Medical institutions that use expired medical devices will be punished in accordance with Article 66, paragraph 1, item (three) of the "Regulations on the Supervision and Administration of Medical Devices": details are as follows:
Article 66 If any of the following circumstances occurs, the food and drug supervision and administration department of the people's government at or above the county level shall order correction and confiscate the medical devices illegally produced, operated or used; if the value of the medical devices illegally produced, operated or used is less than 10,000 yuan, A fine of not less than 20,000 yuan but not more than 50,000 yuan shall be imposed; if the value of the goods exceeds 10,000 yuan, a fine of not less than 5 times but not more than 10 times of the value of the goods shall be imposed; if the circumstances are serious, the company shall be ordered to suspend production and business until the original issuing department revokes the medical certificate. Device registration certificate, medical device production license, and medical device business license:
(3) Operating or using medical devices that do not have certification documents, expired, invalid, or obsolete medical devices, or use medical devices that have not been registered in accordance with the law. Medical devices;
The use of expired medical devices by medical institutions shall be governed by Article 12 of the current "Measures for the Supervision and Administration of the Use of Medical Devices" "Medical device users shall not purchase and use medical devices that have not been registered or prepared in accordance with the law." "Medical devices without certification documents and expired, invalid or obsolete medical devices" and Article 40 of the "Regulations on the Supervision and Administration of Medical Devices" "Medical device business enterprises and user units shall not operate or use medical devices that are not registered in accordance with the law, have no certification documents, expired, invalid or obsolete medical devices" "Invalid and obsolete medical devices" shall be investigated and dealt with in accordance with the provisions of Article 27 (2) of the "Regulations on the Supervision and Administration of the Use of Medical Devices" and Article 66 (3) of the "Regulations on the Supervision and Administration of Medical Devices" shall be punished under this provision. However, there is a view that the investigation and punishment of illegal use of expired medical devices by medical institutions must have evidence to prove that the user unit has used expired medical devices on clinical patients during the diagnosis and treatment process.
The author does not agree with this view. The use of expired medical devices by medical institutions should not be limited to the use of clinical patients or harmful consequences, but should include the "Measures for the Supervision and Management of the Use of Medical Devices" For the entire diagnosis and treatment service process including the procurement, acceptance, storage, use, maintenance and management of medical devices, as long as law enforcement officers discover expired medical devices at the use site, diagnosis and treatment site and drug warehouse, and the medical institution has expired medical devices. If it fails to be cleaned, stored separately or destroyed in a timely manner after it expires, it should be considered as a potential hazard to human health, and the use of expired medical devices should be deemed to have occurred. However, when investigating such illegal cases, what should be paid attention to is whether the expired medical devices stored at the inspection site are mixed with qualified medical devices and whether there are expired product warning signs. If expired medical devices are stored separately and have warning signs, they should not be investigated. If expired medical devices have been opened and used on clinical patients or have caused harmful consequences, they should be dealt with seriously. On the contrary, failure to investigate and punish the medical institution on the grounds that it was not discovered on the spot that the expired medical device was used on the patient's body will not only indulge in the illegal use of expired medical devices, but also lead to the inability to regulate the use of expired and expired medical devices that are not registered in accordance with the law and are not qualified. The investigation and handling of similar cases such as certification documents and obsolete medical devices is not the original intention of the legislation. Just imagine, what is the probability that law enforcement officers will discover at the scene that the user unit is using expired medical devices in the bodies of clinical patients.