FDA issues final guidance for drug-device combo products
Editor's Note The Food & Drug Administration (FDA) on July 22 issued a final guidance for makers of products that combine devices and drugs or biologics. The guidance clarifies how manufacturers should comply with recordkeeping requirements and how they should submit safety reports and avoid duplication.
Joint Commission names five hospitals as 2019 Pioneers in Quality Expert Contributors
Editor's Note The Joint Commission on July 24 named five hospitals/healthcare systems as 2019 Pioneers in Quality Expert Contributors for their leadership efforts in using electronic clinical quality measure (eCQM) practices to drive their quality improvement. The five are: Baptist Health (Jacksonville, Florida) Johns Hopkins Health System (Baltimore, Maryland) Memorial…
FDA: Class I recall of Getinge’s Maquet/Datascope intra-aortic balloon pumps
Editor's Note The Food & Drug Administration on July 23 identified the recall by Getinge of its Maquet/Datascope intra-aortic balloon pumps (IABPs) as Class I, the most serious. Recall of the Cardiosave Hybrid, Cardiosave Rescue, CS300, and CS 100/100i IABPs was initiated because of reports of the IABP batteries failing…
Legal and ethical questions temper excitement about AI--Part 2
As part of a special series on artificial intelligence (AI), OR Manager is taking a deep dive into the many facets of this new technology and its impact on patient care. In this issue we continue our examination of the challenges related to AI, which began in last month’s issue…
Research raises concerns about lubricants used in endoscopes
Current endoscope reprocessing methods are not consistently effective in eliminating organic soil or microbes, and the off-label use of products for defoaming, lubrication, and bleeding control may be contributing to reprocessing failures. Though endoscope manufacturers have cautioned against the use of these products, endoscopists still commonly use them, and many…
Editorial
Our series on artificial intelligence (AI) concludes in this issue with part 2 of an in-depth look at legal and ethical questions (cover story) as well as advice for evaluating new AI products (“Consider all angles when choosing AI technology,” p 13). But insights about future trends like AI do…
Are you prepared for the OR of the Future?
Innovative technology and surgical procedures, including artificial intelligence, will be explored in depth during the OR Manager Conference, September 18-20 in New Orleans. The new OR of the Future gives attendees a unique opportunity to learn through interactive experiences, educational sessions, and discussions with leading experts: product manufacturers as well…
Consider all angles when choosing AI technology
This article concludes OR Manager’s special series on artificial intelligence (AI). Parts 1 and 2 (May 2019 and June 2019) introduced AI, defining the different types of technology and describing its many current and potential applications for surgery. The series also presented examples of AI (June and July 2019). We…
Facilitate and innovate: Ensuring speedy but safe product reviews
Surgeons are the biggest factor in any effort to streamline and standardize the purchase of new surgical devices—and thereby lower costs. But surgeons often balk at getting involved in product review and selection because of the additional demands on their time. Two leading healthcare organizations have moved past this stumbling…
FDA: Class I recall of Hamilton–G5 Ventilators
Editor's Note The Food & Drug Administration on July 12 identified the recall by Hamilton Medical AG (Bonaduz, Switzerland) of its Hamilton-G5 Ventilators as Class I, the most serious. The recall was initiated because of a software failure that stops the ventilators after displaying an error message, leaving patients to…
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