Manufacturers should be aware of their responsibilities and requirements under the Safe Medical Devices Act. They may not, however, be aware of the responsibilities of their customers - hospitals, nursing homes and other user facilities - under the act.
Since the user facilities are required to file semiannual reports with the Food and Drug Administration by July 31, medical device manufacturers should understand the role of the user facilities under the act.
Congress has regulated the area of medical devices for almost 30 years. In 1990, the act expanded the FDA's regulatory role in collecting, recording and maintaining current device-related information from both manufacturers and users. Essentially, the FDA tries to ensure that patients will not be exposed to devices with potential problems and that the devices will be removed from the market if they are dangerous or defective. Thus, manufacturers are required to submit to the FDA a premarket notification including an adequate summary of safety and effectiveness and to make good faith efforts in tracking patients using the devices.
Virtually all types of instruments and machines used in the delivery of health care are covered under the act. The statutory definition includes any apparatus, implement, machine, implant or related article intended for use in diagnosing, treating, curing, or preventing disease, or intended to affect the body's function or structure, which achieves its intended purposes without chemical or metabolic action within the body.
By requiring certain reports from users, Congress extended the FDA's jurisdiction over facilities previously unregulated by the FDA. A "device user facility" may be a hospital, ambulatory surgical facility, nursing home or outpatient facility which is not a physician's office.
Facilities must report every incident in which a device may have caused or contributed to a patient or employee's death or serious injury or illness and other significant adverse experiences determined by the FDA. Determinations of whether or not to report are based upon clinical judgment. Deaths must be reported to the manufacturer and the FDA; serious illness or injury to the manufacturer, or if not known, the FDA. Failure to report, or reporting in a misleading manner, could result in imprisonment and a fine. Civil penalties may also be imposed by the FDA.
In addition to the incident reporting, facilities are required to report semi-annually to the FDA and must include summaries of all events reported to the manufacturer for further investigation by the FDA. By effectively imposing the thread of criminal and regulatory sanctions, the government has established an investigatory arm within private industry. The facilities are also potentially subject to civil suit if they negligently fail to appropriately track and report problem devices.
The consequences of a defective or dangerous device in the marketplace are severe, and not only in terms of patient safety and human loss.
In 1993, the FDA settled a case against a major health care producer for violations of federal law related to the sale and distribution of heart catheters for $61 million. Manufacturers and users alike must be vigilant to protect themselves from unwanted adverse actions by either the regulators or the affected public.
*article courtesy of Ivan J. Punchatz of Buchanan Ingersoll.