Since April, the inspection of the cold chain of medical equipment has gradually spread throughout the country. So far, we have not yet started the operation. And some "early birds" have been supervised. The results of it?
The bad news is that basically every county and city inspection has problems found; the good news is that the problem is generally not serious, and companies are required to rectify or be interviewed within a time limit. So far, no one has been asked to stop production or revoke the license.
The following is the case of the inventory:
Suqian City, Jiangsu Province:
A comprehensive inspection of 40 related product management enterprises in the city, including 9 in vitro diagnostic reagents management companies and 31 other refrigeration and frozen product management enterprises.
In May, the Municipal Bureau conducted a spot check on the work of the counties (districts). During the spot checks, it was found that the temperature and humidity records during the transportation process, the acceptance records, and the incomplete sales records were not carefully examined, and the county and district bureaus were instructed to urge the enterprises to rectify.
In this inspection, a total of 39 relevant units were inspected, 108 inspectors were dispatched, and 2 illegal and illegal enterprises were investigated and dealt with, and 3 companies were required to order rectification.
Zhongyu County, Henan:
Zhongmu County Food and Drug Administration conducted a centralized interview with Henan Debo Biotechnology Co., Ltd., Zhengzhou Boruijia Trading Co., Ltd. and Zhengzhou Fangxin Biological Co., Ltd.
The meeting conveyed the spirit of the "Notice on Carrying out the Supervision and Inspection of Cold Chain Management of Medical Device Management Enterprises in Henan Province"; one by one, one of the issues concerning the imperfect equipment storage and transportation facilities of the cold chain products and the failure of the quality responsible person to perform their duties. In-depth analysis of the causes of the problems and the development of solid rectification measures.
The three enterprises are required to strictly implement the main responsibilities: First, improve the relevant systems for medical equipment cold chain management; second, thoroughly rectify the problems that have occurred; third, submit the rectification report on time and accept the inspection and acceptance by the regulatory authorities.
Economic Development Zone, Jiaxing City, Zhejiang Province:
During the special inspection, some enterprises found the following problems: 1. The refrigeration and refrigeration transportation management system is imperfect, and there is no emergency plan for transportation; 2. The equipment such as cold storage and freezer is not regularly verified; 3. The temperature and humidity monitoring record interval is exceeded. Provisions; 4. The temperature monitoring records during transportation are not collected during the acceptance of refrigerated medical devices.
In response to the problems found, the regulatory authorities require enterprises to immediately carry out rectification, ensure the quality management of cold chain management products is safe and effective, and ensure the safety of the public in the jurisdiction.
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