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Disposable medical devices? To see the world do |
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 clicks: 465  Date: 2018-11-14 |
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Our country's laws and regulations stipulate that disposable medical supplies and disposable public goods should not be reused. However, the reuse of Single Use Device (SUD) has become a hot issue, which stimulates the sensory nerve from time to time. Among them, the reuse of disposable high-value consumables is the current clinical contradiction. Why does this phenomenon exist? How do other countries do that?
I. Historical Development
Before 1970, most medical devices were considered "reusable". Because its products are made of glass, rubber, metal materials, such as probes and surgical instruments, after a little wiping, soaked in disinfection solution can be reused. But as manufacturers develop new medical products such as plastics, hospitals begin to see the label "single-use medical devices" in order to distinguish it from the "reusable products" sold. Gradually, disposable medical devices are well known to us.
Reasons for reuse and potential safety hazards
For a long time, the reuse of SUD is one of the cost-saving measures for medical institutions. It can also reduce the amount of medical waste generated by disposable products. For some reasons, some medical institutions have gradually begun to reprocess medical devices (SUD) labeled as disposable use, such as angioplasty balloons and other cardiovascular catheters. The reprocessing of these consumables requires more complex decontamination and disinfection procedures. With the increasing types of SUD products and material differences, the severity of clinical risk caused by reuse varies greatly. Some products, such as long and narrow pipelines, fragile plastics, electronic controls, are difficult to clean, which can easily cause potential safety hazards for patients.
From August 19, 1996 to December 7, 1999, the FDA Devices and Radiation Health Center (CDRH) received CDRH medical device (MDR) review reports indicating that adverse events in 464 reports (about 300,000 use times) may be due to the reuse of SUDs. Of these, 219 involved reuse of hemodialysis devices. The remaining 245 reports cover about 70 different types of products. These data suggest that the failure modes of reused SUDs are different from those of newly manufactured SUDs. Nosocomial infection control surveys are difficult to identify whether a patient's infection is caused by SUD reuse, but studies have shown that the reason for the performance deterioration of some products is that the reused SUD produces biofilms.
III. National Approaches to SUD
U.S.A
FDA believes that the best way to solve SUD reuse is to establish a unified standard for SUD processing methods.
In 1999, the FDA convened a number of agency representatives to convene SUD reprocessing and reuse workshops, and widely collected opinions on how to reprocess and reuse SUD. The definitions of terms "reuse", "reprocessing" and "re-sterilization" were clarified. The meeting requested that the process of cleaning, disinfection and sterilization of SUD be validated and the definition criteria of reprocessable products be determined, and the classification criteria and catalogues of "high, medium and low-risk SUD" be established.
On December 14, 1999, the FDA convened a meeting of SUD reprocessing stakeholders to inform them of the findings of the study on this complex issue and the policy to be implemented.
In February 2000, FDA issued two discussion papers on the reuse of SUD. One is the risk level proposals for various reusable SUDs. The other is suggestions on the possible risks and management requirements of various reusable SUDs. The public feedback of the two documents was analyzed, and the collected opinions tended to support that all institutions (whether third-party processing companies or hospitals) must carry out SUD reuse according to the same standards. According to your suggestions, the FDA released the draft guiding principles for the new adjustment, clarifying the current SUD classification system and the corresponding law enforcement priorities.
Australia
Australia enacted a disposable medical device reprocessing regulation in August 2003. Similar to the United States, all Australian reprocessing parties (third parties, hospitals, or manufacturers) must meet the requirements of the Medical Goods Authority (TGA) for medical device manufacturers. Because of the high cost and technical requirements of the conformity assessment, hospitals have stopped self-treatment of disposable medical devices.
Germany
After 2000, German law no longer distinguishes between one-time use and multiple use of products, because there are different interpretations of the meaning of "one-time". It is generally believed that "one-time" refers to products that are discarded after one use and cannot be reused. It is also believed that "one-time" refers to only one use in medical institutions, if recycling is processed as necessary. It can be reused.
In 2002, Germany promulgated a new version of the Medical Supplies Amendment Act, which included the reuse of disposable medical devices in national laws and regulations. It was clear that the reuse of disposable medical devices refers specifically to those disposable medical devices with low pathogenicity or sterility. The reuse of disposable medical devices must undergo strict screening, cleaning, disinfection, testing and other procedures to ensure the safety of reuse. For reprocessing, the reprocessor shall confirm and provide validity confirmation data for inspection by itself, but only certified units with qualifications can reprocess disposable medical products and carry out strict inspection regularly.
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