Why Should We Have a Periodic Safety and Performance Program for Medical Devices
Nowadays, more than 10,000 different types of medical devices can be found in hospitals.These devices used in medical centers and hospitals for monitoring and treatment of patients require periodic safety and performance checking in order to have confidence in their functioning and operation. Physi...
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| Format: | Article |
| Language: | English |
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Shiraz University of Medical Sciences
2019-04-01
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| Series: | Journal of Biomedical Physics and Engineering |
| Subjects: | |
| Online Access: | http://jbpe.ir/Journal_OJS/JBPE/index.php/jbpe/article/view/761/470 |
| _version_ | 1811279044125130752 |
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| author | Tavakoli Golpaygani A. |
| author_facet | Tavakoli Golpaygani A. |
| author_sort | Tavakoli Golpaygani A. |
| collection | DOAJ |
| description | Nowadays, more than 10,000 different types of medical devices can be found in hospitals.These devices used in medical centers and hospitals for monitoring and treatment
of patients require periodic safety and performance checking in order to have confidence in their functioning and operation. Physicians need better accurate medical measurements in order to better diagnose diseases, monitor patients and deliver treatments,
in this way failure to ensure appropriate measurements will certainly have diverse effects. Safety and performance testing of medical devices in the medical sector is a one
of the key factor in improving public health. Acquiring results of some investigations
indicate a need for new and severe regulations on periodic performance verifications
and medical equipment quality control program especially in highrisks instruments.
The metrological reliability of four high risk medical devices, Electrosurgical unit,
Defibrillator, Syringe pump and Infant incubator in use some hospitals (privates and
publics) in one of the province of Iran according to international and national standards
was evaluated. Quantitative analysis of Some parameters that impact the safety and
performance showed the amount of the obtained results in some equipment are in critical range and have higher values than standard limitations. General electrical safety
evaluations for measuring the patient leakage currents and patient auxiliary currents
carried out for all of groups,in some cases the amount of leakage currents were over
the standard limitations.
Acquiring results indicate a need for new and severe regulations on periodic performance verifications and medical equipment quality control program especially in high
risk instruments. It is also necessary provide training courses for operating staff in the
field of meterology in medicine and what’s the critical parameters and how they can
get good accuracy results equipment. |
| first_indexed | 2024-04-13T00:47:45Z |
| format | Article |
| id | doaj.art-62a9e17fde0e4914876f1d588e6dab43 |
| institution | Directory Open Access Journal |
| issn | 2251-7200 2251-7200 |
| language | English |
| last_indexed | 2024-04-13T00:47:45Z |
| publishDate | 2019-04-01 |
| publisher | Shiraz University of Medical Sciences |
| record_format | Article |
| series | Journal of Biomedical Physics and Engineering |
| spelling | doaj.art-62a9e17fde0e4914876f1d588e6dab432022-12-22T03:09:58ZengShiraz University of Medical SciencesJournal of Biomedical Physics and Engineering2251-72002251-72002019-04-0192251256Why Should We Have a Periodic Safety and Performance Program for Medical DevicesTavakoli Golpaygani A.0Department of Biomedical Engineering, Standard Research Institiute, Karaj, IranNowadays, more than 10,000 different types of medical devices can be found in hospitals.These devices used in medical centers and hospitals for monitoring and treatment of patients require periodic safety and performance checking in order to have confidence in their functioning and operation. Physicians need better accurate medical measurements in order to better diagnose diseases, monitor patients and deliver treatments, in this way failure to ensure appropriate measurements will certainly have diverse effects. Safety and performance testing of medical devices in the medical sector is a one of the key factor in improving public health. Acquiring results of some investigations indicate a need for new and severe regulations on periodic performance verifications and medical equipment quality control program especially in highrisks instruments. The metrological reliability of four high risk medical devices, Electrosurgical unit, Defibrillator, Syringe pump and Infant incubator in use some hospitals (privates and publics) in one of the province of Iran according to international and national standards was evaluated. Quantitative analysis of Some parameters that impact the safety and performance showed the amount of the obtained results in some equipment are in critical range and have higher values than standard limitations. General electrical safety evaluations for measuring the patient leakage currents and patient auxiliary currents carried out for all of groups,in some cases the amount of leakage currents were over the standard limitations. Acquiring results indicate a need for new and severe regulations on periodic performance verifications and medical equipment quality control program especially in high risk instruments. It is also necessary provide training courses for operating staff in the field of meterology in medicine and what’s the critical parameters and how they can get good accuracy results equipment.http://jbpe.ir/Journal_OJS/JBPE/index.php/jbpe/article/view/761/470MetrologyMedical devicesSafetyPerformanceCalibration |
| spellingShingle | Tavakoli Golpaygani A. Why Should We Have a Periodic Safety and Performance Program for Medical Devices Journal of Biomedical Physics and Engineering Metrology Medical devices Safety Performance Calibration |
| title | Why Should We Have a Periodic Safety and Performance Program for Medical Devices |
| title_full | Why Should We Have a Periodic Safety and Performance Program for Medical Devices |
| title_fullStr | Why Should We Have a Periodic Safety and Performance Program for Medical Devices |
| title_full_unstemmed | Why Should We Have a Periodic Safety and Performance Program for Medical Devices |
| title_short | Why Should We Have a Periodic Safety and Performance Program for Medical Devices |
| title_sort | why should we have a periodic safety and performance program for medical devices |
| topic | Metrology Medical devices Safety Performance Calibration |
| url | http://jbpe.ir/Journal_OJS/JBPE/index.php/jbpe/article/view/761/470 |
| work_keys_str_mv | AT tavakoligolpaygania whyshouldwehaveaperiodicsafetyandperformanceprogramformedicaldevices |