China's regulations prohibit the reuse of disposable medical supplies and disposable public goods. However, the issue of single-use medical device (Single Use Device hereinafter referred to as SUD) reuse is a hot spot, and from time to time stimulates the nerves of the sensory person. The repeated use of one-time high-value consumables is the current clinical contradiction. Why is this happening? How do other countries do it?
1、HISTORY
Most medical devices were considered "reusable" before the 1970s. Because its products are made of glass, rubber, metal, such as probes and surgical instruments, after a little wiping, soaked in the disinfectant solution can be reused. But as manufacturers use plastics to develop new medical products, hospitals have begun to see the label "single use of medical devices" in order to distinguish them from the "reusable products" that are sold. Gradually, disposable medical devices are used by us. Well known.
2、Reasons for reuse and safety hazards
The reuse of SUD has always been one of the cost-saving measures of medical institutions, and it can also reduce the amount of medical waste generated by the use of disposable products. Some medical institutions have gradually started to identify medical devices that are marked as single-use. (SUD) for retreatment, such as angioplasty balloons and other cardiovascular catheters. The reprocessing of these consumables requires more sophisticated decontamination and disinfection procedures. With the increasing types of SUD products, the material differences are large, and the severity of clinical risks caused by reuse is very different. Some products, such as narrow tubes, fragile plastics, and electronic controls, are difficult to clean and can easily cause patient safety hazards.
The FDA Device and Radiation Health Center (CDRH) received a CDRH Medical Device (MDR) review report from August 19, 1996 to December 7, 1999, showing 464 reports (approximately 300,000 uses). Events may be due to the reuse of SUD. Of these, 219 involved multiplexing hemodialyzers. The remaining 245 reports cover approximately 70 different types of products. These data suggest that the multiplexed SUD is different from the new factory SUD failure mode. Hospital infection control surveys have difficulty identifying whether patient infections are caused by SUD reuse, but studies have shown that the performance of some products is degraded because of the biofilm produced by the multiplexed SUD.
3、Other countries' treatment of SUD
United States
The FDA believes that the development of a uniform SUD processing method is the best way to solve SUD reuse.
In 1999, the FDA convened a number of agency representatives to hold SUD reprocessing and reuse work meetings, extensively collected opinions on how SUD reprocessed and reused; and clarified the terms “reuse,” “rework,” and “resterilization”. definition. The meeting requested SUD cleaning, disinfection, and sterilization processes to verify and define the defined standards for reprocessable products, and establish “high, medium, and low-risk SUD” classification standards and catalogues.
On December 14, 1999, the US FDA convened a meeting of SUD reprocessing stakeholders to report on the findings and proposed policies for this complex issue.
In February 2000, the FDA issued two drafts of guidance documents on the reuse of SUD. One is a risk rating recommendation for various multiplexed SUDs. The other is a recommendation for possible risks and management requirements for various multiplexed SUDs. The public feedback on the two documents was analyzed. The opinions collected tend to support all organizations (whether third-party processing companies or hospitals) must be multiplexed according to the same standards. According to everyone's suggestion, the FDA announced a draft of the new revised guidelines, clarifying the current SUD classification system and corresponding enforcement focus.
Australia
In August 2003, Australia enacted regulations for the reprocessing of disposable medical devices. Similar to the United States, all Australian reprocessing parties (third parties, hospitals, or manufacturers) must comply with the Medical Products Authority (TGA) for medical device manufacturers. Requirements. Due to the high cost and technical standards required for the conformity assessment of the standard, the hospital has stopped reprocessing the disposable medical device itself.
Germany
After 2000, German law no longer distinguishes between single-use and multi-use products, because the current interpretation of the meaning of “one-off” is different. It is generally considered that “one-time” means that the product is scrapped after one use. It is not reusable, and there is also a view that “one-time” means that it can only be used once in a medical institution, and can be reused if necessary after recycling.
In 2002, Germany introduced a new version of the Medical Supplies Amendment Act, which included the re-use of disposable medical devices in national regulations, and clarified that the repeated use of disposable medical devices refers to those low-bacteria or sterile disposable medical devices. Reuse must undergo rigorous screening, cleaning, disinfection, testing and other procedures to ensure re-use safety; which products can be re-processed by the re-processor to confirm and provide validation data for inspection, but only certified, there are Only qualified units can reprocess disposable medical products and conduct regular rigorous inspections.
Canada
Health Canada has made it clear that the reuse of SUD significantly increases the risk of cross-contamination of patients and increases the rate of failure due to the adverse effects of rework caused by SUD materials or precision structural features. Therefore, the reuse of SUD involves the safety and legality of patients, and should be given high attention on the legal and ethical level. The Department of Health's registered single-use medical device (SUD) can only be used once during a single treatment and discarded after use. The hospital is fully responsible for the occurrence of adverse events in the reuse of SUD.
Because the Canadian FDA's Medical Device Supervision Regulations emphasize that it does not apply to reprocessed SUDs, Health Canada's “SUD does not recommend reuse” is only “views, attitudes, and recommendations” rather than legislation, and there are no ready-made SUDs. Reprocessing standards, reuse can not be eliminated, management blind spots. The health departments of the provinces of Canada have successively developed their own local policies for SUD reprocessing. The policy tends to be that SUD is handled by a third-party reprocessing company rather than the management model that the hospital itself handles. However, because Canada does not have a regulated third-party reprocessing enterprise, and third-party processing companies in the United States sell back to the Canadian hospital's reprocessing SUD, there is no safety data provided to the Canadian Ministry of Health, management difficulties, legislation is imminent.
At present, there are three provincial policies in Canada's local policies that stipulate that no further SUDs can be processed. Six provinces require third-party processing to process SUD. There are also three provinces that require hospitals to reprocess low-risk SUDs. However, medium and high risk SUDs need to be commissioned by third parties for processing. A provincial regulation may not deal with any medium or high risk SUD. The two provinces are studying the development of a SUD reprocessing policy. Canadian officials and MEDEC (Canada Medical Technology Industry Association) are still actively facing the status quo, trying to improve the unified SUD management standards.
Japan
There are no relevant regulations at present, but the survey shows that the reuse of disposable medical devices is more common. A survey in 2003 found that 80-90% of hospitals have repeated use. However, Japan stipulates that if the product instruction manual has “No Reuse” or the outer packaging is marked “One-time Use”, it shall not be reused. The hospital's reusable behavior is considered to be “off-label use”, resulting in a medical malpractice hospital to pay full responsibility.
China
Many departments of the Ministry of Health of China have issued a document explicitly stressing that medical institutions must not reuse medical devices that are used once.
However, high-value consumables are expensive. If the reuse is forbidden, it will bring a heavy economic burden to the patients, resulting in waste of health resources and environmental protection. Therefore, the implementation of the Regulations on the Supervision and Administration of Medical Devices began on June 1, 2014: "The catalogue of disposable medical devices was formulated, adjusted and announced by the Food and Drug Administration of the State Council in conjunction with the State Council's Health and Family Planning Department. Reuse can ensure safe and effective medical devices, not included in the single-use medical device catalogue. For medical devices that are safe and effective due to improved design, production process, disinfection and sterilization technology, it should be adjusted. A list of disposable medical devices."
other
In other countries' SUD reuse policies, SUD reprocessing legislation and the status quo vary greatly. Most countries prohibit the reprocessing of SUD. Some countries have developed SUD reprocessing quality standards and provide technical guidance for reprocessing.
The EU allows SUD to be reprocessed, but the practices of member states vary. It is prohibited to multiplex the SUD in France. In New Zealand, regulators require disposable medical device reprocessing companies to meet US 510(K), CE certification or Australian TGA requirements for medical device sales. The SUD reprocessing in Sweden must meet the manufacturer's standards, but the reuse must seek patient consent and allow for reuse after signing the informed consent form. In the UK, the official recommendation is not to reprocess and reuse SUD, warning of potential safety issues. There are no relevant regulations in Korea, but the government has maintained interest and supervision in this area. There are currently no relevant national regulations in India, and some private hospitals have established separate regulations for disposable medical devices.
4、Ending
Reusing SUDs carries the risk of infection and performance damage, but huge economic benefits lead to the existence of reuse. Comparing the benefits of multiplexing SUD with the possible trade-offs, there is still no clear decision-making conclusion. Throughout the international SUD market, the management model is also very different. Through professional institutions and official research, it is considered unreasonable whether the reuse can be based on the standard of “blocking or releasing” without losing safety and effectiveness. Regulatory reprocessing and sound regulatory policies are extremely important. The reusable SUD types and reprocessing standard methods are determined according to the risk category. For example, it is a good choice to not only process the precision structure or the SUD that is difficult to clean and disinfect. Since the reuse management of SUD involves the two major management departments of medical and medical equipment, how to coordinate and multi-party evidence, we look forward to active discussion and policy guidance at the national level.
