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through regulation and enforcement.

One of the major flaws in present law affecting devices is the absence of any specific provision regarding the use of investigational devices.

This area is simply too critical for FDA to sit back and await legislation. We have, therefore, devised a means, through our labeling authority, to provide increased protection for human subjects used in studies of investigational devices. By regulation, we plan to require that the labeling specify the investigational nature of the product and that such devices should only be used by practitioners qualified by scientific training and experience to investigate and evaluate such devices. The labeling also will state that investigational studies should be subject to institutional committee review, and that the device should be used only after informed patient consent is obtained. We have already issued such regulations applicable to acupuncture needles.

In the mandatory compliance area, we have undertaken programs to require use of impact resistant eyeglass lenses, and to improve the reliability of artificial cardiac pacemakers and artificial heart valves. A program for intrauterine devices was developed late in 1972 for implementation this year.

The regulation of IUD's illustrates the problem we encountered in determining the difference between a drug and a device--a crucial distinction in delimiting our regulatory authority.

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We treat as a drug IUD's designed to release a drug over

a sustained period of time. But an IUD whose characteristics

as a drug are not so apparent may be classified as a drug only at the risk of extensive litigation.

We are therefore

constrained by existing law to treat it as a device.

The Department Recommends in Favor of Medical Device Legislation

The bill proposed by the Administration, S. 1446, and the bill introduced by the Chairman, S. 2368, are the same in most principal respects. Each would provide for premarket scientific review of certain devices, for the promulgation of safety standards with respect to other devices, for the establishment of regulations prescribing good manufacturing practices, for increased scope of inspection of factories in which medical devices are manufactured, for the registration of device manufacturers, for the maintenance of records and the submission of reports on clinical experience with devices, for the notification of the Secretary of defective devices, and for correcting such defects or reimbursing the purchaser.

However, the criteria for administrative action in some areas such as premarket review and standard setting differ in important respects. In these two areas we continue to believe that S. 1446 provides a more appropriate and sound approach.

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Other differences are of less importance and we would be willing to work out acceptable language. We will be happy to supply the Committee with proposed compromise language.

In addition, certain of the differences between S. 2368 and S. 1446 are attributable to perfecting changes contained in the Chairman's bill and in which we would concur.

The time for the enactment of medical device safety legislation has arrived. We are pleased that there has been so much

progress to date in moving toward a mutually acceptable bill. We hope that the almost universal acceptance of the need for it will prompt the quick response of the Congress in passing this essential consumer protection legislation.

Senator KENNEDY. Our next witness is Sidney Wolfe, M.D. Dr. Wolfe is director of the Health Research Group of Washington, D.C. He is a graduate of Western Reserve Medical School and formerly spent 5 years as a research physician with the National Institutes of Health. We have had the privilege of hearing from Dr. Wolfe during the previous hearings of the subcommittee, and I look forward to hearing his testimony with great interest.

STATEMENT OF SIDNEY WOLFE, M.D., DIRECTOR, HEALTH RESEARCH GROUP, WASHINGTON, D.C.

Dr. WOLFE. Thank you, Senator Kennedy, for the chance to present testimony this morning.

I will read part of the prepared testimony and submit the rest for the record.

In a recent public debate I had with an official from the Pharmaceutical Manufacturer's Association, he took the position that the drug industry is a good business and proceeded to show evidence of this. It is difficult to quarrel with this position. If true for drugs, however, it is true twice over for medical devices.

What other business could boast of the following:

1. Annual sales in excess of $3 billion-projected to double in 10 years.

2. Increasing percentage of sales to Federal Government via medicare.

3. Virtually no existing price-control mechanisms. In a Wall Street analysis of pacemakers, for example, it was said that "Since medicare pays for most pacemakers, the patient is also not concerned with the price. Thus, the demand for pacemakers is somewhat inelastic providing little, if any incentive for manufacturers to cut prices."

4. Profit increases of 20 percent or more year by year for many companies.

5. No Government regulation over the manufacture of devices. 6. Increasing market size for devices, as population ages.

The device industry thrives on being able to develop and market a vast array of artificial prostheses, pacemakers, nerve stimulators and other devices which replace, invade, or stimulate many parts of the human body.

I would be remiss if I did not acknowledge the positive aspect of progress in device technology which has resulted in better monitoring of patients, improved surgical procedures and the prolongation of health and life in many. Despite these benefits, however, the device industry operates much more like an unaccountable business than a part of a humanized health services system.

I have included in the record here a partial list of medical device recalls for just a 14-month period, from July 1972 to August 1973, for which the name of the product is listed, the manufacturer and the reason for the recall.

I will state several examples: The Biotronic pacemaker was recalled because of premature failures.

A portable cardiac defibrillator, used in emergency situations with someone having had a heart attack, was hazardous which caused serious burns and had a self-discharge hazard.

An incubator to be used in the nursery, which had electrical shock hazard.

A Sears, Roebuck belt massager with electrical leakage and a whole variety of implanted devices made out of metal which were recalled because they rusted.

I have also selected four case studies concerning products which appear to have serious problems associated with them. One of them was recalled. Although we understand that it is still being used, the information is not clear on this.

The first case is a defective mitral heart valve. At the present time, there are 1,500 patients in this country in whom the model 105 Travenol-Beall Mitral heart valve has been implanted. Most of these implants were done between January 1972 and June 1973. The majority of these patients will presumably have no medical problems as a result of structural defects in the valve. Approximately 28 of these patients, however (according to an analysis of nonimplanted valves, 1.9 percent of which were defective), may experience a rupture of the supporting strut which holds the disc valve in place. I have a picture of the valve. The ring which supports the disc is shown here. These are the struts which support the disc itself. It is these struts which apparently have broken in several instances and which is the matter of concern in this case.

The chronology of events beginning with the first animal implant of the valve in December 1970 and continuing through the FDA recall, which apparently occurred in June-we have not been able to get the exact date-can be seen in the accompanying diagram. There are several features of this case study which, because of their recurrent nature, bear mentioning.

The first problem is inadequate premarketing testing. The first human implantation occurred

Senator KENNEDY. Before we get into that is this public information?

Mr. WOLFE. There is virtually nothing that has been made public about it. I think it is an appropriate question to ask. This whole thing has been guarded with a lot of secrecy. It has gotten to the point where people within the FDA are unaware of it and other people who should be aware of this problem including a number of doctors who take care of these patients are also unaware of it.

Senator KENNEDY. Will you give us the reasons for that?
Mr. WOLFE. I will suggest some of the reasons for it.

The first human implantation occurred after just 6 months of animal tests and mass marketing was begun just 7 months after the first human implant. Rigorous and well-documented animal testing under conditions of proposed human use-including microscopic inspection of the valve at each stage-might well have uncovered this serious defect before human implantation occurred.

Travenol had changed the strut coating from Teflon, used on models 103 and 104, to Gulf's Pyrolite, known to be more brittle. Where is the evidence that Travenol or Gulf did adequate in-use tests to look for a predictable consequence of brittleness, namely cracking?

The chronology shows four deaths, the first of which occurred in February of this year, the last of which reported occurred in May of this year. I say "reported" because we only know of these cases where autopsies were done and the valves were examined.