Which countries require the use of hygienic isolation washing machines for medical textiles?
Release time:
2025/03/20
Worldwide, the safe washing of medical textiles has always been a crucial aspect of healthcare infection control. Many countries and regions have implemented legislation or industry standards requiring healthcare facilities to use hygienic isolation washers (double-door or twin-door washers). These requirements are primarily based on strict control of cross-infection risks and the promotion of industry best practices. Following are interpretations of relevant national and regional regulations:
1. United States
The United States Centers for Disease Control and Prevention (CDC), in its "Guidelines for Environmental Infection Control in Healthcare Settings," clearly recommends that the washing of medical textiles should strictly separate contaminated areas from clean areas, and double-door washers, due to their physical isolation function, are highlighted as key equipment. Furthermore, the Association of periOperative Registered Nurses (AORN) and the Occupational Safety and Health Administration (OSHA) also emphasize the necessity of such equipment. In some states, such as California, the use of double-door washers is mandated by law, while other states follow industry best practices.
2. European Union Countries
The EU standard EN 14065 (Risk analysis and biocontamination control of textile hygiene treatment, i.e., the RABC system) requires that the washing process strictly isolates contaminated and clean areas, indirectly promoting the application of double-door washers. Hospitals in Germany, France, the United Kingdom, and other countries generally adhere to this standard, and some countries enforce it through local regulations. For example, the German Hospital Hygiene Act explicitly requires that the washing of medical textiles must use isolation equipment to prevent cross-contamination.
3. Canada
Health Canada and CSA standards (such as Z314.23) recommend using double-door washers when handling infectious textiles and consider them essential equipment. Large public hospitals and private laundry companies in Canada generally adopt such equipment to meet infection control requirements.
4. Australia and New Zealand
Australian Standard AS/NZS 4146 (Hygiene Management of Laundry Processes) requires that the washing of medical textiles must achieve physical separation between contaminated and clean areas, and double-door washers are a common solution. Public hospitals and third-party laundry service providers generally use this type of equipment.
5. Brazil
Brazil's medical laundry regulations have been gradually improved in recent years. The Brazilian National Health Surveillance Agency (ANVISA) guidelines emphasize the strict separation of contaminated and clean areas during the washing of medical textiles. Although there is currently no mandatory requirement to use double-door washers, regulations clearly recommend the use of isolation equipment in high-risk areas (such as infectious disease hospitals and operating room textile washing). Furthermore, Brazilian regulations do not mention the use of tunnel washing systems, but rather tend to support equipment and technologies that effectively prevent cross-contamination.
6. Other Regions
In the Middle East, such as Saudi Arabia and the UAE, some countries have adopted European and American standards in newly built hospitals, requiring the use of isolation washers. In Asia, such as Japan and Singapore, although there are no nationwide mandatory regulations, high-end medical institutions and infectious disease hospitals often proactively adopt double-door equipment.
Key Summary
• Mandatory requirement countries: Germany, France (some regions), United States (some states), Canada (high-risk institutions).
• Recommended standard countries: EU member states (EN 14065), Australia, New Zealand, Japan, etc.
• International trend: Even in countries without mandatory requirements, the adoption of double-door washers is considered "best practice" for infection control, especially when handling surgical dressings and textiles from isolation wards.
Professional Discussion and Suggestions on the WS/T508 Standard
• Standard Lagging Issue
Currently, some countries and regions have legislated mandatory requirements for medical institutions to use double-door washing machines, but the revised version of WS/T508 has not yet made corresponding adjustments. In contrast, international practice has regarded double-door washing machines as "best practice" for infection control, while the revised draft of WS/T508 still retains the clause "If used…", indirectly leading to the use of substandard products. It is suggested to further demonstrate the rationality of this clause, which should not contradict the microbial requirement indicators.
• Standard System Connectivity
The EN 14065 standard promotes equipment upgrades through a washing process that strictly isolates contaminated and clean areas, while WS/T508 proposes zoning requirements in building layout but does not explicitly restrict equipment that cannot meet zoning requirements, resulting in insufficient enforcement of the standard. It is recommended to supplement the standard with specific equipment requirements to ensure the effective implementation of zoning requirements.
• Risk Prevention Gaps
The current standard does not adequately reflect the specific requirements for reducing infection rates. In particular, for newly built hospitals and social service institutions, if substandard equipment is used, it will be difficult to replace it in the short term, which may cause long-term patient contact with textiles exceeding microbial standards, increasing the risk of infection. It is recommended to supplement relevant scientific evidence and countermeasures to improve the risk prevention mechanism of the standard.
The above suggestions aim to improve the scientificity and practicality of the standard for reference by the standard-setting department.
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