----- Original Message -----
From: Michael Patterson
To: FDA CDRH Ombudsman
Subject: Request to clarify Federal and FDA jurisdiction, and to notify local and state authorities regarding legal issues and Jurisdiction over the regulation of Federal law regarding FDA approved medical devices.

As we discussed today, here is my

Request to clarify Federal and FDA jurisdiction, and to notify local and state authorities regarding legal issues and Jurisdiction over the regulation of FDA approved medical devices.

I believe that the working group and petitions I have sent in to the FDA may be the last opportunity the FDA will have to protect the public health from the misuse of these FDA approved medical devices.  The issues I'm discussing with the FDA extend to the reuse and reprocessing of ALL FDA approved medical devices.  My requests, petitions and emails do Not ask the FDA to do anything more or anything less than to regulate the SAME types of users and practitioners (medical Doctors and their technicians) that the FDA has in fact regulated before these Devices were approved.  The same problems the FDA pointed out that occured before devices were FDA approved and before clinical trials are in fact occuring with the same or similar FDA approved medical devices. 

In addition my opinion is that anything done by a medical Doctor that violates any laws (whether Federal, state or local) OR any medical ethics OR in any way breaches medical ethics (including, but not limited to the Belmont report, Helsinki guidelines, and Nuremberg code) by definition is Not the practice of medicine.  By definition, anything that is Not the practice of medicine does Not afford anyone protection from the law under practice of medicine principles.  An off-label use MUST HAVE a patient benefit and be "safe" and "effective" for it to be a practice of medicine.  Clearly reusing microkeratome blades is Not and thus the FDA does have jurisdiction (in my opinion).  Equally important is any violation of the IRB guidelines used for the clinical trials and/or the labeling, operators manuals, etc. for these approved medical devices.  If it was up to me, the FDA and the CDC would state clearly that patient injuries caused by violations of the "safety" and "effectiveness" guidelines submitted to the FDA and obvious medical principles (sterilization) will be enforced by the Federal government- both civilly and criminally. 

In addition, Local and state authorities are Not as familiar with regulated medical devices or Federal law as the Federal Government so this request is for the FDA to be helpful by letting them know what jurisdiction they have and the specific laws (or types of laws) they can enforce and in the FDA's opinion need to enforce to protect the public from injury (the public health).  As a third party who is directly effected and is interested in open government and notifying the public (see www.lasikliberty.com ), I would also appreciate it if the FDA could copy me on the letters to any authorities in GA or SC and/or provide the information directly addressed to me.
One other reason why I believe the FDA does have authority over violations of Federal laws regarding FDA regulated medical devices is that the FDA does in fact regulate medical Doctors who use medical devices that are Not FDA approved.  Frankly, I do Not even understand why anyone at the FDA would question the FDA's jurisdiction given that the FDA has already established its jurisdiction and written a letter to Ophthalmologists regarding "black box" and "gray box" lasers (http://www.fda.gov/cdrh/laser797.html).
The reason I feel that the FDA either does Not understand their authority or is Not being truthful is that the FDA's jurisdiction and authority of medical Doctors should INCREASE after a medical device is approved by the FDA, not decrease.  Obviously the FDA has the same jurisdiction over the same users and practictioners after FDA approval as before approval.  "Both 'black box' and 'gray market' lasers for refractive surgery are unapproved Class III medical devices that can be used on patients only after FDA has approved an IDE for a clinical trial. "  Both before and after FDA approval, the stated purpose is "that patients receive the safest treatment possible" (http://www.fda.gov/cdrh/laser797.html).  If the FDA enforces Federal laws and regulates the users and practitioners BEFORE FDA approval, but Not after FDA approval then does the FDA approval mean the FDA knowingly allows approved medical devices to be used in an unsafe and uneffective way that harms patients?  The effect of FDA approval would be that the FDA is in effect providing a Federal approval (by looking the other way so to speak) to harm patients and the public health without any Federal or FDA enforcement at all.  If the FDA has jurisdiction before approval, then the FDA has EVEN MORE jurisdiction after approval. 
If the FDA in fact has No jurisdiction after approval, then I believe the FDA is putting the interests of the FDA and the companies who have obtained approval ahead of the interests of the patients and the public health.  If there's any question which is more important or within the FDA's jurisdiction, then based on the FDA's stated mission and objectives and the fact that it is a government agency means that the patients and the public health have to come first.  Everyone makes mistakes.  If the FDA has erred, then it is important to clarify this error as quickly and clearly as possible.  The FDA does Not have to admit the error- just move to correct the situation with as much clarity as possible. 
Clearly the FDA does have jurisdition over practices that are outside the labeling or Not "safe" and "effective" if they result in "injuries requiring corneal transplantation, additional (and repetitive corneal surgery), severe night vision problems, and frequent overcorrections ( >+2.00D)" and in my opinion regarding other serious patient injuries as well (dry eye, LASIK flap problems, vision quality problems, etc.). 
First, we [the FDA] have uncovered through our own investigations what appears to be a pattern of serious patient injuries attributed to the use of some "black box" lasers. These include several injuries requiring corneal transplantation, additional (and repetitive) corneal surgery, severe night vision problems, and frequent overcorrections ( >+2.00D). These injuries and overcorrections appear to be caused by a laser beam that has a relatively small optical zone, has considerable inhomogeneity, and produces a non-spherical ablation pattern. The injuries from "black box" lasers demonstrate the importance of evaluating the safety and effectiveness of lasers for refractive surgery with a limited number of patients under an FDA-approved Investigational Device Exemption (IDE) and the oversight of an Institutional Review Board, as required by the Federal Food, Drug, and Cosmetic Act (the Act). Data from such studies is critical in establishing the risks and benefits of particular laser designs.

In addition, "black box" lasers may not have adequate fail-safe mechanisms and equipment hazard analyses; furthermore, software validation and verification may not have been performed. We therefore regard the use of unapproved lasers for refractive surgery as a serious public health problem.

Second, with respect to "gray market" lasers, many of the physicians who imported these lasers communicated their belief to the agency that their lasers were the same as the approved Summit lasers. FDA attempted, in the exercise of its enforcement discretion, to resolve the matter and accommodate these physicians by providing an opportunity for them to certify that their lasers were identical in all relevant aspects to approved lasers.


Specifically, the FDA has already asserted its jurisdiction over problems that are caused by "a laser beam that has a relatively small optical zone, has considerable inhomogeneity, and produces a non-spherical ablation pattern."  I have provided sufficient evidence that reusing Microkeratome blades and the Nidek EC5000 laser (the labeling even states that 69% of patients have night driving difficulty) causes these injuries.  Many other FDA approved medical devices do as well.  The FDA is aware that these injuries are Not reported to the FDA properly either during the clinical trials OR after these devices are approved. 
J Refract Surg. 1997 Jul-Aug;13(4):336-8. Related Articles, Links

FDA begins to act against black box excimer lasers.

Kohl M.
Furthermore, here's information about several Federal and FDA enforcement actions and warning letters regarding violations or deviations from Federal law and/or IRB guidelines- just as examples:
1.  a warning letter sent to one researcher, Dr. CaseBeer, noted numerous “deviations” from Title 21 Code of Federal Regulations.


2.  again numerous “violations” from Title 21 Code of Federal Regulations part 50 and part 812, and 21 CFR 50.27 and 50.25a and b.http://www.fda.gov/foi/warning_letters/g4594d.pdf
3.  "Louisiana Ophthalmologist Fined $1.1 Million by FDA For Clinical Study Violations"

“This penalty sends a clear message that FDA will not tolerate conduct that can put patients at risk and erode the trust between research subjects and the medical research community,” said FDA Commissioner Mark B. McClellan, M.D., Ph.D.


4. U.S. marshals have seized unapproved lasers from the
following locations:
     * June 9 -- Photon Data Inc., Winter Park, Fla. -- Nine
unapproved excimer lasers and components valued at over $3
million seized at two company locations.
     * July l -- Woodhams Eye Clinic, Atlanta, Ga. -- One
unapproved excimer laser seized from the office of J. Trevor
Woodhams, M.D.
     * August 28 -- Neumann Eye Institute, Deland, Fla. -- One
unapproved excimer laser seized from the office of Albert C.
Neumann, M.D.
     * August 28 -- Pro Cargo, Miami, Fla. -- One additional
unapproved excimer laser manufactured by Photon Data Inc. seized
at this private freight forwarder.
     * Sept. 2 -- St. George Corrective Vision Center, Chicago,
Ill. -- One unapproved excimer laser seized from the office of
Nicholas Caro, M.D.
     In the past three years, FDA has issued 24 warning letters
to manufacturers and physicians regarding the sale and use of
unapproved excimer lasers.  The agency is continuing to
investigate this activity and plans to take additional
enforcement action.
     Only two lasers are currently approved by FDA for refractive
eye surgery.  They are manufactured by Summit Technology, Inc.,
of Waltham, Mass., and VISX, Inc., of Santa Clara, Calif.  Both
companies conducted clinical studies to demonstrate that their
lasers could treat nearsightedness safely and effectively using a
procedure called photo refractive keratectomy (PRK).
For additional reference, consider the following:

FDA Panel Suggests Adding Black Box Warning To ADHD Medications About Risk Of Sudden Death, Heart Problems

Serzone (nefazodone HCL)
Audience: Psychiatrists, Pharmacists
FDA and BMS added a Black Box Warning and strengthened the WARNINGS, CONTRAINDICATIONS, and PRECAUTIONS sections of the label for Serzone, an antidepressant drug. Rare cases of liver failure leading to transplant and/or death in patients have been reported. A new Patient Package Insert is provided in the product packaging.

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse products or companies

Products Liability Implications of Reprocessing and Reuse of Single-Use Medical Devices

Author: Janice M. Hogan & Thomas E. Colonna
Issue: 53 Food and Drug Law Journal 385-402 (1998)

This article discusses the reuse and reprocessing of single-use medical devices. Specifically, this article reviews the economic forces associated with medical device reprocessing, the Food and Drug Administration's current policies regarding single-use medical device reuse and reprocessing, the legal framework for assessing products liability for industrial equipment reprocessors generally, and an analysis of these general principles as applied to the reprocessing of single-use medical devices. The review concludes with recommendations to minimize potential liability by outsourcing disposable device reprocessing, establishing validation standards, and providing adequate training and communication to employees.



Black Box Warnings in Prescription Drug Labeling: Results of a Survey of 206 Drugs

Author: Judith E. Beach, Gerald A. Faich, F. Gail Bormel & Frank J. Sasinowski
Issue: 53 Food and Drug Law Journal 403-412 (1998).

In any prescription drug labeling, the Food and Drug Administration (FDA) may require cautionary information to be displayed prominently in a boxed warning, or a "black box" warning. In 206 package inserts in the 1995 Physicians' Desk Reference, the authors found that such black box warnings generally highlighted risk(s) of clinical significance requiring the judgment of the medical practitioner to evaluate. FDA requires such warnings for serious or life-threatening drug-associated risks that are well-established and well-defined, supported in nearly all cases by the incidence of such events in controlled clinical trials, and/or based on compelling patterns of postmarketing reporting.



ORA's Role at FDA Headquarters and in the Field for Product Recalls

Author: Sandra Nowlin Whetstone
Issue: 53 Food and Drug Law Journal 513-516 (1998).

The Associate Commissioner for Regulatory Affairs (ACRA) heads the Food and Drug Administration's (FDA's) Office of Regulatory Affairs (ORA) and establishes the agency's general recall policy and procedures. The Office of Enforcement, Division of Compliance Management and Operations Recall Operations Staff (OE/DCMO/ROS) within ORA provides staff support to the ACRA's office with respect to recall policies and procedures, and serves as FDA's focal point for information, advice, and direction regarding the field aspects of all recalls. The staff works closely with FDA Centers during each significant recall with the goal of maintaining agency-wide consistency in policy and procedures. The OE/DCMO/ROS also maintains FDA's recall database and evaluates the overall effectiveness of recall activities.


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J Refract Surg. 1997 Mar-Apr;13(2):124-5. Related Articles, Links

FDA regulation of black box lasers: approximately 50% of users opt to submit investigational device exemptions.

Mandle M.

Michael Patterson, ph.d., bsee