The two provinces announced that these medical tests are not up to standard!

On the eve of March 15, 315, the Medicine and Drug Administration of Jiangxi Province and the Food and Drug Administration of Guangdong Province announced the results of medical device sampling.

On March 13, the official website of the Jiangxi Provincial Food and Drug Administration issued an announcement on the results of the medical device sampling inspection of the province in 2017.

In the whole year of 2017, during the sampling inspection of medical devices by the Jiangxi Provincial Food and Drug Administration, the medical device products that meet the standard requirements for testing items were produced by 125 medical devices. enterprise 31 batches of 300 varieties, another 2 medical equipment manufacturers retested 4 batches of 2 varieties of products; medical equipment products that did not meet the standard requirements had 28 batches of 17 types of medical equipment manufacturing enterprises.

The sampling unit includes all levels hospital , health clinics and a number of sizes pharmacy , The failing indicators are mostly dimensional and sterile indicators (see Table 1 below for details).

At the same time, the Guangdong Provincial Food and Drug Administration also announced the sampling inspection of medical devices in March 2018. In March, the sampling inspection of medical devices in Guangdong Province was divided into 3 phases, which were 40 issues, 41 issues and 42 issues respectively. For special supervision sampling.

Among them, Phase 40 is a special sampling inspection of the kit for the determination of lactate dehydrogenase, sampling a total of 27 batches of samples, involving 14 prefectures and 11 manufacturing enterprises (imports proxy Units), 3 operating companies, 12 medical institutions and 9 production enterprises outside the province (import agency units), the seized 27 batches of samples tested items meet the standard requirements.

The 41st phase is a special sampling of ultrasonic Doppler fetal heart rate monitors. There are 13 batches of sampling samples, covering 8 prefectures and cities in our province, 10 manufacturing companies (importing general agent units), 5 operating companies, and 1 outside the province. A total of 3 batches of samples in 13 batches examined by the manufacturer (import agent) did not meet the standard requirements (see table 2 below for details).

The 42nd period is for the special sampling of hearing aids. A total of 51 batches of samples were sampled, involving 19 prefectures and cities in the province, 6 production companies (importing agency units), 35 operating companies, and 6 production enterprises outside the province (import agent Units. Among the samples tested, 14 batches of tested items did not meet the standard requirements. The main non-conforming items were external markings of equipment or equipment components. This non-compliance involves Siemens's subsidiaries (see Table 2 below for details) ).

Table 1: The 2017 Jiangxi Provincial Food and Drug Administration medical instruments Sampling does not meet the standard product list

Table 2: March 2018 Guangdong Provincial Food and Drug Administration Medical Device Testing Fails to Meet Standards List