Edward M. Basile and Elizabeth A. Schmidtlein CONTINUED

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REQUIREMENTS FOR USER FACILITIES

See Box 2: Requirements for Device User Facilities

Under the new regulations, the term device user facility covers the following entities, provided that they do not meet the definition of a physician's office: hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities, and outpatient treatment facilities. A physician's office is defined as a facility that operates as the office of a physician or other health-care professional for the primary purpose of examination, evaluation, and treatment or referral of patients.

FDA has defined each of the entities that are regulated as user facilities in the new regulations, and facilities providing health services should consult the regulations to see if they are covered. The regulations provide that device user facilities may be either independent entities not part of a provider of services or any other facility, or may be operated (owned, licensed, or controlled) by another medical entity. Such entities must report adverse events that occur in any of their medical departments, regardless of the nature or location of the services. Device user facilities are covered by the regulations whether or not they are licensed by a governmental body or accredited by a recognized accreditation organization.

User Facility Reporting Requirements. Device user facilities are required to submit reports for device-related deaths and serious injuries according to the same reporting standard applied to device manufacturers. The facility must submit reports involving deaths to both FDA and the device manufacturer, if the identity of the manufacturer is known. For serious injuries, the facility must submit its report only to the manufacturer, or, if the identity of the manufacturer is not known, to FDA. All of these reports must be submitted as soon as possible, and no later than 10 working days after the facility has become aware of the information, using FDA form 3500A.

User facilities must report "all information that is reasonably known to them." This includes information from documents in the user facility's possession as well as any information that becomes available as a result of reasonable follow-up within the facility. Unlike manufacturers, however, user facilities are not required to evaluate or investigate the event. The types of information that user facilities are required to report on FDA form 3500A include: (1) general patient information, (2) identification of the adverse event or product problem, (3) patient outcomes attributed to the ad- verse event, (4) description of the event or problem, (5) information about the device involved, (6) information about the person who initially provided information about the event, and (7) user facility information.

It is important to note that FDA has defined the term patient of the facility to include not only patients but also "employees of the facility or individuals affiliated with the facility, who in the course of their duties at the facility suffer a device-related death or serious injury that has or may have been caused or contributed to by a device used at the facility." While the legal authority for such a definition is questionable, it is the definition that FDA has adopted.

Semiannual Reports. The regulations also require device user facilities to submit semiannual reports to FDA summarizing all reportable events that occurred within the previous six months. The reports must be submitted by January 1 and July 1 of each year, using FDA form 3419. They must include information regarding the device user facility; the facility contact person responsible for MDR reporting; the total number of MDR reports submitted during the reporting period; and either copies of all MDR reports submitted to FDA and/or to manufacturers during the reporting period, or a summary of each event reported.

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