Disposable medical devices a class of products what

Disposable medical devices include sanitary materials, disposable medical gloves, disposable infusion sets/transfusion sets, medical textiles, surgical instruments, disposable catheters (such as urinary catheters, drainage tubes, etc.), cardiac surgical instruments, vascular surgical instruments, obstetrics instruments, anesthesia instruments, oxygen masks, and thousands of other varieties.

According to the latest definition from experts at the International Medical Devices Industry Association (IMDIA), the so-called "disposable medical devices" do not mean medical devices that are used only once, but rather medical devices that are used only on a single patient (and of course, can be used multiple times on that patient) but are discarded when they are finished. According to the new definition, many types of medical devices, including "insulin pens" (insulin injection pens) developed and marketed in recent years, can be categorized as disposable medical device products.

The use of disposable medical devices need to strictly comply with the following six systems:

1. Establishment of sterile device procurement, acceptance system, strict implementation and good records. Purchase and acceptance records should at least include: the name of the company that purchased the product, product name, model specifications, the number of products, production batch number, sterilization batch number, product expiration date and so on. According to the record should be able to trace the source of each batch of sterile instruments.

2. Procurement of sterile devices from production or business enterprises, should be verified production or business of the necessary documents (production license, product registration certificate, business license), the legal identity of the sales staff.

3. The establishment of aseptic devices after the use of destruction system. Used sterile instruments must be destroyed in accordance with the provisions of the parts and components no longer have the use of function due to disinfection and harmless disposal, and make a record.

4. If the small package has been found broken, poorly labeled sterile instruments, should immediately stop using, sealing, and timely contact with the manufacturer to be replaced.

5. If found unqualified sterile devices, should immediately stop using, sealing, and timely contact with the manufacturer to be replaced.

6. Suspected adverse events occurring in the use of sterile devices should be reported to the Provincial Medical Device Adverse Event Monitoring Center in a timely manner according to regulations.