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January 16, 2023

  • Organizing the Experts: Practice Greenhealth's virtual cohorts have hosted discussions among some of the most impactful figures in healthcare and sustainability for over six years. Practice Greenhealth invites you to engage with their virtual cohorts to advance your sustainability efforts this year.
     
  • Professional Pointers: AMDR is pleased to promote the Society for Cardiothoracic Surgery's Green Theatre Checklist, which offers simple steps for advancing more environmentally friendly practices at your hospital, like opting for reusable materials and reprocessed equipment instead of disposable, “single-use” medical devices.
     
  • Accepting a Hard Reality: MedTech Dive reports that the European Commission has decided to formally extend the deadline for adopting the new Medical Device Regulation. "Having accepted that notified body capacity 'remains insufficient,'" the article states, "the Commission shared a formal proposal to give manufacturers until 2027 or 2028, depending on risk classification, to get their devices designated under MDR."

Practice Greenhealth: Connecting through cohorts
Practice Greenhealth’s virtual cohorts have been facilitating meaningful dialogue among groups of sustainability and health care professionals for over six years. We continue to drive change in the health care community by bringing together peers and experts to develop new strategies to overcome challenges to implementing sustainability initiatives. As 2023 begins, we invite you to engage with the leaders and innovators available as part of our virtual cohorts to advance your sustainability efforts this year. Learn more about our virtual cohorts, and decide which quarterly sessions you would like to attend. 



PR NewswireFDA Warning Letter Against Innovative Sterilization Technologies (IST) is Closed - ONE TRAY®'s 2006 Clearance Stands
Innovative Sterilization Technologies (IST)/ONE TRAY in Dayton, Ohio has announced that a Warning Letter issued in March 2019 by the U.S. Food and Drug Administration (FDA) has been closed. The FDA, as part of the warning letter review and correspondence, confirmed ONE TRAY's clearance contained a validated 48-hour storage period and has agreed that the company may use the specific language in the company's labeling consistent with the indications for use cleared in 2006. IST also attempted to remove the antiquated term "FLASH" without success, however, IST has agreed with the FDA regarding the uses for which the device may be labeled/marketed and commercialized. During the warning letter closure process, the FDA stated that, "a key distinction of Immediate Use Steam Sterilization (IUSS) is that it cannot and should not be stored."



General Surgery NewsHow Attention to Water Quality and Reprocessing Can Reduce Patient Harm, Long-Term Costs
Water that is deemed safe to drink may not be acceptable for sterilizing reusable surgical devices or reprocessing flexible and semi-rigid endoscopes in healthcare facilities.



Business WireAA Medical Announces Partnership with Certified Endoscopy Products
AA Medical, a provider of sustainable solutions to both the new and resale medical device equipment markets, is pleased to announce it has completed a partnership with Certified Endoscopy Products, a leading Chicago-based medical device reprocessing company specialized in endoscopic devices. Together, AA Medical and Certified Endoscopy will form a preeminent medical device reprocessing company serving the endoscopy, orthopedic, and other surgical device markets.

LinkedIn: Healthcare CEOs must cut carbon from supply chains - Genpact
Healthcare workers can lead the way in fighting #climatechange by cutting #ghgemissions from #hospitals and the medical supply chain through “single-use” #medicaldevice reprocessing and other cost-saving, #circulareconomy solutions.

Learn more in this excellent Supply Chain Digital piece by GenPact's Urvashi Bhatnagar and AMDR President and CEO Daniel J. Vukelich.



LinkedIn: Green Theatre Checklist
Want a handy guide to advance more environmentally friendly practices at your hospital, like opting for reusable materials and remanufactured surgical equipment instead of disposable, “single-use” medical devices?

Visit the Society for Cardiothoracic Surgery (SCTS) to explore the Intercollegiate Green Theatre Checklist for simple steps to help you promote sustainability in healthcare.

Thanks to SCTS, The Royal College of Surgeons of EdinburghThe Royal College of Surgeons of England, and the Royal College of Physicians and Surgeons of Glasgow for this fantastic resource!

Fierce Biotech
EU commission moves forward with proposal to delay MDR implementation
Medical device makers in the European market are one step closer to securing a bit of breathing room after saying new regulatory laws could lead to product shortages among their businesses.



MedTech DiveEuropean Commission formalizes plan to extend MDR transition out to 2027, 2028
Having accepted that notified body capacity “remains insufficient,” the Commission wants to give manufacturers more time to get their devices designated under MDR



Healthcare DiveSen. Bernie Sanders to target high healthcare costs as leader of influential committee
The longtime Congressman and “Medicare for All” proponent will soon assume leadership of the Senate HELP committee, giving him sway in one of the nation’s most broadly influential health policy forums.



Medical Design & OutsourcingHenry Schein launches Practice Green sustainable products initiative
Citing the growing threat of climate change, Henry Schein (Nasdaq:HSIC) is launching an environmental sustainability initiative called Practice Green.



MedTech DiveRethinking 510(k): Studies show risk of using recalled devices as predicates for FDA clearance
Two studies found devices cleared through the FDA’s 510(k) pathway that listed recalled predicate devices were more likely to face recalls themselves.



MedTech Dive
Intuitive forecasts 12%-16% growth in procedures in 2023 even as da Vinci robot sales slowed in Q4
For hospitals that have been reporting growth in robotic procedures, “da Vinci is a relative priority in their capital budgets,” the company said



MedTech Dive: Sterigenics reaches $408M ethylene oxide settlement to resolve hundreds of lawsuits in Illinois
Sterigenics said “years of biased media coverage in the greater Chicago area” underpinned its decision to settle.
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