electrotechnical
Commission (IEC) and United States Food and Drug Administration (FDA)
classifications, as appropriate.
(3) This section establishes requirements for
the registration of a person who receives, possesses, acquires, uses, or
transfers Class IIIb (3B), or Class IV (4) lasers in the healing arts,
veterinary medicine, and industrial, academic, research and development
institutions, and of a person in the business of providing laser services.
(A) A person must not use a Class 3B or Class
4 laser or perform laser services except as authorized in a certificate of
registration issued by the Texas Department of State Health Services
(department) as specified in this section.
(B) A person who receives, possesses, uses,
owns, or acquires a Class 3B or Class 4 laser before receiving a certificate of
registration is subject to the requirements of this chapter.
(4) Class I (1) lasers, Class II
(2) lasers, FDA Class IIIa (3a) lasers, IEC Class 3R lasers, and IPL devices
are not required to be registered. However, the use of Class 1, Class 2, Class
3a, Class 3R lasers, and IPL devices is subject to applicable requirements in
this section.
(b) Scope.
(1) Except as otherwise provided, this
section applies to a person who receives, possesses, acquires, transfers, or
uses lasers that emit or may emit laser radiation. Lasers or IPL devices must
not be used on humans or animals unless under the supervision of a licensed
practitioner of the healing arts (practitioner) or veterinary medicine and
unless the use of lasers or IPL devices is within the scope of their
professional license. This section does not limit the intentional exposure of
patients to laser or IPL device radiation for the purpose of diagnosis,
therapy, or treatment by a practitioner of the healing arts or veterinary
medicine within the scope of their professional license. This section does not
apply to the manufacture of lasers or IPL devices.
(2) This section applies to lasers operating
at wavelengths between 180 nanometers (nm) and 1 millimeter (mm).
(3) This section applies to IPL devices.
These devices must be Class 2 or Class 3 surgical devices certified as
complying with the designing, labeling, and manufacturing standards of the
FDA.
(4) This section applies to
lasers meeting the requirements of IEC standards 60825-1 and 60601-2-22 as
allowed by the FDA Centers for Devices and Radiological Health in the current
Laser Notice guidance document.
(5)
In addition to the requirements of this section, all registrants authorized to
use Class 3B and Class 4 lasers are subject to the following requirements:
(A)
§
289.203 of this chapter (relating
to Notices, Instructions, and Reports to Workers; Inspections) except for
subsection (d), "Notifications and reports to individuals," and information
relating to ionizing radiation or exposure history contained in subsection (i),
"Notice to employees."
(B)
§
289.204 of this chapter (relating
to Fees for Certificates of Registration, Radioactive Material Licenses,
Emergency Planning and Implementation, and Other Regulatory
Services);
(C)
§289.205 (a),
(b), and (h) - (n) of this chapter (relating to Hearing and Enforcement
Procedures); and
(D)
§289.231
(d), (f) - (j), (aa), (bb), (ff), (kk), and (ll)(1), (2), and (5) of this
chapter (relating to General Provisions and Standards for Protection Against
Machine-Produced Radiation) and the applicable definitions in §
289.231(c) of
this chapter.
(c) Prohibitions.
(1) The department prohibits the use of
lasers and IPL devices posing a significant threat or endangering occupational
or public health and safety as specified in §
289.205 and §
289.231 of this chapter.
(2) An individual must not be intentionally
exposed to laser or IPL radiation above the maximum permissible exposure (MPE)
unless a practitioner has authorized such exposure.
(A) Exposure of an individual for training,
demonstration, or other non-healing arts purposes is prohibited unless
authorized by a practitioner.
(B)
Exposure of an individual for the purpose of healing arts screening is
prohibited, except as specifically authorized by the department.
(C) Research and development using radiation
machines on humans is prohibited except for the following.
(i) Any research using radiation machines on
humans must be approved by an Institutional Review Board (IRB) as required by
45 Code of Federal Regulations (CFR) Part 46, and 21 CFR Part 56. The IRB must
include at least one physician to direct any laser radiation or IPL device use
as specified in subsection (b)(1) of this section.
(ii) Facilities with radiation machines, with
investigational device exemptions, involved in clinical studies must follow
regulations governing the conduct of clinical studies and applying to the
manufacturers, sponsors, clinical investigators, IRBs, and the medical device.
These regulations include:
(I) 21 CFR Part
812, Investigational Device Exemptions;
(II) 21 CFR Part 50, Protection of Human
Subjects;
(III) 21 CFR Part 56,
Institutional Review Boards;
(IV)
21 CFR Part 54, Financial Disclosure by Clinical Investigators; and
(V) 21 CFR Part 820, Subpart C, Design
Controls of the Quality System Regulation.
(d) Definitions. The following words and terms, when used in this section, have the following meanings, unless the context indicates otherwise.
(1) Access to laser radiation--Proximity to
radiation not blocked by an intervening barrier or filter.
(2) Accessible emission limit (AEL)--The
maximum accessible emission level permitted within a particular
class.
(3) Accessible laser
radiation--Proximity to radiation not blocked by an intervening barrier or
filter.
(4) American National
Standards Institute (ANSI) standards--Specific standards for lasers and IPL
devices published by the American National Standards Institute.
(5) Aperture--An opening through which
radiation can pass.
(6) Beam--A
collection of rays characterized by direction, diameter (or dimensions), and
divergence (or convergence).
(7)
Class 1 laser--Any laser not permitting human exposure during operation to
levels of visible laser radiation more than the accessible emission limits
contained in ANSI.
(8) Class 2
laser--Any laser permitting human exposure during operation to levels of
visible laser radiation more than the accessible emission limits of Class 1
lasers contained in ANSI but does not permit human exposure during operation to
levels of visible laser radiation more than the accessible emission limits of
Class 2 lasers contained in ANSI.
(9) Class 3a laser, IEC Class 3R--Any laser
permitting human exposure during operation to levels of laser radiation more
than the accessible emission limits of Class 2 lasers contained in ANSI but
does not permit human exposure during operation to levels of laser radiation
more than the accessible emission limits of Class 3a lasers contained in
ANSI.
(10) Class 3B laser--Any
laser permitting human exposure during operation to levels of laser radiation
more than the accessible emission limits of FDA Class 3a lasers in ANSI but
does not permit human exposure during operation to levels of laser radiation in
excess of the emission limits of Class 3B lasers contained in ANSI.
(11) Class 4 laser--Any laser permitting
human exposure during operation to levels of laser radiation more than the
accessible emission limits of Class 3B lasers contained in ANSI.
(12) Coherent--A light beam is coherent when
the electric vector at any point in it is related to any other point by a
definite, continuous function.
(13)
Collateral radiation--Any electromagnetic radiation, except laser radiation,
emitted by a laser that is physically necessary for its operation. The
applicable, accessible emission limits for collateral radiation are found in
21 CFR §
1040.10.
(14) Continuous wave--A laser operating with
a continuous output for greater than or equal to 0.25 seconds is regarded as a
continuous wave laser.
(15)
Controlled area--An area where the occupancy and activity of those within are
subject to control and supervision by the registrant for the purpose of
protection from radiation hazards.
(16) Divergence--The increase in the diameter
of the laser beam with propagation distance from the exit aperture. This is
also referred to as beam spread The value of the divergence is expressed in
radians or milliradians.
(17)
Electromagnetic radiation--Radiation consisting of electromagnetic waves,
including x-ray, ultraviolet, visible, infrared, and radio waves occupying
various portions of the electromagnetic spectrum and differing only in
frequency, wavelength, or photon energy.
(18) Electronic product--Any product or
article defined as follows:
(A) any
manufactured or assembled product, when in operation:
(i) contains or acts as part of an electronic
circuit; and
(ii) emits, or in the
absence of effective shielding or other controls would emit electronic product
radiation; or
(B) any
manufactured or assembled article intended for use as a component, part, or
accessory of a product described in subparagraph (A) of this paragraph and when
in operation emits, or in the absence of effective shielding or other controls
would emit radiation.
(19) Energy--The capacity for doing work.
Energy content is commonly used to characterize the output from pulsed lasers
and is expressed in joules (J).
(20) Engineering controls--Control measures
designed or incorporated into the laser or laser system (e.g., interlocks,
shutters, watchdog timer) or its application.
(21) Healing arts--Any system, treatment,
operation, diagnosis, prescription, cure, relief, palliation, adjustment, or
correction of any human disease, ailment, deformity, injury, or unhealthy or
abnormal physical or mental condition.
(22) Infrared radiation--The region of the
electromagnetic spectrum between the long-wavelength extreme of the visible
spectrum (about 0.7 micrometer (µm)) and the shortest microwaves (about 1
mm).
(23) Inoperable--Incapable of
operation because of damage, disassembly, removal, or inactivation of key
components that cannot be restored without significant repair or
renovation.
(24) Institutional
Review Board (IRB)--Any board, committee, or other group formally designated by
an institution to review, approve the initiation of, and conduct a periodic
review of biomedical research involving human subjects.
(25) Intense-pulsed light (IPL) device--A
device that emits radiation to energy density levels that could cause bodily
harm and used for photothermolysis. This device is a Class 2 or Class 3
surgical device certified as complying with FDA designing, labeling, and
manufacturing standards.
(26)
Invisible radiation--Laser or collateral radiation having wavelengths greater
than or equal to 180 nm but less than or equal to 400 nm or greater than 710 nm
but less than or equal to 1.0 x 106 nm (1
millimeter).
(27)
Irradiance--Radiant power incident per unit area upon a surface, expressed in
watts-per-square-centimeter (W-cm-2).
(28) Joule (J)--A unit of energy. One joule
is equal to one watt. second.
(29)
Laser--An electronic device that emits stimulated radiation to energy density
levels that could cause bodily harm. A laser may also produce an intense,
coherent, directional beam of light by stimulating electronic or molecular
transitions to lower energy levels. The term "laser" includes the assembly of
electrical, mechanical, and optical components associated with the laser. A
laser can be a component of a product or system.
(30) Laser light show--Use of lasers for
entertainment, advertising display, or artistic composition.
(31) Laser product--Any manufactured product
or assemblage of components constituting, incorporating, or intending to
incorporate a laser and is classified as a Class 1, Class 2, Class 3a, Class
3B, or Class 4 laser product according to the performance standards set by the
FDA. A laser intended for use as a component of an electronic product must be
considered a laser product. A laser product can contain an enclosed laser with
an assigned class number higher than the inherent capability of the laser
product in which it is incorporated and where the product's lower
classification is appropriate due to the engineering features limiting
accessible emission.
(32) Laser
safety officer (LSO)--An individual with knowledge of and the authority and
responsibility to apply appropriate laser radiation protection rules,
standards, and practices, and is specifically authorized on a certificate of
laser registration.
(33)
Manufacturer--Any person who designs, manufactures, assembles, fabricates, or
processes a finished laser device.
(34) Maximum permissible exposure (MPE)--The
level of laser radiation a person may be exposed to without hazardous effects
or adverse biological changes in the eye or skin. Maximum permissible exposures
to laser radiation may be found in ANSI.
(35) Medical event--Any adverse patient
health effect directly resulting from the use of laser equipment on an
individual.
(36) Mobile service
operation--The provision of lasers and personnel at temporary sites for limited
time periods. The lasers may be fixed inside a motorized vehicle or a portable
laser that can be removed from the vehicle and taken into a facility for
use.
(37) Nominal hazard zone
(NHZ)--The space where the level of direct, reflected, or scattered radiation
during operation exceeds the applicable MPE. Exposure levels beyond the
boundary of the NHZ are below the applicable MPE level.
(38) Optical density
(Dlambda)--The logarithm to the base ten of the
reciprocal of the transmittance. Dlambda =
-log10taulambda, where
taulambda is transmittance.
(39) Personal protective equipment
(PPE)--Device used to mitigate hazards associated with laser use, including
laser eye protection (LEP), protective clothing, and gloves.
(40) Practitioner--A person licensed under
Texas Occupations Code Title 3 Health Professions. A practitioner's use of a
laser is limited to the person's scope of professional practice as determined
by the appropriate licensing agency.
(41) Protective housing--An enclosure
surrounding the laser preventing access to laser radiation above the applicable
MPE level. The aperture through which the useful beam is emitted is not part of
the protective housing. The protective housing may enclose associated optics
and a workstation and must limit access to other associated radiant energy
emissions and to electrical hazards associated with components and
terminals.
(42) Provider of
lasers--A person providing lasers on a routine basis to a facility for limited
time periods.
(43) Pulse
duration--The duration of a laser pulse. This is measured as the time interval
between the half-power points on the leading and trailing edges of the laser
pulse.
(44) Pulsed laser--A laser
delivering its energy in the form of a single pulse or a train of pulses. In
this section, the duration of a pulse is less than 0.25 seconds.
(45) Reflection--The deviation of laser
radiation following incidence on a surface.
(46) Source--A laser or a laser-illuminated
reflecting surface.
(47)
Supervision--Delegating to a person under the practitioner's authority, the
task of applying laser radiation to persons or animals under this section. The
practitioner assumes full responsibility for these tasks and must ensure the
tasks are administered correctly.
(48) Transmission--Passage of laser radiation
through a medium.
(49) Ultraviolet
radiation--Electromagnetic radiation with wavelengths shorter than those of
visible radiation; for this section, 0.18 to 0.4 µm.
(50) Veterinarian--A person licensed as a
veterinarian by the Texas Board of Veterinary Medical Examiners.
(51) Veterinary medicine--When used in this
chapter, has the same meaning as found in Texas Occupations Code Chapter
801.
(52) Visible radiation
(light)--Electromagnetic radiation that can be detected by the human eye. This
term is commonly used to describe wavelengths in the range of 0.4 to 0.7
µm.
(53) Watt--The unit of
power or radiant flux. 1 watt equals 1 joule per second.
(54) Wavelength
(lambda)--The distance between two successive points on
a periodic wave having the same phase.
(e) Exemptions.
(1) Lasers in storage or transit are exempt
from the requirements of this section. This exemption does not apply to the
providers of lasers.
(2) Inoperable
lasers are exempt from the requirements of this section.
(3) Class 1, Class 2, and Class 3a lasers,
IEC Class 3R lasers, or products and IPL devices are exempt from the
registration requirements of subsections (f) and (g) of this section.
(4) Facilities, including academic
institutions and research or development facilities, registered for the use of
lasers are exempt from the registration requirements of subsection (f) of this
section, regarding laser services, and the applicable paragraphs of subsection
(g) of this section, to the extent their personnel perform laser services only
for the registrant by whom they are employed.
(f) Registration for the use of Class 3B and Class 4 lasers and laser services.
(1) For
purposes of this section, use of Class 3B or Class 4 lasers and laser services
includes:
(A) possession and use of lasers in
the healing arts, veterinary medicine, industry, academics, and research and
development institutions;
(B)
demonstration or sale of lasers requiring the person to operate or cause a
laser to be operated to demonstrate or sell;
(C) provision of lasers on a routine basis to
a facility for limited time periods by a provider of lasers. For healing arts
facilities, the use of lasers must be directed by a practitioner employed by
the contracting facility;
(D)
alignment, calibration, installation, or repair; or
(E) laser light shows.
(2) A person who applies for registration as
specified in this section and uses a Class 3B or Class 4 laser before receiving
a certificate of laser registration is subject to the requirements of this
chapter.
(g) Application requirements.
(1) General application
requirements.
(A) Application for certificate
of laser registration must be completed on forms prescribed by the department
and must contain all the information required by the form and accompanying
instructions.
(B) An LSO must be
designated on each application form. The qualifications of that individual must
be submitted to the department with the application. The LSO must meet the
applicable requirements of subsection (o) of this section and carry out the
responsibilities of subsection (p) of this section.
(C) Each application must be accompanied by a
completed RC Form 226-01 (Business Information Form), which must contain the
legal name of the entity or business. Unless exempt under Texas Business and
Commerce Code Chapter 71, the applicant must:
(i) be authorized to conduct business in the
State of Texas as listed on the Texas Secretary of State (SOS) website;
and
(ii) file an assumed name
certificate with the Texas SOS if using an assumed name in their
application.
(D) Each
application for a certificate of laser registration must be accompanied by the
appropriate fee prescribed in §
289.204 of this chapter.
(E) An application for a certificate of laser
registration may include a request for authorization of one or more
activities.
(F) At any time after
filing the original application, the department may require further information
to determine whether the certificate of laser registration will be issued or
denied.
(G) Applications and
documents submitted to the department may be made available for public
inspection, except the department may withhold any document or part of a
document from public inspection as specified in §
289.231(aa) of
this chapter.
(2)
Application for the use of Class 3B or Class 4 lasers on humans or animals.
(A) In addition to the requirements of
subsection (g)(1) of this section, each person having a Class 3B or Class 4
laser for use in the healing arts or for use on animals must submit an
application to the department within 30 days after beginning operation of the
laser.
(B) Application signatures.
(i) An application for healing arts use must
be signed by a practitioner.
(ii)
An application for veterinary medicine use must be signed by a licensed
veterinarian.
(iii) The signature
of the administrator, president, or chief executive officer will be accepted
instead of the practitioner's signature if the facility is a licensed hospital
or a medical facility.
(iv) A
signature by the administrator, president, or chief executive officer does not
relieve the practitioner or veterinarian from following the requirements of
this section. The LSO must also sign the application.
(C) If a person is furnished a Class 3B or
Class 4 laser by a provider of lasers, that person is responsible for ensuring
a practitioner authorizes intentional exposure of laser radiation to
humans.
(D) The applicant must
ensure a laser machine is operated by a person qualified by training and
experience to use the laser machine for the purpose requested, and in a manner
minimizing danger to occupational and public health and safety.
(3) Application for the use of
Class 3B or Class 4 lasers in industrial, academic, and research and
development institutions.
(A) In addition to
the requirements of subsection (g)(1) of this section, each person having a
laser for use in industrial, academic, and research and development
institutions must apply to the department within 30 days after beginning
operation of the laser.
(B) An
application for the use of Class 3B or Class 4 lasers in industrial, academic,
and research and development institutions must be signed by the applicant or
registrant or a person duly authorized to act on behalf of the applicant or
registrant. The LSO must also sign the application.
(4) Application for registration of laser
services.
(A) In addition to the requirements
of subsection (g)(1) of this section, an applicant who intends to provide laser
services described in subsection (f)(1) of this section must apply and receive
a certificate of registration from the department before providing the
services.
(B) An application for
laser services must be signed by the applicant, registrant, or a person duly
authorized to act on behalf of the applicant or registrant. The LSO must also
sign the application.
(C) Providing
services specified in subsection (f)(1) of this section, not specifically
authorized by the department, is prohibited.
(D) A service provider must not provide laser
machine services for a person who cannot produce evidence of a completed
registration application or a valid certificate of registration issued by the
department, except for the initial installation of the first machine for a new
certificate of registration.
(5) Application for laser light show.
(A) Each applicant must receive a certificate
of laser registration for a laser light show before beginning any
show.
(B) An application to use
Class 3B or Class 4 lasers in a laser light show must be signed by the
applicant, registrant, or a person duly authorized to act on behalf of the
applicant or registrant. The LSO must also sign the application.
(C) According to subparagraph (A) of this
paragraph and in addition to the requirements of subsection (g)(1) of this
section, each applicant must submit:
(i) a
valid variance issued by the FDA, or evidence of an Annual Report on Radiation
Safety Testing of Laser and Laser Light Show Products meeting FDA variance
requirements, for the laser intended to be used, with all applicable documents
required by the variance; and
(ii)
a written notice of the laser light show to be performed in Texas. The
information contained in RC Form 301-05 must be provided at least seven days
before each show. If, in a specific case, the seven-day period would impose an
undue hardship on the applicant, the applicant may, upon written request to the
department, obtain permission to proceed sooner.
(6) Application for mobile service
operation for Class 3B or Class 4 lasers used in the healing arts and
veterinary medicine.
(A) Each applicant must
apply for and receive a certificate of laser registration for mobile service
operation involving Class 3B or Class 4 lasers before beginning mobile service
operation.
(B) In addition to the
requirements of subsection (g)(1) of this section, each applicant must submit
the address of the established main location where the laser and records will
be maintained for inspection. This must be a physical street address, not a
post office box number.
(C) An
application for mobile service operation for the healing arts must be signed by
a practitioner and an application for mobile services for veterinary medicine
must be signed by a licensed veterinarian. The LSO must also sign the
application.
(h) Issuance of certificate of laser registration.
(1) A certificate of
registration application will be approved if the department determines an
application meets the Texas Radiation Control Act (Act) requirements and the
requirements of this chapter. The certificate of registration authorizes the
proposed activity and contains the conditions and limitations the department
requires. The certificate of laser registration must be maintained as specified
in subsection (cc) of this section.
(2) The department may incorporate in the
certificate of laser registration at the time of issuance, or by amendment,
additional requirements and conditions concerning the registrant's receipt,
possession, acquisition, use, and transfer of lasers subject to this section,
as it deems appropriate or necessary to:
(A)
minimize danger to occupational and public health and safety;
(B) prevent loss or theft of lasers;
or
(C) require additional reports
and maintenance records as may be appropriate or necessary.
(3) At the request of the
department the registrant must provide additional information after the
certificate of laser registration has been issued for the department to
determine whether the certificate of laser registration will be modified in
accordance with subsection (n) of this section.
(i) Specific terms and conditions of certificates of laser registration.
(1) Each
certificate of laser registration issued as specified in this section is
subject to the applicable provisions of the Act and the applicable rules in
this chapter and orders issued by the department.
(2) Each person registered by the department
for laser use as specified in this section must confine use and possession of
the laser registered to the locations and purposes authorized in the
certificate.
(3) A certificate of
laser registration issued under this section must not be transferred, assigned,
or in any manner disposed of, either voluntarily or involuntarily, to any
person unless the department authorizes the transfer, in writing.
(4) In determining whether to issue, deny,
amend, renew, revoke, suspend, or restrict a certificate of laser registration,
the department may consider the technical competence and compliance history of
an applicant or holder of a certificate of laser registration.
(5) After an opportunity for a hearing, the
department will deny an application, amendment, or renewal of a certificate of
laser registration if the applicant's compliance history reveals, within the
previous six years, three or more actions have been issued against the
applicant assessing administrative or civil penalties, or revoking or
suspending a certificate of laser registration.
(j) Registrant responsibilities.
(1) The registrant is responsible for
complying with this section and the conditions listed on the certificate of
registration.
(2) The registrant
must designate a qualified individual as the LSO as specified in subsection (o)
of this section and ensure the individual continually performs the
responsibilities of the LSO as identified in subsection (p) of this
section.
(3) A person must not
make, sell, lease, transfer, or lend lasers unless the machine and equipment,
when properly placed in operation and used, meet the applicable requirements of
this section.
(4) The registrant
must notify the department in writing within 30 days of a change in any of the
following:
(A) name and mailing
address;
(B) street address where
laser will be used;
(C) LSO;
or
(D) additional use
location.
(5) Each
registrant must inventory all Class 3B and Class 4 lasers in their possession
at an interval not to exceed 12 months. The inventory record must be maintained
for inspection by the department as specified in subsection (cc) of this
section and must include:
(A) the
manufacturer's name;
(B) the model
and serial number of the laser;
(C)
a description of the laser (for example, yag, silicon, CO2
, neon);
(D) the
location of the laser (for example, room number); and
(E) a complete inventory of equipment
supplied by a provider of lasers as defined in subsection (d)(42) of this
section.
(6)
Notification to the department is required within 30 days of:
(A) any increase in the number of lasers
above those authorized by the certificate of laser registration; or
(B) any change in the category of the machine
type or type of use as specified in §289.231(ll) or as authorized on the
certificate of registration.
(7) The registrant, or the parent company,
must notify the department, in writing, immediately following the filing of a
voluntary or involuntary petition for bankruptcy. The notification must
include:
(A) the name of the bankruptcy court;
and
(B) the case name, and number,
when known, and the date the petition was filed.
(8) A registrant must not engage a person for
services described in subsection (f)(1) of this section until the service
provider demonstrates current registration with the department.
(9) Registrants with certificates of laser
registration as specified in subsection (g)(5) of this section must have the
following documents on site at each laser light show:
(A) certificate of laser
registration;
(B) FDA variance, or
evidence of Annual Report on Radiation Safety Testing of Laser and Laser Light
Show Products meeting FDA variance requirements, with all applicable documents
required by the variance; and
(C)
instructions for the safe use of lasers as specified in subsection (q)(2) of
this section.
(10) Each
registrant must maintain records of receipt, transfer, and disposal of Class 3B
or Class 4 lasers for inspection by the department. The records must include
the following information and be maintained as specified in subsection (cc) of
this section:
(A) manufacturer's
name;
(B) model and serial number
of the laser;
(C) date of the
receipt, transfer, and disposal;
(D) name and address of the person the laser
was received from, transferred to, or disposed by; and
(E) name of the person recording the
information.
(11) A
laser must not be used unless an application for registration is filed with the
department, as specified in subsection (g) of this section, within the first 30
days of use. This section does not apply to operation of a laser for
installation and calibration.
(12)
A service provider must not provide laser services for a person who cannot
produce evidence of a completed application for registration or a valid
certificate of registration issued by the department, except for:
(A) the initial installation of the first
machine for a new certificate of registration; and
(B) the registrant authorized for
demonstration and sale, demonstrates a laser machine as specified in paragraph
(15) of this subsection.
(13) A person authorized to perform
alignment, calibration, installation, and repair of lasers in Texas must
maintain:
(A) a daily log including:
(i) date of service;
(ii) name and address of the customer;
and
(iii) customer's certificate of
registration number, unless the service provided is an initial installation as
described in paragraph (12)(A) of this subsection; and
(B) records of all services for inspection by
the department as specified in subsection (cc) of this section.
(14) A person authorized to
provide lasers must comply with the following.
(A) Providers of equipment must:
(i) ensure all lasers used on humans meet the
requirements of this chapter;
(ii)
provide lasers only to facilities holding a valid certificate of registration;
and
(iii) keep a log of lasers
provided in Texas, and record the following information:
(I) date machine provided;
(II) name of customer; and
(III) customer's certificate of registration
number.
(B)
Records of machines provided must be made and maintained for inspection by the
department as specified in subsection (cc) of this section.
(15) A person authorized to
demonstrate and sell lasers in Texas must comply with the following.
(A) Maintain a log including:
(i) date of all demonstrations and sales of
lasers performed in Texas;
(ii)
name and address of the customer; and
(iii) customer's certificate of registration
number unless the service provided is an initial demonstration as described in
paragraph (12)(B) of this subsection.
(B) Prevent exposure of individuals to a
laser except for healing arts purposes and unless a licensed practitioner of
the healing arts has authorized such exposure. This provision specifically
prohibits the deliberate exposure of an individual for training, demonstrating,
or other non-healing arts purposes.
(C) Demonstrate lasers on phantoms
only.
(D) Document all tests
required by this section when a demonstration of a laser involves exposure
specifically and individually ordered by a practitioner.
(E) Records of demonstrations and sales must
be made and maintained for inspection by the department as specified in
subsection (cc) of this section.
(16) A person using loaner laser machines
must comply with the following.
(A) For a
person having a valid certificate of registration, loaner radiation machines
may be used for up to 30 days. Within 30 days, the registrant must:
(i) notify the department of a change in the
category of the machine type or type of use as specified in §
289.231(ll) of
this title and as authorized in the certificate of registration; or
(ii) notify the department of any increase in
the number of machines beyond those authorized by the certificate of
registration in any machine type or type of use category.
(B) For a person who does not hold a valid
certificate of registration, a loaner laser may be used for human use for up to
30 days, by or under the direction of a practitioner, before applying for a
certificate of registration as specified in subsection (g) of this section.
This does not include mobile services.
(k) Expiration of certificates of laser registration.
(1) Except as provided by
subsection (m) of this section, a certificate of laser registration expires at
11:59 p.m. Central Time in the month and year stated in the certificate of
laser registration.
(2) If a
registrant does not submit an application for renewal of the certificate of
laser registration as specified in subsection (m) of this section, as
applicable, the registrant must, before the expiration date specified in the
certificate of laser registration, terminate use of all lasers and laser
services as specified in subsection (l) of this section.
(3) The expiration of the certificate of
laser registration does not relieve the registrant of the requirements of this
chapter.
(l) Termination of certificates of laser registration.
(1)
When a registrant decides to terminate all activities involving laser or laser
services authorized under the certificate of laser registration, the registrant
must immediately:
(A) request termination of
the certificate of laser registration in writing, signed by the LSO, owner, or
a person authorized to act on behalf of the registrant; and
(B) submit to the department a record of the
disposition of the laser, and, if applicable, include if the laser was
transferred and to whom it was transferred.
(2) The registrant must pay any outstanding
fees as specified in §
289.204 of this chapter.
(m) Renewal of certificate of laser registration.
(1) An application for
renewal of a certificate of laser registration must be filed as specified in
subsection (g)(1)(A) - (G) and (g)(2) of this section.
(2) If a registrant applies for a renewal
before the existing certificate of laser registration expires, the existing
certificate of laser registration does not expire until the application status
has been determined by the department.
(n) Modification, suspension, and revocation of certificates of laser registration.
(1) The
terms and conditions of all certificates of laser registration are subject to
revision or modification.
(2) Any
certificate of laser registration may be revoked, suspended, or modified, in
whole or in part for:
(A) any materially false
statement in the application or any false statement of fact required by the
Act;
(B) information received by
the department indicating a certificate of laser registration should not be
issued;
(C) violation of, or
failure to observe any of the terms and conditions of the Act, this chapter, or
of the certificate of laser registration, or order of the department or a
court; or
(D) existing conditions
threatening occupational safety, public health and safety, or the
environment.
(3) Except
in cases in which occupational and public health or safety requires otherwise,
a registrant will be notified, in writing, of the department's intent to
suspend or revoke a certificate of registration and be provided an opportunity
to demonstrate compliance before proceedings to suspend or revoke
begin.
(o) LSO qualifications. LSO qualifications must be submitted to the department and include:
(1) education related to laser
radiation safety or a laser safety officer course; or
(2) experience in the use and familiarity of
the type of equipment or services registered; and
(3) knowledge of potential laser radiation
hazards, laser emergency situations, and the appropriate response to an
injury.
(p) LSO duties. The LSO must:
(1) ensure users of lasers are
trained in laser safety, as applicable for the class and type of lasers
used;
(2) assume control and have
the authority to institute corrective actions to include the shutdown of
operations, when necessary, in emergencies or unsafe conditions;
(3) specify whether any changes in control
measures are required after:
(A) any service
and maintenance of lasers affecting the output power or operating
characteristics; or
(B) a
deliberate modification is made that could change the laser class and affect
the output power or operating characteristics;
(4) ensure maintenance and other practices
required for the safe operation of the laser are performed;
(5) ensure the proper use of protective
eyewear and other safety measures; and
(6) ensure compliance with the requirements
in this section, the conditions of the certificate of laser registration, and
any engineering or operational controls specified by the registrant.
(q) Requirements for protection against Class 3B or Class 4 lasers and IPL device radiation. These requirements are for Class 3B or Class 4 lasers and IPL devices in their intended mode of operation and include special requirements for service, testing, maintenance, and modification. During some operations, certain engineering controls may be inappropriate. When an engineering control may be inappropriate, for example, during medical procedures or surgery, the LSO must specify alternate controls to obtain equivalent safety protection.
(1)
MPE. A registrant or user of any laser may not permit any individual to be
exposed to levels of laser or collateral radiation higher than are specified in
ANSI and 21 CFR §
1040.10, respectively.
(2) Instructions to personnel. Personnel
using a laser must be provided with written instructions for safe use,
including clear warnings and precautions to avoid possible exposure to laser
and collateral radiation more than the MPE, as specified in ANSI and the
collateral limits listed in 21 CFR §
1040.10. The
instructions to personnel must be maintained as specified in subsection (cc) of
this section for inspection by the department.
(3) Engineering controls.
(A) Protective housing.
(i) Each laser must have a protective housing
preventing human exposure during the operation to laser and collateral
radiation that exceeds the limits of Class 1 lasers as specified in ANSI and
21 CFR §
1040.10, if human exposure is not necessary
for the laser to perform its intended function.
(ii) If human exposure to laser radiation
levels more than the limits of Class 1 is necessary, these levels must not
exceed the limits of the lowest laser class required to perform the intended
function.
(B) Safety
interlocks.
(i) A safety interlock ensuring
radiation is not accessible above MPE limits as specified in ANSI must be
provided for any portion of the protective housing that, by design, can be
removed or displaced during normal operation or maintenance, and thereby allows
exposure to radiation above the MPE limits.
(ii) Adjustment during operation, service,
testing, or maintenance of a laser containing interlocks must not cause the
interlocks to become inoperative or the radiation to exceed MPE limits outside
protective housing except where a laser controlled area as specified in
subparagraph (E) of this paragraph is established.
(iii) For pulsed lasers, interlocks must be
designed to prevent the firing of the laser; for example, by dumping the stored
energy into a dummy load.
(iv) For
continuous wave lasers, the interlocks must turn off the power supply or
interrupt the beam; for example, by using shutters.
(v) An interlock must not allow automatic
accessibility of radiation emission above MPE limits when the interlock is
closed.
(vi) Either multiple safety
interlocks or a means to preclude removal or displacement of the interlocked
portion of the protective housing upon interlock failure must be provided if
failure of a single interlock would allow the following:
(I) human exposure to levels of laser
radiation more than the accessible emission limit of FDA Class 3a laser
radiation; or
(II) laser radiation
more than the accessible emission limits of Class 2 emitted directly through
the opening created by removing or displacing that portion of the protective
housing.
(C)
Viewing optics and windows.
(i) All viewing
ports, viewing optics, or display screens included as an integral part of an
enclosed laser or laser product must incorporate suitable means such as
interlocks, filters, or attenuators to maintain the laser radiation at the
viewing position at or below the applicable MPE as specified in ANSI and the
collateral limits listed in 21 CFR §
1040.10, under any
conditions of operation or use of the laser.
(ii) All collecting optics, such as lenses,
telescopes, microscopes, or endoscopes, intended for viewing use with a laser
must incorporate suitable means such as interlocks, filters, or attenuators to
maintain the laser radiation transmitted through the collecting optics to
levels at or below the appropriate MPE, as specified in ANSI. Normal or
prescription eyewear is not considered collecting optics.
(D) Warning systems. Each Class 3B or Class 4
laser or laser product must provide visual or audible indication during the
emission of accessible laser radiation. In the case of Class 3B lasers, except
those only allowing access to less than 5 milliwatt (mW) peak visible laser
radiation, and Class 4 lasers, the indication must be sufficient before
emission of such radiation to allow appropriate action to avoid exposure. Any
visual indicator must be visible through protective eyewear designed
specifically for the wavelength of the emitted laser radiation. If the laser
and laser energy source are housed separately and can be operated at a
separation distance of greater than two meters, both laser and laser energy
source must incorporate visual or audible indicators. The visual indicators
must be positioned so viewing does not require human exposure to laser
radiation more than the MPE, as specified in ANSI.
(E) Controlled area. With a Class 3B laser,
except those only allowing access to less than 5 mW visible peak power, or
Class 4 laser, a controlled area must be established when exposure to the laser
radiation more than the MPE, as specified in ANSI or the collateral limits
listed in 21 CFR §
1040.10, is possible. The controlled area
must meet the following requirements, as applicable.
(i) The area is posted with hazard signs as
required by subsection (u) of this section.
(ii) Access to the controlled area is
restricted.
(iii) For Class 4
indoor controlled areas, latches, interlocks, or other appropriate means are
used to prevent unauthorized entry into controlled areas.
(I) Such measures are designed to allow rapid
exit by laser personnel and allow admittance to the controlled area for
emergency personnel. For such emergency conditions, a control-disconnect switch
or equivalent device (panic button) must be available for deactivating the
laser.
(II) Where safety latches or
interlocks are not feasible or are inappropriate, for example, during medical
procedures, such as surgery, the following applies.
(-a-) All authorized personnel are trained in
laser safety, and appropriate PPE is provided upon entry.
(-b-) A door, blocking barrier, screen, or
curtains is used to block, screen, or attenuate the laser radiation at the
entryway. The level at the exterior of these devices cannot be more than the
applicable MPE, as specified in ANSI.
(-c-) Within the laser controlled area, there
is a visible or audible signal indicating the laser is energized and operating
at Class 4 levels. A lighted laser warning sign, flashing light (visible
through laser protective eyewear), and other appropriate signage are methods to
accomplish this requirement.
(iv) For Class 4 indoor controlled areas,
during tests requiring continuous operation, the person in charge of the
controlled area is permitted to momentarily override the safety interlocks to
allow access by other authorized personnel if it is evident there is no optical
radiation hazard at the point of entry, and if the necessary protective devices
are being worn by the entering personnel.
(v) For Class 4 indoor controlled areas,
optical paths (for example, windows) from an indoor facility must be controlled
to reduce the transmitted values of the laser radiation to levels at or below
the appropriate ocular MPE, as specified in ANSI and the collateral limits
listed in 21 CFR §
1040.10. When the laser beam must exit the
indoor controlled area (as in the case of exterior atmospheric beam paths), the
operator is responsible for ensuring air traffic is protected from any laser
projecting into navigable air space (contact Federal Aviation Administration
(FAA) or other appropriate agencies, as necessary) or controlled ground space
when the beam irradiance or radiant exposure is above the appropriate MPE, as
specified in ANSI.
(vi) When the
removal of panels or protective covers or overriding of interlocks becomes
necessary, such as for servicing, testing, or maintenance, and accessible laser
radiation exceeds the MPE, as specified in ANSI and the collateral limits
listed in 21 CFR §
1040.10, a temporary controlled area must be
established and posted.
(4) Key control. Each Class 3B or Class 4
laser and IPL device must incorporate a key-actuated or computer-actuated
primary control. The key must be removable, and the Class 3B or Class 4 laser
or IPL device must not be operable when the key is removed. When the device is
not being prepared for operation or is unattended, the key must be removed from
the device and stored in a location away from the machine.
(r) Additional requirements for special lasers and applications.
(1) Infrared laser.
The beam from a laser must be terminated in fire-resistant material, where
necessary. Inspection intervals of absorbent material and actions to be taken
in the event of degradation must be specified in the operating and safety
procedures.
(2) Laser optical fiber
transmission system.
(A) Laser transmission
systems employing optical cables are considered enclosed systems with the
optical cable forming part of the protective housing.
(B) Disconnection of a connector resulting in
exposure to radiation more than the applicable MPE limits, as specified in ANSI
and the collateral limits listed in
21 CFR §
1040.10, must take place in a controlled
area. Except for medical lasers whose manufacture has been approved by the FDA,
the use of a tool is required for the disconnection of a connector for service
and maintenance purposes when the connector is not within a secured enclosure.
All connectors must bear the appropriate label or tag as specified in
subsection (u)(3) of this section.
(s) Additional requirements for safe operation.
(1) Eye protection. Protective
eyewear must be worn by each individual exposed to laser radiation from IPL,
Class 3B, or Class 4 levels of laser radiation. Protective eyewear devices must
meet the following requirements:
(A) provide a
comfortable and appropriate fit all around the area of the eye;
(B) be in proper condition to ensure the
optical filter and holder provide the required optical density or greater at
the desired wavelengths, and retain all protective properties during its
use;
(C) be suitable for the
specific wavelength of the laser and be of optical density adequate for the
energy involved;
(D) have the
optical density or densities and associated wavelength permanently labeled on
the filters or eyewear; and
(E) be
examined, at intervals not to exceed 12 months, to ensure the reliability of
the protective filters and integrity of the protective filter frames.
Unreliable eyewear must be discarded. Documentation of the examination is
required to be maintained as specified in subsection (cc) of this section for
inspection by the department.
(2) Skin protection. When there is a
possibility of exposure to laser radiation more than the MPE limits for skin as
specified in ANSI the registrant must require the use of appropriate
PPE.
(t) NHZ. Where applicable, in the presence of unenclosed Class 3B and Class 4 laser beam paths, an NHZ must be established. If the beam of an unenclosed Class 3B and Class 4 laser is contained within a region by adequate control measures to protect personnel from exposure to levels of radiation more than the MPE, as specified in ANSI, that region is the NHZ. The NHZ may be determined by information supplied by the laser manufacturer, by measurement, or by using the appropriate laser range equation or other equivalent assessment.
(u) Hazard signs, labels, and posting for lasers and IPL devices.
(1) General
requirements. Except as otherwise authorized by the department, signs, symbols,
and labels prescribed by this section must use the design and colors as
specified in paragraph (3) of this subsection.
(2) Posting. The laser controlled area must
be conspicuously posted with a sign or signs as specified in paragraph (3) of
this subsection.
(3) Labeling
lasers and posting laser facilities. All signs and labels associated with Class
2, 3a, 3B, and 4 lasers must contain the following wording or sign posting
requirements found in ANSI.
(A) Danger sign.
(i) The signal word "DANGER" indicating death
or serious injury will occur if required control measures are not implemented
to mitigate the hazards within the laser controlled area. This signal word is
restricted to those Class 4 lasers with high (e.g., multi-kilowatt) output
power or pulse energies with exposed beams.
(ii) The danger sign must include:
(I) The signal word "DANGER" in white letters
on a rectangular safety red background placed at the top of the sign.
(II) "Class 4 Laser Controlled
Area."
(III) "Avoid eye or skin
exposure to direct or scattered radiation."
(IV) "Laser eye protection required," and
include:
(-a-) optical density;
(-b-) laser type;
(-c-) wavelength; and
(-d-) wattage.
(iii) The safety alert symbol must
precede the signal word.
(I) The base of the
symbol must be on the same horizontal line as the base of the letter of the
signal word.
(II) The height of the
safety alert symbol must be equal to or exceed the signal word letter
height.
(III) The words "Avoid eye
or skin exposure to direct or scattered radiation" must appear to the right of
the safety alert symbol.
(iv) The following sign meets the
requirements of this subparagraph.
(B) Warning sign.
(i) The signal word "WARNING" must be used
with all signs and labels associated with lasers and laser systems whose output
is more than the applicable MPE for irradiance, including all Class 3B and most
Class 4 lasers and laser systems.
(ii) The warning sign must include:
(I) The signal word "WARNING" in black
letters on a rectangular orange background placed at the top of the
sign.
(II) "Class 4 Laser
Controlled Area."
(III) "Avoid eye
or skin exposure to direct or scattered radiation."
(IV) "Do not enter when light is
illuminated."
(V) "Laser eye
protection required," and include:
(-a-)
optical density;
(-b-) laser
type;
(-c-) wavelength;
and
(-d-) wattage.
(iii) The safety alert
symbol must precede the signal word.
(I) The
base of the symbol must be the same horizontal line as the base of the letter
of the signal word.
(II) The height
of the safety alert symbol must be equal to or exceed the signal word letter
height.
(III) The words "Avoid eye
or skin exposure to direct or scattered radiation" must appear to the right of
the safety alert symbol.
(iv) The following sign meets the
requirements of this subparagraph.
(C) Caution sign.
(i) The signal word "CAUTION" must be used
with all signs and labels associated with Class 2 and Class 2M lasers and laser
systems not more than the applicable MPE for irradiance.
(ii) The caution sign must include:
(I) The signal word "CAUTION" in black
letters on a rectangular yellow background placed at the top of the
sign.
(II) "Class 2M Laser In
Use."
(III) "Do not stare into beam
or view directly with optical instruments," and include:
(-a-) optical density, if provided by the
manufacturer;
(-b-) laser
type;
(-c-) wavelength;
and
(-d-) wattage.
(iii) The safety alert
symbol must precede the signal word.
(I) The
base of the symbol must be on the same horizontal line as the base of the
letters of the signal word.
(II)
The height of the safety alert symbol must be equal to or exceed the signal
word letter height.
(III) The words
"Do not stare into beam or view directly with optical instruments" must appear
to the right of the safety alert symbol.
(iv) The following sign meets the
requirements of this subparagraph.
(D) Lasers, except a laser used in the
practice of medicine or veterinary medicine, must have a label in close
proximity to each aperture emitting accessible laser or collateral radiation in
excess of the limits specified in ANSI and the collateral limits listed in
21 CFR §
1040.10, labeled with the following as
applicable:
(i) "AVOID EXPOSURE - Laser
radiation is emitted from this aperture," if the radiation emitted through the
aperture is laser radiation;
(ii)
"AVOID EXPOSURE - Hazardous electromagnetic radiation is emitted from this
aperture," if the radiation emitted through the aperture is collateral
radiation; or
(iii) "AVOID EXPOSURE
- Hazardous x-rays are emitted from this aperture," if the radiation emitted
through the aperture is collateral x-ray radiation.
(E) Each defeatable or non-interlocked
portion of the protective housing or enclosure designed to be displaced or
removed during normal operation or servicing that permits human exposure to
laser or collateral radiation must have the following label:
(i) for Class 3B accessible laser radiation,
the wording, "DANGER - LASER RADIATION WHEN OPEN. AVOID DIRECT EXPOSURE TO
BEAM";
(ii) for Class 4 accessible
laser radiation, the wording, "DANGER - LASER RADIATION WHEN OPEN. AVOID EYE OR
SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION"; or
(iii) for collateral radiation more than the
emission limits as specified in
21 CFR §
1040.10, "CAUTION - HAZARDOUS ELECTROMAGNETIC
RADIATION WHEN OPEN" and "CAUTION - HAZARDOUS X-RAY RADIATION" as
applicable.
(F) For
protective housing or enclosures providing a defeatable interlock, the words
"and interlock defeated" must be included in the labels as specified in
subparagraph (E)(i) and (ii) of this paragraph.
(G) Other required information.
(i) The word "invisible" must immediately
precede the word "radiation" on labels and signs required by this subparagraph
for wavelengths of laser and collateral radiation outside of the range of 400
to 700 nm.
(ii) The words "visible
and invisible" must immediately precede the word "radiation" on labels and
signs required by this subparagraph for wavelengths of laser and collateral
radiation both within and outside the range of 400 to 700 nm.
(H) Labels and signs required by
this subparagraph must be clearly visible, legible, and permanently attached to
the laser or facility.
(4) In lieu of the requirements in paragraphs
(1) - (3) of this subsection, the department will accept labeling and signage
as specified by:
(A)
21 CFR §
1040.10;
(B) ANSI; and
(C) IEC standards 60825-1 and
60601-2-22.
(v) Surveys. Each registrant must conduct surveys necessary to comply with this section and maintain records of the surveys as specified in subsection (cc) of this section for inspection by the department. Surveys must be performed at intervals not to exceed 12 months, and include:
(1) a determination if all laser and
IPL protective devices are labeled correctly, functioning within the design
specifications, and properly chosen for lasers and IPL devices in
use;
(2) a determination if all
warning devices are functioning within their design specifications;
(3) a determination if the controlled area is
properly controlled and posted with accurate warning signs as specified in
subsection (u) of this section;
(4)
a re-evaluation of potential hazards from surfaces associated with beam paths;
and
(5) additional surveys to
evaluate the primary and collateral radiation hazard incident to the use of
lasers and IPL devices.
(w) Records or documents. Each registrant must maintain current records or documents required by this subsection as specified in subsection (cc) of this section for inspection by the department.
(x) Measurements and instrumentation. Each determination requiring a measurement for compliance with this section must use instrumentation calibrated and designed for use with the laser or IPL device to be tested. Records of measurements and instrumentation must be maintained as specified in subsection (cc) of this section.
(y) Notification of injury other than a medical event.
(1) Each registrant of Class 3B
or Class 4 lasers or user of an IPL device must immediately seek appropriate
medical attention for the injured individual and notify the department by
telephone of any injury involving a laser possessed by the registrant or an IPL
device, other than intentional exposure of patients for medical purposes, that
has or may have caused:
(A) an injury to an
individual involving the partial or total loss of sight in either eye;
or
(B) an injury to an individual
involving intentional perforation of the skin or other serious injury excluding
eye injury.
(2) Each
registrant of Class 3B or Class 4 lasers or user of an IPL device must, within
24 hours of the discovery of an injury, notify the department of any injury
involving a laser possessed by the registrant or IPL device possessed by a
user, as applicable, other than intentional exposure of patients for medical
purposes, that has or may have caused, or threatens to cause, exposure to an
individual with second or third-degree burns to the skin or potential injury
and partial loss of sight. Record of a notification of injury must be
documented and maintained as specified in subsection (cc) of this
section.
(z) Reports of injuries.
(1) Each registrant of Class 3B or
Class 4 lasers or user of an IPL device must make a report, in writing, or by
electronic transmittal, within 30 days to the department of any injury required
to be reported as specified in subsection (y) of this section.
(2) Each report must describe:
(A) the extent of injury to each individual
from radiation caused by lasers or IPL devices;
(B) power output of laser or IPL device
involved;
(C) the cause of the
injury; and
(D) corrective steps
taken or planned to prevent a recurrence.
(3) A report filed with the department as
specified in this subsection must include the full name of each individual
injured and a description of the injury. The report must include personally
identifying information in a separate part of the report.
(4) When a registrant or user of an IPL
device is required, as specified in paragraphs (1) - (3) of this subsection, to
report to the department any injury of an individual caused by radiation from a
laser or IPL device, the registrant or user of an IPL device must notify the
individual. The notice must be sent to the individual at the same time the
report is sent to the department. Record of a report of injury must be
documented and maintained as specified in subsection (cc) of this
section.
(aa) Medical event.
(1) The registrant of a Class 3B or
Class 4 laser or user of an IPL device must notify the department, by telephone
or electronic transmittal, within 24 hours of the discovery of a medical event
involving a Class 3B or Class 4 laser resulting in injury or death of a
patient. Within 30 days after a 24-hour notification is made, the registrant of
a Class 3B or Class 4 laser or the user of an IPL device must submit a written
report to the department of the event. Record of a medical event must be
documented and maintained as specified in subsection (cc) of this
section.
(2) The written report
must include:
(A) the registrant's or user's
name;
(B) a brief description of
the event;
(C) the effect on the
patient;
(D) the action taken to
prevent recurrence; and
(E) whether
the registrant or user informed the patient or the patient's responsible
relative or legal guardian.
(3) When a medical event occurs, the
registrant or user must promptly investigate its cause, make a record for
department review, and retain the records as specified in subsection (cc) of
this section.
(bb) Reports of stolen, lost, or missing Class 3B or Class 4 lasers and IPL devices.
(1) Each registrant of Class 3B or Class 4
lasers or user of an IPL device must report to the department by telephone at
(512) 458-7460, or email at RAMAssist@dshs.texas.gov, a stolen, lost, or
missing laser or IPL device within 24 hours after its occurrence becomes known
to the registrant or IPL device user.
(2) Each person required to make a report as
specified in paragraph (1) of this subsection must, within 30 days after making
the telephone or email report, make a written report to the department
including:
(A) a description of the laser or
IPL device involved, including the manufacturer, model, serial number, and
class;
(B) a description of the
circumstances under which the loss or theft occurred;
(C) a statement of disposition, or probable
disposition, of the laser or IPL device involved;
(D) actions taken, or to be taken, to recover
the laser or IPL device; and
(E)
procedures or measures taken to prevent a recurrence of the loss or theft of
lasers or IPL devices.
(3) Report of a stolen, lost, or missing
Class 3B or Class 4 laser and IPL device must be maintained as specified in
subsection (cc) of this section.
(cc) Record or document retention requirements for registration of a radiation machine. Each registrant must maintain the following records or documents at each site, including authorized records sites for mobile services at the time intervals specified for inspection by the department.
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