Policy Manual sample

MDT Home Health Care Agency, Inc. REPORTING MEDICAL DEVICE EVENTS PURPOSE: To comply with regulations mandated by the Safe Medical Devices Act of 1990. POLICY: The Safe Medical Devices Act (1990) requires home health agencies to report adverse events related to medical devices under a uniform reporting system. Under this law, a reportable adverse Medical Device Event is defined as follows: Death or serious injury that may have been attributed to a medical device; a situation in which a medical device may been a factor in a death, illness, or serious injury, including events occurring as a result of failure, malfunction, improper or inadequate design, manufacture, labeling, or user error. An injury or illness is defined as a life-threatening event or an event that results in permanent impairment of a body function or permanent damage to body structure. Death or injury may be of a patient, employee, or individual affiliated with the agency who, in the course of care or duties, suffers a device-related injury. The agency is required to report Medical Device Events to the Food and Drug Administration (FDA) and/or to the manufacturer, when it has information that reasonably suggests that a reportable adverse event has occurred. Once an event has been reported, should the FDA request further information, the agency will comply with such requests. As states in the regulations, the agency reporting of a Medical Device Event does not constitute an admission that the device, the agency, or the agency staff have causes or contributed to a reportable event. PROCEDURE: · Device-related adverse events are immediately reported to a Manager and documented as an “incident” using the Incident Report Form. All licensed clinical staff is expected to report and document such incidents. · The Manager immediately forwards this report to the Director of Nursing, Clinical Manager or the Administrator. The Manager simultaneously notifies the Manager of QI of the potential reportable Medical Device Event. · The Manager of QI evaluates whether the event is reportable. If the event is reportable, it will be documented on FDA Form 3500A “User Facility Report” and submitted within ten (10) days after the agency becomes aware of the event (see attached copies of FDA Form 3500A). Reports of death are sent to the FDA and to the manufacturer, if known. Reports of serious injuries are sent directly to the manufacturer, and, if the manufacturer is unknown, to the FDA. · The Manager of QI maintains a file of the Medical Device Report events. Even if an event is not reportable, the investigation and evaluation of the event is documented and placed in the Medical Device Report file as well as being included in the quarterly QI Committee meeting. · In the determination of reportable events, the Manager of QI staff will confer with the Administrator as needed. · The Manager of QI will be responsible for filing semiannual reports (on January 1 and July 1) with the FDA. These reports and information associated with the filing of these reports will be maintained in the Medical Device Report file. No semi-annual report is required if no reports have been made to the FDA or the manufacturer in the previous six months. · Reports of Medical Device Events will be maintained for two (2) years from the date of the event. Home Health Agency - - Skilled Professional Services C-34