The Safe Medical Devices Act of 1990 was signed into law by President Bush on November 28,1990. Among other things, it requires that “device user facilities” (hospitals, nursing homes, outpatient centers, etc.) report instances in which there is information that “resonably suggests that there is a probability that a device has caused or contributed to the death … or serious illness of a patient of the facility.”
Although the FDA is now preparing regulations to implement the law, the statute specifically requires that reporting begin on November 28, 1991, regardless of the existence of a regulation. The law contains many ambiguities that should be defined by the regulations. The FDA recently held a conference attended by about 200 representatives of a broad spectrum of facilities and organizations that will be affected by the law to solicit opinions in preparation for Creating a first draft of the regulations.
This law is hilly to have important medico-legal implications for facilities and individual users and may create a substantial reporting burden. The FDA is hoping to minimize such negative effects by writing useful but minimally burdensome regulations. The effectiveness of that effort remains to be seen.
How did this law come to be? It appears to have been motivated primarily from the Congress, some members of which have been dissatisfied with the success of the original 1976 Medical Device Amendments in preventing device-related injuries. Some of the evidence for that came from a 1986 study by the General Accounting Office, which found that less than one percent of device-related incidents were being reported to & FDA. Another GAO study in 1989 charged that reporting problems still existed despite the implementation of regulations requiring manufacturers to report serious device-related occurrences (the Medical Device Reporting or MDR regulations). Although the wisdom of the law was questioned by some organizations, &re was apparently little opposition voiced at congressional hearings.
Many participants at the conference noted serious concerns about & heavy reporting burden, the potential for increased numbers of device-related lawsuits and the possibility the reporting will not be useful since no additional resources have been allocated to the FDA, which is already overburdened from MDR reporting. Despite these concerns, the participants in the conference worked diligently to generate ideas for how the law could be implemented in a way that is useful but with minimal negative effects.
There is little for hospitals to do immediately except to become familiar with the law, be aware of the impending need for reporting, and to watch for the appearance of the proposed regulations. It would also be wise to examine existing systems for device event reporting and to consider who should be responsible for implementing the new reporting requirements. One way or another, the following elements of the law will be implemented:
Essentially all healthcare facilities, but not including physicians’ offices, wig be required to report events in which there is information to suggest that a device has contributed to death, serious injury, or serious illness. The reports must be filed within ten working days after discovery of the event. Deaths must be reported to the FDA and the manufacturer while serious injuries or illness need be reported only to the manufacturer, if known and, if not known, to the FDA. Summaries will be required semiannually.
What remains to be determined is exactly what constitutes a “reasonable probability,” how broad is the definition of serious injury or illness, exactly in what way must the device have “contributed” to the event and how wig reports be filed? The issue of confidentiality and protection of users and facilities, although written into the law, is unclear. Despite prohibitions from disclosing information, there are circumstances under which information would become accessible to the public and, thus, to actual or potential plaintiffs attorneys.
For more information, a good summary of the law and its possible implications for user facilities can be obtained from ECRI (Hospital Risk Control Update, February, 1991 or ELM Advisory on the Safe Medical Devices Act of 1990 (Feb., 1991); contact ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462; (215) 825-6000 or consult your hospital attorney, risk manager, or Biomedical Engineering Department, which may have the information). The FDA will also provide a copy of the user reporting sections of the law (write to Ralph Bunge, FDA (HFZ-250), 1901 Chapman Avenue, Rockville, MD 20857).
Dr. Cooper of the Executive Committee, APSF is Director, Anesthesia Technology, Massachusetts General Hospital, Boston, MA.