Chang-Hong Whitney10.21.06
Regional agencies also have been participating in these types of efforts in recent years. Shenzhen’s FDA was the first agency in the country to draft and implement guidance, Shenzhen City Medical Equipment Usage Management Procedure, which details the requirements that medical providers must follow in monitoring the quality and performance of medical devices as well as reporting adverse incidents in the healthcare facilities.
This procedure, effective as of Oct. 1, 2006, requires hospitals that use Class II and III products to have a medical equipment management department and written procedures for all levels of a hospital from procurement to usage reports to incident reporting—as well as disposable procedures for medical waste and single-use items. Incoming inspection, storage, inventory control and tracking systems are clearly defined. Products in high-risk categories (eg, implantable devices, invasive equipment and devices) are controlled more closely with detailed records and signatures of responsible personnel.