Medical devices product safety and practitioners of cardiology information on the procedures to unsafe levels of products
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Abstract (EN)
The term medical devices cover a very vide range from tongue depressor, catheter, cardiac pacemaker to magnetic resonance. Like medications and other health technologies, medical devices are basic requirements for hospitals, clinics in rural areas and other special hospitals.Being dependent on other countries in getting medical devices appropriate for its own special epidemiological structure, Turkey has difficulties in differenciating high-quality medical devices from the ones of poor quality. This results from mostly because technological assessments and regulations for prohibiting the usage and import of low-quality medical devices are insufficient. Nearly 95%of medical devices are imported in our country. This fact literally makes the patients experimental objects for markets and put them at risk. Therefore in order to assure the security of their citizens, countries have started to adopt new policies such as providing high-quality products, secure and appropriate usage of them and removing those products after their usage.In our research, it is aimed to determine the knowledge level of cardiology experts on the product security and processes related to insecure products. 54 cardiology experts who are members of Turkish Cardiology Association have participated in this research and a questionnaire comprised of 23 questions has been used to assess their opinions.In this thesis, according to the analysis, doctors have declared that they have sufficient knowledge related to the devices they use. Nearly 85% of the doctors participating in the research have stated that they assess the harms and benefits of a newly released or newly used device before they apply it. However majority of the doctors nearly 69.2% of them have stated they hesitate to use a medical device. Most important reasons for this hesitation are the probability of adverse and undesired effects and probable negative effects on patients. Also the cost of the device triggers the hesitations. Moreover, approximately 28% of doctors have stated that these devices are not cost-efficient; risks are bigger than benefits. These results lead us to the need that the awareness of Turkish Drug and Medical Device Institution should be increased, activities and studies should be explained to wider masses and new activities to increase the trustworthiness of the institution should be encouraged.
Author
Reyhan Yalçın Bozkurt
Institution
How to Cite
Reyhan Yalçın Bozkurt (Master Thesis). Medical devices product safety and practitioners of cardiology information on the procedures to unsafe levels of products, 2012, Başkent University.
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