Proactive steps paramount for greater surgical stapler safety
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…
Is point-of-use treatment an integral part of your sterilization process?
Providing sterile instrumentation for patient care is a basic fundamental of surgery, and ensuring sterility means that instrumentation must first be thoroughly cleaned, step by step. Point-of-use treatment, an important part of this process, is gaining the attention of accrediting agencies such as the Joint Commission, and it is included…
FDA sets meeting to discuss EO sterilization
Editor's Note The Food & Drug Administration (FDA) announced September 4 that it will hold a Medical Devices Advisory Committee Meeting in November to discuss ethylene oxide (EO) sterilization of medical devices, including methods to reduce EO emissions. The committee also will provide recommendations on reducing infection risks from reprocessed…
Surgical smoke exposure in OR personnel
Editor's Note This review article finds that surgical smoke is dangerous, but the severity of the risk has yet to be been determined. Therefore, no safe level is known. Though numerous studies have been performed on the chemical composition of surgical smoke, the components remain unclear. The variability is likely…
Inspections reveal need to overhaul bronchoscope reprocessing methods
Extensive research by Cori L. Ofstead, MSPH, and her colleagues at Ofstead & Associates (St Paul, Minnesota) has raised concerns about insufficient reprocessing of gastrointestinal endoscopes and ureteroscopes—even when recommended practices are followed—and their new study makes a compelling case for more stringent reprocessing of bronchoscopes as well. In their…
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…
What should you do if your sterilizer fails?
A sterilization failure is a significant event. Receiving a positive biological indicator (BI) result from a sterilizer can be devastating and presents a patient safety concern because it could result in infection. This article addresses the proper action to take in the event of a positive BI result and biological…
'Coming clean' in the SPD requires collaboration and competency—Part 2
Contaminated surgical instruments pose a danger to patients and to an organization’s bottom line. In Part 1 of this two-part series, we discussed prevention strategies (OR Manager, April 2019, 14-15, 19). In Part 2, the focus is on investigating potential contamination, along with design considerations. Detective work Despite best…
'Coming clean' in the SPD requires collaboration and competency—Part 1
Contaminated surgical instruments made ECRI Institute’s 2019 annual top 10 list of health technology hazards, coming in at number five: “Mishandling flexible endoscopes after disinfection can lead to patient infections.” Number two on the list in 2018 was “Endoscope reprocessing failures continue to expose patients to infection risk.” It’s not…
FDA issues letter on risks linked with staplers, implantable staples
Editor's Note The Food and Drug Administration (FDA) on March 8 issued a letter to alert healthcare providers about an increasing number of medical device reports on surgical staplers for internal use and implantable surgical staples. The most common reported problems include opening of the staple line, malformation of staples,…
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