What is the Duty of Health Care Facilities when a Medical Device Malfunctions?
The Safe Medical Devices Act requires health care facilities to report to the manufacturers any injuries or illnesses in patients or employees caused by the use of the manufacturers’ medical devices. If a patient or employee happens to die as a result of the device being used, the FDA should be contacted as well. This ensures that a manufacturer is made aware of the defect. Whom Exactly Does this Act Apply to? This Act states that all healthcare employees who have experienced some incident with a device that has or could have resulted in a detrimental consequence to the patient or the employee must report the incident to the manufacturer. These employees can include: • Physicians • Nurses • Allied health professionals • Students and volunteers • All other employees associated with the facilityWhat is the Duty of the Employee when They Discover a Defect in a Device? An employee must take the following steps when a medical device has been found to be defective: • Put the device and all i
