The Inner Mongolia Xing'an League Market Supervision and Administration Bureau has recently carried out a specialized inspection on the quality and safety of medical devices used at key institutions within its jurisdiction, including blood stations and disease prevention and control centers. The initiative focuses on implementing precise supervision in high-risk areas to ensure the safety of medical device use for the public.

Targeting High-Risk Areas with Precision

This special inspection adopts a problem-oriented and risk-oriented approach, precisely targeting high-risk categories of medical devices. It places emphasis on scrutinizing products that attract significant public attention and carry high safety risks, such as in vitro diagnostic reagents, sterile and implantable medical devices, and medical devices requiring cold chain management. Simultaneously, the inspection rigorously verifies whether user units comply with product instruction manuals by standardizing the inspection, testing, calibration, maintenance, and servicing of medical devices, and maintaining comprehensive records to ensure these devices remain in a safe and functional condition. By accurately identifying key supervision targets, the effort effectively avoids inefficient inspections, directing regulatory resources towards the most prominent risks and public concerns, thereby enhancing the precision and foresight of regulatory work.

Implementing Full-Process Closed-Loop Control to Eliminate Blind Spots in Risk Detection

The inspection focuses on critical aspects, including whether user units employ unregistered (or unrecorded) or expired medical devices, source medical devices from legitimate and compliant channels, strictly implement purchase verification and record-keeping systems, meet standard storage and maintenance conditions for medical devices, and ensure the stable and normal operation of cold chain management facilities and equipment. Key areas such as user unit laboratories, warehouses, and blood collection vehicles are thoroughly examined to assess the operation and storage management of facilities and equipment. Supervision extends to verifying qualifications of high-risk medical device suppliers, accompanying delivery documents, warehousing acceptance records, usage records, and calibration reports for key facilities like refrigeration equipment.

For any risks or hazards identified during the inspection, relevant units are ordered to make immediate corrections or rectify issues within a specified timeframe. Suspected violations of laws and regulations will be strictly investigated and dealt with in accordance with legal provisions. The initiative aims to establish a full-process closed-loop management mechanism of "problem identification, rectification promotion, and accountability enforcement," resolutely eliminating various safety risks and hazards at their nascent stages.

In the next phase, the Xing'an League Market Supervision and Administration Bureau will continue to prioritize the quality and safety supervision of medical devices as a key annual task, promoting its implementation as a routine practice. Weak links in regulatory work will be comprehensively reviewed, and a dynamic ledger for risk and hazard identification will be established, managed through task completion tracking. By deepening intra-departmental and cross-departmental collaboration, regularly conducting risk analysis consultations, and leveraging smart regulatory technologies, the bureau will continuously enhance the effectiveness of medical device supervision. The goal is to accelerate the establishment of a new governance framework for medical device safety characterized by "social co-governance, source prevention and control, and full-process controllability," ensuring robust and effective regulatory measures to safeguard public safety in medical device usage.