Editor's Note The Food and Drug Administration (FDA), on April 12, issued a Safety Communication recommending that consumers, healthcare providers, and facilities not use certain surgical N95 respirators and to use caution with certain surgical masks and pediatric face masks, all manufactured by O&M Halyard. The FDA says it is…
Editor's Note The Joint Commission, on April 10, released a new Quick Safety advisory on preventing patient burns from light sources used during laparoscopic or arthroscopic procedures. Burns from these light sources can go unnoticed because they typically do not produce smoke or charring, even of surgical drapes, The Joint…
Editor's Note ECRI, on April 10, released a statement saying it is “deeply disturbed” by reports that nearly 99% of US hospitals have third-party tracking on their websites that transfers patient data to technology and social media companies, advertising firms, and data brokers. Besides the violation of privacy, ECRI says…
Editor's Note The Food and Drug Administration, on April 7, identified the recall by Philips Respironics of certain reworked DreamStation continuous positive airway pressure (CPAP) and bileveled positive airway pressure (BiPAP) machines as Class I, the most serious. These machines also were recalled in June 2021. The recall was initiated…
Editor's Note The American Society of Anesthesiologists (ASA), on March 29, issued a news report urging the public to learn to recognize and respond to an opioid overdose, now that the Food and Drug Administration has approved naloxone for sale over the counter. Naloxone, which is commonly sold as a…
Editor's Note The Joint Commission, on March 22, announced that it is seeking comments on proposed new requirements to address environmental sustainability for the hospital and critical access hospital programs. The aim of the proposed new Leadership (LD) Standard LD.05.01.01 is to help facilities minimize their carbon footprints as they…
Editor's Note Centers for Disease Control and Prevention data show 1,706 COVID-19 deaths for the week ending March 15, the lowest number since March 25, 2020, according to the March 20 US News & World Report. COVID-19 cases and hospitalizations also continue to drop, with weekly infections at their lowest…
Editor's Note The Food and Drug Administration (FDA) on March 16 updated its list of COVID-19 medical device shortages to reflect changes in estimated shortage durations during the public health emergency. These include: Radiological devices General plastic surgery devices Cardiac diagnostic and monitoring products General ICU/hospital products Specimen collection, testing…
Editor's Note Health and Human Services (HHS) Secretary Xavier Becerra on March 15 amended the February 4, 2020, COVID-19 emergency use authorizations for: diagnostics for detection and/or diagnosis of COVID-19 personal respiratory protective equipment other medical devices including alternative products used as medical devices drug and biological products. These emergency…
The medical device industry aims to create valuable innovations that help improve patient outcomes, reduce costs, and improve efficiencies for OR staff. Because these technologies and devices have a myriad of benefits, improving speed to value is a top priority. A key component of extracting the full value of these…