FDA issues draft guidance on initiating voluntary recalls
Editor's Note The Food and Drug Administration (FDA) on April 23 issued a new draft guidance to help manufacturers avoid delays in preparing, planning, and executing voluntary recalls. The guidance includes recommendations in three areas: proper training of personnel thorough and organized record keeping written recall initiation procedures. The guidance…
Increased duration of surgical antimicrobial prophylaxis linked to adverse events
Editor's Note In this multi-center study, longer durations of surgical prophylaxis did not result in further reductions in surgical site infections (SSIs) but were associated with increasing adverse events. Of 79,058 surgical patients in the VA healthcare system, SSI was not associated with duration of prophylaxis, but odds of acute…
Joint Commission announces updates to E-dition
Editor's Note The Joint Commission on April 24 announced that it will be posting spring 2019 updates to the E-dition® of its accreditation and certification manuals in May. The changes, which can be viewed on an organization’s Joint Commission Connect® extranet site, will go into effect July 1 unless otherwise…
Off-label use of simethicone, lubricants, and tissue glue contributes to endoscope reprocessing failures
Editor's Note The off-label use of defoaming agents, lubricants, and tissue glue is common, and these insoluable substances are not removed during reprocessing, this study finds. Of 69 fully reprocessed endoscopes examined in four hospitals, microbial cultures were positive for 50% or more. The researchers, led by Cori Ofstead, MSPH,…
FDA considering additional regulatory actions to reduce duodenoscope risks
Editor's Note The Food & Drug Administration on April 16 announced it is considering additional regulatory actions, including consulting with federal health experts for guidance, to reduce the risks of contamination and infections associated with duodenoscopes. The FDA is also working with manufacturers of disposable duodenoscopes that would make reprocessing…
Preop functional status predicts total hip outcomes
Editor's Note Compared with preoperative independent functional status, preoperative dependent functional status was independently associated with worse outcomes after primary total hip arthroplasty in this study. Of 43,179 patients analyzed, those who were less able to care for themselves: were 2 to 3 times more likely to have surgical complications…
FDA announces new efforts to protect patients from risks associated with surgical staplers, implantable staples
Editor's Note The Food & Drug Administration on April 23 announced new steps it will be taking to help reduce risks associated with surgical staplers for internal use and implantable staples. The proposed steps include: Reclassifying surgical staplers from Class I (low risk) to Class II (moderate risk). Issuing guidance to…
Study: CMS policy changes cut readmission fines
Editor's Note The Centers for Medicare & Medicaid Services (CMS) recent changes to its Hospital Readmission Reduction Program resulted in a drop in readmission fines for academic, safety-net, and rural hospitals, this study finds. This analysis of 3,049 hospitals found that because of policy changes that now separate hospitals into…
FDA orders manufacturers to stop selling gynecologic mesh
Editor's Note The Food and Drug Administration (FDA) on April 16 announced that it had ordered manufacturers of surgical mesh products indicated for transvaginal repair of pelvic organ prolapse to stop selling and distributing their products in the US, immediately. The FDA has determined that manufacturers, Boston Scientific and Coloplast,…
How will artificial intelligence impact surgical patient care? Part 1
Artificial intelligence (AI) may be coming to your OR sooner than you think. AI is already being used to identify areas needing quality improvement by analyzing surgical workflow, communication patterns, and errors that went unnoticed during a procedure. OR leaders need to understand AI and participate in its development and…