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 agency announced yesterday. Sterigenics processed nearly 600 types of medical devices at the facility, including products such as sutures, clamps, knives, stents and needles. “At this time, the FDA isn’t aware of any device shortages attributable to the Willowbrook facility closure,” said FDA Commissioner Scott Gottlieb, M.D. “We’re closely monitoring the situation and will continue to provide updates.” FDA also expects a sterilizing facility operated by Viant in Grand Rapids, Mich., to close later this year. The agency is encouraging medical device manufacturers to consider alternative contract sterilizers that can process their devices. Among other actions, FDA has established an email address for reporting anticipated device shortages or distribution delays at deviceshortages@fda.hhs.gov.

Related News Articles

Headline
The Food and Drug Administration today announced a voluntary pilot program to expedite approvals of certain changes to ethylene oxide sterilization processes…
Headline
The Food and Drug Administration Friday approved the first duodenoscope with a disposable elevator component, a part difficult to clean and reprocess. The…
Headline
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…
Headline
The Food and Drug Administration Friday warned physicians and patients who use medical devices to monitor levels of the blood thinner warfarin that certain…
Headline
The Healthcare and Public Health Sector Coordinating Council (HSCC) today released a consensus-based guide to developing, deploying and supporting cyber-secure…
Headline
Early results from studies to better understand how duodenoscopes are reprocessed in real-world settings have found higher than expected contamination rates…