What are the products of a single-use medical device?


Disposable medical equipment covers sanitary materials, […]

Disposable medical equipment covers sanitary materials, disposable medical gloves, disposable infusion sets/blood transfusion sets, medical textiles, surgical instruments, disposable catheters (such as catheters, drainage tubes, etc.), cardiology surgical instruments, blood vessels Thousands of varieties such as surgical instruments, obstetric instruments, anesthesia instruments, and oxygen masks.
According to the latest interpretation of the experts of the International Medical Device Industry Association, the so-called "disposable medical device" does not refer to a medical device that is used only once, but refers to only one patient (of course, it can be used multiple times), but Medical device products that are discarded after use. According to this new definition, many kinds of medical devices, including the "insulin pen" (insulin injection pen) developed and marketed in recent years, can be classified as disposable medical device products.
The use of disposable medical devices needs to strictly abide by the following six systems:

1. Establish a sterile equipment procurement and acceptance system, strictly implement it and keep records. The purchase acceptance record should at least include: the name of the company purchasing the product, product name, model specification, product quantity, production batch number, sterilization batch number, product expiration date, etc. According to the records, the source of purchase of each batch of sterile instruments should be traced.
2. Purchasing sterile instruments from a production or operation enterprise shall verify the necessary documents (production license, product registration certificate, and operation license) of the production or enterprise and the legal identity of the sales personnel.
3. Establish a system for the destruction of sterile instruments after use. The used sterile instruments must be destroyed in accordance with regulations, and the parts and components that no longer have the function of use have been disinfected and harmlessly treated, and records should be kept.
4. If a sterile instrument with a damaged small package and unclear label is found, immediately stop using it, seal it up, and contact the manufacturer in time to replace it.
5. If unqualified sterile instruments are found, they should immediately stop using them, seal them up, and contact the manufacturer in time to replace them.
6. When a suspicious adverse event occurs when using sterile instruments, it should be reported to the Provincial Medical Device Adverse Event Monitoring Center in a timely manner as required.