The Federal Food and Drug administration is the agency in charge of monitoring medical devices in this country. According to the Federal Food, Drug and Cosmetic Act, there are at least 1800 categories of medical devices. Some of the more common devices include heart valves, pacemakers, prosthetic knee and hip devices, ventilators, x-ray machines, biopsy equipment, ultrasound, and infusion pumps.
Before medical devices become available for use, the manufacturer must first obtain approval for marketing that product from the FDA. Since 1976, the FDA has required that new medical devices be proven safe and effective before being marketed. However, in spite of a rigorous premarket process, medical devices are only as safe as the information known at the moment in time when the review process takes place.
Typically, the clinical trials upon which premarket approval is based, may only involve a few hundred patients. More importantly, most medical devices are not tested functionally, or in real life situations. Most testing is performed as “bench testing” (based on the concept of putting the device on a bench and hitting it in different ways). Thus, even if the FDA grants premarket approval to a device manufacturer, healthcare professionals and the public at large cannot assume that the FDA has determined that the product is absolutely safe for human use.
Moreover, just because the FDA approves a device for a particular use, this does not preclude a physician from prescribing that device for non-approved uses. This is because the physicians are not governed by the FDA approved uses. Only the manufacturer is governed by the FDA in terms of how it can market the product for use.
An example of this arose recently in a prosthetic knee device approved by the FDA for use with bone cement. However, the device was designed with the idea that bone cement would not be necessary because the bone could grow through porous holes in the device(bony in growth). Since the FDA only approved the device for cemented use, the manufacturer was prohibited from marketing the device for bony in growth. However, the physicians knew of the bony in growth potential and were actively implanting the device without bone cement. When the device ultimately failed, the physicians were upset with the manufacturer for not informing them of this limitation in advance.
The FDA requires “device user facilities” and manufacturers and distributors to promptly notify the FDA about device-related failures or events that may have caused a death, serious injury, or illness. These reports called Medical Device Reports (MDR’s), are required to ensure that the most serious problems will be identified to the user. Typically, problems with medical devices fall into one of three broad categories: (i) Device problems; (ii) Use problems; and (iii) Clinical problems.
Each year, the FDA receives approximately 100,000 reports through the MDR route and another 5,000 device reports through the voluntary MedWatch route. Nurses submit about 25% of the voluntary reports with biomedical engineers submitting 21% of these reports. Physicians only submit about 8% of these reports.