Surgical Site Infection Reporting

The Centers for Disease Control and Prevention National Safety Healthcare Network (CDC NHSN) published in January guidance for the Patient Safety Component Manual. Please check your specific areas to look at items that are pertinent to your facility. It is worth refreshing with your surgical areas and infection prevention professionals and providers, the classification for surgical site infections.

FDA Duodenoscope Update

The FDA's latest safety recommendation is to transition to innovative designs to enhance safety. This includes, moving away from fixed endcaps, use of disposables, quality checks, and better reprocessing procedures. Two duodenoscopes with disposable endcap design have been approved. They are: 1) Fujifilm Corporation, Duodenoscope model ED-580XT (cleared under K181745) 2) Pentax Medical, Duodenoscope model ED34-i10T (cleared under K163614 and K181522) #highleveldisinfectio

July 2020 Maternal Care Standards - Get Ready Now!

As of July 1, 2020 there are new requirements within the Provision of Care, Treatment, and Services (PC) chapter at PC.06.01.01 and PC.06.01.03. These 13 new elements are designed to improve the quality and safety of care provided to women during all stages of pregnancy and postpartum. PC.06.01.01 addresses reducing harm related to maternal hemorrhage. This includes seven elements requiring evidence-based assessment and management, drills, and education. PC.06.01.03 contains

FDA Seeks Comment On MRI Safety

On August 2, 2019, the FDA issued a docket requesting comments regarding the magnetic resonance (MR) environment and device safety. The proposed rule recommends expanding testing for "all implanted medical devices, external medical devices that are fastened to or carried by a patient (e.g., external insulin pump), and all medical devices that are intended to enter the MR environment." It suggested standardized labeling for the device to include MR safe, MR unsafe and MR