Can disposable medical devices be reused?

Summary:

At the beginning of this year, the State Council issued the "Notice on the Import of Protective Clothing and Other Related Issues during the Epidemic Period" (hereinafter referred to as the "Notice") by the Medical Material Assurance Group of the Joint Prevention and Control Mechanism for the Joint Prevention and Control Mechanism of the Novel Coronavirus Infection with Pneumonia.

Release Date:

Oct 19,2021

At the beginning of this year, the State Council issued the "Notice on the Import of Protective Clothing and Other Related Issues during the Epidemic Period" (hereinafter referred to as the "Notice") by the Medical Material Assurance Group of the Joint Prevention and Control Mechanism for the Joint Prevention and Control Mechanism of the Novel Coronavirus Infection with Pneumonia. The "Notice" clarified that in order to meet the needs of epidemic prevention and control, enterprises can urgently import products that meet the standards of medical protective clothing in Japan, the United States and Europe, and enterprises can provide overseas medical device listing certification documents and inspection reports, and make product quality and safety commitments. Emergency use; in an emergency situation where the supply of disposable medical goggles is insufficient, they can be reused after strict disinfection. The "Notice" specifically pointed out that the above measures are temporary emergency measures during the epidemic prevention and control period and will be lifted automatically after the epidemic is over.

In this new crown pneumonia epidemic, there has been a shortage of epidemic prevention materials including various medical devices. The repeated use of disposable medical devices is purely a helpless and emergency action during the epidemic.

So, can disposable medical devices, so-called disposable devices, be re-sterilized and reused? In fact, this is a topic that has been controversial for more than 20 years. China's "Regulations on the Supervision and Administration of Medical Devices" stipulates: “Medical institutions shall not reuse single-use medical devices. "But in reality, one-time high-value medical consumables cannot be charged at their own prices, resulting in high medical costs, so reuse has become the choice of some hospitals.

Before the 1970s, most medical equipment was considered "reusable". Because its products are made of glass, rubber, and metal materials, such as probes and surgical instruments, they can be reused after a little wipe, soaked in a disinfectant solution. However, as manufacturers use plastics to develop new medical products, hospitals have begun to see medical devices marked with a "single use medical device" logo to distinguish them from the sold "reusable products". Gradually, single-use medical devices (SUD) became known to us.

For a long time, the reuse of SUD has been one of the cost-saving measures for medical institutions, and it can also reduce the amount of medical waste generated by the use of disposable products. For other reasons, some medical institutions have gradually begun to label them as single-use Of medical devices, such as angioplasty balloons and other cardiovascular catheters. The reprocessing of these consumables requires more complicated decontamination and disinfection procedures. However, as the types of SUD products continue to increase, the materials vary greatly, and the clinical risks caused by reuse continue to increase. Therefore, the Ministry of Health of our country has issued documents clearly stressing that medical institutions shall not reuse single-use medical devices.

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