1. Except as
otherwise provided in NAC
639.6945, a
medical products provider shall:
(a) Provide
services for all medical products sold, leased or otherwise provided by the
medical products provider, including, without limitation, set up, repair and
maintenance.
(b) Employ an
administrator and other employees sufficient to provide the services described
in paragraph (a).
(c) Ensure that
each employee is trained to:
(1) Use, set up,
repair and maintain the medical products sold, leased or otherwise provided by
the medical products provider that an employee is authorized to sell, lease or
otherwise provide to a consumer; and
(2) Instruct consumers concerning the use,
set up and maintenance of the medical products sold, leased or otherwise
provided by the medical products provider that an employee is authorized to
sell, lease or provide to a consumer.
(d) Maintain an inventory of medical products
that is adequate to serve the needs of the consumers served by the medical
products provider.
(e) Maintain a
suitable physical location, other than a residence, at which the medical
products provider can:
(1) Store
inventory;
(2) Repair or service
any equipment which the medical products provider sells, leases or otherwise
provides; and
(3) Keep all current
records related to the business of the medical products provider.
(f) Have a functioning restroom
containing a toilet and a sink with hot and cold water at the place of business
of the medical products provider.
(g) Maintain the place of business of the
medical products provider in a clean, orderly and sanitary condition.
(h) Ensure that the place of business
complies at all times with applicable federal, state and local laws,
regulations and rules, including, without limitation, applicable occupational
safety rules, fire codes, building codes and health codes.
(i) Maintain liability insurance of at least
$1,000,000, which must include product liability insurance if the medical
products provider:
(1) Designs, fabricates or
manufactures medical products; or
(2) Substantially modifies commercially
available medical products.
(j) Maintain a log or other record regarding
all repairs made to a medical product provided by the medical products
provider. For a medical product repaired by the medical products provider, the
log or record must identify:
(1) The type of
medical product;
(2) The
manufacturer;
(3) The model or
model number;
(4) The serial
number;
(5) The date of the
repair;
(6) The specific repair
made;
(7) The name of the person or
company who performed the repair; and
(8) A certification that the medical product
has been returned to the specifications of the manufacturer as a result of the
repair.
2. If
the medical products provider cannot certify that the repaired medical product
has been returned to the specifications of the manufacturer as a result of the
repair, the medical products provider must:
(a) Determine whether the medical product can
be safely and effectively used for a limited purpose, in which case the medical
products provider must note that the medical product must only be used for a
limited purpose and must ensure that the medical product is only used for such
a limited purpose; or
(b) Ensure
that the medical product is removed from service and is not sold, leased or
otherwise provided to any person without a written statement acknowledging that
the medical product:
(1) Was
repaired;
(2) Could not be repaired
to the specifications of the manufacturer; and
(3) Cannot be used by the consumer for the
purposes for which the medical product was intended.
3. Any device used by a medical
products provider to calibrate or test equipment must be accurate and must be
maintained according to the directions and specifications of the manufacturer.
The scales used to weigh reservoirs of liquid oxygen must be accurate and must
be certified annually by the State Sealer of Consumer Equitability.
4. The business premises of any medical
products provider must be open and accessible to the public and the Board at
all times during regular hours of operation.
5. A medical products provider shall not
operate at the same location as another medical products provider.
6. A medical products provider shall develop
and use a written procedure for addressing consumer complaints, including,
without limitation, procedures for maintaining a complaint file that documents
all complaints from consumers and the resolution of each complaint.
Added to NAC by Bd. of
Pharmacy by R008-01, eff. 11-1-2001; A by R033-07, 8-26-2008; A by
R085-22A,
eff. 9/19/2022
