With the theme of “Development Status and Trend Prospects of Safety Protection Textiles”, the research content covers market, fiber and technological innovation, product development, standard system construction, downstream applications, intelligent development and other professional fields, comprehensively interpreting the development of safety protection textiles. Current status and trends.
AAMI 4 is the barrier property of protective surgical gowns and surgical drapes used in operating rooms in the AAMI PB 70 “Liquid-proof Performance and Classification of Protective Clothing and Sheets Used in Healthcare Facilities” standard organized by the American Medical Equipment Development Association. A level of evaluation. The AAMI BP 70 standard regulates the liquid barrier performance and classification of surgical gowns, protective clothing and surgical drapes, and divides the barrier performance levels into 4 levels. Level 4 requires that surgical gowns or other protective clothing must pass through blood and Viral leakage 2 tests. AAMI Level 4 has very strict requirements for surgical gowns. It requires that the entire garment can form a barrier to human blood and viruses to prevent the transmission of viruses, such as Ebola virus, SARS, etc.
The AAMI 4 fabric and surgical gown independently developed by our company uses a composite material made of 2 layers of spunbond fabric and 1 layer of non-microporous hydrophilic and moisture-permeable film in the middle. Because composite materials are non-porous, they can effectively block and prevent the spread of viruses. At the same time, the non-microporous film in the middle of the composite cloth is hydrophilic and can dissipate the heat emitted by the human body through the transfer of water molecules, thus having a high water vapor permeability and excellent antistatic properties, which can improve medical care. Personnel comfort.
In addition to the anti-droplet and anti-virus properties of the material itself, special processing techniques are required to meet the protective requirements of AAMI level 4 surgical gowns. Key parts of the surgical gown, such as sleeves and waistband connection points, must pass the ASTM F 1670 standard (prevention of synthetic blood penetration under certain pressure and time) and ASTM F 1671 standard (prevention of microbial penetration). Practice has proven that only using traditional sewing or ultrasonic suturing in key parts of surgical gowns cannot meet the stringent AAMI Level 4 testing requirements. Therefore, we use self-developed specially designed heat sealing equipment to sew key parts such as the sleeves of surgical gowns. All products have passed the strict testing of Nelson Laboratory ASTM PB 70 standards. In the attached picture, you can clearly see the stable and uniform effect of our heat sealing process.
Based on your company’s success in the U.S. market.Experience, what experience do you have to share?
The United States is the world’s largest disposable medical device market, accounting for more than 40% of global medical consumption. The demand for nonwovens in the U.S. medical textiles market alone continues to increase at a rate of about 5% per year. This reflects the fact that nonwovens have been used to make medical supplies for more than 30 years and have now penetrated and occupied 90% of the U.S. medical textiles market. development history. In the United States, surgical drapes and surgical gowns are one of the largest application areas of nonwovens in the medical disposable products market, accounting for approximately 1/3 of the market value of nonwovens disposable medical products, and the market share has reached 90% %. The U.S. nonwoven medical disposable products market is composed of: surgical bags and surgical drapes (30% share), central supply room sterilization wraps (21%), surgical gowns (14%), and dressing materials (12%) %), bottom pads (5%), surgical materials (6%), shoe covers/head coverings (6%), isolation gowns (6%).
In the United States, medical devices are supervised by the US FDA, and the certification system for medical protective clothing has complete standards, usage specifications, technical support and supervision agencies and mechanisms. AAMI regulates the liquid barrier performance and classification of medical products such as surgical gowns, protective clothing, and surgical drapes, and manages key parts of surgical gowns, isolation gowns, and surgical drapes that are susceptible to infection by zoning and grading. General performance indicators are not specified in AAMI PB 70. Manufacturers must provide material performance indicators themselves according to relevant standards as the basis for review, and choose FDA (U.S. Food and Drug Administration) or NFPA (National Fire Protection Association) standards for implementation depending on actual needs.
Therefore, if you want to enter the field of medical nonwovens in the United States, manufacturers must not only have sufficient production to meet the demand of this market, but also must provide medical nonwovens that meet U.S. standards and the special properties required for surgery and virus protection. Manufacturing plants must also strictly implement the US 21 CFR Part 820 quality system regulations and FDA requirements, and certify a complete set of management systems.
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