RENDELL-BAKER

It is our hope that with this past experience, a much more flexible and enlightened method of control will be evolved for medical devices. I am sure that the observations and recommendations set forth here will be helpful in evolving such a system.

National Conference

The Association for the Advancement of Medical Instrumentation is in many ways unique in the wide range of disciplines and interests represented by its members. Within the membership are manufacturers who produce all types of medical equipment; hospitals and medical societies, such as the American College of Surgeons, American College of Physicians, American College of Cardiology, American College of Pathologists, and similar medical organizations; physicians from all specialties, and investigators, engineers, and scientists from all fields.

The Association was formed out of the sincere belief that patient care could be advanced by a close, cooperative effort of medicine, engineering, and industry, all dedicated to the advancement in design, safety, and utilization of medical instrumentation. No doubt it is because AAMI encompasses so many disciplines concerned with medical devices that the Food and Drug Administration invited us to organize this conference.

The objectives of this conference were:

(1) to bring together nearly 200 authorities from all disciplines to make recommendations on how to improve the development and coordination of medical device standards.

(2) to bring together organizations to discuss how duplication of standards activities, so wasteful of our limited resources, may be avoided,

(3) to give wide publicity to the recommendations produced by the conference in the hope that this will provide the necessary stimulus and impetus for a new effort by all for device standards;

(4) to provide a broad spectrum of experience and advice upon which our legislators and administrators can draw to guide their actions as they become increasingly more involved in the medical device field; and

(5) finally, to make medicine, engineering, industry, and government aware of the implications of medical device standards.

The conference opened on May 20 with four keynote speakers who have wide experience in the medical device field. Their papers provided participants with necessary perspective and background.

The seven working groups of approximately 25 participants each then retired to meeting rooms to develop their observations and recommendations on the subject to which they were assigned Each participant represented a medical, engineering, hospital, scientific, governmental, or industrial organization. All participants in the conference were selected by their organizations.

On May 21, the documents prepared the day before by the seven working groups were distributed to all of the conference

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participants. These documents were read during the morning plenary session, after which comments were received from the floor on each of the seven documents. While there were some differences of opinion on specific points in some of the documents, there was general agreement on most of the overall concepts expressed in the documents

Conference Consensus

There was a broad consensus by the conference on the following principles:

(1) A national body should be established to coordinate and stimulate the development of medical device standards.

(2) The national coordinating effort should function separately from any single standards-making group to ensure that all interests are represented.

(3) All disciplines, interests, and competent standards organizations should be involved in the coordination and development of medical device standards.

(4) The Food and Drug Administration should consider the immediate development of resources for the coordination and stimulation of standards activities.

(5) The conference was in substantial agreement with provisions of Title I of the Medical Device Safety Act (H.R. 12316), now pending in Congress, relating to the mechanism for developing and setting standards for medical devices.

(6) Medical and engineering groups should become more actively involved with medical device standards activities.

(7) Medical device standards activities and regulations must carefully consider the role of the small innovator so that his significant contributions to patient care are not restricted.

(8) There are no serious legal restrictions to standards activities conducted with reasonable care, and no adverse legal impli cations should result from well motivated, voluntary standards, nor from governmental standards developed with broad representation and adequate consultation with qualified persons.

(9) A more effective and better organized communications system among physicians, engineers, hospitals, manufacturers, and government must be developed.

(10) Imposition of mandatory standards must be very carefully considered, after clear demonstration of a need for additional criteria for judging safety, efficacy, and reliability.

(11) Safety and performance standards are preferred over other types of standards in that they allow more flexibility in the design and manufacture of medical devices in the best interest of the patient, user, and manufacturer.

There are two important aspects of this conference: constructive recommendations and wide publicity. The device conference documents have been submitted to all major medical, engineering, scientific, hospital, and industrial publications for broad dis

semination.

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Standards For Standards

Introduction

STANDARDS

The mandates have been well articulated. Your preparations are the foundations on which you meet now to adjudicate and to synthesize opinions. As one privileged to participate in the opening session, my initial reaction was to try to answer all of the questions that have been asked. What a relief it is to discover that that is not my job but yours: you, the experts who have thought and worked and are now assembled.

Dwight E. Harken, MD, Clinical Professor of Surgery Emeritus, Harvard Medical School, discusses recent developments affecting medical device standards.

In attempting to give useful purpose to my own presentation, I find it promising to look at some of the circumstances and background resources that can, without torturing reason, be placed in six progressively narrower steps that lead to this meeting.

I. Medical devices are central to the delivery of health care II. Devices have become classified as drugs (Difco and AMP). III. The National Device Conference of 1969 outlined basic problems and offered some reasonable suggestions.

JOURNAL OF THE ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION Copyright © 1972 by The Williams & Wilkins Company

IV. The Cooper Report of 1970 was a response to the public and the President's appeal.

V. Device legislation requires direction from this Conference. VI. Voluntary and government (national and international)

standards setting needs further focus, for which the ISO Cardiovascular Secretariat offers a unique opportunity. Before elaborating on these six steps, I paraphrase Vermont Royster:

The great ceremonial occasions of life are so endlessly repeated that the more important observations they evoke, the more hackneyed they seem.

At the risk of seeming frivolous at the outset of this important conference, I should like to illustrate our presence here with 1 story. A plane went down in the Mediterranean Sea. The passengers were three Frenchmen, three Italians, three Englishmen. and three Russians. In each threesome there were two men and one woman. These passengers survived and made their way on the life raft to an uninhabited island. A year later an American rescue ship found them and found the following society to have evolved. The Frenchmen and the Frenchwoman had established a ménage à trois - all three were happy. One Italian had murdered the other Italian and was living with the Italian woman. The Englishmen and the Englishwoman had come to an understanding and had settled down. The Russians had written a letter to Moscow asking for instructions. Had there been Americans, they would have, by this time, divided the island into regions and organized a symposium to discuss the apparent rise in crime.

I. The Problem - Devices and the Delivery of Health Care Hospital costs went up 110% between 1965 and 1971. The Health Care Industry is a 70 billion dollar-a-year industry. The delivery of health services increased from 3.6 billion dollars or 4% of the gross national product in 1928 and 1929, to 60 3 billion or 7% of the GNP for 1968-1969. This same 20-year period spans the device evolution from implantable orthopedic and dental devices to implantable life-saving heart valves, pacemakers, and electronic devices. This massive extension of greatly complicated monitoring, diagnostic, and therapeutic devices has made it pos sible for the treatment of critical illness to advance from acciden tal trauma that was uniformly fatal to routine survival of similar degrees of elective surgical stress. With powerful devices rendering powerful life-saving service have come some misuse, abuse, and attendant hazards. These have had sensational, often counterproductive, lay emphasis. There appears to be media and public satisfaction in crying, "There ought to be a law." Seeing Ralph Hotchkiss at this meeting reminds me of an unfortunate example

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of well intentioned but counterproductive publicity - Mr. Ralph Nader's report in the March 1971 Ladies Home Journal indicting hospitals as horror chambers and supporting this sensational article with some inaccurate data. I feel that this was the wrong type of report offered at the wrong time to the wrong people. Mothers and children necessarily use our hospital outpatient departments, yet were frightened when indeed most are not even exposed to sensitive areas. My disappointment was probably shared by physicians, engineers, editors of the Ladies Home Journal, and indeed some conscientious members of Mr. Nader's excellent staff. It is hardly news that powerful agents can have powerful side effects and must be used carefully. In short, medical devices are a very significant part of one of our nation's most significant problems, namely the delivery of health services.

II. Devices Have Become Classified as Drugs (Difco and AMP) Court decisions in 1969 created legal and regulatory confusion on the differences between devices and drugs. Suddenly, in 1969, an undetermined number of devices became classified as drugs, without a clear definition of a device. The FDA became responsible for the safety and efficacy of many devices as well as drugs. Already overwhelmed by their responsibilities and sorely criticized for obstructing research and development of new drugs, the FDA suddenly became saddled with new responsibilities without limit and without resources. Paradoxically, it was at once burdened with too little- and too much, too soon- and too late.

III. The National Device Conference of 1969

The 1969 conference, a collaborative effort among the National Institutes of Health, industry, and the Association for the Advancement of Medical Instrumentation, constituted a logical precursor for this conference.

As a precursor of this meeting, two features should be mentioned. The first has to do with the recommendations of the Task Force on Standards and Standardization of that 1969 conference; the second feature has to do with the massive public exposure given the proceedings of that 1969 National Devices Conference. As for the recommendations of the Task Force on Standards, I can risk oversimplification because the proceedings themselves have been put in your hands.

In summary, the Task Force on Standards and Standardization recommended:

1. A central organization involved in the broad overview of developing standards for medical devices should be created. This should embrace a directory of organizations involved in such standards.

2. A central library of available standards for medical devices should be created.

3 Industry should supply instructions for critical testing of medical devices when possible, provide information on comparison of all prosthetic devices implanted in the body, and supply wiring diagrams, testing circuits, etc., for electrical and electronic devices.

4. Each medical specialty group should develop effective working committees concerned with safety, standards, and standardization of medical devices. Their official journals should assume responsibility for publishing relevant standards.

Already substantial effect is manifested by FDA efforts, to wit, by compiling a list of organizations involved in standards by the

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FDA committees on classification of devices and by this very conference.

The second area of relevance to the Device Conference of 1969 is that of public exposure of the proceedings of that conference which provides a precedent for this conference. There will be widespread simultaneous publication in August of your recommendations and observations in leading engineering, industrial, and medical journals. All of this anticipated public exposure sharpens our public conscience and adds to the likelihood of implementation. The realization of this imminent exposure of your deliberations should only render your sense of obligation more

acute.

This widespread and protean exposure to lay, professional, and industrial audiences forces me to put into these proceedings definitions of the three classical S's: Specifications, Standardization, and Standards. This is done with apology to you, a very sophisticated group in its sphere, but as a courtesy to those who may be less familiar with terms basic to an understanding of our report.

Specifications are descriptive demands prepared for items and processes relative to the manufacture of items. These vary in complexity from paper clips to missile weapon systems or electronic cardiac diagnostic and therapeutic apparatus.

Standardization covers the agreement in the common interest for the utilization of specifications shared in common, such as the gauge of railroads, the thread on bolts, the sockets for light bulbs, electrical connections, etc.

A Standard represents a uniform method or material clearly established through expertise. Such a standard represents an operational reference for present or future use. Standards are documents created primarily to serve the needs of designers and to control variety. Standards may cover materials, items, features of items, engineering practices, processes, codes, symbols, type designations, definitions, nomenclature, test inspections, packaging, preservation methods and materials, definitions, and classifications.

IV. The Cooper Report of 1970

The legislative task force recommendations of the National Conference on Medical Device Standards of 1969 are before you and have had widespread publication.

A very significant forward step was the report of a Study Group headed by Doctor Theodore Cooper, Director of the National Heart and Lung Institute. His group recognized the inherent differences between drugs and devices and the need for differences in regulation. While a number of questions remained unanswered, the Cooper Report provided a reasonable basis for ultimate legislation. The Cooper Study Group recognized, among other things, the need to classify devices into three categories: (1) devices for which standards or pre-market clearance need not apply; (2) devices requiring standards; and (3) devices requiring pre-market clearance. They further recommended the appointment of multidisciplinary advisory councils.

V. Significant Device Legislation Has Been Introduced Early after presentation of the Cooper Report, Congressman Paul Rogers of Florida, chairman of the Congressional Public Health Subcommittee, introduced a bill intended to be the legis lative embodiment of the Cooper Report. Other legislative proposals were submitted with greater or lesser variations up to and including what is termed the "Administration's Medical Device Safety Act, H.R. 12316 and S. 3028." This whole spectrum of bills has much in common with respect to principles, strength,