TY - JOUR
AB - Biomedical Safety & Standards Concise, accurate news reports for medical device safety professionals BS&S FEATURE March 1, 2020 Volume 50 Reports of Patients’ Deaths Linked to Number 4 IN THIS ISSUE Heart Devices Lurk Below Radar Recalls & Field Christina Jewett Corrections—Class II Site-Rite 8 Ultrasound The FDA continues to file thousands of reports of patients’ deaths related to Systems ............................. 25 medical devices through a reporting system that keeps the safety data out of the Steris Eagle 3000 public eye. Sterilizer ........................... 27 HeartStart XL+ The system is similar to a vast program exposed earlier this year by KHN Defibrillator/Monitor ....... 28 that kept device-injury reports effectively hidden within the agency. The FDA Neocis Guidance System shuttered the program after the article about it was published and released Fiducial Array .................. 28 millions of records. Medicom Safemask Premier The result of this remaining so-called registry exemption program is that key Plus ................................... 28 death data about heart devices sits in inaccessible FDA reports that can take up Boston Scientific Dilation/ to 2 years for the public to see under open-records laws. Device-related death Extension Catheters ......... 28 reports are typically open, allowing researchers to track and alert their 
TI - Maquet Cardiopulmonary Rotaflow Drive
JF - Biomedical Safety & Standards
DO - 10.1097/01.BMSAS.0000655848.95842.ee
DA - 2020-03-01
UR - https://www.deepdyve.com/lp/wolters-kluwer-health/maquet-cardiopulmonary-rotaflow-drive-apS7ejsjMj
SP - 32
EP - 32
VL - 50
IS - 4
DP - DeepDyve
ER -