TY - JOUR AB - Biomedical Safety & Standards Concise, accurate news reports for medical device safety professionals BS&S FEATURE October 1, 2019 Volume 49 Two FDA Medical Device Sterilization Number 17 IN THIS ISSUE Challenges Underway Recalls & Field The FDA is sponsoring 2 public innovation challenges to encourage the Corrections—Class I development of new approaches to medical device sterilization. Abbott Ellipse ICDs .......129 Challenge 1 is focused on identifying alternatives to ethylene oxide (EtO) Qiagen Sciences Filter Tips for sterilization methods. Challenge 2 is focused on developing strategies to reduce QIAsymphony SP/AS .....131 EtO emissions. Centurion Medical Products Airway Kit With Sheridan These efforts are in response to the March 2019 closure of a large device Endotracheal Tubes ........131 sterilization facility. The FDA says it is taking steps to ensure that hospitals, health care providers, and patients have access to medical devices that are Recalls & Field safely and effectively sterilized. Corrections—Class II Philips HeartStart MRx ...132 For challenge 1, the goal is to identify safe and effective sterilization methods Zoll Pro-padz Liquid Gel or technologies for medical devices that do not rely on EtO and that meet these Radiolucent ....................132 criteria: Zoll AED PRO ..............132 • Compatibility. The method or technology TI - GE MAC VU360 Electrocardiograph JF - Biomedical Safety & Standards DO - 10.1097/01.BMSAS.0000582508.13451.17 DA - 2019-10-01 UR - https://www.deepdyve.com/lp/wolters-kluwer-health/ge-mac-vu360-electrocardiograph-tNnFvdvcwM SP - 132 EP - 132 VL - 49 IS - 17 DP - DeepDyve ER -