Biomaterials, Medical Devices, and Artificial Organs
ISSN: 0090-5488 (Print) (Online) Journal homepage: http://www.tandfonline.com/loi/ianb16
Legislation to Regulate Medical Devices Margaret Harris To cite this article: Margaret Harris (1975) Legislation to Regulate Medical Devices, Biomaterials, Medical Devices, and Artificial Organs, 3:3, 261-275, DOI: 10.3109/10731197509118626 To link to this article: http://dx.doi.org/10.3109/10731197509118626
Published online: 11 Jul 2009.
Submit your article to this journal
Article views: 3
View related articles
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ianb16 Download by: [UNSW Library]
Date: 26 April 2016, At: 05:03
BIOMAT., MED. DEV., ART. ORG., 3(3), 261-275 (1975) REVIEW
Legislation to Regulate Medical Devices
Downloaded by [UNSW Library] at 05:03 26 April 2016
MARGARET HARRIS,* M.P.H. Office of Federal Health Relations School of Medicine University of Southern California Los Angeles, California 90033
In Congressional hearings on legislation to give the Food and Drug Administration authority to regulate medical devices, a physician testified: "Under current standards of nonregulation in the United States, I could take a paper clip and fashion it into an IUD (intrauterine device). I could then begin inserting it into women without even informing them that i t is an experimental and never-tested IUD. And I would not even have to inform the FDA of my newly invented IUD." Physicians, scientists, consumers, manufacturers, Congress and the Nixon Administration were all in agreement that FDA needs additional authority, through new legislation, to oversee the safety and efficacy of medical devices. An HEW commission recommended that medical devices be classified by FDA into three categories: those requiring testing prior to marketing, those for which standards would be sufficient to protect the public health and safety, and those generally recognized as safe and requiring neither standards nor premarket scientific review. FDA has already conducted an inventory of medical devices and initiated classification into categories. Legislation giving FDA authority to establish standards and require premarket testing of medical devices is expected to pass Congress and become law in 1975. *Present address: Division of Health Services Administration, School of Public Health, UCLA, Los Angeles, California 90024.
26 1 Copyright 0 1976 by Marcel Dekker, Inc. All Rights Reserved. Neither this work nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage and retrieval system, ..:LL-..A
:--:-:-
.-:&:--
C---
rh-
..
hI:-l.--
26 2
HARRIS
Downloaded by [UNSW Library] at 05:03 26 April 2016
I.
INTRODUCTION
Medical device manufacturing is a $3 to 5 billion industry, about half the size of the pharmaceutical industry. The sophistication of the device field has increased significantly since World War 11 with developments in electronic miniaturization, biomedical engineering, and plastics. Advances have produced complex medical devices such as heart valves, cardiac pacemakers, renal dialysis units, defibrillators, surgical implants, artificial veins, and intensive c a r e monitoring equipment. Since the 1938 amendments to the Food, Drug, and Cosmetic Act, FDA has had some regulatory authority over medical device manufacture, labeling and advertising. However, FDA can bring legal action against devices only after they a r e marketed and sold in interstate commerce. FDA has no authority to require premarket testing for safety. In 1969, President Nixon stated in his consumer message to Congress: "Certain minimum standards should be established for devices; the government should be given authority to require premarketing clearance in certain cases." In 1970, the HEW commission on medical devices, chaired by Dr. Theodore Cooper, then director of the National Heart and Lung Institute, reported recommendations for medical device legislation. The Cooper Commission report became the basis for current legislative proposals. The commission recommended a review of all devices by FDA-appointed task forces representative of the scientific community to classify devices into three categories: those which would be exempt from standard- setting and premarket review, those for which standards are needed to assure safety and reliability, and those for which premarket review should be required. The commission advised scientific review of the safety and effectiveness of medical devices in current and future use, and recommended a definition of the federal role in establishing standards and monitoring compliance. FDA h a s since compiled an inventory of over 12,000 devices produced by more than 1100 manufacturers and begun classifying them into the three categories described by the Cooper Commission report. The inventory is based on voluntary compliance by manufacturers since FDA has no legal authority to require registration of devices. 11.
L E G A L CASES
FDA's only recourse for protecting the public against dangerous or ineffective medical devices since the 1938 amendments to the
Downloaded by [UNSW Library] at 05:03 26 April 2016
LEGISLATION TO REGULATE MEDICAL DEVICES
263
Food, Drug, and Cosmetic Act h a s been through lawsuits. Legal actions have proven costly and time consuming. The burden of proof of mislabeling r e s t s with the government, and FDA can take action against a device only after it is marketed. A number of fraudulant electrical devices have been brought to court by FDA because of their potential hazards and false claims. In 1966, the FDA filed suit against the Relaxicisor, an electrical machine sold for $200 to 400. Manufacturers claimed the machine would make people slim. FDA found no basis for such claims and found the machine to be hazardous when used on the chest o r during pregnancy. Legal proceedings took 5 years and cost the government half a million dollars. When the Relaxicisor w a s finally removed from the market, Americans had purchased 400,000 of the machines. A young man was recently eIectrocuted by a Relaxicisor in Texas. The Relaxicisor case demonstrates how difficult it has been under current laws for FDA to protect the public against hazardous medical devices. Another such device is the Micro-Dynameter, a string galvanometer which measures degree of resistance to electrical current on the skin (Fig. 1). The device was advertised as being capable of detecting stomach ulcers, epilepsy, cancer, tooth infection, diabetes, and insanity. A 1963 court decision found the device incapable of all uses claimed for i t and in violation of labeling requirements in the 1938 Food, Drug, and Cosmetic Act. A subsequent California court decision ruled that fraudulent therapeutic devices, though harmless in themselves, a r e dangerous because ignorant and gullible people are likely to rely on them rather than seek qualified professional help. Another bogus device that FDA removed from the market by legal action w a s the Halox Therapeutic Generator. The generator emitted chlorine gas from a sodium chloride solution by electrolysis. The patient breathing the gas through a tube was being "treated" for arthritis, sinusitis, and other ailments. Halox Therapeutic Generat o r s were handsomely encased in leather- covered plywood, had control panels, and inside a glass jar held the sodium chloride solution. A California district court ruled that the generators being shipped to chiropractors in California were not exempt from FDA labeling requirements pertaining to interstate marketing of devices. Court decisions have also given FDA a precedent for expanding i t s authority by redefining certain devices as drugs. In 1968 a nylon suture was determined to be a drug rather than a device. A BactoUnidisk for testing sensitivity to antibiotic drugs was classified as a drug by a Supreme Court decision. These decisions provided an adequate legal precedent for FDA to classify as drugs the following
Downloaded by [UNSW Library] at 05:03 26 April 2016
264
HARRIS
FIG. 1. The court ruled Micro-Dynameter misbranded under the Food, Drug, and Cosmetic Act. It was incapable of detecting any diseases and was dangerously being promoted through false advertising claims. devices: IUD's, cardiac pacemakers, intravascular catheters, and other devices implanted or inserted into the body for extended periods. Classification a s drugs would have subjected these devices to premarket review. However, FDA did not choose to use i t s expanded authority. In March 1973, FDA published regulations classifying only IUD's which actually release drugs o r metallic ions a s drugs. FDA developed a distinction between drugs and devices based on whether the intended action is chemical o r not. Pregnancy tests, weight reducing kits, and soft contact lenses were also reclassified a s drugs after the legal decisions on the nylon suture and Bacto-Unidisk.
LEGISLATION TO REGULATE MEDICAL DEVICES 111.
26 5
THE NEED FOR LEGISLATION
An FDA representative told the Senate Health Subcommittee: "If we reclassified IUD's as new drugs, we would be legally required immediately to take all IUD's off the market until the new drug applications had been approved. .we concluded that the development of legislation.. .was the far more reasonable way to approach the problem." "The increasing sophistication of medical devices has outpaced the department's ability to protect the public from those that are faulty," noted Dr. Charles Edwards, Assistant Secretary for Health. FDA lacks specific authority to require premarket testing o r set safety standards for devices. Dr. Edwards explained other regulatory deficiencies to the Senate Health Subcommittee. FDA lacks authority to:
Downloaded by [UNSW Library] at 05:03 26 April 2016
.
1. Create "good manufacturing practice" regulations for devices. 2. Require registration of manufacturers and obtain a list of
devices currently produced. 3. Inspect quality control records, consumer complaints, and plant facilities. 4. Establish a procedure for requiring mandatory compliance with safety standards, o r require replacement, o r return of devices which violate regulations. Adverse reaction reporting is another problem for FDA under current laws. "Precise data on the number of injuries caused by faulty medical devices.. .is not available partly because these devices are commonly used in critical situations in which a causeand-effect relationship between defect and patient condition cannot be definitely determined. A more important reason for our lack of data, however, is that unlike adverse reaction experience from new drugs, adverse reaction experience with medical devices is not ordinarily brought to the attention of the Food and Drug Administration because there is no legal requirement that this be done," Dr. Edwards explained. One researcher, Major Russel J. Thomsen, M.D., noted, "What I found (after a survey of literature) was the evidence that despite adequate proof that IUD's a r e capable of producing serious and even fatal complications in young women, they are a lucrative arena of medical devices which-beyond FDA regulation-breeds poor research, deceptive advertising and actual medical hucksterism."
Downloaded by [UNSW Library] at 05:03 26 April 2016
266
HARRIS
Major Thomsen spoke before a Governmental Operations Subcommittee on the need for further regulation of IUD's. (Future subcommittee hearings are planned related to regulation of pacemakers, heart valves, intravascular catheters, and impact resistant eyeglasses [ 13.) Major Thomsen discussed research on the Dalkon Shield which misleadingly claimed to have covered a 12-month period, even though the average insertion was for only 5.5 months. Advertising claims for the degree of discomfort a woman might feel with insertion of the device and the number of complications which might occur were misleadingly understated. "To place the current state of IUD's into perspective one could conjecture a new drug being put on the market without even notifying the FDA. Also conjecture that this new drug had been-despite rather small studies and profit-inspired optimism-already proven to cause death, sterility, hemorrhage leading to anemia, disabling pain, unwanted pregnancy, miscarriage, ruptured tuba1 pregnancy, thousands of major surgical procedures.. .and untold numbers of x-rays to the ovaries of young women." In concluding statements Major Thomsen noted: "My concern with IUD's.. .has not been that they a r e used clinically, but that their invention, production, and promotion have often been based on inadequate advertising, on failure to record actual complications, and on a calculated advertising effort to misrepresent IUD's to the extent of taking away the woman's right of informed consent." A representative of the manufacturer of the Dalkon Shield, A. H. Robins Co., categorically refuted Major Thomsen's charges of fraud and deceit in the selection of studies used. He testified that A. H. Robins had sponsored extensive clinical trials of the Dalkon Shield. After an estimated 1.8 million insertions, the manufacturer had received approximately 400 voluntary reports of problems associated with the shield. The company kept records, but the reports of complaints were never referred voluntarily to the FDA. A consumer advocate approach to the device industry was presented by Sidney Wolfe, M.D., director of the Health Research Group. "What other business could boast the following: 1. Annual sales in excess of $3 billion-projected to double in 10 years. 2. Increasing percentage of sales to the 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 not concerned
LEGISLATION TO REGULATE MEDICAL DEVICES
267
Downloaded by [UNSW Library] at 05:03 26 April 2016
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% o r 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." Dr. Wolfe describes a case of a defective mitral heart valve used in 1500 patients. A supporting strut which holds the disk valve in place was found to be brittle and easily broken in 1.9% of the valves inspected. Four deaths were reported due to the broken strut. Virtually none of the information on this valve has been made public. Dr. Wolfe attributed the problem with the device to several factors: inadequate testing prior to marketing, reluctance by the manufacturers to accept the responsibility for the defect, and a desire to keep the information quiet. The device was marketed after 6 months of animal testing and 7 months of testing in humans. Well documented animal testing- including microscopic inspection of the valve a t each stage-might have disclosed the structural defect, Dr. Wolfe noted. A letter was sent to doctors, and the labeling of the product was revised 14 months after the device was marketed. The letter urged hospital personnel not to subject the device to abnormal bending s t r e s s which could cause cracking of the strut, The company reportedly informed cardiac surgeons but did not inform cardiologists and internists of the defect. The "Super Coil" is an abortion device which has not been properly tested and is dangerous for use on patients, Dr. Wolfe explained. There are no published reports documenting its safety. In fact, it is "not based on sound physiologic principles," reports Dr. Wolfe. The "Super Coil" abortion method involves insertion into the uterus of 13-inch plastic strips. The shoelace-like strips are inserted until the patient feels discomfort-after four to 12 strips are inserted. Of 15 women who had "Super Coil" abortions in a Philadelphia clinic in 1972, nine women had complications and three had major problems including lacerations of the uterus. The "Super Coil" dramatically demonstrates the need for better regulation of medical devices. If there is agreement on the need for some regulation, there is also concern that laws not be overly restrictive. "The problem in regard to legislation is that we need a screen, not a dam," noted Arthur G. Beall, M.D., professor of surgery from Baylor College of Medicine. He emphasized the importance of the risk-benefit ratio in considering new devices. Although about 500 people have
HARRIS
Downloaded by [UNSW Library] at 05:03 26 April 2016
26 8
died from imperfections in artificial valves, over 200,000 a r e alive who would have died without the artificial valves. Investigations of new devices should be reviewed by local review committees; there are simply too many sophisticated investigations being conducted to r e f e r them to the FDA for approval, Dr. Beall argued. Manufacturers a l s o told House and Senate subcommittees that regulations should not be more rigorous than necessary. In general they agreed with provisions of the legislation calling for: a definition of devices as distinct from drugs, exclusion of custom devices, allowance f o r changes in rapidly developing products, and allowance for appeals of FDA panel decisions. Manufacturers do not want the language of standards to be overly specific; it should allow for new developments. IV.
LEGISLATION
The 93rd Congress introduced three major legislative proposals, all of which basically followed the recommendations of the Cooper Commission. Senator Gaylord Nelson's (D- Wis.) bill requires premarket clearance of any device which the HEW Secretary determines should be premarket tested to protect the public health and safety. The Administration legislation, introduced by Senator Jacob Javits (R-N.Y.) and Representative Harley Staggers (D- W. Va.), calls for premarket testing of any device "intended for u s e in life threatening situations" and requires standards f o r devices which present "unreasonable" r i s k of illness o r injury. But the strongest impetus for medical device legislation came when Senate and House health subcommittee chairmen agreed to sponsor similar bills. In August 1973, Senator Edward Kennedy (D-Mass.), Health Subcommittee chairman, and Representative Paul Rogers (D- Fla.), chairman of the Public Health and Environment Subcommittee introduced identical bills calling for premarket scientific review of devices which present "unreasonable r i s k of illness o r injury." The Kennedy-Rogers bill is titled "Medical Device Amendments of 1973" and amends the Food, Drug, and Cosmetic Act. On February 1, 1974, the Senate unanimously approved an amended version of Senator Kennedy's "Medical Device Amendments of 1973." Representative Roger' s subcommittee identified loopholes in the bill and held up its passage in the 93rd Congress. Senator Kennedy re-introduced essentially the s a m e bill i n 1975. The Labor and Public Welfare Committee reported the bill in March, and the full Senate approved it on April 17, 1975. The House of Representatives'
LEGISLATION TO REGULATE MEDICAL DEVICES
269
Public Health and Environment Subcommittee expects to report an amended version of the bill soon.
Downloaded by [UNSW Library] at 05:03 26 April 2016
A.
Definition
The Senate bill includes a new definition for the term "device": "Instruments, apparatus, implements, machines, contrivances, implants, in vitro reagents and other similar o r related articles, including their components, parts and accessories (1) recognized in the official National Formulary, the official United States pharmacopeia o r any supplement to them: o r (2) intended for use in the diagnosis of o r in the cure, mitigation, treatment, o r prevention of disease in man o r other animals; o r (3) intended to affect the structure o r any function of the body of man o r other animals; and (4) which do not achieve any of their principal intended purposes through chemical action within o r on the body of man o r other animals and which are not dependent upon being metabolized for the achievement of any of their principal intended purposes." B.
Classification
In the Senate bill the HEW Secretary may appoint panels of experts, o r use existing FDA panels, to classify all medical devices intended for human use. Appointment of panels must take place within 60 days after funds are appropriated. Panels must submit reports of findings within 1 year of their appointment. The same panels which classify devices will review devices prior to marketing and assure that devices meet standards. Panels will include representatives of clinical and administrative medicine, engineering biology, and physical sciences. Two nonvoting members would sit on each panel: a representative of consumer interests and a representative of industry interests. The three categories for medical devices in the Senate bill are essentially the same as the Cooper Commission recommended: those requiring review prior to marketing, those requiring standards, and devices which are safe. The bill describes the categories as: "1, Those devices for which insufficient information exists to assure effectiveness o r assure that exposure to such devices will not cause unreasonable risk of illness o r injury and for which standards o r other means may not be appropriate to reduce o r eliminate such risk of illness o r injury and which therefore should
HARRIS
270
..
be subject to premarket scientific review.. Such review, either initial o r continuing, shall be required if the panels determine that such device purports o r is representated to be for a use which is life sustaining o r life supporting. 2. Those devices for which in order to assure effectiveness o r to reduce o r eliminate unreasonable risk of illness o r injury it is appropriate to establish reasonable performance standards. relating to safety and effectiveness and for which other means may not be appropriate to reduce o r eliminate such risk of illness o r injury. 3. Those devices which are safe and effective when used in conjunction with instructions for usage and warnings of limitation, which a r e adequate for the persons by whom the device is represented o r intended for use, which present a minimum risk, and which should be exempt from requirements for scientific review or performance standards."
Downloaded by [UNSW Library] at 05:03 26 April 2016
..
Proposed classifications of devices will be printed in the Federal Register for review and comment by interested persons.
C. S t a n d a r d s The Senate bill gives the HEW Secretary authority to issue performance standards for any device when a standard would be appropriate "to eliminate unreasonable risk of illness o r injury associated with exposure to o r use of a device." Standards relate to safety and effectiveness over time as well as composition, construction, properties, uniform identification, and performance. Standards regulate indicated uses, proper labeling, instructions for use, and warnings. Provision for testing may be included in the prescribed standard. Performance standards will be rechecked periodically since the state of the a r t of medical device technology is changing rapidly. Consultation with other organizations concerned with standard setting is to be used to the maximum extent possible. The Cooper Commission report included a partial list of organizations developing standards for medical devices. Among these groups are: the American National Standards Institute, preparing standards for electrical safety aspects of devices and anesthesia equipment; Underwriters' Laboratories, Inc., for standards relating to wiring and plugs; United States Pharmacopial Convention, Inc., for specifications for plastics; American Dental Association, preparing standards for materials and dental instruments; and the United
Downloaded by [UNSW Library] at 05:03 26 April 2016
LEGISLATION TO REGULATE MEDICAL DEVICES
271
States of America Standards Institute, which is preparing standards for ECG monitoring equipment, internal cardiac pacemakers, and an overall safety code for other devices. A number of professional associations have formed committees to determine standards for medical devices. These include the Association for the Advancement of Medical Instrumentation, American College of Physicians, American College of Surgeons, American Heart Association, and Society for Quality Control. Government organizations which determine standards include the Bureau of Radiological Health, which works on standards for radiological apparatus; the Communicable Disease Center, which s e t s performance standards for clinical pathology laboratories; the Department of Defense and Veterans Administration, which have purchasing standards for prosthetic devices and other equipment; and the National Bureau of Standards. The Senate bill describes in detail the process of establishing a standard. First, the HEW Secretary announces in the Federal Register the intent to set standards for a particular device o r class of devices. Then, interested parties can either offer a standard o r offer to develop one. When more than one qualified offer is made, the Secretary would choose one with no proprietary interest in the device in question. HEW may contribute to the cost of developing the standard. Within 1 year, the HEW Secretary would publish the proposed standard in the Federal Register. After a review and comment period, the standard would become effective unless there were strong criticisms. A standard can be appealed through courts o r a manufacturer may refer the case to one of HEW'S standing scientific advisory committees for an independent review. Veterinary and custom devices are exempt from standards and premarket scientific review requirements. A custom device is defined as one which is not being used regularly as a "course of conduct" nor is it marketed o r advertised. Other provisions protect the public against quack devices. The HEW Secretary can ban a device which presents an unreasonable risk of harm o r deception, if performance standards and premarket review would not adequately protect the public. FDA gains authority to regulate devices used in intrastate commerce. In the past, FDA could act only on devices used in interstate commerce. D.
P r e m a r k e t Scientific Review
In the Senate bill, devices are subject to premarket review if the HEW Secretary, after consultation with appropriate panels, finds
272
HARRIS
Downloaded by [UNSW Library] at 05:03 26 April 2016
review necessary to insure safety and effectiveness o r to reduce o r eliminate unreasonable risk of illness o r injury. Also devices considered to be "life supporting o r life sustaining" would be subject to premarket testing. Additionally, even if the classification panels do not recommend premarket clearance for a device, the Secretary can require premarket review whenever he feels it is necessary. Premarket review is to be used only when there is no more practical way available to reduce risk of illness o r injury. Scientific review of a medical device requires an application to the HEW Secretary containing the following information: 1. Investigations of safety, reliability, and effectiveness of the device. 2. Composition, properties, construction, and principles of operation of the device. 3. Methods, facilities, and controls for manufacturing, processing, packing, and installation of the device. 4. Identification of any standards applicable to the device o r its components and adequate information either to show that the device meets the standards o r to justify any deviation. 5. Samples of the device and specimens of proposed labeling. 6. Any other information which the Secretary may require.
Well-controlled investigations, including clinical trials, must show the device to be effective. However, the HEW Secretary can determine that other scientific evidence may establish the effectiveness of the device. Optimum freedom is provided for scientific investigation of the new devices. Investigators are exempt from the premarket review requirements while using new devices for investigational purposes. After approval by an institution's review committee, the application for investigational use of a device is submitted to the HEW Secretary for approval within 30 days. HEW cannot delay the beginning of an investigation beyond 30 days unless it finds objection to the research. Certain devices subject to rapid obsolescence and frequent modification will be exempt from premarket review when pending legislation is signed into law. These devices can be tested under a product development protocol which takes into account the rapidly changing developments. A protocol must stipulate: the investigational procedures used before clinical trials; monitoring of clinical trials by an institutional review committee; the type and quality of clinical trials; and informed consent from human subjects.
LEGISLATION TO REGULATE MEDICAL DEVICES
Downloaded by [UNSW Library] at 05:03 26 April 2016
E.
273
Notification
The Senate bill will require companies to report consumer complaints of faulty devices. Any person with information which reasonably shows that the device contains a defect which could create a substantial risk to the public health and safety, o r which fails to comply with a safety standard, must report the defect immediately to the HEW Secretary. Notice of defects will go to the general public, unless the Secretary determines that such notification would endanger public health o r is not warranted because of the insignificant deviation from the standard. If a device presents a substantial hazard, the manufacturer may be required to either bring the device into compliance with standards, replace the device, o r refund the purchase price. F.
Good M a n u f a c t u r i n g P r a c t i c e
The bill requires the HEW Secretary to issue regulations for manufacturing, processing, and handling of medical devices. The regulations a r e to be established with input from both industry and consumers. Manufacturers must make reports to FDA on clinical experience. FDA is also authorized to inspect establishments which manufacture devices. Inspection may include records, files, processes, controls, and facilities. G.
Research
The bill gives FDA authority to conduct research and training, either directly o r through contracts. Research may focus on causes and prevention of injuries and disease associated with the use of devices, FDA can also conduct research on medical device performance standards. Education and training of health professionals in the proper installation and use of devices is also authorized. V.
FDA's F I R S T S T E P S
Following recommendations of the Cooper Commission in 1970, FDA developed an inventory of all medical devices and began classification into categories suggested in the report. Panels of
2 74
Downloaded by [UNSW Library] at 05:03 26 April 2016
physicians, scientists, engineers, industry representatives, and qualified consumers made decisions on the categories of devices. Panels were designated by medical specialties and use of the devices as follows: orthopedics; cardiovascular; dental; anesthesiology; obstetrics and gynecology; gastroenterology and urology; radiology; neurological disease; ear, nose, and throat; opthalmic; general and plastic surgery; general hospital and personal use; physical medicine (physiatry); and laboratory medicine. The f i r s t six panels are functioning and the next eight will be added soon. The cardiovascular panel has completed its preliminary classification report [ 2 ] . VI.
CONCLUSIONS
The history of medical device regulation began with the need to r i d the marketplace of bogus inventions which were either harmful in themselves o r harmful because they delayed meaningful treatment of illness. Since World W a r 11, sophistication in medical technology and development of electronic and other types of medical devices has created a new need for regulation of safety and performance of devices used to c u r e and mitigate disease in man. The 1938 amendments to the Food, Drug, and Cosmetic Act gave FDA authority over labeling and advertising of devices, enforceable only after devices 'were marketed. In 1969 a study by an HEW commission documented the need for further legislation. The commission recommended three categories of medical devices: those requiring premarket clearance o r scientific review, those for which standards could be established to protect the public, and those which a r e generally recognized as safe and for which no standards would be necessary. In 1974 the Senate unanimously approved Senator Kennedy's "Medical Device Amendments of 1973" legislation which fulfills the recommendations of the HEW commission report. The House of Representatives failed to pass their version of the legislation in the 93rd Congress. Senator Kennedy re-introduced the bill in the 94th Congress and it passed the Senate in April 1975. Representative Rogers re-introduced an amended bill. The bill is expected to become law in 1975. ACKNOWLEDGMENTS The author appreciates assistance from L a r r y Horowitz, M.D., of the Senate Health Subcommittee staff, George Flesh, M.D., and many helpful people a t the Los Angeles County/USC Medical Center.
LEGISLATION TO REGULATE MEDICAL DEVICES
275
REFERENCES
[ 11 For further information, contact the Subcommittee on Intergovernmental Relations, 2157 Rayburn House Office Building, U.S. House of Representatives, Washington, D.C. 20515. [2] Public summaries of panel meeting minutes are available from FDA, Bureau of Medical Devices and Diagnostic Products, Division of Classification and Scientific Evaluation (HSM- 120), Rockville, Maryland 20852.
Downloaded by [UNSW Library] at 05:03 26 April 2016
Received by editor November 14, 1974
ISSN: 0090-5488 (Print) (Online) Journal homepage: http://www.tandfonline.com/loi/ianb16
Legislation to Regulate Medical Devices Margaret Harris To cite this article: Margaret Harris (1975) Legislation to Regulate Medical Devices, Biomaterials, Medical Devices, and Artificial Organs, 3:3, 261-275, DOI: 10.3109/10731197509118626 To link to this article: http://dx.doi.org/10.3109/10731197509118626
Published online: 11 Jul 2009.
Submit your article to this journal
Article views: 3
View related articles
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ianb16 Download by: [UNSW Library]
Date: 26 April 2016, At: 05:03
BIOMAT., MED. DEV., ART. ORG., 3(3), 261-275 (1975) REVIEW
Legislation to Regulate Medical Devices
Downloaded by [UNSW Library] at 05:03 26 April 2016
MARGARET HARRIS,* M.P.H. Office of Federal Health Relations School of Medicine University of Southern California Los Angeles, California 90033
In Congressional hearings on legislation to give the Food and Drug Administration authority to regulate medical devices, a physician testified: "Under current standards of nonregulation in the United States, I could take a paper clip and fashion it into an IUD (intrauterine device). I could then begin inserting it into women without even informing them that i t is an experimental and never-tested IUD. And I would not even have to inform the FDA of my newly invented IUD." Physicians, scientists, consumers, manufacturers, Congress and the Nixon Administration were all in agreement that FDA needs additional authority, through new legislation, to oversee the safety and efficacy of medical devices. An HEW commission recommended that medical devices be classified by FDA into three categories: those requiring testing prior to marketing, those for which standards would be sufficient to protect the public health and safety, and those generally recognized as safe and requiring neither standards nor premarket scientific review. FDA has already conducted an inventory of medical devices and initiated classification into categories. Legislation giving FDA authority to establish standards and require premarket testing of medical devices is expected to pass Congress and become law in 1975. *Present address: Division of Health Services Administration, School of Public Health, UCLA, Los Angeles, California 90024.
26 1 Copyright 0 1976 by Marcel Dekker, Inc. All Rights Reserved. Neither this work nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage and retrieval system, ..:LL-..A
:--:-:-
.-:&:--
C---
rh-
..
hI:-l.--
26 2
HARRIS
Downloaded by [UNSW Library] at 05:03 26 April 2016
I.
INTRODUCTION
Medical device manufacturing is a $3 to 5 billion industry, about half the size of the pharmaceutical industry. The sophistication of the device field has increased significantly since World War 11 with developments in electronic miniaturization, biomedical engineering, and plastics. Advances have produced complex medical devices such as heart valves, cardiac pacemakers, renal dialysis units, defibrillators, surgical implants, artificial veins, and intensive c a r e monitoring equipment. Since the 1938 amendments to the Food, Drug, and Cosmetic Act, FDA has had some regulatory authority over medical device manufacture, labeling and advertising. However, FDA can bring legal action against devices only after they a r e marketed and sold in interstate commerce. FDA has no authority to require premarket testing for safety. In 1969, President Nixon stated in his consumer message to Congress: "Certain minimum standards should be established for devices; the government should be given authority to require premarketing clearance in certain cases." In 1970, the HEW commission on medical devices, chaired by Dr. Theodore Cooper, then director of the National Heart and Lung Institute, reported recommendations for medical device legislation. The Cooper Commission report became the basis for current legislative proposals. The commission recommended a review of all devices by FDA-appointed task forces representative of the scientific community to classify devices into three categories: those which would be exempt from standard- setting and premarket review, those for which standards are needed to assure safety and reliability, and those for which premarket review should be required. The commission advised scientific review of the safety and effectiveness of medical devices in current and future use, and recommended a definition of the federal role in establishing standards and monitoring compliance. FDA h a s since compiled an inventory of over 12,000 devices produced by more than 1100 manufacturers and begun classifying them into the three categories described by the Cooper Commission report. The inventory is based on voluntary compliance by manufacturers since FDA has no legal authority to require registration of devices. 11.
L E G A L CASES
FDA's only recourse for protecting the public against dangerous or ineffective medical devices since the 1938 amendments to the
Downloaded by [UNSW Library] at 05:03 26 April 2016
LEGISLATION TO REGULATE MEDICAL DEVICES
263
Food, Drug, and Cosmetic Act h a s been through lawsuits. Legal actions have proven costly and time consuming. The burden of proof of mislabeling r e s t s with the government, and FDA can take action against a device only after it is marketed. A number of fraudulant electrical devices have been brought to court by FDA because of their potential hazards and false claims. In 1966, the FDA filed suit against the Relaxicisor, an electrical machine sold for $200 to 400. Manufacturers claimed the machine would make people slim. FDA found no basis for such claims and found the machine to be hazardous when used on the chest o r during pregnancy. Legal proceedings took 5 years and cost the government half a million dollars. When the Relaxicisor w a s finally removed from the market, Americans had purchased 400,000 of the machines. A young man was recently eIectrocuted by a Relaxicisor in Texas. The Relaxicisor case demonstrates how difficult it has been under current laws for FDA to protect the public against hazardous medical devices. Another such device is the Micro-Dynameter, a string galvanometer which measures degree of resistance to electrical current on the skin (Fig. 1). The device was advertised as being capable of detecting stomach ulcers, epilepsy, cancer, tooth infection, diabetes, and insanity. A 1963 court decision found the device incapable of all uses claimed for i t and in violation of labeling requirements in the 1938 Food, Drug, and Cosmetic Act. A subsequent California court decision ruled that fraudulent therapeutic devices, though harmless in themselves, a r e dangerous because ignorant and gullible people are likely to rely on them rather than seek qualified professional help. Another bogus device that FDA removed from the market by legal action w a s the Halox Therapeutic Generator. The generator emitted chlorine gas from a sodium chloride solution by electrolysis. The patient breathing the gas through a tube was being "treated" for arthritis, sinusitis, and other ailments. Halox Therapeutic Generat o r s were handsomely encased in leather- covered plywood, had control panels, and inside a glass jar held the sodium chloride solution. A California district court ruled that the generators being shipped to chiropractors in California were not exempt from FDA labeling requirements pertaining to interstate marketing of devices. Court decisions have also given FDA a precedent for expanding i t s authority by redefining certain devices as drugs. In 1968 a nylon suture was determined to be a drug rather than a device. A BactoUnidisk for testing sensitivity to antibiotic drugs was classified as a drug by a Supreme Court decision. These decisions provided an adequate legal precedent for FDA to classify as drugs the following
Downloaded by [UNSW Library] at 05:03 26 April 2016
264
HARRIS
FIG. 1. The court ruled Micro-Dynameter misbranded under the Food, Drug, and Cosmetic Act. It was incapable of detecting any diseases and was dangerously being promoted through false advertising claims. devices: IUD's, cardiac pacemakers, intravascular catheters, and other devices implanted or inserted into the body for extended periods. Classification a s drugs would have subjected these devices to premarket review. However, FDA did not choose to use i t s expanded authority. In March 1973, FDA published regulations classifying only IUD's which actually release drugs o r metallic ions a s drugs. FDA developed a distinction between drugs and devices based on whether the intended action is chemical o r not. Pregnancy tests, weight reducing kits, and soft contact lenses were also reclassified a s drugs after the legal decisions on the nylon suture and Bacto-Unidisk.
LEGISLATION TO REGULATE MEDICAL DEVICES 111.
26 5
THE NEED FOR LEGISLATION
An FDA representative told the Senate Health Subcommittee: "If we reclassified IUD's as new drugs, we would be legally required immediately to take all IUD's off the market until the new drug applications had been approved. .we concluded that the development of legislation.. .was the far more reasonable way to approach the problem." "The increasing sophistication of medical devices has outpaced the department's ability to protect the public from those that are faulty," noted Dr. Charles Edwards, Assistant Secretary for Health. FDA lacks specific authority to require premarket testing o r set safety standards for devices. Dr. Edwards explained other regulatory deficiencies to the Senate Health Subcommittee. FDA lacks authority to:
Downloaded by [UNSW Library] at 05:03 26 April 2016
.
1. Create "good manufacturing practice" regulations for devices. 2. Require registration of manufacturers and obtain a list of
devices currently produced. 3. Inspect quality control records, consumer complaints, and plant facilities. 4. Establish a procedure for requiring mandatory compliance with safety standards, o r require replacement, o r return of devices which violate regulations. Adverse reaction reporting is another problem for FDA under current laws. "Precise data on the number of injuries caused by faulty medical devices.. .is not available partly because these devices are commonly used in critical situations in which a causeand-effect relationship between defect and patient condition cannot be definitely determined. A more important reason for our lack of data, however, is that unlike adverse reaction experience from new drugs, adverse reaction experience with medical devices is not ordinarily brought to the attention of the Food and Drug Administration because there is no legal requirement that this be done," Dr. Edwards explained. One researcher, Major Russel J. Thomsen, M.D., noted, "What I found (after a survey of literature) was the evidence that despite adequate proof that IUD's a r e capable of producing serious and even fatal complications in young women, they are a lucrative arena of medical devices which-beyond FDA regulation-breeds poor research, deceptive advertising and actual medical hucksterism."
Downloaded by [UNSW Library] at 05:03 26 April 2016
266
HARRIS
Major Thomsen spoke before a Governmental Operations Subcommittee on the need for further regulation of IUD's. (Future subcommittee hearings are planned related to regulation of pacemakers, heart valves, intravascular catheters, and impact resistant eyeglasses [ 13.) Major Thomsen discussed research on the Dalkon Shield which misleadingly claimed to have covered a 12-month period, even though the average insertion was for only 5.5 months. Advertising claims for the degree of discomfort a woman might feel with insertion of the device and the number of complications which might occur were misleadingly understated. "To place the current state of IUD's into perspective one could conjecture a new drug being put on the market without even notifying the FDA. Also conjecture that this new drug had been-despite rather small studies and profit-inspired optimism-already proven to cause death, sterility, hemorrhage leading to anemia, disabling pain, unwanted pregnancy, miscarriage, ruptured tuba1 pregnancy, thousands of major surgical procedures.. .and untold numbers of x-rays to the ovaries of young women." In concluding statements Major Thomsen noted: "My concern with IUD's.. .has not been that they a r e used clinically, but that their invention, production, and promotion have often been based on inadequate advertising, on failure to record actual complications, and on a calculated advertising effort to misrepresent IUD's to the extent of taking away the woman's right of informed consent." A representative of the manufacturer of the Dalkon Shield, A. H. Robins Co., categorically refuted Major Thomsen's charges of fraud and deceit in the selection of studies used. He testified that A. H. Robins had sponsored extensive clinical trials of the Dalkon Shield. After an estimated 1.8 million insertions, the manufacturer had received approximately 400 voluntary reports of problems associated with the shield. The company kept records, but the reports of complaints were never referred voluntarily to the FDA. A consumer advocate approach to the device industry was presented by Sidney Wolfe, M.D., director of the Health Research Group. "What other business could boast the following: 1. Annual sales in excess of $3 billion-projected to double in 10 years. 2. Increasing percentage of sales to the 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 not concerned
LEGISLATION TO REGULATE MEDICAL DEVICES
267
Downloaded by [UNSW Library] at 05:03 26 April 2016
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% o r 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." Dr. Wolfe describes a case of a defective mitral heart valve used in 1500 patients. A supporting strut which holds the disk valve in place was found to be brittle and easily broken in 1.9% of the valves inspected. Four deaths were reported due to the broken strut. Virtually none of the information on this valve has been made public. Dr. Wolfe attributed the problem with the device to several factors: inadequate testing prior to marketing, reluctance by the manufacturers to accept the responsibility for the defect, and a desire to keep the information quiet. The device was marketed after 6 months of animal testing and 7 months of testing in humans. Well documented animal testing- including microscopic inspection of the valve a t each stage-might have disclosed the structural defect, Dr. Wolfe noted. A letter was sent to doctors, and the labeling of the product was revised 14 months after the device was marketed. The letter urged hospital personnel not to subject the device to abnormal bending s t r e s s which could cause cracking of the strut, The company reportedly informed cardiac surgeons but did not inform cardiologists and internists of the defect. The "Super Coil" is an abortion device which has not been properly tested and is dangerous for use on patients, Dr. Wolfe explained. There are no published reports documenting its safety. In fact, it is "not based on sound physiologic principles," reports Dr. Wolfe. The "Super Coil" abortion method involves insertion into the uterus of 13-inch plastic strips. The shoelace-like strips are inserted until the patient feels discomfort-after four to 12 strips are inserted. Of 15 women who had "Super Coil" abortions in a Philadelphia clinic in 1972, nine women had complications and three had major problems including lacerations of the uterus. The "Super Coil" dramatically demonstrates the need for better regulation of medical devices. If there is agreement on the need for some regulation, there is also concern that laws not be overly restrictive. "The problem in regard to legislation is that we need a screen, not a dam," noted Arthur G. Beall, M.D., professor of surgery from Baylor College of Medicine. He emphasized the importance of the risk-benefit ratio in considering new devices. Although about 500 people have
HARRIS
Downloaded by [UNSW Library] at 05:03 26 April 2016
26 8
died from imperfections in artificial valves, over 200,000 a r e alive who would have died without the artificial valves. Investigations of new devices should be reviewed by local review committees; there are simply too many sophisticated investigations being conducted to r e f e r them to the FDA for approval, Dr. Beall argued. Manufacturers a l s o told House and Senate subcommittees that regulations should not be more rigorous than necessary. In general they agreed with provisions of the legislation calling for: a definition of devices as distinct from drugs, exclusion of custom devices, allowance f o r changes in rapidly developing products, and allowance for appeals of FDA panel decisions. Manufacturers do not want the language of standards to be overly specific; it should allow for new developments. IV.
LEGISLATION
The 93rd Congress introduced three major legislative proposals, all of which basically followed the recommendations of the Cooper Commission. Senator Gaylord Nelson's (D- Wis.) bill requires premarket clearance of any device which the HEW Secretary determines should be premarket tested to protect the public health and safety. The Administration legislation, introduced by Senator Jacob Javits (R-N.Y.) and Representative Harley Staggers (D- W. Va.), calls for premarket testing of any device "intended for u s e in life threatening situations" and requires standards f o r devices which present "unreasonable" r i s k of illness o r injury. But the strongest impetus for medical device legislation came when Senate and House health subcommittee chairmen agreed to sponsor similar bills. In August 1973, Senator Edward Kennedy (D-Mass.), Health Subcommittee chairman, and Representative Paul Rogers (D- Fla.), chairman of the Public Health and Environment Subcommittee introduced identical bills calling for premarket scientific review of devices which present "unreasonable r i s k of illness o r injury." The Kennedy-Rogers bill is titled "Medical Device Amendments of 1973" and amends the Food, Drug, and Cosmetic Act. On February 1, 1974, the Senate unanimously approved an amended version of Senator Kennedy's "Medical Device Amendments of 1973." Representative Roger' s subcommittee identified loopholes in the bill and held up its passage in the 93rd Congress. Senator Kennedy re-introduced essentially the s a m e bill i n 1975. The Labor and Public Welfare Committee reported the bill in March, and the full Senate approved it on April 17, 1975. The House of Representatives'
LEGISLATION TO REGULATE MEDICAL DEVICES
269
Public Health and Environment Subcommittee expects to report an amended version of the bill soon.
Downloaded by [UNSW Library] at 05:03 26 April 2016
A.
Definition
The Senate bill includes a new definition for the term "device": "Instruments, apparatus, implements, machines, contrivances, implants, in vitro reagents and other similar o r related articles, including their components, parts and accessories (1) recognized in the official National Formulary, the official United States pharmacopeia o r any supplement to them: o r (2) intended for use in the diagnosis of o r in the cure, mitigation, treatment, o r prevention of disease in man o r other animals; o r (3) intended to affect the structure o r any function of the body of man o r other animals; and (4) which do not achieve any of their principal intended purposes through chemical action within o r on the body of man o r other animals and which are not dependent upon being metabolized for the achievement of any of their principal intended purposes." B.
Classification
In the Senate bill the HEW Secretary may appoint panels of experts, o r use existing FDA panels, to classify all medical devices intended for human use. Appointment of panels must take place within 60 days after funds are appropriated. Panels must submit reports of findings within 1 year of their appointment. The same panels which classify devices will review devices prior to marketing and assure that devices meet standards. Panels will include representatives of clinical and administrative medicine, engineering biology, and physical sciences. Two nonvoting members would sit on each panel: a representative of consumer interests and a representative of industry interests. The three categories for medical devices in the Senate bill are essentially the same as the Cooper Commission recommended: those requiring review prior to marketing, those requiring standards, and devices which are safe. The bill describes the categories as: "1, Those devices for which insufficient information exists to assure effectiveness o r assure that exposure to such devices will not cause unreasonable risk of illness o r injury and for which standards o r other means may not be appropriate to reduce o r eliminate such risk of illness o r injury and which therefore should
HARRIS
270
..
be subject to premarket scientific review.. Such review, either initial o r continuing, shall be required if the panels determine that such device purports o r is representated to be for a use which is life sustaining o r life supporting. 2. Those devices for which in order to assure effectiveness o r to reduce o r eliminate unreasonable risk of illness o r injury it is appropriate to establish reasonable performance standards. relating to safety and effectiveness and for which other means may not be appropriate to reduce o r eliminate such risk of illness o r injury. 3. Those devices which are safe and effective when used in conjunction with instructions for usage and warnings of limitation, which a r e adequate for the persons by whom the device is represented o r intended for use, which present a minimum risk, and which should be exempt from requirements for scientific review or performance standards."
Downloaded by [UNSW Library] at 05:03 26 April 2016
..
Proposed classifications of devices will be printed in the Federal Register for review and comment by interested persons.
C. S t a n d a r d s The Senate bill gives the HEW Secretary authority to issue performance standards for any device when a standard would be appropriate "to eliminate unreasonable risk of illness o r injury associated with exposure to o r use of a device." Standards relate to safety and effectiveness over time as well as composition, construction, properties, uniform identification, and performance. Standards regulate indicated uses, proper labeling, instructions for use, and warnings. Provision for testing may be included in the prescribed standard. Performance standards will be rechecked periodically since the state of the a r t of medical device technology is changing rapidly. Consultation with other organizations concerned with standard setting is to be used to the maximum extent possible. The Cooper Commission report included a partial list of organizations developing standards for medical devices. Among these groups are: the American National Standards Institute, preparing standards for electrical safety aspects of devices and anesthesia equipment; Underwriters' Laboratories, Inc., for standards relating to wiring and plugs; United States Pharmacopial Convention, Inc., for specifications for plastics; American Dental Association, preparing standards for materials and dental instruments; and the United
Downloaded by [UNSW Library] at 05:03 26 April 2016
LEGISLATION TO REGULATE MEDICAL DEVICES
271
States of America Standards Institute, which is preparing standards for ECG monitoring equipment, internal cardiac pacemakers, and an overall safety code for other devices. A number of professional associations have formed committees to determine standards for medical devices. These include the Association for the Advancement of Medical Instrumentation, American College of Physicians, American College of Surgeons, American Heart Association, and Society for Quality Control. Government organizations which determine standards include the Bureau of Radiological Health, which works on standards for radiological apparatus; the Communicable Disease Center, which s e t s performance standards for clinical pathology laboratories; the Department of Defense and Veterans Administration, which have purchasing standards for prosthetic devices and other equipment; and the National Bureau of Standards. The Senate bill describes in detail the process of establishing a standard. First, the HEW Secretary announces in the Federal Register the intent to set standards for a particular device o r class of devices. Then, interested parties can either offer a standard o r offer to develop one. When more than one qualified offer is made, the Secretary would choose one with no proprietary interest in the device in question. HEW may contribute to the cost of developing the standard. Within 1 year, the HEW Secretary would publish the proposed standard in the Federal Register. After a review and comment period, the standard would become effective unless there were strong criticisms. A standard can be appealed through courts o r a manufacturer may refer the case to one of HEW'S standing scientific advisory committees for an independent review. Veterinary and custom devices are exempt from standards and premarket scientific review requirements. A custom device is defined as one which is not being used regularly as a "course of conduct" nor is it marketed o r advertised. Other provisions protect the public against quack devices. The HEW Secretary can ban a device which presents an unreasonable risk of harm o r deception, if performance standards and premarket review would not adequately protect the public. FDA gains authority to regulate devices used in intrastate commerce. In the past, FDA could act only on devices used in interstate commerce. D.
P r e m a r k e t Scientific Review
In the Senate bill, devices are subject to premarket review if the HEW Secretary, after consultation with appropriate panels, finds
272
HARRIS
Downloaded by [UNSW Library] at 05:03 26 April 2016
review necessary to insure safety and effectiveness o r to reduce o r eliminate unreasonable risk of illness o r injury. Also devices considered to be "life supporting o r life sustaining" would be subject to premarket testing. Additionally, even if the classification panels do not recommend premarket clearance for a device, the Secretary can require premarket review whenever he feels it is necessary. Premarket review is to be used only when there is no more practical way available to reduce risk of illness o r injury. Scientific review of a medical device requires an application to the HEW Secretary containing the following information: 1. Investigations of safety, reliability, and effectiveness of the device. 2. Composition, properties, construction, and principles of operation of the device. 3. Methods, facilities, and controls for manufacturing, processing, packing, and installation of the device. 4. Identification of any standards applicable to the device o r its components and adequate information either to show that the device meets the standards o r to justify any deviation. 5. Samples of the device and specimens of proposed labeling. 6. Any other information which the Secretary may require.
Well-controlled investigations, including clinical trials, must show the device to be effective. However, the HEW Secretary can determine that other scientific evidence may establish the effectiveness of the device. Optimum freedom is provided for scientific investigation of the new devices. Investigators are exempt from the premarket review requirements while using new devices for investigational purposes. After approval by an institution's review committee, the application for investigational use of a device is submitted to the HEW Secretary for approval within 30 days. HEW cannot delay the beginning of an investigation beyond 30 days unless it finds objection to the research. Certain devices subject to rapid obsolescence and frequent modification will be exempt from premarket review when pending legislation is signed into law. These devices can be tested under a product development protocol which takes into account the rapidly changing developments. A protocol must stipulate: the investigational procedures used before clinical trials; monitoring of clinical trials by an institutional review committee; the type and quality of clinical trials; and informed consent from human subjects.
LEGISLATION TO REGULATE MEDICAL DEVICES
Downloaded by [UNSW Library] at 05:03 26 April 2016
E.
273
Notification
The Senate bill will require companies to report consumer complaints of faulty devices. Any person with information which reasonably shows that the device contains a defect which could create a substantial risk to the public health and safety, o r which fails to comply with a safety standard, must report the defect immediately to the HEW Secretary. Notice of defects will go to the general public, unless the Secretary determines that such notification would endanger public health o r is not warranted because of the insignificant deviation from the standard. If a device presents a substantial hazard, the manufacturer may be required to either bring the device into compliance with standards, replace the device, o r refund the purchase price. F.
Good M a n u f a c t u r i n g P r a c t i c e
The bill requires the HEW Secretary to issue regulations for manufacturing, processing, and handling of medical devices. The regulations a r e to be established with input from both industry and consumers. Manufacturers must make reports to FDA on clinical experience. FDA is also authorized to inspect establishments which manufacture devices. Inspection may include records, files, processes, controls, and facilities. G.
Research
The bill gives FDA authority to conduct research and training, either directly o r through contracts. Research may focus on causes and prevention of injuries and disease associated with the use of devices, FDA can also conduct research on medical device performance standards. Education and training of health professionals in the proper installation and use of devices is also authorized. V.
FDA's F I R S T S T E P S
Following recommendations of the Cooper Commission in 1970, FDA developed an inventory of all medical devices and began classification into categories suggested in the report. Panels of
2 74
Downloaded by [UNSW Library] at 05:03 26 April 2016
physicians, scientists, engineers, industry representatives, and qualified consumers made decisions on the categories of devices. Panels were designated by medical specialties and use of the devices as follows: orthopedics; cardiovascular; dental; anesthesiology; obstetrics and gynecology; gastroenterology and urology; radiology; neurological disease; ear, nose, and throat; opthalmic; general and plastic surgery; general hospital and personal use; physical medicine (physiatry); and laboratory medicine. The f i r s t six panels are functioning and the next eight will be added soon. The cardiovascular panel has completed its preliminary classification report [ 2 ] . VI.
CONCLUSIONS
The history of medical device regulation began with the need to r i d the marketplace of bogus inventions which were either harmful in themselves o r harmful because they delayed meaningful treatment of illness. Since World W a r 11, sophistication in medical technology and development of electronic and other types of medical devices has created a new need for regulation of safety and performance of devices used to c u r e and mitigate disease in man. The 1938 amendments to the Food, Drug, and Cosmetic Act gave FDA authority over labeling and advertising of devices, enforceable only after devices 'were marketed. In 1969 a study by an HEW commission documented the need for further legislation. The commission recommended three categories of medical devices: those requiring premarket clearance o r scientific review, those for which standards could be established to protect the public, and those which a r e generally recognized as safe and for which no standards would be necessary. In 1974 the Senate unanimously approved Senator Kennedy's "Medical Device Amendments of 1973" legislation which fulfills the recommendations of the HEW commission report. The House of Representatives failed to pass their version of the legislation in the 93rd Congress. Senator Kennedy re-introduced the bill in the 94th Congress and it passed the Senate in April 1975. Representative Rogers re-introduced an amended bill. The bill is expected to become law in 1975. ACKNOWLEDGMENTS The author appreciates assistance from L a r r y Horowitz, M.D., of the Senate Health Subcommittee staff, George Flesh, M.D., and many helpful people a t the Los Angeles County/USC Medical Center.
LEGISLATION TO REGULATE MEDICAL DEVICES
275
REFERENCES
[ 11 For further information, contact the Subcommittee on Intergovernmental Relations, 2157 Rayburn House Office Building, U.S. House of Representatives, Washington, D.C. 20515. [2] Public summaries of panel meeting minutes are available from FDA, Bureau of Medical Devices and Diagnostic Products, Division of Classification and Scientific Evaluation (HSM- 120), Rockville, Maryland 20852.
Downloaded by [UNSW Library] at 05:03 26 April 2016
Received by editor November 14, 1974
