What responsibilities does my office practice have for reporting medical device adverse events?
The Safe Medical Devices Act (SMDA) requires that any “device user facility” report certain types of medical device-related events to the Food and Drug Administration (FDA). Besides a hospital, a device user facility includes: • an ambulatory surgical facility, • a nursing home, or • an outpatient diagnostic or treatment facility (such as a mammography unit or home health agency). The requirements do not apply to a physician’s office, which is defined as one used for the primary purpose of examination, evaluation, and treatment/referral of patients. All qualifying device user facilities have the same reporting responsibilities, regardless of size or complexity. Medical device-related deaths must be reported directly to the FDA and the manufacturer (if known), while events meeting the definition of device-related serious illness and serious injury are reported only to the manufacturer. (In the event a manufacturer is unknown, these reports go to the FDA.) Device user facilities are also
Related Questions
- If we report to MedSun, do we still have to report adverse medical device events to FDA and manufacturers on MedWatch Form 3500A?
- What responsibilities does my office practice have for reporting medical device adverse events?
- Where can I find the reporting codes for adverse events that I use with medical device reports?
