Cases of improperly reusing single-use medical materials have not stopped more than 10 years ago. In 2018, there were again a number of medical institutions in Taiwan that illegally dealt with single-use medical materials. That is to say, the medical equipment marked as disposable medical materials on the imitation list is re-sterilized, sterilized and reused, and the "second-hand", "third-hand" or multi-hand medical materials are used without the patient's knowledge. Possible risk of cross contamination. As soon as the incident broke out, the Ministry of Health and Welfare immediately responded: "In order to ensure the safety of patients and the rights and interests of patients, single-use medical materials should be based on the principle of one-time use and disposal."
However, surprisingly, the response was in More than a year after the incident was revealed, there was a sharp turn in policy! At the end of last year, the Ministry of Health and Welfare announced that it would loosen relevant regulations and open up photo retouching medical institutions to allow some single-use medical materials to be cleaned, disinfected or sterilized, and repackaged for reuse by the next patient. From January 1, 2011 to December 31, 2012, the transition period for the implementation of the draft is open, and applications from various medical institutions are open to the Ministry of Health and Welfare.
Starting from 20113, the unit that reprocesses a single medical material will be regarded as a manufacturer, and the unit that has obtained the approval of the Ministry of Health and Welfare of Taiwan and has obtained the GMP license and the license for reprocessing equipment can only reprocess. Reprocessing a single medical material is quietly legal 3 years transition period During the 3-year transition period, for a single reprocessing of medical materials, each hospital only needs to set up a special committee to be responsible for formulating and implementing management matters such as risk, functional assessment, and auditing of reprocessing medical materials. However, the problem is: each medical institution is not qualified as a medical material manufacturer,