Medical Device Technology
The Food and Drug Administration today announced a voluntary pilot program to expedite approvals of certain changes to ethylene oxide sterilization processes and facilities.
The Food and Drug Administration Friday approved the first duodenoscope with a disposable elevator component, a part difficult to clean and reprocess.
The Centers for Disease Control and Prevention this week announced an anticipated shortage of Aplisol, one of two TB skin tests licensed by the Food and Drug Administration.
The Food and Drug Administration is working to prevent potential medical device shortages due to the closing of a Willowbrook, Ill., facility that sterilizes medical devices.
The AHA responds to the request for information on medical device interoperability from the Networking and Information Technology Research and Development’s Health Information Technology Research and Development Interagency Working Group.
The Food and Drug Administration Friday warned physicians and patients who use medical devices to monitor levels of the blood thinner warfarin that certain test strips used with the devices may provide inaccurate results and should not be relied on to adjust the drug dosage.
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The Food and Drug Administration today issued draft guidance that provides recommendations to the medical device industry on cybersecurity considerations for device design, labeling and documentation that the FDA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…