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The risk of using a Class I medical device with the example of prescription reading glasses
Long Commerce Ltd. , Siroki Brijeg , Bosnia and Herzegovina
Emergency Medicine Clinic KCUS Bosnia and Herzegovina
Faculty of Medical Sciences, University of Kragujevac , Kragujevac , Serbia
Institute for Rehabilitation , Belgrade , Serbia
Oral Surgery Clinic, Faculty of Dentistry Pancevo, University of Business Novi Sad , Novi Sad , Serbia
Faculty of Pharmacy and Health , Travnik , Bosnia and Herzegovina
J.U. Health Center of Canton Sarajevo , Sarajevo , Bosnia and Herzegovina
Faculty of Health Studies, Vitez University , Travnik , Bosnia and Herzegovina
Oral Surgery Clinic, Faculty of Dentistry Pancevo, University of Business Novi Sad , Novi Sad , Serbia
Faculty of Pharmacy and Health , Travnik , Bosnia and Herzegovina
Published: 01.05.2019.
Volume 35, Issue 2 (2019)
pp. 1769-1775;
Abstract
The aim of the study was to investigate the degree of exposure to the health risk of the user by using a medical prescription reading goggles, which are classified as low risk, and whether the data from the package leaflet are correctly applied. Medical devices are instruments, apparatus, materials and other products intended to be used for humans and which do not achieve its basic purpose on the basis of pharmacological, immunological or metabolic activity, but are used alone or in combination, including the software required for proper use. Depending on the categories to which they belong, medical devices have greater or lesser risk of adverse health effects on patients. Medical devices are classified to classes according to the degree of risk for the user ranging from low risk to high risk. Research was conducted in retail stores: pharmacies, optical stores and facilities for selling consumer goods. The survey questionnaire methodology collected data on habits of customers - users of diopter reading glasses. The survey was conducted among the masters of pharmacies, opticians and retailers in the period from March to June 2019. Twenty-five facilities were included in the survey in the area of Tuzla, Sarajevo and Zenica.Statistical data processing was done in Microsoft Excel. Study showed that 35% of the respondents answered that patients visited ophthalmologists and brought medical report with needed corrective diopter, while significantly larger number of respondents – 65% answered that patients didn’t visit ophthalmologists and didn’t have a medical report with needed corrective diopter. Research has shown that 73.75% of patients don’t read the instructions for use, while only 26.25% of patients read instructions for use.
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