News and Notes

The FDA has released its report “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices” in accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA).

The Spectrum IQ system is the first-of-its-kind designed specifically for bi-directional electronic medical records (EMR) integration.

Mercy Medical Center recently became the first health care facility in Ohio’s Stark County to disinfect hospital surfaces using robots that safely emit germicidal ultraviolet (UVC) rays.

Case Medical was issued U.S. Patent 9,885,664 for Case Soil, a wash monitoring system that represents the organic soils and bioburden found on surgical instruments that need to be cleaned and prepared for their next use at health care facilities.

TSO3 Inc., an innovator in sterilization technology for medical devices in health care settings, has received clearance from U.S. regulators for its most recent 510(k) submission for the terminal sterilization of multi-channeled flexible endoscopes using the Company’s STERIZONE VP4 Sterilizer.

Under this final order, the FDA has reclassified the needle destruction device from a class III to a class II device and renamed the device type to sharps needle destruction device.