Medical institutions start a special inspection of molecular sieve equipment
China Investment Consulting Network News In recent years, the proportion of medical institutions using medical molecular sieve oxygen production equipment (hereinafter referred to as molecular sieve equipment) as the oxygen source of the centralized oxygen supply system has been increasing. In order to further strengthen supervision and ensure the safety of patients with oxygen, in accordance with the "Regulations on the Supervision and Administration of Medical Devices" and the "Notice on the Management of Medical Oxygen", the State Food and Drug Administration has decided to carry out special inspections on molecular sieve equipment and issued relevant issues a few days ago. Notice.
This inspection will be implemented in three phases: self-inspection, random inspection and supervision from April 1st to July 21st. During the self-examination phase, the provincial bureaus will notify the medical institutions within their jurisdiction that use molecular sieve equipment as a centralized oxygen source to carry out self-examination in accordance with the content determined in the "Medical Molecular Sieve Oxygen Equipment Special Inspection Medical Institution Self-examination Form". After the self-inspection is over, the medical institution shall truthfully fill in the self-inspection form and report the form and related materials to the provincial bureau of its jurisdiction.
In the spot check stage, the provincial bureaus will check the registration and operation of molecular sieve equipment based on the self-inspection reported by the medical institution and the content determined in the "Special Inspection of Medical Molecular Sieve Oxygen Equipment in the Provincial Bureau". In principle, the number of random inspection medical institutions in each province (region, city) is 10 or not less than 10% of the total number. After the verification, fill in the spot check form truthfully. When necessary, provincial-level bureaus shall conduct tests on the oxygen concentration of oxygen produced by molecular sieve equipment (hereinafter referred to as produced gas).
The notice emphasizes that during the inspection process, the regulatory authority shall verify the registration certificate of molecular sieve equipment medical device with the corresponding approval department and record the relevant conditions; check the operation and use of molecular sieve equipment, and focus on the inspection of medical institution training records, recent maintenance records, and oxygen concentration Monitoring/testing records, oxygen concentration monitoring/testing instrument calibration records, etc.; the gas produced by molecular sieve oxygen production equipment shall be sampled to determine whether it meets the oxygen concentration requirements in the standard of "General Technical Specifications for Medical Molecular Sieve Oxygen Production Equipment".
The notice pointed out that if molecular sieve equipment is not registered, it shall be handled in accordance with Article 42 of the Regulations on the Supervision and Administration of Medical Devices; if there are problems in the operation and use of molecular sieve equipment, the corresponding medical institution shall be required to rectify within a time limit and improve the corresponding work procedures. Good maintenance and calibration of testing equipment to ensure that molecular sieve oxygen production equipment is operating well; after sampling, if the oxygen concentration of the produced gas does not meet the standard requirements, the medical institution shall be ordered to make rectification within a specified time to ensure that the produced gas meets the industry standard requirements; during the rectification period, Medical institutions should stop using the corresponding molecular sieve equipment.