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Part VII: The Medical Device Reporting Regulation: The First Year

REPORTS SUBMITTED DURING THE FIRST YEAR

The Medical Device Reporting (MDR) Regulation [1] became effective on December 13, 1985. During the first year of MDR Regulation, 12,226 firms, 2/3 of which were manufacturers, registered with the U.S. Food and Drug Administration (FDA). FDA received 15,034 Reports from 434 of these firms. Domestic manufacturers accounted for 80% of the reporting firms and importers 20%. Slightly more than half (51%) of the reports were  803.24(d)(2) reports of device malfunctions which, if it recurred, would be likely to cause death or serious injury, 45% were  803.24(d)(1) reports of serious injuries, and 552 were  803.24(d)(1) reports of deaths.

Over 1/3 (37%) of the reports received by FDA were about cardiovascular devices. Six percent of the cardiovascular device reports included reports of deaths, 65% included reports of serious injuries, and 47% included reports of malfunctions. The second most frequently reported (18%) category was anesthesiology devices, followed by general hospital devices (11%), surgery devices (7%), gastroenterology and urology devices (6%), chemistry (4%), and obstetrics and gynecology (3%). Three percent of the anesthesiology device reports included reports of deaths, 4% included reports of serious injuries, and 97% included reports of malfunctions. Three percent of the general hospital device reports included reports of deaths, 20% included reports of serious injuries, and 80% included reports of malfunctions. The second most frequently reported (14%) category for serious injuries was general and plastic surgery devices, followed by obstetrics and gynecology devices (6%), and orthopedic and general hospital devices (each 5%). The most frequently reported (34%) category for malfunctions was anesthesiology devices, followed by cardiovascular devices (24%), and general hospital devices (17%). Other device classifications and the percentage of reports about them are orthopedics (3%), hematology (2%), ophythalmics (2%), radiology (1%), neurology (1%). Devices classified as dental, physical medicine, toxicology, ear, nose, and throat, microbiology, and pathology each accounted for less than 1% of the reports.

The ten devices reported most frequently ("Top Ten") accounted for 60% of all reports received by FDA. The leaders were implantable and electrode pacemakers which accounted for 47% and 26% of reports involving cardiovascular devices and 18% and 9% of all reports. Ventilators were third on the list and accounted for 8% of all reports. The other seven members of the Top Ten were gas anesthesia machines (5%), inflatable breast prostheses, intravenous administration sets, and hexokinase/glucose devices (each 4%), infusion pumps and heart values (each 3%), and automatic blood cells separators (2%). The second ten most reported devices were unscented menstrual tampons (2%), silicone gel filled breast prostheses, disposable peritoneal dialysis devices, gas respiratory humidifier, and intravenous catheters (each 1%), and contact lenses, urological catheters, delivery systems for dialysis, contraceptive intrauterine devices, and area detectors (each less than 1%).

The ten devices reported most frequently in connection with deaths ("Top Ten Killers") also accounted for 60% of all reports of death received by FDA. Number 9 on the Top Ten list, heart valves, was number 1 on the list of Top Ten Killers (16%). Low energy DC defibrillator, which did not appear in the Top Ten list, were second on the list of Top Ten Killers (12%), and ventilators (7%) were in third place on both lists. The other seven members of the Top Ten Killers list were implantable pacemakers (6%), infusion pumps (5%), high energy DC defibrillator, gas anesthesia machines, unscented menstrual tampons, and electrode pacemakers (each 3%), and diagnostic intravenous catheters (2%).

The ten devices reported most frequently in connection with a serious injury ("Top Ten Injurers") accounted for about 2/3 of all reports of serious injuries received by FDA. Implantable and electrode pacemakers accounted for 14% and 13% of all reports of serious injuries. Implantable breast prostheses and heart valves were each the subject of 5% of serious injury reports. The remaining six members of the Top Ten Injurers list were unscented menstrual tampons and silicone gel filled breast prostheses (each 3%), contact lenses (2%), infusion pumps, vascular grafts, sets for the administration of peritoneal dialysis, and urological catheters (each 1%).

The ten devices reported most frequently in connection with malfunctions ("Top Ten Failures") also accounted for about 2/3 of all reported malfunctions. Ventilators accounted for 16% of all reported malfunctions, gas anesthesia machines accounted for 9%, and implantable pacemakers accounted for 8%. The other seven members of the Top Ten Failures list were sets for intravenous administration and electrode pacemakers (each 7%), hexokinase/glucose devices (6%), infusion pumps (5%), automated blood separators (3%), respiratory humidifiers and sets for the administration of peritoneal dialysis (2%).

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