Legal Metrology: Medical Devices

Abstract

Abstract. Medical devices with measuring function are regularly used in healthcare systems all over the world with the aim of prevention, diagnosis, and treatment of diseases. Considering the importance of these devices in daily activities of medical professionals and impact of their measurements on the health of patients, safety and accuracy of their measurements is becoming the topic of interest. Numerous international guidelines define how healthcare institutions should perform these conformity assessment but in some countries, where those guidelines are not adopted, it is necessary to implement directives of new approach for various groups of medical devices. Directives of new approach in terms of medical devices and their conformity assessment can be implemented in the area of legal metrology, as it is done in Bosnia and Herzegovina. This paper presents achievements and activities of Institute of Metrology of Bosnia and Herzegovina (IMBIH), the competent state authority for metrology in Bosnia and Herzegovina, in the area of legal metrology for the particular group of medical devices with measuring function. These achievements and activities refer to the adoption of appropriate legislation for type approval, verification, and creating an adequate legal framework for controlling medical devices after they are sold on the market. In addition, considering complexity and variety of medical devices related to measuring characteristics, and also due to the problem of inadequate or not defined traceability routes, the medical devices will continue to be in focus of metrological practice and science. Establishing the comparative approach to the type approval for these devices in the area of the legal metrology is the final aim.

Systematic review on the implementation of metrological assurance systems for medical devices in Latin America

“…This research stands out as the first systematic review comprehensively addressing metrological assurance systems for medical devices in Latin America. Unlike other studies that focus on specific aspects or evaluate institutions or countries (5)(6)(7)(8)(9)(10)(11)(12), this analysis considers the various standards used in regional institutions. Understanding metrological assurance systems opens new opportunities to improve institutional design and functionality, promoting the creation of protocols or manuals that benefit the quality assurance of processes.…”

“…Legal Metrology in Healthcare is a challenge present in several countries, including those within the European Union. Bošnjaković and Džemić (5), from the Institute of Metrology of Bosnia and Herzegovina, highlight that this area is not harmonized among different Union members, except for equipment covered by directives NAWI 2014/31/EU and MID 2014/32/EU (6). Thus, the implementation of a Legal Metrology system is left to the discretion of each member country.…”

Oʻzbekiston Respublikasida Qonunlashtiruvchi Tibbiyot Metrologiyasi Samaradorligi

“…Malakali tibbiyot xodimlaridan tashqari, tibbiy texnika sogʻliqni saqlash tizimining funksionalligini ta'minlaydigan asosiy komponent hisoblanadi [2]. Bugungi kunda jahon bozorida 2 milliondan ortiq turli xil tibbiy texnika mavjud boʻlib, ular 7 000 dan ortiq guruhlarga boʻlinadi [3]. Tibbiyot mutaxassislari tomonidan qo'yiladigan tashxis va muolajalarning 90 foizdan ortig'i TOʻV yordamida amalga oshirilgan tahlil natijalari, qolgan 10 foizi esa bevosita �izik tekshiruv va anamnez kabi boshqa diagnostika usullariga asoslangan holda bajariladi [4,5].…”

“…Ispaniya, Portugaliya, Saudiya Arabistoni, Serbiya Respublikasi, Bosniya va Gersegovina [5] hamda Chexiya Respublikasida TOʻV qonuniy metrologiyasi joriy etilgan va TOʻV davriy ravishda metrologik tekshiruvdan oʻtkaziladi. Alen Bosnjakovich [3] tadqiqotlarida metrologik tekshiruvlar samaradorligi akkreditatsiyalangan qiyoslash laboratoriyalari tomonidan amalga oshirilishi va tekshirish natijalari yagona reyestrga kiritilishi bilan izchil bogʻliqligi keltirilgan. L. Gurbeta va boshqalar [20] tadqiqotlarida esa TOʻVni doimiy monitoring qilish, ularning samaradorligini baholash, potensial xav�larni aniqlash hamda ularning oldini olishni qonunlashtiruvchi tibbiyot metrologiyasining asosiy tendensiyasi sifatida oʻrganilgan.…”

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KirishCOVID-19 pandemiyasi davrida tibbiyot oʻlchash vositalari (TOʻV)ning favqulodda avtorizatsiya qilinishi butun sogʻliqni saqlash sohasi, xususan, TOʻVga alohida e'tibor qaratish zarurligini koʻrsatdi [1].Malakali tibbiyot xodimlaridan tashqari, tibbiy texnika sogʻliqni saqlash tizimining funksionalligini ta'minlaydigan asosiy komponent hisoblanadi [2]. Bugungi kunda jahon bozorida 2 milliondan ortiq turli xil tibbiy texnika mavjud boʻlib, ular 7 000 dan ortiq guruhlarga boʻlinadi [3]. Tibbiyot mutaxassislari tomonidan qo'yiladigan tashxis va muolajalarning 90 foizdan ortig'i TOʻV yordamida amalga oshirilgan tahlil natijalari, qolgan 10 foizi esa bevosita �izik tekshiruv va anamnez kabi boshqa diagnostika usullariga asoslangan holda bajariladi [4,5].Yevropa Ittifoqi va Amerika Qoʻshma Shtatlari (AQSh) Oziq-ovqat va farmatsevtika idorasi (FDA) TOʻVning notoʻgʻri ish-

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