On October 21, 2015, China Food and Drug Administration issued No.18 order Medical Device Quality Supervision and Administration Measures (hereinafter referred to as the Measures), and has implemented since February 1, 2016. Local departments have started acting and concerning!

I. Serious problem in the link of use of medical device

At present, in the link of use, some hospitals have nonconforming behavior and illegal channel when purchasing medical device; ignore the maintenance of medical device, medical equipment with “defect” seriously affects the medical treatment quality and patient safety. 

II. Frequent attack of medical device supervision and administration storm

Increasingly frequent spot check and gradually improved supervision and administration system, etc. make medical device industry face unprecedented strict supervision and administration, especially the proposal and implementation of full-process supervision and administration of medical device, the storm of supervision and administration sweeps and brings the industry with huge earthquake. 

III. Analysis from Beijing Municipal Administration of Hospitals on the current situation of management work of affiliated hospital functional departments according to the Measures:

 (I) Hospital medical equipment management organization and department are incomplete

 (II) Daily management work shall be further refined and information-based

 (III) Medical device management system is lagged

IV. Beijing Municipal Administration of Hospitals issued guiding opinion on this:

• Implement relevant national regulation on medical device management, formulate hospital medical device management system and supervise the execution;

• Responsible for organizing, formulating, implementing medical device configuration planning and annual purchase plan;

• Responsible for the full-process management of hospital medical device purchase, acceptance, quality control, maintenance, repair, measurement, application analysis and disposal, etc. and provide technical guarantee;

• Guarantee that in-service medical device is in safe and usable status;

• Provide technical support to clinical using department, organize medical device training, regulate use of medical device, improve safety and rationality of using medical device, promote full life circle information management of in-service medical device;

• Conduct medical engineering subject construction, constantly strengthen talent training, improve medical device management ability and technical guarantee level.

V. The Measures have been implemented, how can medical institution cope with?

Article 17 of the Measures “Medical device user can require medical device production and operation enterprise to provide medical device maintenance and repair service according to the contract stipulation, or entrust repair service institution with condition and capacity to maintain and repair medical device, or independently maintain and repair in-service medical device.” The original factory monopoly is broken, and the choice for hospital is more diversified.

At present, the medical equipment socialized overall outsourcing service solution provider represented by “TOPMED” has been formed in China. “TOPMED” takes medical equipment information management system as the core, puts the service situation of all hospital medical equipment online, establishes scientific system of medical engineering management, moves the focus of equipment management forward, completely changes the situation of emphasizing on repair instead of management in the past, conducts equipment full life circle management that meets the national supervision and administration code, focuses on training and maintenance, so as to reduce equipment average failure rate and improve comprehensive equipment service level. At present, “TOPMED” has undertaken a batch of equipment full life circle outsourcing management service covering community clinic, secondary and third level medical institution.