Medical Device Technology
The Healthcare and Public Health Sector Coordinating Council (HSCC) today released a consensus-based guide to developing, deploying and supporting cyber-secure medical devices and health information technology across the product lifecycle and improving information sharing between manufacturers and…
Early results from studies to better understand how duodenoscopes are reprocessed in real-world settings have found higher than expected contamination rates after reprocessing.
The Food and Drug Administration’s policies and procedures were insufficient for handling postmarket medical device cybersecurity events, and the agency has not adequately tested its ability to respond to emergencies resulting from cybersecurity events in medical devices.
The Food and Drug Administration today issued draft guidance that provides recommendations to the medical device industry on cybersecurity considerations for device design, labeling and documentation that the FDA recommends be included in premarket submissions for medical devices with cybersecurity…
The Food and Drug Administration today released a framework to help hospitals and other health care providers plan for and respond to cybersecurity incidents involving medical devices.