Safety use of medical equipment is ignored by the Ministry of Health to fill the blank regulations
Release time: 2009-11-18 & nbsp & nbsp & nbsp Source:
"The results of the spot check shocked us." A family of threeHospitalRelevant person in charge said.
To understandMedicalEquipmentSafe in clinical use,They did a sample inspection at the hospital in the system,As a result, it was found that 4 hospitals (first batch of sampling) 1314 equipmentQualificationThe rate is around 83%。But the discharge rate of the ventilator is 44%,Anesthesiomer's unqualified rate is 55%。The 12th sampling of the 12 hospitals,None of the ventilator of one hospital is qualified,None of the anesthesia machine in 2 hospitals is qualified,But still use it to make anesthesiaSurgery。
"Everyone is surprised。"The above person said the above person,"It's all products from famous brand manufacturers,How can there be so many unqualified? "For this reason, everyone agreed that the professional committee should be established,Establish a set of standards to detect medical equipment。”
This also attracted the attention of regulatory regulations.
"Safety use clinical use of medical equipmentManagementSpecifications are expected to be discussed and approved in December。"November 6,in "ChinaHospital Dean "Magazine's" China Hospital Dean 2009 Meeting ",Ministry of HealthMedicalSanitaryDirector of the Management Office Liang Minghui revealed.
Medical equipment clinical use andPatientsMedical costs occupy a large proportion,But China's regulatory status is a heavy productProductionApproval,Light clinical safe use。Lack of clinical use of safety management regulations at the same time,Recall and trackingSystemLack of problems.
As one of the supporting documents of the reform of the public hospital,The Ministry of Health will introduce the safety specifications of clinical use of new medical devices,Focus on strengthening the safety monitoring and evaluation system of medical equipment in the clinical use of medical equipment,and use this as one of the contents of the performance evaluation of public hospitals。
stake betting appLiang Minghui is locatedResearchInstitutionParticipated in the research and drafting work of the relevant policies of the Department of Medical Service Supervision of the Ministry of Health,He revealed,"New regulations will strengthen the supervision of medical devices in clinical application。"New regulations proposed to strengthen clinical access and evaluation management of medical equipment,Establishing medical device procurement argument、Technical evaluation and procurement management system、Autonomous review and evaluation system for establishing medical devices。
New regulations also propose to strengthen clinical use management, rightMedicineEstablishing training for engineering and technical personnel、Evaluation System,Strengthen Stake Sports Bettingstake betting appclinical use technical specifications and regulations,Establishing the reporting system of the detection information of clinical safety event of medical device。
Regulate the medical quality and safety of the hospital,It is the main responsibility of the health administrative departments of various countries,Among them, the supervision of clinical use of medical equipment。
"In the past, the hospital usually treats medical equipment asAssetsManagement,Pay attention to the hidden dangers of clinical use of clinical use。"Relevant persons of the Medical Service Supervision Department of the Ministry of Health,The hospital pays more attention to the input of medical devices to generate benefits,There is no good specification in clinical safety testing and management。For this,The next step of the Ministry of Health will strengthen supervision of this field,Among them, the focus is the three hospitals。
Liang Ming will disclose,The Ministry of Health is brewing specifically for evaluating the standard system for the three hospitals,and medical equipment content,will give specifications from 10 aspects,Including the establishment of clinical safety incident testing and reporting system for the establishment of medical devices,Internal assessment system, etc.。
After the management specifications are introduced,There are also related supporting implementation rules。If the clinical safety management test of medical equipmentScheme. The plan may choose some of the whole countryMedical InstitutionPilot,Then on the basis of the pilot,Gradually expand in three stages,Finally implemented in all hospitals。Liang Ming will say,Evaluation results for clinical safety use of medical equipment,It will be included in the performance assessment of the hospital。
Clinical quality management gap
"China's access to medical devices is very strict,No less than other countries,But the use of medical devices in medical institutions lacks binding power。"Liang Ming will say。
From the current regulations,Medical Device Specifications are more complete in the production field。Such as 2000,CountryFoodDrugThe Supervision and Administration Bureau issued the "Regulations on the Supervision and Administration of Medical Devices"。2004,I also introduced the "Medical Device Manual、Regulations on the Management of Tags and Packaging Signs "、"Measures for the Supervision and Management of Medical Devices"。
At the clinical use of the hospital,Specific regulatory rules and regulations are almost blank。Article 26 of the "Regulations on the Supervision and Administration of Medical Device" stipulates that "medical institutions shall be produced from" medical device productionEnterpriseLicense "production enterprise,Or the business company that obtains the "medical device business enterprise license" purchased for a qualified medical equipment。"" "" Medical institutions must not use unregistered、No qualified certificate、Expired、Medical equipment that fails or eliminateds。"and Article 27 stipulate that" medical institutions shall not be reused for one -time medical equipment for one -time use,I have used,Destruction shall be destroyed in accordance with relevant national regulations,Predse records。”
From the perspective of macro supervision,At present, the lack of clinical use of clinical use of medical devices,No equipment recall system and tracking system,Quality Management and Inspection and Inspection Stream in Form,Nor established data management -based detection and early warning evaluation system。and see from the internal management of the micro stake betting apphospital,Many hospitals stake betting appdo not have special medical devices in the management department of clinical use of medical devices,Lack of unified and orderly internal management mechanisms, etc.。
The person in charge of the above three hospitals revealed that theyInvestigation"23 cases of 12 provinces and cities on the ventilatorPatientsDeath"Discovery,The error of the ventilator is 39%,22%of the power connection problem,22%of the problem of gas source connection,The host fails 9%,Uninterrupted pipelines accounted for 2%。Medical accident compensation caused by these medical disputes is 300,000。
To understandMedicalEquipmentSafe in clinical use,They did a sample inspection at the hospital in the system,As a result, it was found that 4 hospitals (first batch of sampling) 1314 equipmentQualificationThe rate is around 83%。But the discharge rate of the ventilator is 44%,Anesthesiomer's unqualified rate is 55%。The 12th sampling of the 12 hospitals,None of the ventilator of one hospital is qualified,None of the anesthesia machine in 2 hospitals is qualified,But still use it to make anesthesiaSurgery。
"Everyone is surprised。"The above person said the above person,"It's all products from famous brand manufacturers,How can there be so many unqualified? "For this reason, everyone agreed that the professional committee should be established,Establish a set of standards to detect medical equipment。”
This also attracted the attention of regulatory regulations.
"Safety use clinical use of medical equipmentManagementSpecifications are expected to be discussed and approved in December。"November 6,in "ChinaHospital Dean "Magazine's" China Hospital Dean 2009 Meeting ",Ministry of HealthMedicalSanitaryDirector of the Management Office Liang Minghui revealed.
Medical equipment clinical use andPatientsMedical costs occupy a large proportion,But China's regulatory status is a heavy productProductionApproval,Light clinical safe use。Lack of clinical use of safety management regulations at the same time,Recall and trackingSystemLack of problems.
As one of the supporting documents of the reform of the public hospital,The Ministry of Health will introduce the safety specifications of clinical use of new medical devices,Focus on strengthening the safety monitoring and evaluation system of medical equipment in the clinical use of medical equipment,and use this as one of the contents of the performance evaluation of public hospitals。
stake betting appLiang Minghui is locatedResearchInstitutionParticipated in the research and drafting work of the relevant policies of the Department of Medical Service Supervision of the Ministry of Health,He revealed,"New regulations will strengthen the supervision of medical devices in clinical application。"New regulations proposed to strengthen clinical access and evaluation management of medical equipment,Establishing medical device procurement argument、Technical evaluation and procurement management system、Autonomous review and evaluation system for establishing medical devices。
New regulations also propose to strengthen clinical use management, rightMedicineEstablishing training for engineering and technical personnel、Evaluation System,Strengthen Stake Sports Bettingstake betting appclinical use technical specifications and regulations,Establishing the reporting system of the detection information of clinical safety event of medical device。
Regulate the medical quality and safety of the hospital,It is the main responsibility of the health administrative departments of various countries,Among them, the supervision of clinical use of medical equipment。
"In the past, the hospital usually treats medical equipment asAssetsManagement,Pay attention to the hidden dangers of clinical use of clinical use。"Relevant persons of the Medical Service Supervision Department of the Ministry of Health,The hospital pays more attention to the input of medical devices to generate benefits,There is no good specification in clinical safety testing and management。For this,The next step of the Ministry of Health will strengthen supervision of this field,Among them, the focus is the three hospitals。
Liang Ming will disclose,The Ministry of Health is brewing specifically for evaluating the standard system for the three hospitals,and medical equipment content,will give specifications from 10 aspects,Including the establishment of clinical safety incident testing and reporting system for the establishment of medical devices,Internal assessment system, etc.。
After the management specifications are introduced,There are also related supporting implementation rules。If the clinical safety management test of medical equipmentScheme. The plan may choose some of the whole countryMedical InstitutionPilot,Then on the basis of the pilot,Gradually expand in three stages,Finally implemented in all hospitals。Liang Ming will say,Evaluation results for clinical safety use of medical equipment,It will be included in the performance assessment of the hospital。
Clinical quality management gap
"China's access to medical devices is very strict,No less than other countries,But the use of medical devices in medical institutions lacks binding power。"Liang Ming will say。
From the current regulations,Medical Device Specifications are more complete in the production field。Such as 2000,CountryFoodDrugThe Supervision and Administration Bureau issued the "Regulations on the Supervision and Administration of Medical Devices"。2004,I also introduced the "Medical Device Manual、Regulations on the Management of Tags and Packaging Signs "、"Measures for the Supervision and Management of Medical Devices"。
At the clinical use of the hospital,Specific regulatory rules and regulations are almost blank。Article 26 of the "Regulations on the Supervision and Administration of Medical Device" stipulates that "medical institutions shall be produced from" medical device productionEnterpriseLicense "production enterprise,Or the business company that obtains the "medical device business enterprise license" purchased for a qualified medical equipment。"" "" Medical institutions must not use unregistered、No qualified certificate、Expired、Medical equipment that fails or eliminateds。"and Article 27 stipulate that" medical institutions shall not be reused for one -time medical equipment for one -time use,I have used,Destruction shall be destroyed in accordance with relevant national regulations,Predse records。”
From the perspective of macro supervision,At present, the lack of clinical use of clinical use of medical devices,No equipment recall system and tracking system,Quality Management and Inspection and Inspection Stream in Form,Nor established data management -based detection and early warning evaluation system。and see from the internal management of the micro stake betting apphospital,Many hospitals stake betting appdo not have special medical devices in the management department of clinical use of medical devices,Lack of unified and orderly internal management mechanisms, etc.。
The person in charge of the above three hospitals revealed that theyInvestigation"23 cases of 12 provinces and cities on the ventilatorPatientsDeath"Discovery,The error of the ventilator is 39%,22%of the power connection problem,22%of the problem of gas source connection,The host fails 9%,Uninterrupted pipelines accounted for 2%。Medical accident compensation caused by these medical disputes is 300,000。
