NHFPC will issue new guidelines on Central Sterile Supply Department Management Regulations

20160331043618695 The creation, implementation, and enforcement of policies, processes and standards plays a critical role in safety and efficiency in the healthcare industry. For example, to improve patient safety and reduce medical device-related errors, injuries, and deaths, the Food and Drug Administration (FDA) has introduced a new requirement, Unique Device Identification (UDI), to improve identification and tracking of medical devices. Under UDI, every medical device in use in the U.S. will have a unique code embedded within it and displayed on its packaging. By tracking these codes in a central database and recording reports of adverse events, the FDA will be able to identify product problems faster, target recalls more accurately, and reduce related errors, injuries, and deaths. To comply with these new regulations, medical device manufacturers must be able to capture, enrich, and manage accurate device attributes from their enterprise databases so they can then submit accurate, consistent, complete, and timely data to the FDA Global Unique Device Identification Database (GUDID).

With the same objectives to strengthen the supervision and management of medical devices and the sterile process in China, the National Health and Family Planning Commission of China (NHFPC) has recently revised the Central Sterile Supply Department Management Regulations which will be released soon. These new guidelines will help define and ensure traceability and auditability of sterile medical devices as well as a system to ensure data accuracy and continuous process improvement of the sterilization management.

At the Third International Healthcare Internet of Things Summit in Shanghai this week, this new regulation was highlighted as a means to also digitally transform the medical device and sterilization process to improve patient safety, eliminate medical errors, improve efficiency in tracking medical devices, and potentially bridge previously unlinked “sterile” data with analytical tools which can provide real-time data and insight into operational and clinical workflows.

Chinese healthcare providers would be able to take advantage of bar code and RFID technologies to meet with this new compliance for medical device traceability and replace labor-intensive paper-based processes. RFID is the key enabler for the Internet of Things in healthcare and its auto-id capture systems can identify and track surgical instruments before and after surgical procedures, sterilization, and storage, ensuring no instruments are left behind during surgery and that hospital staff can find instruments when needed.

Xerafy has been awarded the 2016 Frost and Sullivan Global Product Innovation Award for RFID Surgical Instrument Tracking. Frost & Sullivan recognizes a growing demand for RFID technology in healthcare as hospitals can experience a fast ROI. Furthermore, Frost & Sullivan estimates that cloud-based RFID systems, with integrated analytics accessed through web-based applications will see a greater demand, as the Internet of Things’ influence increasingly affects the healthcare industry.

Contact Xerafy to see how we can help you digitally transform the way you operate.

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