The risk of using a Class I medical device with the example of prescription reading glasses

Azra Hodzic ,
Azra Hodzic

Long Commerce Ltd. , Siroki Brijeg , Bosnia and Herzegovina

Senada Dzebo ,
Senada Dzebo

Emergency Medicine Clinic KCUS Bosnia and Herzegovina

Dusan Djuric ,
Dusan Djuric

Faculty of Medical Sciences, University of Kragujevac , Kragujevac , Serbia

Institute for Rehabilitation , Belgrade , Serbia

Vladimir Biocanin ,
Vladimir Biocanin

Oral Surgery Clinic, Faculty of Dentistry Pancevo, University of Business Novi Sad , Novi Sad , Serbia

Faculty of Pharmacy and Health , Travnik , Bosnia and Herzegovina

Samra Trtak ,
Samra Trtak

J.U. Health Center of Canton Sarajevo , Sarajevo , Bosnia and Herzegovina

Amra Colic ,
Amra Colic

Faculty of Health Studies, Vitez University , Travnik , Bosnia and Herzegovina

Jovanka Trifunovic
Jovanka Trifunovic

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.

Keywords

References

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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 

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