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Professional Medical Education Association, Inc.
The Laser Training Institute™
FDA RULES FOR MEDICAL APPLICATIONS OF LASERS:
The FDA does NOT regulate physicians or nurses in the
practice of medicine or the use of any laser product. They regulate the companies that
manufacture and sell the medical laser products. A company must be approved by the FDA to
market their device, and these companies are allowed to promote the medical use of their
laser products ONLY for the specifically approved applications. This does NOT mean that
physicians are limited to only these approved applications. It simply means that the
company cannot promote a use if it is not officially approved for such by the FDA. If it
is approved for ANY use at all, an institution may purchase the equipment and make their
own decisions about how to use it. This is a common and legitimate practice with laser use
and, even though there are no further regulatory constraints in using a laser in any way
you want, the "reasonable man standard" would dictate that physicians wanting to
use lasers for non-approved uses simply submit a credible proposal to their own
institutional review board (IRB) for review and approval. Third party payers vary in their
policies about whether or not they'll reimburse for "non-approved" applications,
and this should be discussed with the patient and insurer beforehand.
FDA RULES FOR TECHNICAL INFORMATION AND SERVICE:
Listed below is a brief summary of FDA rules for laser manufacturer's and
dealers in supplying technical service manuals for all users, plus a link to the FDA site
with the complete Code of Federal Regulations. The FDA contact for enforcement of these
standards is also included.
FDA Technical & Service Requirements:
- Power Calibration:
The power output, and internal
power meter of your laser is required to be calibrated once every six months. This must be
done using an external power meter which has been referenced to a national standard. (More
information on power meters and suppliers is provided in our Laser Maintenance class).
Your laser's internal meter must indicate plus or minus 20% of the actual delivered power at the
output of the delivery device. This 20% variance applies to both the high and low ends of
the power output. The user must check the power output of their laser in every case (using
only the laser's meter - not an external one).
- Service Manuals: Laser Manufacturers are
REQUIRED by the FDA, through the Code of Federal Regulations, to provide service manuals
to servicing dealers and distributors, "and others" UPON REQUEST.
It must be made available at a cost not to exceed the reasonable cost of preparation, and
must have adequate instructions for service adjustments and service procedures for each
laser product model . . . . Part of the original reasoning for this requirement is that if
the company goes out of business at some point, that users may still maintain their
equipment. These requirements are found in
21CFR 1040.10 H2II.
(Informational Requirements - Purchasing and Servicing Information) For type III and IV lasers (virtually all medical lasers) they must supply
the SPECIFIC calibration procedures for the laser as found in
21CFR 1040.11 A2. These
hyperlinks will take you to the actual CFR's, or click on the FDA links below to see the
overall index and general FDA pages. You should review your service manual upon delivery
to ensure that it is COMPLETE with required alignment and calibration procedures.
There is NO REQUIREMENT that you have attended any of that company's service
training, or in any other way be "authorized" by the company in order to obtain
the complete service manual. You or your hospital simply have to own the laser - in fact
the regulation is worded "and others", so that anyone may request a service
manual. Failure of the company to comply with this requirement could potentially result in
the FDA shutting them down.
- IF you have problems obtaining complete service manuals..
Should you have a problem in obtaining such service information from the manufacturer,
call the FDA enforcement officer and obtain the name and telephone number of
that company's REGULATORY AFFAIRS person. Call that person at the company and politely
explain to them the problems you are having, and that you are aware of the CFR
requirements to supply such information. They will usually resolve the problem for you
quickly. If you continue to have problems, or continue to receive incomplete information,
you should call the FDA enforcement officer to initiate compliance. If you've had any
problems with laser companies not supplying such service manuals or parts, we'd appreciate
it if you'd also let us know so that we can keep hospitals and users advised of potential
problems.
Click Here to send us an email about it.
- FDA Contacts and Links:
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CFR's