Why Should We Have a Periodic Safety and Performance Program for Medical Devices

Abstract

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.

Evaluation of the standard test methods for optical coherence tomograph for the posterior segment of the human eye

“…Consequently, proper maintenance, routine inspection, and periodic calibration of the OCT instruments are essential to uphold the precision of OCT measurements and the overall quality of medical services. This upkeep relies on reasonable and standardized test devices and methods [9]. Furthermore, from a regulatory perspective, reasonable, applicable, and traceable standards are required so that the quality of OCT instruments on the market can be ensured and monitored [10].…”

Investigation of the ophthalmic optical coherence tomography lateral resolution measurement using the standard test method

“…Lateral resolution is one of the crucial factors that determine the quality of the OCT images and subsequent analysis. The lateral resolution of an ophthalmic OCT device is constantly measured and monitored since its development, manufacturing, and regulation 5 , till the periodic medical instrument maintenance and calibration in the hospital 6 . Therefore, a standardized testing device and testing method that provides accurate, consistent, and traceable lateral resolution measurements of an ophthalmic OCT device is essential.…”

Incubator Analyzer Function Test in Laboratory Scale: Temperature Uniformity, Relative Humidity, Noise Level and Airflow

“…These measurement points are positioned in parallel, 10 cm above the mattress. This configuration ensures the measurement of temperature stability in the baby incubator room, which is a crucial factor in preventing incidents such as apnea [8].…”