Nuts and bolts of new technology acquisition--Part 2
Technology acquisitions require OR leaders to weigh the competing demands of stakeholders—including physicians, nursing staff, the finance department, and patients—and to make sure they address those demands when justifying a new purchase. “New technology can be what’s needed to keep competitive in the current environment,” says Beth Bozzelli, MBA, RN,…
Latest sterilization packaging guideline backed by evidence
In October 2019, AORN released its updated Guideline for Sterilization Packaging, which is based on evidence from peer-reviewed literature. This article includes recommendations from that guideline and addresses common misconceptions about sterilization packaging. Other resources for proper use of sterilization packaging include the Association for the Advancement of Medical Instrumentation…
Coronavirus could disrupt healthcare supply chain
Editor's Note The US healthcare industry should prepare for a disruption in the supply chain for disposable medical-surgical devices and high-tech therapeutic and diagnostic products from China amid the coronavirus outbreak, the January 31 Modern Healthcare reports. Data show that devices and diagnostic products from China account for about 3%…
Medline’s Illinois ethylene oxide sterilization facility hopes to reopen end of January
Editor's Note Medline Industries has not operated its Waukegan, Illinois, sterilization facility since December 13, 2019, when it was temporarily closed because it couldn’t meet Illinois’ new state standards for ethylene oxide, the January 21 MedTech Dive reports. A Lake County Health Department update on January 17 says Medline began…
Nuts and bolts of new technology acquisition--Part 1
Surgeons often are eager to acquire the newest technology, particularly right after attending a conference with a vendor-packed exhibit hall. How can OR leaders weigh surgeon demands with organizational cost constraints to ensure they meet patient needs while being fiscally responsible? The first step is to acknowledge the complexity of…
Recycling program evolves to sustain gains in waste reduction
Approximately 5.9 million tons of waste annually comes from the healthcare industry, and one-third of that waste comes directly from the OR. Each year, an increasing number of disposable products are used in the OR. To address this dilemma, an OR recycling performance improvement committee was formed at Massachusetts General…
Boston Scientific receives FDA clearance for single-use duodenoscope
Editor's Note Boston Scientific announced December 13 that it had received Food & Drug Administration (FDA) 510(k) clearance for the EXALT Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The EXALT Model D, which was granted Breakthrough Device Designation from the FDA, eliminates the need for…
ECRI Institute opposes proposed ban of EtO sterilization
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…
FDA of device shortages because of sterilization facility closures
Editor's Note The Food and Drug Administration (FDA) on October 25 released a statement warning of possible device shortages because of interruptions in ethylene oxide (EO) sterilization services due to facility closures in Illinois and Georgia. In the statement, the acting FDA Commissioner, Ned Sharpless, noted that “at this time…
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…
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