How to ensure the safety, stability, effectiveness and traceability of implantable medical orthopedic devices, and protect the legitimate rights and interests of patients with equipment?

1. Improve laws and regulations

At present, no matter at the national level or in various regions, there are no special laws and regulations for implantable medical orthopedic devices. Therefore, there is an urgent need to improve the top-level design and formulate national and local laws and regulations for implantable medical orthopedic devices. In particular, it is necessary to develop a recycling system for implanted devices that have been taken out of patients and used to fill the legal gaps Regulatory authorities have laws to follow. At the same time, medical institutions should strengthen system construction, formulate effective systems covering procurement, acceptance, use, follow-up visits, adverse event monitoring, destruction and other links, and use the system to improve the management level of implantable orthopedic devices.

2. Straighten out internal mechanisms

Implantable medical orthopedic devices are often more expensive, and some doctors are driven by interests to replace the procurement, acceptance and other work that should be the responsibility of hospital equipment or device departments. In this regard, the health and drug supervision departments should form a joint supervision and urge the hospital to rationalize the internal management mechanism. The hospital equipment department or equipment department shall be responsible for liaison, procurement, inspection and acceptance, and other departments and individuals shall not purchase without authorization.

3. Acceptance system

The uncertainty of the specifications and quantity of implantable orthopedic devices used in the operation has objectively caused more varieties and quantities of orthopedic implantable medical devices to enter the hospital than planned purchases. This requires the hospital to pre-accept the full set of implantable medical orthopedic devices supplied by the supplier to ensure the legality of the product.

4. Leave marks during use

Implantable medical orthopedic devices are high-risk products. There is no real and complete record of use. Once an adverse medical device event or medical accident occurs, it cannot be traced back. Therefore, the use record is as important as the pre-acceptance record, which is an important basis for post-operative follow-up monitoring of implantable medical orthopedic devices.

5. Eliminate repeated use

Hospitals should properly dispose of used implanted medical orthopedic devices, and destroying them according to regulations is an effective measure to prevent such devices from being reused. The hospital shall faithfully record and record the orthopedic implanted medical devices removed from the patient. After the surgeon and the nurse nurse sign the record sheet, the surgical nurse shall single out the implanted medical orthopedic device together with the records and hand it over to the medical The waste management personnel shall be signed by the management personnel on the record sheet. Record a single triple, one is retained by the Department of Orthopedics, one is reported to the Device Department for filing, and one is handed over to medical waste management personnel.