Editor's Note The Food & Drug Administration on November 7 identified the recall by Zimmer Biomet of its ROSA Brain 3.0 Robotic Surgery System as Class I, the most serious. The recall was initiated because of a software issue that incorrectly positions the robotic arm. The company has received five…
Editor's Note ECRI Institute on November 7 announced that it opposes a total ban of commercial ethylene oxide (EtO) sterilization operations because it could result in widespread shortages of sterile medical devices. Hospitals around the country reported device shortages after a large Illinois-based sterilization plant closed because of state environmental…
Editor's Note In this study, a new machine learning Complexity Score algorithm outperformed three commonly used risk scores in predicting postoperative morbidity, 30-day readmission, 90-day readmission, and postoperative surper-use. Study patients underwent colectomy, abdominal aortic aneurysm repair, coronary artery bypass grafting, total hip or knee replacement, or lung resection. The…
Editor's Note The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) Surgical Risk Calculator accurately predicted four quality-of-life outcomes that transcend traditional measures of successful surgery and now reflects the expected effects of surgery on an older patient’s ability to function independently, finds this study presented October…
Editor's Note Heartvista (Los Altos, California) has obtained clearance from the Food and Drug Administration (FDA) for its artificial intelligence (AI)-assisted One Click autonomous MRI acquisition software for cardiac ischemia exams, the October 30 BioWorld MedTech reports. Integrated with existing MRI scanners, the software uses AI to guide image acquisition,…
Editor's Note An artificial intelligence (AI) model was able to detect breast cancer with nearly 90% accuracy when combined with analysis from radiologists, the October 18 Health IT Analytics reports. Researchers from New York University Schools of Medicine and Data Science developed the model to first consider small patches of…
Internal surgical staplers made headline news in 2019. Reports discussed the little-known US Food and Drug Administration database housing tens of thousands of stapler-related problem reports and covered the agency’s recent proposal to reclassify staplers as Class II devices, instead of the more lightly regulated Class I. ECRI Institute named…
Total knee arthroplasty (TKA) is a highly effective treatment for end-stage degenerative joint disease and has helped patients regain functional mobility with reduced pain and improved quality of life. Every year, almost 700,000 primary TKA procedures are performed in the US.1 This number is expected to grow to 3.48…
Editor's Note The ECRI Institute on October 7 released its annual safety report identifying the top 10 device hazards in hospitals, medical practices, and homecare for 2020. Topping the list was surgical stapler misuse and malfunction that can lead to patient harm. Third on the list is sterile processing errors…
Editor's Note Nurses have always played an important role when new health information technology (IT) has been implemented, and the emergence of artificial intelligence (AI) and the changes it can bring to healthcare will be no exception, reports the September 27 HealthcareITNews. Though some nurses may view AI as another…