The United States Food and Drug Administration (FDA) was established in 1931. In the 1970s the United States Congress perceived a specific need to regulate medical devices in order to “assure reasonable safety and efficacy.”
The Editor was, at that time, a representative of organized neurosurgery in the drug and device area and a subsequent chairman of a FDA Advisory Panel on Neurologic Devices. The desire for device regulation at the time was reasonable but the perceived justification for the need for legislation was irrational. The perceived need was based on the high failure rate of implanted cardiac pacemakers. As it happens the risks were indeed high but were much higher than not having such a device to prolong life. In fact the U.S. pacemakers were the best in the world at that time.
There were, at that time, two competing versions (Edward Kennedy, Massachusetts and Paul Rogers, Florida) of the proposed law. The Rogers version prevailed and became the 1976 Medical Device Amendment to the Food, Drug and Cosmetic Act. The legislation created three classes of Medical Devices (I, II, III) based on the risk inherent in using the device with Class III the highest risk.
In addition to the classes seven categories were created to determine the degree of FDA scrutiny required:
As with many things in government the Enabling Legislation differed significantly from the Rules and Regulation published in the Federal Register and this differed significantly from subsequent enforcement. In fact the Rogers legislation was specific in pointing out that the law was not intended to insinuate government into the practice of medicine. This did not turn out to be the case. Complaints by the Rogers staff (who wrote the law) to the FDA gained the retort “that you alone do not reflect the wishes of the entire U.S. Congress.”
On December 13, 1984 FDA Medical Device Reporting (MDR) regulations were expanded to include two additional categories:
On June 16, 1992 then President Bush signed into law the Medical Device Amendments of 1992. Although since 1984 the medical device industry was required to report to the FDA all device-related deaths, serious injuries, and certain device malfunctions there was a concern that there was widespread underreporting. This law was intended to address these shortcomings in reporting. The concerns regarding such reporting have only been heightened by a number of studies including the report released in August, 2004 by HealthGrades (a healthcare quality company) that indicated in the years 2000, 2001, and 2002 there were 195,000 patient hospital deaths (each year) due to potentially preventable in-hospital medical errors.
Where Are We At Now?
There can be no question but that medical devices need to be as safe and effective as possible. Unfortunately, following a great deal of effort that goal is far from being realized.
One can simply not expect that medical devices be more the very best in manufacture and quality. The Editor’s personal experience suggests that the present meaningful liabilities lie beyond the manufacturing process but should also be a FDA responsibility.
All of the medical device legislation has required the providing of “informed consent” by the physician in the application of the device. This aspect of device use has some serious problems. “True” informed consent requires:
The patient be reasonably knowledgeable about the subject.
The patient be informed, by their physician, with all significant risks.
The patient be informed, by their physician, of any existing conflicts of interest.
The patient be informed, by their physician, about all viable alternatives.
Confirmation that the patient understands the information provided.
Attention to the above would be important in making patients aware of safer, cheaper and better alternatives and promote these technologies as opposed to those in the best interest of the manufacturer or physician.
It is not to our credit that we live in an era characterized by “media medicine” where treatment options often depend on “hype” rather than reality. FDA control of “marketing budgets” would go a long way to even the playing field and switch back the responsibility for information to the physician who would also be held to the requirements of “true” informed consent.