Articles on Law, Science, and Engineering

PART VI: An Overview of the Medical Device Reporting Regulation

IN SEPTEMBER, 1984, The Subcommittee on Oversight and Investigations of The House Committee on Energy and Commerce held hearings on anesthesia machine failures. The hearing was the result of the death of four individuals who had been under anesthesia controlled by machines manufactured by Puritan-Bennet Corp. The Subcommittee focused on how Puritan-Bennet Corp. responded to the reports of the deaths and the indications that problems might be associated with their anesthesia machines and how well the U.S. Food and Drug Administration ensured that anesthesia machines are safe and effective.

Other congressional hearings highlighted significant problems that can arise when medical device manufacturers keep inadequate complaint file. For example, some hearings focused on FDA's charges that certain device manufacturers failed to properly identify and process complaints, as required then by the medical device Good Manufacturing Practices (GMP) regulation. One firm's GMP complaint file had omitted relevant information contained in lawsuit files. As a result, FDA was unaware of deaths associated with the device involved. When FDA learned of the existence of this information and requested it, the firm refused, contending that lawsuits are not "complaints" and therefore need not be reported. Another device manufacturer did not classify reported malfunctions as complaints until the malfunctioning device was retrieved and examined to verify initial reports.

By early 1984 it was apparent from data collected during routine FDA GMP inspections that some medical device manufacturers were not complying with complaint file requirements to the extent that they should. Frequently, manufacturers failed to include all the pertinent information available to it in the complaint file, and many failed to follow through to properly investigate complaints. Approximately one of twelve manufacturers had no individual who was responsible for investigations or complaints or complaint file maintenance; one of nine failed to investigate all complaints of malfunction; and one of eleven held some complaint information in interim files without making entries in the complaint file. As a result of these violations of the GMP, information on injuries and deaths attributable to medical devices sometimes reached FDA in a delayed manner, or not at all.

After some prodding by Congress,[fn1] FDA published the Medical Device Reporting Regulation. The Regulation requires manufacturers and importers of medical devices (including in vitro diagnostic devices) to report to FDA within specific time periods information that suggests that one of their devices may pose a threat of serious injury. In addition, device importers are required to establish and maintain complaint files, and manufacturers are subject to this requirement under the GMP Regulation.

The criteria for reporting are contained in  803.1 and 803.24(a). A report must be submitted to FDA whenever a manufacturer or importer becomes aware of information that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury or malfunctioned in such a manner that, should a malfunction recur, is likely to cause or contribute to a death or serious injury. A firm may become aware of such information from individuals such as physicians, nurses, and patients, institutions such as hospitals, the medical or scientific literature, or through its own research, testing, evaluation, servicing or maintenance of its products.

 803.24 describes when and how the report is to be made. In cases where a death or serious injury has occurred, a report should be submitted to FDA by telephone as soon as possible but no later than five (5) calendar days after receipt of the information, and in writing within fifteen (15) working days of receipt of the information. In the case of malfunction which is likely to cause or contribute to a death or serious injury if it recurs, a written report should be submitted to FDA as soon as the necessary information is obtained, but no later than fifteen (15) working days after receipt of the information. A firm must report to FDA each time it becomes aware of a reportable event, even if an event of the same or similar nature has been reported previously, or if it is believed to be the result of user error, faulty service, improper maintenance, or the like.

What to report is described in  803.24. A telephone or written report should identify the device by brand and common name, and, if know by model, catalog or other identification number/code, manufacturing lot, serial number, and the like. The report should also identify the domestic manufacturer or importer and foreign manufacturer, the name, address, and telephone number of the individual making the report to FDA, and the name and address of the person who submitted the information to the manufacturer or importer. The report should describe the event, including whether any death or serious injury occurred, the number of persons who died or were seriously injured, and a copy of any article appearing in the scientific or medical literature describing the event. The report should state whether the reported event has occurred more frequently or with greater severity than is stated on the labeling of the device or is usual for the device if there is no pertinent statement in the labeling, and whether additional information will be submitted and, if so, when.

No report of a malfunction is required if all of the following conditions are met:

1. There has been no death or serious injury.
2. The potential for death or the type of serious injury that may result is specified in the labeling for the device.
3. The malfunction and the routine service, repair, or maintenance instructions to correct the malfunction are described in the labeling for the device.
4. The malfunction is occurring at or below its expected frequency and severity.
5. The malfunction does not lead the manufacturer or importer to undertake a remedial action.

 803.31 of the Regulation requires that manufacturers and importers establish and maintain a complaint file containing all information, including written or oral communications, received by a manufacturer or importer concerning a death, serious injury, or a device malfunction that requires a report under the Regulation. The file is also required to contain a copy of the report and other information submitted to FDA. Any authorized FDA employee must be allowed access to records in complaint files at all reasonable times. Copies of records in complaint files at all reasonable times. Copies of MDR records kept by importers must be maintained at its principal place of business in the United States for a period of two (2) years from the date that the report or additional information about the report is submitted to FDA, even if the firm ceases to import the device. Manufacturers must maintain its MDR records for two (2) years from the date that the report or additional information was submitted or for a period of time equal to the design and expected life of the device, whichever is greater.

 803.24(e) of the Regulation empowers FDA to request additional information whenever FDA determines that the protection of the public health requires additional information. The FDA request will be in writing, and it will stipulate the reason for the request and a due date for its submission. Items in addition to those required under  803.24(c) that FDA may request include all evaluations of the risk of death or serious injury, including any evaluation by a practitioner of the reported event, and all evaluations used by or available to the manufacturer or importer in making any determination and the basis for such determination, including the determination of whether or not the reported event is attributable to the device; all analyses used by or available to the manufacturer or importer in making any determination, including laboratory analyses; all information on which it was determined that the reported event is occurring more frequently or with greater severity than is stated in the labeling or is usual for the device; information about the manufacture and distribution of the device; and a copy of any communication proposing a remedial action.

While reporting an event is not an admission of liability, MDR records are available to the public and therefore have substantial implications in the context of liability of manufacturers, importers, distributors, and health care providers.[fn2]

Some questions commonly asked about MDR Regulations and their answers are:

1. WHO IS AN "IMPORTER"? Any person who imports a device into the United States.
2. WHO IS A "MANUFACTURER"? A manufacturer is any person who is required to register under 21 CFR Part 807, other than a person who initially distributes a device imported into the United States.
3. WHO IS A "PERSON"? Any legal entity including individuals, partnerships, corporations, associations, scientific or academic establishments, Government agencies, and organizational units thereof.
4. WHAT INFORMATION "REASONABLY SUGGESTS A CONCLUSION"? Any information from which a reasonable person would reach the conclusion, or a statement to a manufacturer or importer by a health care provider reaching the conclusion.
5. WHAT IS A "MALFUNCTION"? Any failure of a device to meet any of its performance specifications or otherwise perform as intended.
6. WHAT IS "REMEDIAL ACTION"? Any recall, repair, modification, adjustment, relabeling, destruction, inspection, notification, or any other action that is initiated by a manufacturer or importer in response to information that is required to be reported under the MDR Regulation.
7. WHAT IS A "SERIOUS INJURY"? An injury that is (a) life-threatening, (b) results in permanent impairment of a body function or permanent damage to body structure, or (c) necessitates medical or surgical intervention by a health care professional to (i) preclude permanent impairment of a body function or permanent damage to body structure, or (ii) relieve unanticipated temporary impairment of a body function or unanticipated temporary damaged to body structure.
8. WHAT IS AN "ANTICIPATED TEMPORARY IMPAIRMENT"? Temporary impairment of a body function or temporary damage to body structure is unanticipated if no reference to such damage or impairment is stated in the labeling for the device, or, if such reference is made in the labeling for the device, the manufacturer of the device determines that such damage or impairment is occurring more frequently or with greater severity than is usual for the device. Firms should not use annual production rates of all product lines to develop malfunction and severity rates. In addition, a firm must be able to provide FDA with adequate documentation as to why a malfunction rate or severity is usual. In general, firms can use the last two to ten years of experience with a device to ascertain malfunction rates as long as similar events appear as numerators over denominators of appropriate production size.
9. WHAT IS A "HEALTH CARE PROFESSIONAL"? A person who had medical or special education, training, experience, expertise or knowledge, including physicians, nurses, dentists, pharmacists, therapists, clinical engineers, and hospital administrators.
10. HOW DOES A COMPLAINT FROM A HEALTH CARE PROFESSIONAL DIFFER FROM A COMPLAINT FROM A LAY PERSON? The MDR Regulation, in recognition of the special ability of health care professionals to determine if a reportable event has occurred, requires that an event be reported whenever a health care professional indicates that a device may have caused or contributed to a death or serious injury. On the other hand, when a lay person indicates that a device may have caused or contributed to a death or serious injury, a firm may determine if the information received reasonably suggests that a reportable event has occurred.
11. MUST INFORMATION RECEIVED FROM ATTORNEYS REPRESENTING PATIENTS NJURED BY A DEVICE BY REPORTED? Yes, a report from a lawyer, even a plaintiff's lawyer, falls in the same category as a report from a person who is not a health care professional. Unless it is so clearly outside the reporting requirements as to reasonably suggest a basis that an event is not reportable, the event must be reported.
12. DOES EVERY REPORT OF DEATH OR SERIOUS INJURY SUBMITTED BY A HEALTH CARE PROVIDER REQUIRE A REPORT? No. There must be at least an implication that the device may have caused or contributed to a death or serious injury. Further, no Report would be required if the firm determines within five (5) calendar days that the device is not its products, that a death or serious injury did not occur, or that the device falls under an approved Investigational Device Exemption.
13. HOW DOES A FIRM REQUEST AN INVESTIGATIONAL DEVICE EXEMPTION?  803.24(d) (4) states that any firm may request an exemption from reporting events under the MDR Regulation. The request should include a complete description of the device, the specific type of event for which the firm wants exemption, the reason an exemption should be granted (e.g., why the problem does not pose a risk), the number or reports the firm has made to date or the number anticipated, and why the firm believes that other action, such as changes in design, labeling, manufacturing, and the like, is not feasible or necessary to resolve the problem.
14. WHAT DOES "LIKELY" IN THE PHRASE "LIKELY TO CAUSE OF CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR" MEAN? The preamble to the MDR Regulation indicates that ""likely" means "more probably than not." However, this does not signify statistical probability, e.g., greater than 0.5. "More probable than not: is a qualitative and quantitative evaluation of the likelihood that a malfunction would cause or contribute to a death or serious injury. Relevant factors include whether or not the device has a properly functioning fail-safe system which would prevent a death or serious injury if the malfunction occurs, device history that the same malfunction has not resulted in a serious injury or that the injury rate for the malfunction is so law that serious injury is no more than a remote possibility, safeguards suggested in device labeling, and the like.
15. WHAT ARE "WORKING DAYS" FOR SUBMITTING WRITTEN REPORTS? Working days include all calendar days except Saturdays and Sundays (or any other two days of the week that a manufacturer is routinely closed for business) and scheduled Federal holidays. The number of days for filing a report begins on the first working day after the firm first receives information that must be reported.
16. CAN DOMESTIC DEVICE MANUFACTURERS CONTRACT RESPONSIBILITY TO FILE REPORTS TO DISTRIBUTORS? The MDR Regulation does not apply to firms that function only as a distributor of domestically manufactured devices. The domestic manufacturer has responsibility for filing, and any firm that does not file because it believes it has contracted out the responsibility to file to a distributor would be in violation of the MDR Regulation unless the distributor is also acting as agent for the firm. A distributor may be designated to report events if there is joint ownership and control of the device with the manufacturer.
17. ARE REPORTS REQUIRED FOR PRODUCTS UNDER RECALL? Yes.
18. IF A FIRM STOPS MANUFACTURING A DEVICE, WHEN IS IT NO LONGER REQUIRED TO REPORT UNDER THE MDR REGULATION? When it disposes of the last device it manufactured.
19. IF A DEVICE CAUSES A DEATH OR SERIOUS INJURY WHILE IT IS BEING MISUSED OR USED FOR AN UNAPPROVED PURPOSE, IS THAT EVENT REPORTABLE? Yes.
20. ARE MANUFACTURERS REQUIRED TO PERFORM, REVIEW, AND/OR KEEP RECORDS ON FAILURE ANALYSIS, LABORATORY TESTING, AND OTHER ANALYSES OF DEVICE PERFORMANCE? The GMP Regulation requires that conclusions on device malfunctions be reached and recorded whenever a distributed device fails to meet specifications. The failure analysis must consist of a formal program which follows a written, documented protocol.
21. IN WHAT WAYS ARE A FIRM'S SERVICE AND REPAIR ACTIVITIES IMPORTANT? In order to comply with MDR and GMP Regulations, firms must have a quality assurance program which assures that information from service and repair requests is evaluated for reportable events, for incidents requiring further investigation, and for incidents that should be included in complaint files. 21 CFR 820.162 requires manufacturers to maintain records on all finished devices returned for repair when the need for repair is due to a failure to meet specifications. Records of the service and repair performed must also be maintained. Compliance with the MDR Regulation also involves the need for such information if a reportable event is attributable to device malfunction and involves serious injury or death.
22. HOW CAN A FIRM DISTINGUISH BETWEEN "REGULAR" SERVICE/REPAIR ACTIVITIES AND THOSE WHICH CONSTITUTE COMPLAINTS? "Regular" maintenance is required for failures which occur with their expected degree of frequency. Ordinarily, expected events such as random component failure or failure due to components that wear after their life expectancy need not be considered for the complaint file. However, even such instances as these may required a Report if the event that led to the service request meets MDR criteria. The same is true of user error if the result is serious enough to require a Report. Further, instances of misapplication should be evaluated in terms of adequacy of labeling and instructions accompanying the device. Finally, when maintenance, adjustment or repair requests reflect a trend, or when requests involve malfunction or other causes of a normally unanticipated nature, they should be evaluated as candidates for the complaint file.
23. WHAT CRITERIA AND PROCEDURES MUST A FIRM HAVE IN PLACE IN ORDER TO ASSURE THAT ITS DEVICE PROBLEM IDENTIFICATION ACTIVITIES ARE ADEQUATE? All manufacturers must have a quality assurance program which assures that complaint and maintenance records are monitored for trends. When a trend occurs, effective and timely action must be taken to prevent further failure. When questions of frequency or severity are being considered, this type of information is needed to establish incidence rates for defects as a basis for labeling statements, corrective action plans, or for justification that remedial action is unnecessary.
24. WHEN ARE TELEPHONE REPORTS RECEIVED BY FDA? Professional personnel receive calls form 8:00 am to 4:30 pm Eastern time on Mondays through Fridays. Other calls are received by a telephone answering machine. A special emergency number is (202) 857-8400.
25. CAN I USE TELEFAX FOR SERIOUS INJURY AND DEATH REPORTS? Yes. First call (301) 427-7500 and ask to speak with the FDA analyst in the appropriate product area. Next. within five (5) calendar days, telefax the complete report containing all information required under  803.24(c) and a statement indicating that no additional information is anticipated, or, if additional information is anticipated, the nature of the information and the approximate date it will be submitted.

FOOTNOTES

1. On August 24, 1984 Representative Gore wrote Secretary Heckler to request that she appear before the Oversight and Investigations Subcommittee Hearings on Anesthesia Machine Failures and explain why the Medical Device Reporting Regulation, which had been on her desk for several months, was not yet final. Three days later she signed the Regulation, and it was published as a final regulation on September 14, 1984, to be effective December 13, 1984. [return to text]

2. Walter C: Engineering and the Law. Part V: Medical Device Regulation Reports: Implications for Liability, IEEE Engineering in Medicine and Biology Magazine, (6(3): pp. 48-50, 1987. [return to text]