The net result is that Americans are less healthy than they could be absent these regulations. During the early 1990s, the FDA began to regulate medical device manufacturers much more harshly than before. It has required an MDR in every case of death or injury that might have been caused by a medical device. Studies have shown that the bulk of such incidents involve operator error or improper maintenance of the equipment, not defective devices. Nonetheless, the FDA continues to demand scores of thousands of MDRs annually, even though it lacks the ability to analyze so many reports, and hence the high costs of providing the data contain a large element of waste.
Independent experts consider the entire MDR system ill-designed and needlessly costly.
During the fiscal years 1991-94, the FDA approved, on average, only half as many new medical devices annually as it had in the preceding eight years. Waiting times quadrupled for marketing approval of new devices, reaching nearly 900 days in 1994, and doubled for improved versions of old devices, reaching 214 days in 1994. For example, in the summer of 1992 the agency, having discovered paperwork violations at Bunnell, Inc., ordered the company to recall its Life Pulse High Frequency Jet Ventilator and tell hospitals to stop using it. Doctors protested that without the device, for which no effective substitute existed, many tiny premature infants would be unable to breathe and would die. Some 60 hospitals refused to comply with the order, but others did comply, and babies did die.