China's regulations on disposable medical supplies and disposable public goods are not required to reuse. But a single use of medical equipment (Single Use Device hereinafter referred to as SUD) reuse problem as a hot spot, from time to time to stimulate the sensory nerve. Which re-use of high-value one-time supplies is the current clinical contradictions. Why is there such a phenomenon? What other countries do?
First, the historical development
By the 1970s, most medical devices were considered "reusable". Because of its products are made of glass, rubber, metal materials, such as probes and surgical instruments, a little wipe, soaked in disinfection solution can be reused after treatment. But with the use of plastic manufacturers to develop new medical products, the hospital began to see marked "single use of medical equipment" logo, and sales of "reusable products" distinction, gradually, one-time use of medical equipment by our Well known.
Second, the reasons for re-use and security risks
Recycling of SUD has been one of the cost-saving measures of medical institutions, and it has also been possible to reduce the amount of medical waste generated by disposable products. For some reasons, some medical institutions have gradually begun to use medical devices identified as disposable (SUD), such as angioplasty balloon and other cardiovascular catheters. The reprocessing of these consumables requires more complex decontamination and disinfection procedures. With the SUD product type increasing, material differences, multiple re-caused by the severity of clinical risk there is a big difference. Some products, such as narrow pipelines, fragile plastic, electronic controls, it is difficult to clean, easily lead to patient safety risks.
The US FDA Equipment and Radiation Health Center (CDRH) received a CDRH Medical Device (MDR) review report from August 19, 1996 to December 7, 1996, showing 464 reports (about 300,000 times in use) The event may be due to the reuse of the SUD. Of which 219 were involved in multiplexed hemodialyzers. The remaining 245 reports covered about 70 different types of products. These data suggest that the multiplexed SUD is different from the newly created SUD failure mode. It is difficult to identify whether the patient's infection is caused by SUD reuse, but the study shows that the performance of some products is due to the fact that the multiplexed SUD produces a biofilm.
Third, the countries of the SUD approach
United States
FDA believes that the development of a unified SUD processing method is the best way to solve SUD reuse.
In 1999, the FDA convened a number of agency representatives to convene SUD re-processing and reuse work conference, extensive collection of SUD how to re-processing and re-use of the views; clear the terms "re-use", "re-processing" and "re-sterilization" definition. The meeting requires SUD cleaning, disinfection, sterilization process to verify and determine the reprocessing of the product can be defined standards, the establishment of "high, medium and low risk SUD" classification standards and catalog.
December 14, 1999 US FDA convened a meeting of SUD re-processing stakeholders to inform the findings of the complex issues and the proposed implementation of the policy.
In February 2000, the FDA issued two guidance documents for the reuse of SUD. One is the risk rating of various reuse SUDs. The other is the possible risk of various reuse SUDs and management requirements. And the public feedback on the two documents was analyzed, and the views collected tend to support all agencies (whether third parties to deal with companies or hospitals) must be in accordance with the same standards for SUD reuse. According to our recommendations, the FDA has published a draft of the new guidelines for clarification, clarifying the current SUD classification system and corresponding enforcement priorities.
Australia
Australia has enacted regulations for disposable medical device reprocessing in August 2003. Similar to the United States, all Australian reprocessors (third parties, hospitals, or producers) must comply with the Medical Products Authority (TGA) for medical device manufacturers The request. As the standard compliance assessment of the cost and technical standards require a higher, the hospital has stopped self-treatment of disposable medical devices.
Germany
After 2000, German law no longer distinguish between disposable and multiple use of the product, because the current "one-time" meaning to explain the difference is generally considered "one-time" refers to the product after a use of scrapped, Can not be reused, there are views that "one-time" refers to the medical institutions can only be used once, if the recovery of the necessary treatment can be reused.
In 2002, Germany introduced a new version of the "Pharmaceutical Products Amendment Act", the repeated use of disposable medical devices included in the national regulations, a clear disposable medical device re-use, especially those low-grade bacteria or sterile disposable medical equipment, its Re-use must undergo a rigorous screening, cleaning, disinfection, testing and other procedures to ensure the safety of re-use; which products can be re-processed by the reprocessor to confirm and provide validation data for inspection, but only certified, Qualified units can be a one-time medical products for re-processing and regular rigorous inspection.
Canada
The Canadian Department of Health has made it clear that multiplexed SUD significantly increases the risk of cross-infection and increases the failure rate due to the adverse effects of reprocessing caused by SUD materials or precision structural features. Therefore, reuse of SUD involves the patient's safety and legitimacy, should be in the legal and moral level to give high attention. The Canadian Department of Health provides a one-time use of medical equipment (SUD), which can only be used once in a single course of treatment and discarded after use. The hospital is responsible for the adverse events of the multiplexing SUD.
Since the Canadian FDA's Medical Device Supervision Regulations emphasize that it does not apply to reprocessing the SUD, the Canadian Department of Health is only "opinion, attitude and advice" rather than legislation, and there is no ready-made SUD Re-processing standards, reuse can not be eliminated, the management of blind spots. The health departments of the Canadian provinces have developed their own SUD re-processing local policies. Policy tends to deal with SUD by a third-party re-processing company, rather than a management model that the hospital handles. However, due to Canada does not regulate the third-party re-processing enterprises, and in the United States third-party processing enterprises to return to the Canadian hospital re-processing SUD, did not provide security data to the Canadian Ministry of Health, management difficulties, legislation is imminent.
At present, Canada has implemented local policies that have three provincial policies that require no further processing of any SUDs. Six provinces require a third party to process the SUD again. There are three provinces that require hospitals to deal with low-risk SUD. However, high-risk SUDs need to be commissioned by third-party processing. A province does not have to deal with any medium or high risk SUD. Two provinces are discussing the development of SUD re-processing policies. Canadian officials and MEDEC (Canadian Medical Technology Industry Association) are still actively facing the status quo, trying to improve the unified SUD management standards.
Japan
There are no relevant laws and regulations, but the survey shows that disposable medical device reuse is more common in 2003, a survey found 80-90% of the hospital has repeated use of the phenomenon. However, Japanese regulations: If the product manual has "no reuse", or packaging mark "one-time use", may not be reused. The hospital's multiplexing behavior is considered "off-label use", resulting in a medical malpractice hospital.
China
China's Ministry of Health issued a number of departments clearly stressed that medical institutions on the use of disposable medical devices shall not be reused.
However, high value supplies are expensive, if the prohibition of reuse, will give patients a heavy financial burden, resulting in waste of health resources, is not conducive to environmental protection. Therefore, in June 1, 2014 from the implementation of the "Medical Device Supervision and Management Ordinance," made a partial explanation: "in a one-time use of medical devices by the State Council Food and Drug Administration in conjunction with the State Council department in charge of health to develop, adjust and publish . Repeated use can ensure safe and effective medical equipment, not included in the disposable medical device directory. For the design, production process, disinfection and sterilization technology to improve the use of repeated use can ensure safe and effective medical equipment, should be adjusted A list of disposable medical devices. "
other
SUD reuse policy in other countries, SUD re-processing legislation and the status of great differences. Most countries prohibit the re-processing of SUDs. Some countries have developed SUD reprocessing quality standards for enforcement and provide technical guidance on reprocessing.
The EU allows the reuse of SUDs, but the practice varies from member to member. The reuse of SUD in France is illegal. 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 re-processing in Sweden must meet the manufacturer's standard, but the reuse must be approved by the patient, allowing the reuse of the informed consent form. In the UK, it is advisable not to re-use the SUD to warn of potential security problems. South Korea has no relevant laws and regulations, but the government has maintained interest in the field and the possibility of regulation. India is currently no relevant national laws and regulations, some private hospitals to develop their own disposable medical device multiplexing regulations.
Fourth, concluding remarks
Multiplexing SUD has the risk of infection and performance damage, but the huge economic benefits lead to reuse of available space. There is no clear decision-making conclusion on the benefits of the reuse of SUDs and the possible trade-offs. Throughout the international SUD market, the management model is also very different. Through professional institutions and official research that can reuse should not lose the safety and effectiveness of the standard, the policy "blocking or put" the two extremes are unwise. Regulatory re-processing and sound regulatory policies are extremely important. It is a good choice to determine the reprocessable SUD type and reprocessing standard method according to the risk category, such as the requirement that the SUD not only for precision structures or difficult to clean and disinfect. As SUD reuse management involves medical and health care and medical equipment management, how to coordinate and multi-evidence-based, look forward to the active discussion at the national level and policy guidance.