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        The pressure of big mountain! Enterprise medical devices need to bear the adverse event monitoring
        Author: AST   Time:2013-6-7 9:30:11

          19 journalists from the State Administration of food and drug administration was informed, "standard" quality management of medical equipment business now beginning. According to the norms of business enterprise, medical device shall be equipped with full-time or part-time staff, bear the medical device adverse event monitoring and reporting work shall be carried out on the adverse events, the food and Drug Administration of medical device adverse event monitoring mechanism, survey cooperate.

          According to the introduction, the introduction of norms aimed at strengthening medical quality management, standardize the medical equipment management behavior, safeguard public safety and effective. Specification requirements, enterprises should establish and perfect the medical equipment quality management system according to the standard, effective quality control measures is taken in the link of medical equipment procurement, acceptance, storage, transportation, sale, after sale service, guarantee the quality and safety management in the process of.

          According to the specification, retail enterprises should be checked periodically for medical equipment retail display, storage, focus on examination of dismantling zero medical instruments and nearly valid medical devices. Found a medical device quality question should promptly remove the cabinet, to stop selling, by quality management personnel recognised and dealt with, and keep the relevant records.

          In the procurement of medical equipment, specification explicitly enterprises shall establish a record of the purchase. Records shall be name, list the medical equipment specification (model), registration or filing document number, quantity, unit price, unit, the amount of supplier, purchase date, etc.. Acceptance of medical devices need to be refrigerated, frozen, should focus on examination of the control state of the mode of transport and transport process of the temperature record, the transportation time, temperature and the arrival of quality records shall be rejected, do not meet the requirements of temperature.

          In the after sale service, specification requirements, enterprises should according to the purchasing contract with the supplier quality after sale service agreement responsibility and responsibility, ensure the safe use of medical customer service. In addition, enterprises should also assist the medical device production enterprise in performing their duty of recall, and timely communication, in accordance with the recall plan request feedback medical device recall information, control and recover the medical quality of the existing security risks, and the establishment of medical device recall records.