The quality of medical equipment in usage is critical to ensure the safety. If hospitals neglect the maintenance of medical equipment, it will directly lead to damage to patients.
March 24, 2011, the Ministry of Health issued the " Measures for the Administration of Medical Equipment in Medical and Health Institutions" to regulate and strengthen the medical equipment management in healthcare institutions, and promote the rational allocation of medical equipment, ensure safety and effectiveness. In 2014, the Regulations on the Supervision and Administration of Medical Devices issued by the State Council (State Council No. 650) has greatly increased the clauses on the supervision and control of the use of medical devices, the establishment of the use of medical equipment safety management obligations, enrich the supervision and the measures for the quality control in medical devices usage. October 21, 2015, the State Food and Drug Administration issued the 18th General Office of the " Supervision and Management on Medical Device Usage Quality" and come into force from February 1, 2016.
According to the regulation, hospitals should establish the quality system for medical equipment prior to usage, and the recording system for implantation and intervention devices, and management system for the maintenance of medical equipment. Hospitals shall conduct regular medical equipment inspection, inspection, calibration, maintenance, maintenance work in accordance with the requirements of the product manuals.
Regulations further clarify that hospitals shall buy maintenance and repair services either from manufacturers or third-party maintenance companies, or hospitals shall do it by themselves. Manufactures are obliged to provide maintenance manuals, operation manuals, software backup, fault code table, spare parts list, spare parts, maintenance passwords and other maintenance-related materials if hospitals maintenance equipment by themselves or through third-party companies.
Regulations made clear responsibilities and requirements on hospitals, and also made clear responsibilities and obligations on medical equipment manufacturers. It provides a regulatory and policy support for the medical equipment management service providers.