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-LETTER BY MICHAEL PATTERSON, PHD,
BSEE SENT TO FDA COMMISSIONER ANDREW VON ESCHENBACH-
-VIA REGULAR MAIL-
April 22nd, 2008:
Andrew C. Von Eschenbach, M.D.
Commissioner
U.S. Food & Drug Administration
5600 Fishers Lane
Room 14-71, HF-1
Rockville, MD 20857
(301) 827-2410
Commissioner@fda.gov
Dear Commissioner von Eschenbach:
During your visit to the Centers for Disease
Control (“CDC”) in November 2007, you discussed Medical Device
Safety and reuse of Single Use Devices (“SUDs”) with me during the
question and answer session. You also invited me to write you a
letter regarding my concerns about how the FDA is addressing Medical
Device Safety and the reuse/reprocessing of SUDs. When I asked how
the FDA defines “safe” and determines safety, you answered that the
FDA evaluates safety with a risk/benefit analysis.
I believe that if a risk/benefit analysis by
the FDA was performed for LASIK, it may have been inadequate. A
former FDA employee advised me that the risk/benefit analysis was
“truncated” during the PMA approach process and the safety of LASIK
was not allowed to be compared to any alternative (e.g., contacts or
glasses) during the approval process.
On Friday, April 25, 2008 the Ophthalmic
Device Advisory Panel will be meeting to discuss issues related to
the safety of LASIK procedures (which involve medical device safety
of the FDA approved lasers and microkeratome blades, SUDs that
regrettably are reused for LASIK). I will be the first presenter at
the opening of the meeting. My understanding is that since the FDA
approval of devices for LASIK around 1999 or 2000, millions of
patients have had this surgery performed on one or both eyes at user
facilities, including hundreds of LASIK ambulatory surgical
facilities (“ASFs”).
I did complain to the ASF where my LASIK
surgery was performed about several adverse events which ruined my
vision (I found out later the microkeratome blade, a Single Use
Device, was reused and there was a microkeratome failure that was
not reported). I filed a report with the FDA system and I did get a
response from the manufacturer of the FDA approved laser device used
on me (the Nidek EC5000)
, but I do not know if my report is one of the
140 complaints which the CDRH has indicated is the total. Likewise,
I know scores of other adversely affected individuals who have
complained to these ASFs about their adverse experience (including
other patients at the ASF where my LASIK was done); but, we have no
way of knowing whether Medical Device Reports (“MDRs”) were
transmitted to the CDRH as required by law and regulation. Many of
the LASIK device users admit to reusing SUDs (the microkeratomes
blades). I question whether these ASFs are reporting the adverse
events because I have personally talked to almost 140 people who
experienced serious injuries from LASIK, and there are thousands of
adverse events mentioned in the LASIK literature. The numbers don’t
add up.
As a layman, I have read the MDR regulation
appearing at 21 C.F.R. Part 803, and it is clear to me that these
hundreds of ASFs have a responsibility to comply with this
regulation.
http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=803
The requirements that
apply to the LASIK ASFs include the following:
1)
Written MDR procedures for:
a) Internal management systems for recording, reviewing, etc.,
events and
b) Documentation and record keeping requirements as identified
in the MDR regulation;
2) Establishing and maintaining MDR event files;
3) Retaining MDR event files relating to an adverse event for a
period of 2 years from the event;
4)
Reporting to the CDRH any death of or serious injury to a patient
within 30 days of the event;
5) Submitting to the CDRH an annual report of MDR events on a
FDR FORM 3419.
See 21 C.F.R.
Sections 803.17, 803.18, 803.30 and 803.33.
Can you advise me as to whether the FDA/CDRH
has inspected any or all of the LASIK ASFs since 2000? If yes, how
many have been inspected, and how many have been identified as
deficient in their responsibility to comply with the MDR
regulation? Have any Warning Letters relating to MDR violations
been issued to any ASFs?
Because of the importance of this subject and
the FDA/CDRH responsibility to consumers and patients, please do not
reply by asking that I submit a Freedom of Information Act (“FOIA”)
request. If you are to suggest that I must submit a FOIA request,
then consider this letter to be such a request. Irrespective of the
method to be applied, I request that this information be produced
promptly in the best interests of the Public Health and the FDA’s
missions and goals.
Finally, with regard to the recent
announcement of the formation of a joint FDA “LASIK Task Force,” has
any consideration been given to using independent, unbiased
researchers and/or the appointment of a patient or “consumer”
representative?
Thank you for your personal concern and
attention to these serious matters. Again, I appreciate you
offering me the opportunity to write to you directly.
Sincerely,
Michael
Patterson
Michael Patterson, Ph.D., B.S.E.E.
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