The Food and Drug Administration is encouraging health care professionals –and patients – to report adverse events associated with medical devices, as part of an effort to address the potential for cyberattacks on medical equipment and medical devices, including implanted medical devices.
The agency has become aware of "cybersecurity vulnerabilities and incidents that could directly affect medical devices or hospital network operations," according to a statement on the FDA’s MedWatch site.
The statement adds, however, that the FDA "is not aware of any patient injuries or deaths associated with these incidents nor do we have any indication that any specific devices or systems in clinical use have been purposely targeted at this time."
The FDA is working with manufacturers and other federal agencies to address this issue. The agency has recommended that manufacturers and health care facilities institute safeguards to reduce the risk of medical device failures caused by a cyberattack, including evaluating network security at hospitals and health care facilities. Efforts include draft guidance for industry and FDA staff.
Adverse events associated with devices should be reported to the MedWatch Safety Information and Adverse Event Reporting Program or by calling 800-332-1081.