November 2018 Edition. Volume XVIII

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 at that time. As it happens the risks were indeed high but were significantly higher than not having such a device to prolong life by patients requiring such.  In fact the U.S. pacemakers were the  best in the world at that time.

There were, at that time, two competing congressional legislative 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:

Pre-Market
Post-Market
Substantial Equivalent
Implant
Custom
Investigational
Transitional

As with many things in government the Enabling Legislation differed significantly from the Rules and Regulation subsequently published in the Federal Register and this differed significantly from subsequent enforcement of the legislation. 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 were rejected with 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:

Post-Marketing Surveillance
Device Tracking

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 widespread under reporting of these events was occurring.  This law was intended to address these shortcomings in reporting.  The concerns regarding such reporting have only been heightened by a number of subsequent studies which documented continuing patient hospital deaths occurring 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 assume that medical devices are 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, as to 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.

Burton Report is an independent and non-commercial internet journal which was first published on January 1, 2000 and is dedicated to the principle that health care and the health care process MUST reflect truth and integrity as well as the best interests of the patient.

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