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JCAHO Essential Education Information on Environment of Care - Equipment Management for HEALTH CARE PROVIDERS - Safe medical Device Act (SMDA) Reporting | |
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What is the Safe Medical Device Act? It is a federal regulation that mandates the reporting or any serious injury or death that may be associated with the use of a medical device.
Who Must Report? Hospitals, ambulatory surgical facilities, nursing homes, home health agencies, ambulance providers, rescue groups, skilled nursing facilities, rehabilitation facilities, hospices, psychiatric facilities, and all other outpatient treatment and diagnostic facilities that are not a physician’s office. Who is Exempt from the Reporting Requirements? Independent Physician’s offices and groups performing functions similar to physician’s offices, such as dental offices and offices of other healthcare practitioners. What Events Must be Reported? Information from any source that reasonably suggests that a device has or may have “caused or contributed” to the death or serious injury of a patient or employee of the facility. Deaths must be reported directly to the FDA and the manufacturer, if known. Serious injuries must be reported directly to the manufacturer, or to FDA if manufacturer is unknown. Semiannual reports must be submitted to FDA. “Caused or contributed” is defined by the regulation to mean “that death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury.” How Does the Regulation Define Serious Injury? A serious injury or illness thatØ Is life threatening Ø Results in permanent impairment of a body function, or permanent damage to a body structure; or Ø Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. When Must Reports be Filed? Within 10 working days of “becoming aware” of information that reasonably suggests the device’s role in a death or serious injury. Who Files the Reports? At XXXXX, the Department of Risk Management generates these reports. Safe Medical Device Management Process For more information, contact Clinical Engineering (###-####) or Risk Management (###-####).
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