About medical devices | 'Recall' | You should also understand these

Medical Network August 6th Recently, the safe production of medical products has become a hot topic of discussion among the public. The mandatory recall of the vaccine has caused many people to worry.

What does the word 'recall' mean? Should medical companies take the initiative to recall or eliminate the recall? This time, we have made some discussions on the monitoring and recall of adverse events in the medical device industry to let more people understand the medical device industry' Recalling ' .

There are many types of medical devices and large spans, which vary greatly depending on the equipment level, type and management method. Workers and patients have great risks in using and abusing medical devices. Therefore, the safety of medical device production is particularly important. It should be supervised from development, production to use, and scrapping the entire life cycle.

Among them, the recall of medical devices reflects the ability of the national regulatory authorities to supervise batches, models and categories of defects in medical devices after listing, and is also an obligation for enterprises with risk awareness and safety responsibilities to cooperate with them. The department investigates, evaluates, and recalls defective products in a timely manner.

Similar to the automobile industry, there are many production parts and components of medical equipment, and the production process is complicated. Inevitably, there will be defective products. While the company is strictly controlling in the production process, it should actively monitor adverse events and actively recall after discovering problems. In order to comprehensively reduce the risk of using medical devices in use. According to the National Annual Report on Monitoring of Adverse Events of Medical Devices issued by the State Drug Administration, in 2017, China’s monitoring report on adverse events exceeded 370,000 copies. Active detection of problems, representing the entire medical machinery industry risk management awareness and level of improvement.

For example, Mindray, a domestic medical device company, has been recalling more than 30 active products including China, the United States, the European Union, and Australia for its continuous monitoring of its monitors, central monitoring systems, anesthesia machines, and reagents for four consecutive years starting in 2015. The recall, which has also been rated as an advanced unit of adverse event monitoring for four consecutive years.

According to the first part, that is, from May 1, 2017, the “Administrative Measures for Medical Device Recall” (hereinafter referred to as the “Measures”), the medical device recall refers to the medical device manufacturer’s compliance with the prescribed procedures. The medical device products of a certain type, model or batch of defects that are listed for sale shall be handled by warning, inspection, repair, re-labeling, modification and improvement of instructions, software update, replacement, recovery, destruction, etc.

According to industry analysts, due to the existence of certain risk factors in medical devices, some medical devices also have certain risks in the use process. Only by continuously testing and monitoring the quality of medical device products can the potential of medical devices be maximized. The risk of ensuring the safe use of medical devices.

The sound medical device supervision system, especially the recall system, not only can guarantee the safety of medical devices, but also promote the improvement and upgrading of products, promote the research and development of new products, and promote the healthy development of China's medical device industry.

In fact, the medical device recall system is an effective model for managing medical devices with hidden dangers in the world. As early as 1938, American lawmakers clearly recognized the challenges that medical devices pose to safety, and in the past Food, medicine and cosmetic The bill includes the medical device as a special category of regulated products in the bill, which has been more than 75 years old.

From January 1, 2010 to December 31, 2015, the FDA issued 183 draft guidelines or final guidance documents on the management of medical device lifecycles, during which the first-level recalls grew at an annual rate of 29%. In 2014, the total number of recalls was 543.

China's medical device supervision model draws heavily on the regulatory experience of the United States and the European Union. Like most countries, it implements classified management of medical devices. It also has pre-market approval and post-market supervision, and completes re-approval to heavy supervision. Transformation.

In fact, before the implementation of the Measures, China's medical device supervision system is still in the process of continuous improvement. In the past, the voluntary recall of medical device products seems to have always been a foreign-funded enterprise, importing products. In recent years, with the The full implementation and implementation of the "", a part of the domestic medical equipment with risk responsibility and safety responsibility, take the initiative to recall their products.

According to the data, on August 17, 2016, the Shanghai Food and Drug Administration issued a new announcement of 25 medical device voluntary recalls. Among them, only the main body of the recall was the domestic medical device manufacturer, and the recalled products were also made in China. In 2017, the number of recalls of domestic medical device companies in Shanghai doubled. In the first quarter alone, the number of voluntary recalls issued increased by 110% year-on-year.

In the first half of 2018, the public data of the Shanghai Food and Drug Administration showed that the number of voluntary recalls increased by 66.7% year-on-year. The number of voluntary recalls of domestic medical devices increased, and 11 domestic medical devices were actively recalled.

The industry believes that at present, in the post-marketing supervision of medical medical equipment, China's regulatory part has formed an effective linkage with the production enterprises in the medical equipment supervision sampling inspection, flight inspection and voluntary recall work, initially forming a regulatory force.

In fact, according to the relevant regulations on medical device management, medical device production and operation enterprises, the use unit shall carry out adverse event monitoring on the medical devices produced or used; and discover medical device adverse events or suspicious adverse events, according to the food of the State Council. drug Supervisory management regulations, medical instruments Report of the technical agency for adverse event monitoring.

Medical device production and operation enterprise The user shall cooperate with the medical device adverse event monitoring technical organization and the food and drug supervision and management department to investigate the medical device adverse event investigation.

In this respect, Mindray and other medical equipment companies have been in line with international control of 'adverse events', targeting adverse events in different countries. Regulation , also established a series of programs also played a demonstration role in the industry.

However, the post-marketing supervision of China's medical device companies is still in its infancy, and it is necessary to gradually improve cognition and improvement. However, the industry believes that as the company's awareness of active control over adverse events increases, the safety of medical devices will also increase. On a new stairs.