than 4,000 had been sold for $2,400 to $4,000 apiece by the time the FDA moved to seize the product, and treatments cost consumers an average of $10 each.

Numerous defects in electronic equipment used in critical care units of 12 leadings hospitals. A study, prepared by Dr. Henry L. Green, G. E. Hieb, and Dr. Irwin J. Schatz of Wayne State University College of Medicine, and reported to the American Heart Association in March, 1971, revealed that: of 51 defibrillators studies, malfunction was common; of 95 monitors examined, 56 had substandard frequency response and leakage; of 51 electrocardiographs and direct writers examined, over half showed unsafe leakage current and 75 percent had frequency responses that failed to meet 1967 criteria of the American Heart Association; of 57 pacemakers tested, 28 had grossly abnormal activity; aspirators and portable X-ray machines showed excessive leakage current.

The report pointed up another serious problem-the misuse of medical devices and lack of expertise in operating and maintaining complicated electronic equipment. The report concluded that many of the problems found in the hospitals resulted from lack of communication between manufacturers and users of cardiac care equipment. It stated:

Engineers have not always considered the manner in which the equipment will be employed or the skill of the personnel responsible for it. At times, more consideration seems to have been given to economy of production than to future servicing. Physicians in turn have not related problems of utilizing these devices to the manufacturer in order that he might improve his design. Both physicians and nurses should know more about how to use their equipment.

The investigators stressed the need for a program of preventive maintenance and for a highly developed medical electronic repair service.

A Special HEW Committee on Medical Devices, chaired by Theodore Cooper, M.D., director of the National Heart and Lung Institute, recommended in September 1970, that the authority of the FDA be extended legislatively to regulate medical devices prior to marketing. The Cooper Committee also expressed concern about the use of devices after marketing. The report stated:

Some consultants pointed out that many of the reported accidents associated with medical devices arose not from design and manufacture, but from improper installation, interconnection with other devices and frank misuse. Consequently, regulation of devices themselves would not resolve all problems.

It is clear that in dealing with the medical device issue legislatively, attention must be paid to the post-market, operational problem as well. It may be that additional legislation governing the use of certain devices will be necessary.

WHAT THE MEDICAL DEVICE BILL DOES

The bill authorizes the Secretary of Health, Education and Welfare to establish standards for devices when such action will protect public health and safety. In developing standards, the Secretary is required to consult with other Federal agencies, standard-setting organizations, and representatives of scientific, professional, industry, and consumer organizations.

The Secretary may refer to independent ad hoc advisory committees of experts for reports and recommendations on standards.

Devices now on the market would be subject to the standards set by HEW. Premarket clearance for devices is required, to assure that a device is safe, reliable and effective. Conditions are set forth as to when premarket clearance is required. A procedure is established for applying to HEW for clearance of a device.

The Secretary is required to maintain and publish a list of devices and their

uses.

Certain devices would be exempt from the standard-setting and premarket clearance requirements. These would include devices used solely for investigational purposes by persons qualified to conduct such investigations, based on conditions set forth in the bill.

The bill also provides for exemptions of devices when the Medical Device Advisory Council, established by the bill, unanimously finds it unnecessary to regulate such products for the purpose of protecting the public health and safety. The bill requires quality manufacturing controls and requires that manufacturers maintain and make available information received by them or distributors concerning the safety and effectiveness of products.

The Secretary can withdraw approval of devices when doubt of safety or effectiveness arises.

The Medical Device Advisory Council would advise the Secretary on policy matters. It would be comprised of 15 members appointed by the Secretary for their special knowledge in the field.

It is my hope that hearings on the subject of medical device regulation and use will be held and that legislation will be enacted during this session of Congress. Mr. President, I ask unanimous consent that the bill, a section-by-section analysis, and supportive material be rinted in the RECORD following these remarks.

There being no objection, the bill and material were ordered to be printed in the RECORD, as follows:

[The text of S. 1337 appears on p. 134.]

Senator KENNEDY. We are delighted to welcome Hon. L. H. Fountain as our first witness this morning before the Senate Health Subcommittee. Congressman Fountain represents the Second Congressional District of North Carolina. He is chairman of the House Intergovernmental Relations Subcommittee, which last May and June held hearings which bear directly on our proceedings here, particularly with regard to the IUD.

We know we can expect some extremely helpful testimony from Congressman Fountain.

STATEMENT OF HON. L. H. FOUNTAIN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NORTH CAROLINA, ACCOMPANIED BY GILBERT S. GOLDHAMMER, CONSULTANT, INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE, COMMITTEE ON GOVERNMENT OPERATIONS

Mr. FOUNTAIN. Mr. Chairman, members of the subcommittee, I am pleased to have this opportunity to appear before you today to offer my observations on the several bills under consideration which would amend the Federal Food, Drug and Cosmetic Act to assure the safety and effectiveness of medical devices.

Medical device legislation is sorely needed, and it is indeed gratifying to me to see this subcommittee facing up to that need by scheduling hearings so promptly after you, Mr. Chairman, introduced S. 2368, on August 3, 1973. The American people are being well served by your leadership in seeking new and more effective medical device legislation.

I appear before this subcommittee to endorse the general purposes of the legislation now before you. My testimony is not intended to endorse a particular bill as such, but, rather, is concerned with the need for legislation and the difficulties I foresee from several of the provisions contained in the bills you are considering.

For convenience, however, I shall direct my comments primarily to such provisions as they appear in S. 2368.

Since March of this year the House Intergovernmental Relations Subcommittee, which I chair, has been conducting an in-depth study of how well medical devices are regulated by the Food and Drug Administration and the Federal Trade Commission-the two Federal agencies which share jurisdiction in this field.

A great deal of information has been developed so far and some of it is deeply disturbing. Five days of hearings were held during the period May 30 to June 13, 1973, which we devoted mainly to issues

concerning the safety and effectiveness of intrauterine contraceptive devices, the IUD's, as they are commonly known.

These hearings were of an oversight nature for the purpose of determining the quality of public protection provided by the FDA and FTC under existing laws; they were not concerned with any specific new legislation. Our hearings have produced a very substantial record of 576 pages which has just been printed and is now being distributed.

The subcommittee plans to hold additional hearings this year on other devices such as pacemakers, heart valves, and intravascular catheters which have been represented in medical literature and elsewhere as presenting serious health problems.

The Federal Trade Commission was invited to appear before our subcommittee because it is responsible for assuring the honest advertising of medical devices under the 1938 Wheeler-Lee amendment to the Federal Trade Commission Act.

Quite surprisingly, the witnesses testified that the FTC has not attempted to enforce this statutory prohibition against false advertising as it applies to prescription medical devices because the Commission does not have, nor has it sought to obtain, the scientific and technical expertise needed to evaluate the truth or falsity of such advertising.

The FTC witnesses favored the transfer of this responsibility to the FDA, an agency which the FTC believes does have the required scientific and technical competence.

It appears that S. 2368 would accomplish this transfer of enforcement responsibility through the proposed new section 707. The latter would amend section 502 of the Food, Drug and Cosmetic Act by adding at the end thereof a new paragraph (r) defining a prescription medical device as misbranded if, and I quote: "its advertising is false or misleading in any particular."

However, S. 2368 does not contain any provision which would preclude a dual jurisdiction by the FTC and FDA over prescription device advertising. As it now reads, S. 2368 provides authority to FDS while leaving undisturbed FTC's existing authority over the same advertising. I believe it is undesirable to have two separate regulatory agencies charged with the enforcement of identical legal requirements with respect to advertising of prescription medical devices.

It is my recommendation, therefore, that the language of section 707 be expanded to provide that no advertisement of a prescription device will be subject to the provisions of sections 12 through 17 of the Federal Trade Commission Act, as amended (15 U.S.C. 52-57). A precedent and model for such language is found in section 502 (n) (6) of the Federal Food, Drug and Cosmetic Act, which is concerned with prescription drug advertising.

S. 2368 would add new sections 511 and 514 to the Food, Drug and Cosmetic Act authorizing the Secretary of Health, Education, and Welfare to appoint and utilize standing advisory panels. These panels. of experts will review all devices for classification purposes, and also serve as scientific review panels for the consideration of those device applications which are made subject to FDA preclearance requirements.

What concerns me in this connection is the following provision in section 511 which is also made applicable to section 514:

Notwithstanding any other provisions of law governing the appointment and compensation of employees of the United States, the Secretary may appoint individuals associated with or employed by persons manufacturing or using medical devices or persons otherwise potentially affected by the provisions of this Act, to such panels

This provision appears to exempt panel members from the conflictof-interest laws by permitting representatives of the affected industries to serve on the panels. This would be a highly unusual arrangement, and, in my opinion, an undesirable one. I would strongly recommend that the provision be worded in such manner as to make abundantly clear that the conflict-of-interest laws are applicable to all panels, committees, and advisory councils authorized by S. 2638.

While I recognize that industry personnel have a great deal of scientific and technical expertise in the medical device field, it should be possible to draw upon that expertise without appointing industry representatives to the panels themselves.

S. 2368 makes the classification panels responsible for designating those devices which would be subject to premarket scientific review pursuant to the proposed new section 514(a) of the Food, Drug and Cosmetic Act, whereas S. 1446 simply assigns this responsibility to the Secretary.

While S. 1337 is not specific as to where the responsibility lies, it follows the pattern of the new drug provisions by making the criterion of recognition of safety and effectiveness by qualified experts a determining factor in whether or not FDA preclearance is a prerequisite to marketing. Other determinants in S. 1337 include whether or not the device is to be implanted in the body or subjects the body to ionizing radiation.

The bills referred to follow :]

93D CONGRESS 1ST SESSION

S. 2368

IN THE SENATE OF THE UNITED STATES

AUGUST 3, 1973

Mr. KENNEDY (for himself, Mr. CRANSTON, Mr. MONDALE, Mr. PELL, and Mr. RANDOLPH) introduced the following bill; which was read twice and referred to the Committee on Labor and Public Welfare

A BILL

To protect the public health by amending the Federal Food, Drug, and Cosmetic Act to assure the safety and effectiveness of medical devices.

1

Be it enacted by the Senate and House of Representa

2 tives of the United States of America in Congress assembled,

3

4

SHORT TITLE; REFERENCES TO ACT

SECTION 1. (a) This Act may be cited as the "Medical

5 Device Amendments of 1973".

6

7

(b) Unless otherwise specified, whenever in this Act

an amendment or repeal is expressed in terms of an amend

8 ment to, or repeal of, a section or other provision, the section

9

or other provision amended or repealed is a section of the

10 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).