Sunshine Act: CMS sends final regulations to the Office of Management & Budget

From Medical Design & Outsourcing

• Sterigenics sues Ga. county to keep EtO plant open after emergency
  Sterigenics has sued the government of a Georgia county to force a permanent reopening of the company’s Atlanta medtech sterilization plant. Officials of Cobb County, Ga. recently gave Sterigenics permission to reopen the plant for 21 days to sterilize personal protective equipment for healthcare workers treating COVID-19 patients. Sterigenics had told county officials it has… […]
• Medline to reprocess N95 respirators to fight COVID-19 spread
  Medline Industries has agreed to reprocess 100,000 N95 respirators and other face masks per day in its facilities beginning as early as this week. The process that Medline plans to use is close to receiving FDA emergency use approval (EUA) and will supplement the more than 38 million masks the  company has distributed on average… […]
• How FDA is changing medtech regulation under the coronavirus
  The FDA’s Center for Devices & Radiological Health (CDRH) has issued a letter to the medtech industry that outlined the steps it is taking to address the impact of the COVID-19 pandemic. The administration has already expressed its openness to issuing emergency use authorization (EUA) for ventilator devices amid a shortage in the U.S. Last… […]
• More dangerous than the virus? Converting manual resuscitators to ventilators
  The shortage of respiratory ventilators in the face of the COVID-19 pandemic has led to numerous efforts aimed at turning hand-operated plastic pouches called bag-valve resuscitators into makeshift ventilators. The resuscitators, also called Ambu bags, are generally on-hand in large quantities. They are designed to be operated by hand, by trained technicians, to inflate patient… […]
• Could respirator decontamination solve shortage problems?
  The FDA has issued an emergency use authorization for the Battelle Critical Care Decontamination System, which can decontaminate tens of thousands of respirator masks per day so that health personnel can reuse them. The Columbus, Ohio-based nonprofit tech development company announced on March 28 that it began rapid manufacturing of its system to decontaminate N95 respirator masks and other… […]
• Medline reopens Illinois medtech sterilization plant
  Medline Industries resumed sterilization operations at its Waukegan, Ill., plant on Friday, following state certification of the company’s $10 million in emission-control upgrades, the company announced. The Waukegan plant reopening follows the decision this week by officials in Cobb County, Ga., to allow an Atlanta Sterigenics EtO plant to reopen for 21 days to sterilize… […]
• DeviceTalks Weekly Podcast: Deconstructing medtech’s alphabet soup – DPA, MDR, FDA are all in the news
  In this week’s DeviceTalks Weekly, we’ll examine how governmental effort, both foreign and domestic, are hitting the medtech industry. Our guests include Tracy Eberly, CEO of Fang Consulting, a regulatory advisory group. Eberly will update listeners on what pushing back the MDR deadline could mean for medtech companies and why some companies may be less than… […]
• AdvaMed: Invoking Defense Production Act could hinder U.S. medtech imports
  Forcing manufacturers to repurpose their production lines to make equipment to fight the coronavirus epidemic might actually hurt the U.S. supply of those items, the head of medtech trade group AdvaMed said today. AdvaMed officials have talked with U.S. secretary of Health and Human Services Alex Azar and FDA commissioner Dr. Stephen Hahn about medtech… […]
• March 2020 Issue: Is software key to medical 3D printing innovation?
  What’s the word on ethylene oxide? The coronavirus pandemic has pushed a lot of news out of people’s minds, but medtech has other big issues to deal with. For instance, 8 months have passed since the FDA issued a public challenge for alternatives to ethylene oxide (EtO) as a sterilant for medical devices. As I… […]
• GE Healthcare quadruples ventilator production at Wisconsin plant
  General Electric Healthcare (NYSE:GE) this week announced that it is  doubling its production capacity for ventilators and expanding its Madison, Wisconsin, production line to 24-hour operation. In a report on GE’s website, the company shared that it has doubled its capacity of ventilator production with plans to double it again by the end of the second… […]
• FDA issues FAQ on 3D-printed equipment against coronavirus
  Intrepid 3D printing companies and individuals who want to print masks, gowns and other personal protective equipment (PPE) to fight the coronavirus pandemic might want to take a look at the FDA’s new frequently asked questions page on the topic. While it says it welcomes coronavirus-fighting efforts, the agency said that 3D-printed masks are unlikely… […]