Three Tips to Improve the Quality of In Vitro Diagnostic Reagents

In recent years, with the improvement of medical insurance policies and the rise of new technologies, the in vitro diagnostic industry has developed rapidly and has become one of the most active areas in the medical device market. Not long ago, the ''China Pharmaceutical Health Blue Book'' released by the China Pharmaceutical Industry Information Center mentioned that in 2014, the total medical device market in my country reached 276 billion billion yuan, and the top three sectors were medical imaging equipment, in vitro diagnostic products, and high-value medical supplies. And implants, in vitro diagnostic reagents accounted for 16%.

Due to the wide range of in vitro diagnostic reagents, large clinical use, simple production process, and relatively easy to innovate, a new product may be developed in one or two years, so there are many manufacturers.

From the current situation of the production, operation and use of in vitro diagnostic reagents in China, there are mainly the following problems:

First, the scale of production enterprises is small, the product grade is low, and there are few high-end varieties. Some enterprises produce and sell unregistered in vitro diagnostic reagents, calibrators and quality control products.

Second, some operating enterprises have the phenomenon of operating in vitro diagnostic reagents without permission or record.

Third, some users use unregistered in vitro diagnostic reagents, calibrators and quality control materials without authorization. Due to lax management, some users still use expired products.

Fourth, the storage and transportation conditions of in vitro diagnostic reagents for individual operating enterprises and users do not meet the requirements. These risks lay hidden dangers for the quality and safety of in vitro diagnostic reagents.

In the first half of this year, the Food and Drug Administration carried out large-scale risk investigation and comprehensive management work nationwide, and rectified a number of problematic in vitro diagnostic reagent manufacturers. In order to comprehensively improve the quality and safety level of in vitro diagnostic reagents, Chinese medical devices have the following three suggestions:

Tips 1. to achieve innovation-driven
In the field of in vitro diagnostic reagents, high-end products and core technologies are still in the hands of foreign companies. Many domestic in vitro diagnostic companies only make reagents and do not have their own testing equipment. They also rely on imports of reagent raw materials. Once the price of imported product suppliers increases, the company will be controlled by others. Therefore, the innovation of enterprises should not be limited to adding fancy functions, changing specifications and models to the original products, but should pay more attention to new products and new medical service models, and should be closely integrated with medical institutions, especially those large hospitals. we should try our best to turn their needs into our products.

Tips 2. should pay attention to quality management
No product can be zero-risk and absolutely safe, but any risk that we think is a small probability, once it falls on the patient, is 100 percent of the safety accidents. To ensure product quality and safety, it is necessary to have a complete quality management system, standardized production operation procedures, and strict quality release procedures. It is necessary to implement production quality management standards to every post and every person. The new version of the "Medical Device Production Quality Management Regulations" has been officially implemented on March 1, and detailed regulations have been made on all links and elements of production activities. Production enterprises must improve the quality management system in accordance with the specifications and rules.

Tips 3. to strengthen risk prevention and control
In addition to a complete quality management system, standardized production operation procedures, and strict quality release procedures, it is also necessary to have the ability to prevent, control and manage risks. Enterprises should not wait until there is a crisis to carry out risk prevention and control, but should take the initiative to find hidden risks in the production process before problems occur, collect adverse events after products are put on the market, and pay attention to solving problems, eliminating hidden dangers, and improving product quality.

At the same time, we should take the initiative to exchange products, production management and risk control with peers, regulatory authorities and inspection and testing institutions, share risk prevention and control and management experience, learn from each other's strong points, and actively introduce relevant knowledge of enterprise products to the public, media and customers, share information on quality and safety incidents and risk prevention and control measures, so that everyone can reach a consensus on risks and have a rational analysis and judgment when encountering problems.

To strengthen risk prevention and control means to pay a lot of costs. Many companies may not be willing to take the initiative to carry out this work, but in the long run, if you ignore risk prevention and control, companies will eventually pay a greater economic price.

(Information from China In Vitro Diagnostic Network)