Home E-Weekly June 13, 2017

News & Notes

Published: June 12, 2017

  • FDA requires validation data for the cleaning, disinfection and sterilization of reusable medical devices The Food and Drug Administration has published a list of reusable medical devices that will soon require validated instructions for use and validation data regarding cleaning, disinfection and sterilization in their premarket notification submissions. The FDA believes these devices pose the greatest risk of infection transmission and "inadequate performance" if not adequately reprocessed, so this action should help make provide clear, comprehensive reprocessing instructions to healthcare facilities that reprocess these devices.
  • Obesity complicates shoulder arthroplasty Patients with a BMI of 30 or higher who undergo shoulder replacement surgery are at increased risk of reoperation due to mechanical failure, loosening of the implant or wound infection, according to research published in the Journal of Bone & Joint Surgery. Risk of revision surgery for mechanical failure increased by 5% for every one-unit increase in BMI, according to the researchers, who suggest risk stratification is needed to increase reimbursement for surgeons who perform complex cases on overweight individuals.
  • New guidance on equivalent supplies and implants ECRI Institute, a non-profit healthcare research company, has introduced a new platform that offers guidance on equivalent alternatives for surgical supplies and implants. The goal of CrossCHEQ, says ECRI, is to identify cost-saving opportunities, as well as opportunities for standardization and alternatives when needed items are unavailable.
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