Baisaifei leads the formulation! China's first anti-bacterial adhesion medical coating standard was officially released to promote the innovative development of antibacterial devices

NEWS

With the support and guidance of the Chinese Society of Biomaterials, the anti-bacterial adhesion coating-related group standard led by Beisifei, 'Test Method for Anti-bacterial Adhesion Performance of Coatings' (Standard No.: T/CSBM 0059-2025), was officially released recently. The standard was drafted by Dr. Li Dan, general manager of Bysaifei, as the first drafter, and was jointly drafted by Jiangsu Byaifei Biotechnology Co., Ltd., Baiint Surface and Interface Inspection and Testing Technology (Suzhou) Co., Ltd., Suzhou Industrial Park Biomaterial Surface and Interface Engineering Research Institute, Shandong Medical Device and Drug Packaging Inspection Research Institute, Sichuan University and other professional research institutions and enterprises.

Standard setting background:

Filling the gap in evaluation standards for anti-bacterial adhesion coatings

The problem of hospital infection caused by catheters is one of the core factors leading to clinical infection complications. In recent years, it has also driven a large number of catheter manufacturers to vigorously develop catheter antibacterial and anti-infection strategies. Among them, antibacterial adhesion coatings have attracted widespread attention and application verification. Anti-bacterial adhesion coating can be used for indwelling catheter devices such as urinary interventional catheters, drainage tubes, and central venous catheters. It can resist bacterial adhesion, colonization, and growth, thereby reducing the probability of infection, and has important clinical significance. Although the industrial application of anti-bacterial adhesion coatings is in its infancy, it has shown a rapid growth trend. However, methods and standards for scientific evaluation of the effectiveness of this coating are still lacking. In the field of medical devices, the industry often confuses the mechanisms of 'anti-bacterial adhesion' with 'sterilization' and 'bacteriostatic'; the detection and evaluation methods used by different companies are different or even wrong, resulting in the effectiveness of the product being unable to be scientifically and reasonably evaluated or the performance data lacking comparability. There is an urgent need to unify standards and standardize the testing process.

Against this background, the Chinese Biomaterials Society organized relevant units to carry out standard development, aiming to establish a scientific and reproducible anti-bacterial adhesion performance evaluation method and provide technical support for the development, testing and supervision of coating products.

Standard release meaning:

Standardization of test methods for effectiveness of antibacterial adhesion coatings

Based on years of experience in coating product application and coating performance testing methods and data accumulation, Bysaifei has established a complete in vitro evaluation method including After verification by multiple medical device inspection and testing institutions and companies, the standard content released this time has been formed.'strain preparation - sample incubation - bacterial recovery - result calculation ' .

• Unified evaluation benchmark : Ending the current situation of 'no standard to rely on' for anti-bacterial adhesion coating testing, providing unified technical methods for enterprise R&D and testing agency evaluation, and improving data comparability.

• Support quality supervision : Provide scientific performance evaluation basis for medical device regulatory authorities and help standardize market access for coating products.

• Promote technology development : Facilitate design, development and verification of enterprises, accelerate the development of catheter products with anti-bacterial adhesion coating, and obtain clinical benefits as soon as possible.

As a leading company in the domestic medical functional coating industry, Baisaifei's core R&D team has been deeply engaged in the field of basic coating research for more than 20 years. In the nearly ten years of coating technology transformation, it has independently developed multiple series of medical functional coating products and led a number of coating performance evaluation standards. Among them, the antibacterial series products include Baclear® ^{antibacterial adhesion/lubrication dual-effect coating, SurfInert®} phosphorylcholine ^{antibacterial adhesion coating, and Bashock® antibacterial} coating ^, which have been used in a variety of medical devices (such as drainage tubes, urinary catheters, CVC etc.), and some were approved for marketing. At the same time, a coating safety and effectiveness evaluation method system was established, and a comprehensive customer service system covering coating material supply, process equipment matching, design and development verification support and product registration support was formed to ensure the efficient implementation of customer product applications.