Ethylene oxide plant reopening won’t halt FDA plans to seek alternatives

July 18, 2019 By Nancy Crotti Leave a Comment

The FDA will continue its efforts to find alternative medical device sterilization methods to ethylene oxide (EO), even though a major EO plant is slated to reopen.

Yesterday, medtech sterilization company Sterigenics and the state of Illinois announced they had reached a proposed consent agreement to reopen a plant in Willowbrook, Ill., which the state shut down in February, citing excessive emissions of EO, a carcinogenic gas. The plant had sterilized millions of devices annually — 594 types of devices, according to the FDA, including sutures, clamps, knives, stents and needles.

Get the full story on our sister site, Medical Design & Outsourcing.

FDA relaxes rules around ECMO devices during pandemic
The FDA has issued new guidance to help expand the availability of devices used in extracorporeal membrane oxygenation (ECMO) therapy to treat COVID-19 patients. Extracorporeal circuits and accessories for long-term respiratory/cardiopulmonary failure, including devices used for ECMO therapy, provide assisted extracorporeal circulation and physiologic gas exchange of a patient’s blood for more than 6 hours.… […]
Cantel Medical ups production of dental masks for COVID-19
Cantel Medical (NYSE:CMD) announced last week that it is increasing production of its surgical earloop dental mask amid the COVID-19 pandemic. The company is increasing manufacturing by its HuFriedyGroup dental division to 24 hours a day, seven days a week at its two New York manufacturing sites. The expectation is that production volume will increase by… […]
Carbon partners with Adidas, Resolution Medical on COVID-19 response
Carbon, the 3D printing company, announced today that it is working with Adidas on face shields for healthcare workers and with Resolution Medical on nasal swabs for COVID-19 testing. Adidas tweeted about its work with longtime collaborator Carbon, saying the athleticwear company is aiding Carbon’s production of face shields, which healthcare providers are using to… […]
German automotive supplier shifts production to face masks to battle COVID-19
Automotive supplier Wrapping Solutions (Rosengarten, Germany) is partnering with Optima Life Science to produce face masks to help fight the coronavirus pandemic. Wrapping Solutions specializes in producing interior fittings for cars — but has transitioned to sewing 24,000 masks per day at 20 workplaces since March 23. Over the long term, the company plans to… […]
Qosina touts single-use bioprocessing components for coronavirus response
With the bioprocess industry mobilizing to support the development of tests, vaccines and treatments for COVID-19, medtech distributor Qosina said that its supply of single-use bioprocessing components can offer significantly reduced time to clinic and market over multi-use systems during situations like the coronavirus pandemic. Ronkokoma, N.Y.-based Qosina said it also provides 3D CAD models… […]
Could these DIY ventilators stop coronavirus from killing people?
Amid the global crisis caused by the coronavirus pandemic, hospitals and healthcare facilities are reporting shortages of vital equipment that not only keeps the patients safe, but the staffers, too. One important device for which demand has ramped up is ventilators for patients who need assistance with their breathing due to the respiratory effects of… […]
How medtech manufacturers are bringing the fight to coronavirus
As the coronavirus pandemic spreads across the world, contract manufacturers and OEMs continue pivoting to meet the needs of front-line healthcare providers. Here are some of the latest examples: Stryker Stryker (NYSE:SYK) recently announced that it has developed a low-cost, limited-release emergency response bed for use in hospital emergency departments, triage and pop-up areas of… […]
DeviceTalks Weekly: Ep.4 — What does Medtronic’s Puritan reveal mean for medtech?
What does Medtronic’s Puritan reveal mean for medtech? Medtronic earned plaudits and praise for sharing the design specifications for its Puritan Bennett 560 (PB560) ventilators. But will the gesture actually lead to more ventilators being manufactured? In this episode of DeviceTalks Weekly, we’ll talk with experts who will tell us what the plans do and… […]
Newest shortage: Respiratory ventilator repair manuals?
The U.S. Public Interest Research Group says that many manufacturers or respiratory ventilators do not provide access to repair documentation, limiting who can repair the equipment. The advocacy group claims this practice discourages third-party medical repair companies or in-house medical engineers from trying to fix things. So USPIRG, which also sponsors a Right to Repair Campaign, says… […]
Webinar: The digital production floor transformation: Extending your digital edge beyond core systems
Tuesday, May 5, 2020 11:30 am Eastern time / 8:30 am Pacific time Digital transformation efforts are accelerating in a variety of manufacturing areas, yet many producers stop short of digitizing their device history records (DHRs) and other shop floor data collection efforts. Despite the investments manufacturers have made in tried-and-true digitization and… […]
Hospital survey reveals front-line needs, desperate measures
Hospitals across the U.S. have begun resorting to unorthodox means of replacing or sanitizing personal protective equipment (PPE) and atypical sourcing of PPE and other supplies needed to fight the coronavirus pandemic, according to a government survey. The Department of Human Services’ Office of the Inspector General (OIG) conducted the random survey of 323 hospitals… […]