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The consequences of overdue use of medical devices are very serious

The consequences of overdue use of medical devices are very serious

  • Categories:Industry News
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  • Time of issue:2021-06-24
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(Summary description)本报讯(记者王岚通讯员夏静励彤)日常生活中,有些设施设备,虽然有明确的使用期限,但因为各种原因,超期使用的也不少。但这样的情况,如果出现在医疗器械上,那就是违法行为,后果有点严重。近日,海曙区市场监管局在医疗机构专项检查中,就查处了这样一起案件。  执法人员在一中医门诊部检查时,发现在用的一批名为特定电磁波治疗器的医疗器械超出使用期限却仍在正常使用,违反了刚修订的《医疗器械监督管理条例》。这是新修

The consequences of overdue use of medical devices are very serious

(Summary description)本报讯(记者王岚通讯员夏静励彤)日常生活中,有些设施设备,虽然有明确的使用期限,但因为各种原因,超期使用的也不少。但这样的情况,如果出现在医疗器械上,那就是违法行为,后果有点严重。近日,海曙区市场监管局在医疗机构专项检查中,就查处了这样一起案件。  执法人员在一中医门诊部检查时,发现在用的一批名为特定电磁波治疗器的医疗器械超出使用期限却仍在正常使用,违反了刚修订的《医疗器械监督管理条例》。这是新修

  • Categories:Industry News
  • Author:
  • Origin:
  • Time of issue:2021-06-24
  • Views:0
Information
Our news (reporter Wang Lan correspondent Xia Jing Litong) in daily life, although some facilities and equipment have a clear service life, many of them are overdue for various reasons. However, if such a situation occurs on medical devices, it is an illegal act, and the consequences are a little serious. Recently, Haishu district market supervision bureau investigated and dealt with such a case in the special inspection of medical institutions.
During an inspection at a TCM outpatient department, law enforcement officers found that a batch of medical devices called specific electromagnetic wave therapeutic devices in use were still in normal use beyond the service life, in violation of the newly revised regulations on the supervision and administration of medical devices. This is the first case of overdue use of medical devices seized by Haishu since the implementation of the newly revised regulations on the supervision and administration of medical devices on June 1.
During the on-site inspection, the law enforcement personnel noticed that the specific electromagnetic wave therapeutic device being used in the TCM outpatient department is a class II medical device, which is mainly used for anti-inflammatory, analgesic, antipruritic and dredging microcirculation channels after acupuncture and physiotherapy. The appearance of the device is mottled, old and used for a long time. Through further inspection, it is found that the service life of the equipment logo is 3 years. There are 13 specific electromagnetic wave therapists in use in four clinics in the outpatient department. The product production dates are "March 1, 2017" and "February 8, 2017", which have exceeded the service life of the logo. According to the regulations, the medical devices should be stopped and the equipment should be updated.
However, when communicating with the parties, the law enforcement officers found that the person in charge and the clinic doctors had the dangerous idea that the medical devices were different from drugs and the undamaged equipment had little problem with the extended use.
It is understood that medical devices such as specific electromagnetic wave therapeutic devices mainly transmit energy through electromagnetic radiation. After exceeding the service life, there may be problems such as heating plate damage, coil aging and trace element oxidation, which will not achieve the therapeutic effect, but destroy the original balance of the human body. If the fuselage is damaged, there will be problems of heating and leakage, which has great potential safety hazards.
The behavior of the TCM outpatient department is suspected of violating the relevant provisions of the regulations on the supervision and administration of medical devices. Law enforcement officers detained 13 treatment equipment involved according to law on the spot. At present, the case is under further investigation.
"The inspection, inspection, calibration, maintenance and maintenance of medical equipment are to ensure that the medical equipment is in good condition within its service life and ensure the service quality." The relevant person in charge of Haishu District Market Supervision Bureau said.
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本报讯(记者王岚通讯员夏静励彤)日常生活中,有些设施设备,虽然有明确的使用期限,但因为各种原因,超期使用的也不少。但这样的情况,如果出现在医疗器械上,那就是违法行为,后果有点严重。近日,海曙区市场监管局在医疗机构专项检查中,就查处了这样一起案件。  执法人员在一中医门诊部检查时,发现在用的一批名为特定电磁波治疗器的医疗器械超出使用期限却仍在正常使用,违反了刚修订的《医疗器械监督管理条例》。这是新修
See more information
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Time of issue:2021-06-28 17:52:44

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