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Página inicialInformações sobre a indústriaSee how countries around the world regulate disposable medical devices

See how countries around the world regulate disposable medical devices

2019-01-28

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?

First, historical development

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.

Second, the reasons for repeated use and security risks

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.