In 1974 the Editor had the privilege of being a member of a United States Biomedical Instrumentation delegation to the Soviet Union. There were many eye openers during that experience. Some of the most pertinent observations made over a quarter of a century ago are even more pertinent today. (click here for pdf copy of article).
In 1944 three U.S. B-29s were forced to land in Vladivostok in the Soviet Union following bombing missions against the Japanese. Because Russia was not at war with Japan at that time the crews were interned and returned to the United States, by a circuitous route, before the end of the war (but the planes never were). On August 3, 1947, at the Aviation Day Parade fly-over at the Tushino Airport, Moscow Stalin delighted in presenting a flight of TU-4s. They were ” a rivet-for-rivet” copy of the U.S. B-29. Subsequently it is believed that a total of 1,200 TU-4s were built by the Russians. The TU-4 story was certainly one of the most dramatic examples of the Soviet tour-de-force in “reverse engineering.” By 1974 the Soviet Union became masters at copying as well as hijacking western technology. In July, 1946 the Soviets conned Rolls Royce into selling them their advanced jet engines. This sale, combined with a bit of “stealth” espionage, allowed the development of the MiG 15 jet fighter responsible for the deaths of many American and British Pilot Seating over Korea in the 1950s.
As the Soviet Union continued to perfect its innovative means of narrowing existing technology gaps United States President, Gerald Ford, was occupied signing, on May 28, 1976, the Medical Device Amendments of 1976 (MDA1976) into law. The expressed purpose of this legislation was to increase United States device safety but not impede the innovation of new devices. The justification for the need for this legislation was the high incidence of deaths in individuals who had had cardiac pacemakers implanted. The fact that almost all of these patients, at that time, would have died without the devices was not considered. The information that these devices, for their time, were the best in the world, was also not thought out. In the Soviet Union, at that time all cardiac pacemakers were made in Hungary; except for members of the Supreme Soviet who received Medtronic pacemakers provided by cardiologists in Paris.
In fact, the implementation of medical device laws by the United States Food and Drug Administration, since 1976, has significantly impeded medical device innovation and creativity. In addition the insinuation of the FDA into device manufacture and medical practice has, at times, set back common sense and has created unnecessary medical-legal problems for the country. An infamous example of this has been the “pedicle-screw” fiasco.
Over-regulation carries with it its own liabilities. Following a 20/20 TV program “expose” in 1993 7,000 plaintiffs with 1,650 complaints filed legal suits. This resulted purely from inappropriate FDA classification of pedicle screw devices which resulted in their being considered “investigational” when they were, in fact, standard in spine practice. In 1996The FDA reclassified these devices and thus ended the medical-legal “feeding frenzy” it created in the first place. This occurred only after over $100 million was paid to settle cases which were basically informed consent issues.
On August 11, 2002 an article “A pattern of lax oversight, poor results” appeared in the Minneapolis Star Tribune regarding the death of a 42 year old woman who had a diseased heart valve replaced with an artificial valve manufactured by the St. Jude Medical firm. The replaced valve failed, was replaced by a second which also failed and in May 2000 a third valve was implanted. The patient died of cardiac arrest one month later. It was because the woman’s “heart never having fully recovered” from the strain of three open heart surgeries. The valve in question was a new model with a silver coating added to decrease infection and was never tested clinically.
This death was a tragedy but, the change in the device was minimal. Constant change (hopefully for the better) is the life blood of medical devices as it is with cars and planes. If the FDA had to investigate every variation in medical devices innovation and creativity would cease and the FDA would have no time for anything else. The march of technology has allowed many to live or function when it was Nature’s intent that they not do so.. The great increase in our longevity reflects this ever-advancing technology. The implication of “lax oversight” is unfair to the FDA which needs to maintain a reasonable balance between regulation and freedom in the marketplace.
There are no easy answers to this challenge but the most rational solution is to require manufactures of medical devices, particularly, life-supporting medical devices, to be held to a much higher standard of medical problem and failure reporting for these devices so that true informed consent is available for patients having to make difficult decisions. A patient being in “the driver’s seat” only works when they provided with accurate information. True informed consent is not possible without this. It is clear that the medical device industry has been lax in this regard and can not be relied upon for honest reporting. Once again such behavior does not change unless there are meaningful consequences.