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. 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.

Antibacterial Susceptibility Pattern of the Pseudomonas aeruginosa and Staphylococcus aureus after Exposure to Electromagnetic Waves Emitted from Mobile Phone Simulator.

BACKGROUND: The increasing use of telecommunication devices such as Wi-Fi modems and mobile phones in the recent years can change the cellular structure of microorganisms so the generation of electromagnetic waves has led to concern in the community whenever be exposed to these fields and may have harmful effects on human health. MATERIAL AND METHODS: In this experimental study, standard strains of bacteria were prepared on Mueller-Hinton agar for bacterial growth to obtain 0.5 McFarland turbidity (1.5 × 108 CFU) of bacteria. Antibiotic susceptibility test using the Kirby-Bauer disk diffusion method was done. For Staphylococcus aureus and Pseudomonas aeruginosa, antibiotics susceptibility test was conducted. The test group was exposed to electromagnetic waves emitted by mobile phone simulator with a frequency of 900 MHz and the control group were not exposed. RESULTS: The results revealed that increasing duration of exposure to electromagnetic waves emitted by the mobile simulators with a frequency of 900 MHz especially after 24 h of exposure, can increase bacterial resistance in S. aureus, and P. aeruginosa. CONCLUSION: Several factors can cause bacterial resistance against antibiotics. One of these factors is the electromagnetic waves emitted from mobile simulator with a frequency of 900 MHz, which can increase the permeability of the cell wall of bacteria.

A Study on Performance and Safety Tests of Defibrillator Equipment.

INTRODUCTION: Nowadays, more than 10,000 different types of medical devices can be found in hospitals. This way, medical electrical equipment is being employed in a wide variety of fields in medical sciences with different physiological effects and measurements. Hospitals and medical centers must ensure that their critical medical devices are safe, accurate, reliable and operational at the required level of performance. Defibrillators are critical resuscitation devices. The use of reliable defibirillators has led to more effective treatments and improved patient safety through better control and management of complications during Cardiopulmonary Resuscitation (CPR). MATERIALS AND METHODS: The metrological reliability of twenty frequent use, manual defibrillators in use ten hospitals (4 private and 6 public) in one of the provinces of Iran according to international and national standards was evaluated. RESULTS: Quantitative analysis of control and instrument accuracy showed the amount of the obtained results in many units are critical which had less value over the standard limitations especially in devices with poor battery. For the accuracy of delivered energy analysis, only twelve units delivered acceptable output values and the precision in the output energy measurements especialy in weak battry condition, after activation of discharge alarm, were low. CONCLUSION: Obtained results indicate a need for new and severe regulations on periodic performance verifications and medical equipment quality control program especially for high risk instruments. It is also necessary to provide training courses on the fundumentals of operation and performane parameters for medical staff in the field of meterology in medicine and how one can get good accuracy results especially in high risk medical devices.

A Study on Performance and Safety Tests of Electrosurgical Equipment.

INTRODUCTION: Modern medicine employs a wide variety of instruments with different physiological effects and measurements. Periodic verifications are routinely used in legal metrology for industrial measuring instruments. The correct operation of electrosurgical generators is essential to ensure patient's safety and management of the risks associated with the use of high and low frequency electrical currents on human body. MATERIAL AND METHODS: The metrological reliability of 20 electrosurgical equipment in six hospitals (3 private and 3 public) was evaluated in one of the provinces of Iran according to international and national standards. RESULTS: The achieved results show that HF leakage current of ground-referenced generators are more than isolated generators and the power analysis of only eight units delivered acceptable output values and the precision in the output power measurements was low. CONCLUSION: 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 to provide training courses for operating staff in the field of meterology in medicine to be acquianted with critical parameters to get accuracy results with operation room equipment.