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Hosp Technol Ser. 1993 Oct;12(11):1-27.

Safe Medical Devices Act: management guidance for hospital compliance with the new FDA requirements.


The Safe Medical Devices Act of 1990 (Public Law 101-629) was signed by President George Bush almost three years ago on November 28, 1990. The law expanded the Food and Drug Administration's (FDA) authority to regulate medical devices and grew out of congressional concerns about the FDA's ability to quickly learn when a medical device caused an adverse patient event, and to ensure that hazardous devices are removed from hospitals and other health care facilities in a timely manner. The Safe Medical Devices Act is an extension of the Medical Device Amendments of 1976, which imposed production, distribution, and sales rules on medical device manufacturers. It gives the FDA the legal authority to directly regulate the use of medical devices in health care facilities. Among the Safe Medical Devices Act's provisions are specific requirements for hospitals, health professionals, and other users of medical devices to report patient incidents involving medical devices to the manufacturer and to the FDA if a device caused or contributed to a serious injury, death, or other "adverse experience." Adverse experiences are defined by the FDA to include concussions, fractures, burns, temporary paralysis, and temporary loss of sight, hearing, or smell. Hospitals have been required to comply with this provision of the law, called user reporting, since 1991. Hospitals are also required to participate in tracking certain medical devices whose failure could result in a serious adverse health outcome. The law requires distributors and manufacturers of specific devices to adopt a method for device tracking. Hospitals are required to cooperate with and provide device manufacturers with information about patients with permanently implantable devices and life-sustaining and life-supporting devices used outside device user facilities. The law also gives the FDA the authority to designate other devices subject to tracking if the agency determines such tracking is warranted to preserve the patient's health. This provision of the law is called device tracking. Device tracking became effective on August 29, 1993. This special report addresses some of the major questions about implementing user reporting and device tracking in hospitals. Over the past two years the FDA has issued a series of rules and regulations that have caused a great deal of confusion and misunderstanding. Some of the law's provisions are straightforward; however, some basic issues and rules--such as the definition of a reportable event--are unclear. While there are still some open questions about the reporting and tracking requirements, the following is the best information available at this time.(ABSTRACT TRUNCATED AT 400 WORDS)

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