Medical equipment "internal injury" can not afford to hurt

Broken orthopedic internal fixators, artificial lenses implanted after cataract removal, turbidity, etc. These "internal injuries" all belong to "medical device adverse events." According to statistics from the Municipal Food and Drug Administration on the 9th, according to statistics, more than 340 relevant units in the city reported 1399 cases of adverse medical device incidents this year, ranking first in Jiangsu Province. However, the reporter found during the interview that most of the reported adverse events were pharmacies and other business units, and most public hospitals were rarely involved.

An adverse event does not mean that the quality problem "A medical device adverse event actually refers to a harmful event that has been approved for marketing and has a qualified medical device and that has not been used in the normal use of the medical device. The relevant person in charge of the SFDA According to the report, many citizens know about adverse drug reactions but do not understand what is wrong with medical devices. When they see "adverse events," they think that there must be a problem with the quality. In fact, any medical device product is just like a drug and is used clinically. There are certain risks in the process, and the medical devices that are approved for listing are "risk-risk" and "risk-acceptable" products. Especially those medical devices that are in contact with the human body for a long period of time, are used for a long time, and are implanted in the human body are inevitably at the same time risky in the diagnosis and treatment of diseases.

Most public hospitals are reluctant to submit reports. At present, Xicheng medical institutions are the main sites for medical devices. They are widely used in diagnosis and treatment, and the probability of adverse events should also increase. However, the reporter found during the interview that most of the units that reported adverse events were pharmacies and other operating companies, and public hospitals reported less optimistic conditions. Among them, Wuxi Wuyuan reported less than 20 adverse events this year, but it is already the largest number of reported public hospitals in the city. It was learned from several hospitals that hospitals would notify manufacturers or suppliers to resolve medical device failures. In addition, some medical device manufacturers are reluctant to report adverse events to hospitals, resulting in loss of profits. At the same time, hospitals are also worried that reporting, filling in forms, and analyzing adverse events will increase the workload of medical staff, and they are even more concerned about the increase in adverse events reported and will have a negative impact on hospitals.

Why did 361 medical institutions set up monitoring commissioners to report medical device adverse events? The person in charge of the Municipal Food and Drug Administration stated that Wuxi is a major medical device industry in China and there are more than 200 medical device manufacturers and 313 operating companies in the city. By monitoring the medical device after its listing, it can provide supervision basis for the supervision and management department to reduce or avoid the recurrence of adverse events of similar medical devices. Currently, there are monitoring commissioners in all production and business enterprises and 361 medical institutions and health service centers, and they are registered on the national adverse drug reaction monitoring system.

In addition to the existing regulatory network platform and QQ group, the drug administration department has also actively explored the use of new models such as Weibo to build an interactive communication platform so as to create a good monitoring atmosphere for everyone involved. For this reason, the drug administration department reminded that the public should read the instructions for use of medical devices carefully before using medical devices. If any medical device adverse events that cause or may cause serious injury or death are discovered, they should promptly report to the drug administration department to prevent adverse events from happening again. occur.