FDA and CDC Issue An Alert on Properly Cleaning Medical Devices – On September 11, 2015, the CDC and FDA issued a joint advisory alerting providers and facilities about properly cleaning medical devices, due to concern with recent media reports describing patient risk from lack of basic cleaning, disinfection, and sterilization of medical devices. The advisory emphasized that health care providers “that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines.” The advisory also urged providers and facilities to provide training to all personnel who reprocess medical devices, as well as, among other recommendations, to regularly audit cleaning, disinfection, sterilization and storage procedures and to implement procedures to follow in the event of a recognized reprocessing error or failure.
Obama Administration Launching Initiative to Crack Down on Antibiotic-Resistant “Superbugs” – On September 15, 2015, the U.S. Department of Health and Human Services (HHS), U.S. Department of Agriculture, and the U.S. Department of Defense announced a 15-member council that “will provide advice, information, and recommendations to the HHS Secretary on programs and policies related to combating antibiotic-resistant bacteria.” This move was prompted by the agencies’ concern that a growing number of bacterial infections do not respond to even the most powerful antibiotics, putting patients at high risk for severe infections, sometimes even resulting in death. “Detecting, preventing, and controlling antibiotic resistance requires a strategic, coordinated, and sustained effort,” the agencies said in a statement. The announcement of the panel came the same day that the CDC unveiled guidelines for improving antibiotic use in nursing homes, and the day after the Joint Commission announced an educational campaign on the appropriate and safe use of antibiotics.
Study: Readmissions Correlated with Patient Characteristics, Not Care Quality – A recent study, published by the American Medical Association on September 14, 2015, concludes that patient characteristics not included in Medicare’s current risk-adjustment methods under the Hospital Readmissions Reduction Program explained much of the difference in readmission risk between patients admitted to hospitals with higher versus lower readmission rates. Consequently, the study concludes that hospitals with high readmission rates may be penalized to a large extent based on the patients they serve. The study, entitled Patient Characteristics and Differences in Hospital Readmission Rates, was authored by Drs. Michael Barnett, John Hsu, and Michael McWilliams and is available online here to JAMA Internal Medicine subscribers.
Join Us for King & Spalding’s 2015 Medical Device Summit on September 29-30 – King & Spalding, in conjunction with The Gray Sheet, will hold its 2015 Medical Device Summit on September 29-30 in Chicago. Exploring the cutting-edge issues facing the medical device industry, this year’s Summit will address regulatory updates, enforcement trends, developments in clinical trials, a legislative briefing, cybersecurity and other topics that demand the attention of medical device manufacturers in the coming year. More information and registration options are available here.
