Unlike drugs, which are specified only by a physician on behalf of a patient, or purchased over the counter without a prescription, most external medical devices are selected for purchase or use with many additional levels of control-by hospital administrators and purchasing agents, by purchasing committees, by nurses and operating room supervisors, and by biomedical engineers. Implants, again, are the exception. Therefore, we recommend that a more flexible system of regulation apply to medical devices and that the costs for such a program be kept in proper perspective.

The often-heard argument that massive efforts or expenditures are justified, even if only to have a single human life, is as specious and counterproductive in regard to medical devices as it is in any other area of health care. While, as a public relations ploy, it is helpful to evoke the image of a dying child or the listener's grandmother to extract grants, contracts, appropriations, or sell equipment, such emotional appeals badly distort priorities. If a large proportion of the limited pot available for health care is spent to protect a relatively small risk population, then the overall population suffers because funds are not available for high-yield programs. The penalty is a higher national patient mortality.

How much is improvement in medical device safety and performance worth to the country? There is no hard and fast answer. It is clear, however, that among medical device problems, those associated with implants need far more attention than do other classes of devices.

The manufacturer's responsibility is clear. He must provide instrumentation which, within the limits of the state of the art and medical knowledge, is efficacious, reasonably safe, and truly and correctly represented in technical and advertising description.

It is the health community which has day-to-day legal, moral, and technical responsibility for patient care and which must balance priorities and problems. The responsibility of Congress, Federal agencies, and consumer advocates is secondary and remote. They are neither directly responsible nor as vulnerable as health care facilities or health professionals for decisions which prove wrong and result in dead or injured patients. Whenever command and its responsibilities for consequences are separated, there are usually serious and undesirable effects. This historical spectre and inevitability haunts the health community. It is the physician, nurse, administrator, and allied health professional who are accountable for patients. Few, if any, diagnostic or therapeutic procedures are devoid of risk. In each individual instance, whether or not a specific patient should be subjected to specific procedures or devices is a decision which can only be made by the physicians and nurses directly responsible for the patient's care. This decision cannot be made by manufacturers, biomedical engineers, attorneys, technicians, or agencies, Federal or otherwise. Each has specific responsibilities, but under no circumstances does this responsibility include making a judgment as to the appropriateness of using a specific medical device on an individual patient.

I have recited a long list of problems which will plague implementation of medical device regulation. Difficulties and problems are not, however, an invitation to inaction. They are obstacles to be overcome in pursuit of a desirable objective. Despite all of these problems, I am

optimistic about the favorable effect that judicious legislation may have in protecting the American public.

With passage of legislation, Congress will have fulfilled its responsibility. Effective implementation of the legislation by the Office of Medical Devices will be a long and arduous task, and one which our organization is pledged to support and assist. By not addressing yourselves, in the proposed legislation, to the serious problems of operator error and technical competence, you are giving the health community not a loophole or permission to ignore the problem, but a challenge to fulfill its responsibility on a voluntary basis. Thank you.

Senator KENNEDY. Yours is a unique organization that has done an extraordinary amount of work in this area. It is the only one of its kind, I believe, and you are one of the pioneers in this area. We value very highly your testimony in coming.

Let me ask this. How widespread is the practice of dumping shoddy American products in foreign countries? Do you have any information on that?

Dr. NOBEL. We do not have a statistical handle on it. We have three or four cases that we can point to. It ranges in scope from devices which are seized in this country such as oxygen canisters which were, reportedly, to go to an importer in Thailand, to the sale of used equipment, especially to Latin American nations, where they cannot afford brand new current state-of-the-art equipment, and there is inadequate service backup to make it continue to work.

There are diplomatic repercussions on occasion such as the effectof using a defective American made resuscitator-following the assassination of an African political figure.

Senator KENNEDY. Well, thank you very much.

Dr. NOBEL. Thank you, sir.

Senator KENNEDY. The subcommittee stands in recess until Monday at 10 o'clock.

[Whereupon, at 12:30 p.m., the subcommittee was recessed, to reconvene Monday, September 17, 1973, at 10 a.m.]

MEDICAL DEVICE AMENDMENTS, 1973

MONDAY, SEPTEMBER 17, 1973

U.S. SENATE,

SUBCOMMITTEE ON HEALTH OF THE

COMMITTEE ON LABOR AND PUBLIC WELFARE,

Washington, D.C.

The committee met, pursuant to recess, at 10:06 a.m. in room 4232, Dirksen Building, Senator Edward M. Kennedy, subcommittee chairman, presiding.

Present: Senators Kennedy and Dominick.

Senator KENNEDY. The subcommittee will come to order. The Health Subcommittee resumes its hearings on legislation to regulate the development and marketing of medical devices.

On Friday we saw the substantial toll that defective medical devices can take. Some of these defects caused the death of patients. Others resulted in serious injury.

All interested parties agreed that we must enact device legislation, and we must enact it now.

I am grateful for the cooperation we have had from the administration and from the device industry in our attempt to meet the problem. Gentlemen, we welcome you this morning.

Our first witness is Mr. Foster Whitlock. Mr. Whitlock is chairmanelect of the board of directors of the Pharmaceutical Manufacturers Association and vice chairman of the board of directors of the Johnson & Johnson Co. He will be representing five medical devices organizations.

Mr. Whitlock is accompanied by representatives of each of these five organizations, and I know he will be happy to introduce them to

us.

Gentlemen, welcome to the Senate Health Subcommittee.

STATEMENT OF FOSTER WHITLOCK, VICE CHAIRMAN, BOARD OF DIRECTORS, JOHNSON & JOHNSON, AND CHAIRMAN-ELECT, BOARD OF DIRECTORS, PHARMACEUTICAL MANUFACTURERS ASSOCIATION, ACCOMPANIED BY KENNETH A. MARSHALL, REPRESENTING HEALTH INDUSTRIES ASSOCIATION; JAMES D. LIERMAN, REPRESENTING MEDICAL-SURGICAL MANUFACTURERS ASSOCIATION; THOMAS E. HOLLORAN, REPRESENTING NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION; RODNEY R. MUNSEY, REPRESENTING PHARMACEUTICAL MANUFACTURERS ASSOCIATION; AND ADRIEN L. RINGUETTE, REPRESENTING SCIENTIFIC APPARATUS MAKERS ASSOCIATION

Mr. WHITLOCK. Mr. Chairman, my name is Foster B. Whitlock and I am vice chairman of the board of directors of Johnson & Johnson

and chairman-elect of the board of directors of the Pharmaceutical Manufacturers Association.

I am accompanied today by Mr. David E. Collins, secretary and associate general counsel of Johnson & Johnson. I am here this morning to present a statement concerning S. 2368, 92d Congress, on behalf of the five industry trade associations representing a broad spectrum of the "device" industry. Representatives of these associations are with me this morning and I should like to take this opportunity to intro

duce them.

Kenneth A. Marshall, representing Health Industries Association; James D. Lierman, representing Medical-Surgical Manufacturers Association; Thomas E. Holloran, representing National Electrical Manufacturers Association; Rodney R. Munsey, representing Pharmaceutical Manufacturers Association; and Adrien L. Ringuette, representing Scientific Apparatus Makers Association.

The five associations have elected to present a joint statement because they believe it is important to convey to the subcommittee the agreement which exists as to major issues involved. Following my remarks, each of the association representatives will add some brief individual comments. The panel will then be pleased to answer questions. Let me start by saying that in our opinion, S. 2368 is, in most respects, responsive to the needs of the public. We are in basic accord with its major provisions. We, however, will ask you to give consideration to certain changes or amendments to the bill.

Let me detail, if I may, in brief some of the efforts made by industry over the past several years to achieve adequate and effective medical device legislation.

In 1969, several court decisions created uncertainty about the applicability of the drug provisions of the Federal Food, Drug, and Cosmetic Act to medical devices. In an effort to cope more effectively with resulting difficulties, a group of professional and industry associations formed what has come to be loosely known as the interassociation ad hoc committee on medical devices.

All five of the associations present at this table today are members of that group. While this is not a decisionmaking body, it has, in my judgment, made significant contributions to the effort put forth by Government, the professions, and industry to develop legislation.

Subcommittees of the interassociation committee made major contributions toward the development of a new device definition. Members of the group gave vulnerable assistance to the Food and Drug Administration in developing the first national medical device inventory, and in the structuring and implementation of its ongoing medical device classification project.

More detail on these projects is contained in the written comments submitted by various associations for the record. These few examples, however, demonstrate a point which I would like to emphasize.

Industry, the professions, and Government have, over the past several years, worked hard toward the development of adequate device legislation. It is our belief that this concept of teamwork should be preserved as an essential element in any new legislation.

There is a second point, which may not be obvious but it is related to the interassociation activity. That is the diversity of the medical

device industry. Among the companies represented here today are: electrical device manufacturers; manufacturers of laboratory aids, reagents, and diagnostics; manufacturers of sterile disposable devices; manufacturers of heart valves, pacemakers, and other implants, as well as numerous other medical devices. Also represented in the Interassociation group are associations representing the compressed gas industry and manufacturers of dental products.

The consensus which I represent is not limited to the views of only a small number of large companies. To the contrary, there is a large number of companies in the medical device field. Estimates I have seen range from a minimum of 1,300 companies to upwards of 5,000. The companies manufacture a minimum of 8,500 different products and product classes to more than 100,000 individual products, including different sizes and shapes.

This is an industry where the small company is of great importance, both in terms of production and in terms of innovation. We are firmly convinced of the need for this subcommittee to fully understand the diverse structure and dynamics of the medical device industry. Only with this understanding can the full impact of S. 2368 be understood.

Let me turn now specifically to S. 2368. We are encouraged that the bill includes several provisions which were not contained in, and in our opinion improve, the Administration's bill S. 1446. For example, the definition of medical device is a significant and important addition, one which will hopefully end the confusion created by the 1969 court decisions to which I referred earlier.

The inclusion of the premarketing protocol concept in section 514 (m) is also an important innovation responsive to the need for assurance of safety and effectiveness while, at the same time, taking into account the complex nature of many devices and the need for continued development.

Similarly, we applaud the bill's recognition of the need to continue the availability of custom devices, and the distribution of products deviating from existing standards through the temporary permit procedure. While we feel certain changes should be made in these sections. we are encouraged by the concern evidenced in the provisions to preserve the developmental process. We also appreciate the understanding of the peculiar and intimate relationship between the surgeon. other health practitioners, and the manufacturer which they demonstrate. We also are pleased with the inclusion of a strong Federal preemption clause in S. 2368.

On behalf of the five associations represented here, I urge specific amendments. I will not go into detail on each one but rather will attempt to point out generally the reasons for our concern. The individual statements of the various associations will go into detail on these and other suggested changes.

Our first and perhaps primary concern is with the criteria established in the bill for determining whether a product should be subject to scientific review or in other words, premarket clearance. It is our firm belief that premarket clearance should be limited in the medical device field to those products where standards cannot do the job of insuring safety and effectiveness for the patient.