Vaqt oʻtishi bilan tibbiyot oʻlchash vositalarining xavfsizligi va ishonchliligi muhim ahamiyat kasb etib bormoqda. COVID-19 kabi inqirozli vaziyatlar tibbiyot oʻlchash vositalarini nazorat qilish mexanizmlarining yetishmasligi natijasida yuzaga kelishi mumkin boʻlgan salbiy ta’sirlarni yanada yorqinroq koʻrsatib berdi. Ushbu tadqiqotning maqsadi Dori vositalari, tibbiy buyumlar va tibbiy texnika ekspertizasi va standartlashtirish Davlat markazi (DVTBTTESDM) hamda Oʻzbekiston Milliy metrologiya instituti (OʻzMMI) tomonidan joriy etilgan tibbiyot metrologiyasi huquqiy asoslari natijalarini taqdim etishdan iborat. Tadqiqot 2016-yildan 2021-yilgacha boʻlgan davrda barcha sogʻliqni saqlash muassasalarida 11 turdagi tibbiyot oʻlchash vositalari yillik metrologik tekshiruvi natijalaridan toʻplangan ma’lumotlarga asoslanadi. Xulosa chiqarish uchun ma’lumotlar konvertini tahlil qilish (Data envelopment analysis) metodidan foydalanildi hamda natijalar Bosniya va Gersegovina davlatlarida olib borilgan tadqiqot natijalari bilan taqqoslandi. Tadqiqot davomida shu narsa ma’lum bo‘ldiki, sog‘liqni saqlash sohasida metrologiyani qonuniylashtirish tibbiyot oʻlchash vositalari aniqligini sezilarli darajada oshirishga olib keladi. Bu esa diagnostika va davolash jarayonlarining ishonchliligi va bemorlar xavfsizligini oshiradi.
Vaqt oʻtishi bilan tibbiyot oʻlchash vositalarining xavfsizligi va ishonchliligi muhim ahamiyat kasb etib bormoqda. COVID-19 kabi inqirozli vaziyatlar tibbiyot oʻlchash vositalarini nazorat qilish mexanizmlarining yetishmasligi natijasida yuzaga kelishi mumkin boʻlgan salbiy ta’sirlarni yanada yorqinroq koʻrsatib berdi. Ushbu tadqiqotning maqsadi Dori vositalari, tibbiy buyumlar va tibbiy texnika ekspertizasi va standartlashtirish Davlat markazi (DVTBTTESDM) hamda Oʻzbekiston Milliy metrologiya instituti (OʻzMMI) tomonidan joriy etilgan tibbiyot metrologiyasi huquqiy asoslari natijalarini taqdim etishdan iborat. Tadqiqot 2016-yildan 2021-yilgacha boʻlgan davrda barcha sogʻliqni saqlash muassasalarida 11 turdagi tibbiyot oʻlchash vositalari yillik metrologik tekshiruvi natijalaridan toʻplangan ma’lumotlarga asoslanadi. Xulosa chiqarish uchun ma’lumotlar konvertini tahlil qilish (Data envelopment analysis) metodidan foydalanildi hamda natijalar Bosniya va Gersegovina davlatlarida olib borilgan tadqiqot natijalari bilan taqqoslandi. Tadqiqot davomida shu narsa ma’lum bo‘ldiki, sog‘liqni saqlash sohasida metrologiyani qonuniylashtirish tibbiyot oʻlchash vositalari aniqligini sezilarli darajada oshirishga olib keladi. Bu esa diagnostika va davolash jarayonlarining ishonchliligi va bemorlar xavfsizligini oshiradi.
С течением времени все большее внимание уделяется безопасности и надежности медицинских устройств. Кризисные ситуации, такие как COVID-19, продемонстрировали негативные последствия, к которым может привести отсутствие механизмов наблюдения за медицинскими устройствами. Целью данного исследования является представление результатов внедрения основ законодательной метрологии, проведенных совместными усилиями Государственного
центра экспертизы и стандартизации лекарственных средств, изделий медицинского назначения и медицинской техники и Узбекского национального института метрологии. Исследование основано на данных, собранных в ходе ежегодных проверок эффективности во всех учреждениях здравоохранения в период с 2016 по 2021 годы по 11 видам медицинских изделий. Для получения выводов использовался анализ охвата данных, а результаты сравнивались с результатами анализа по Боснии и Герцеговине. Результаты показывают, что внедрение нормативно-правовой базы метрологии способствует значительному повышению точности медицинских изделий, что приводит к повышению надежности диагностических и терапевтических процессов и безопасности пациентов.
Safety and reliability of medical devices are becoming more emphasized as the time passess. Crisis situations such as COVID-19 have shown the negative effects that can be brought upon by lack of medical device surveillance mechanisms. This aim of this study is to present the results of implementation of legal metrology framework conducted by joint efforts of the State Center of Expertise and Standardization of Medicines, Medical Devices, and Medical Equipment and Uzbek National Institute of Metrology. The study was based upon the data collected from annual performance inspectionsin all healthcare institutions in the period from 2016 to 2021 for 11 types of medical devices. Data envelopment analysis was used to derive conclusions and the results were compared with results from Bosnia and Herzegovina. Results indicate that the implementation of legal metrology framework leads to a significant increase in the accuracy of medical devices hence leading to increased reliability and patient safety in diagnostic and therapeutic processes.
| № | Muallifning F.I.Sh. | Lavozimi | Tashkilot nomi |
|---|---|---|---|
| 1 | Nishonov V.X. | 1-toifali mutaxassis | Oʻzbekiston milliy metrologiya instituti |
| 2 | Badnjevich A.. | texnika fanlari boʻyicha falsafa doktori (PhD), farmatsiya fakulteti professori, “Verlab Ltd” tibbiyot oʻlchash vositalarini qiyoslash laboratoriyasi direktori | Sarayevo universiteti (Bosniya va Gersegovina) |
| 3 | Muminov N.S. | texnika fanlari doktori, Ukraina metrologiyasi akademiyasi akademigi | Toshkent davlat agrar universiteti |
| № | Havola nomi |
|---|---|
| 1 | Badnjević A.L. Risks of emergency use authorizations for medical products during outbreak situations: a COVID-19 case study. BioMed Eng OnLine, 2020, vol. 19 (75), pp. 1-4. DOI: 10.1186/ s12938-020-00820-0/. |
| 2 | World Health Organization. 2010. Monitoring the building blocks of health systems: a handbook of indicators and their measurement strategies. World Health Organization. Available at: https:// www.who.int/health-topics/medical-devices/. |
| 3 | Bosnjakovic A., Dzemic Z. Legal Metrology: Medical Devices. Proceedings of the International Conference on Medical and Biological Engineering, 2017, March 15, vol. 62, Sarajevo, B&H. DOI: 10.1007/978-981-10-4166-2_88/. |
| 4 | Badnjević A., Cifrek M., Magjarević R., Džemić Z. (eds.) Inspection of Medical Devices. Series in Biomedical Engineering, 2018, Springer, Singapore. |
| 5 | Badnjević A. et al. Post-market Surveillance of Medical Devices: A Review. 2022, Jan. 1, pp. 1–15. |
| 6 | MAUDE database. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/ search.cfm/. |
| 7 | EUDAMED database. Available at: https://ec.europa.eu/tools/eudamed/eudamed/. |
| 8 | Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. Available at: https://eur-lex.europa.eu/legalcontent/EN/ALL/?uri=celex:31990L0385/. |
| 9 | Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Available at:https:// eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042/. |
| 10 | Regulation (eu) 2017/745 of the European parliament and of the council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Available at: https:// eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745/. |
| 11 | Regulation (eu) 2017/746 of the European parliament and of the council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/ PDF/?uri=CELEX:32017R0746 |
| 12 | Australian regulatory guidelines for medical devices (ARGMD). 2011 May, Version 1.1. |
| 13 | Zhang W., Liu R., Chatwin Ch. Marketing authorization of medical devices in China. Journal of Commercial Biotechnology, 2016, January. DOI: 10.5912/jcb720/. |
| 14 | Konishi A., Isobe S., Sato D. New Regulatory Framework for Medical Devices in Japan: Current Regulatory Considerations Regarding Clinical Studies. Journal of Vascular and Interventional Radiology, 2018, May 1, vol. 29, iss. 5, pp. 657–660. DOI: 10.1016/j.jvir.2017.12.022/. |
| 15 | Gurbeta L., Alic B., Dzemic Z., Badnjevic A. Testing of infusion pumps in healthcare institutions in Bosnia and Herzegovina. EMBEC & NBC, 2017, Springer, Singapore, pp. 390–393. |
| 16 | Gurbeta L., Alic B., Dzemic Z., Badnjevic A. Testing of dialysis machines in healthcare institutions in Bosnia and Herzegovina. EMBEC & NBC, 2017, Jun 11, pp. 470-473. Springer, Singapore. |
| 17 | Gurbeta L, Badnjevic A, Dzemic Z, Jimenez ER, Jakupovic A. Testing of therapeutic ultrasound in healthcare institutions in Bosnia and Herzegovina. Proceedings of the 2nd EAI International Conference on Future Access Enablers of Ubiquitous and Intelligent Infrastructures, 2016, Oct., pp. 24–25. |
| 18 | Badnjevic A., Gurbeta L., Jimenez E.R., Iadanza E. Testing of mechanical ventilators and infant incubators in healthcare institutions. Technology and Health Care, 2017, Jan 1, vol. 25 (2), pp. 237–250. |
| 19 | Gurbeta L., Dzemic Z., Bego T., Sejdic E., Badnjevic A. Testing of anesthesia machines and defibrillators in healthcare institutions. Journal of Medical Systems, 2017, vol. 41 (9), pp. 1–10. |
| 20 | Gurbeta L., Badnjević A. Inspection process of medical devices in healthcare institutions: software solution. Health and Technology, 2017, Mar., vol. 7 (1), pp. 109–117. |
| 21 | Gurbeta L., Badnjević A., Žunić E., Pinjo N., Ljumić F. Software package for tracking status of inspection dates and reports of medical devices in healthcare institutions of Bosnia and Herzegovina. Proceedings of the 2015 XXV International Conference on Information, Communication and Automation Technologies (ICAT), 2015, Oct 29, pp. 1–5. IEEE. |
| 22 | Pires C., Duarte D., Cavaco A. Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations. Acta Médica Portuguesa, 2021, Mar 1, vol. 34 (3), pp. 201–208. |
| 23 | Ivanovska E., Tonić-Ribarska J., Lazova J., Popstefanova N., Davcheva-Jovanoska M., TrajkovićJolevska S. Obezbeđivanje kliničkih dokaza u skladu sa MDR 2017/745-novi izazovi za proizvođače u industriji medicinskih sredstava [Providing clinical evidence in accordance with MDR 2017/745 - new challenges for manufacturers in the medical device industry]. Arhiv za farmaciju – Archives for Pharmacy, 2019, Jan, vol. 69 (1), pp. 39–49. |
| 24 | Al-Surimi K., Househ M., Almohandis E., Alshagathrh F. Establishing a national medical device registry in Saudi Arabia: lessons learned and future work. Enabling Health Informatics Applications, IOS Press, 2015, pp. 23–26. |
| 25 | The National Institute of standards and technology. Available at: http://www.nist.gov/medicaldevices-portal.cfm/. |
| 26 | France’s National Metrology Institute. Available at: http://www.lne.eu/en/markets/medicalhealth.asp/. |
| 27 | National Metrology Institute of Germany Available at: http://www.ptb.de/cms/en/ fachabteilungen/abt8/. |
| 28 | Karaboci B. et all. Medical metrology studies at Tübitak UME. Proceedings of the 17 International Congress of Metrology, 2015, Paris, France. |
| 29 | Jonesa G.R.D., Jackson C. The Joint Committee for Traceability in Laboratory Medicine (JCTLM) – its history and operation. Clinica Chimica Acta, 2016, no. 453, pp. 86–94. |
| 30 | Ministry of Health of the Republic of Uzbekistan. Available at: https://ssv.uz/uz/open_ ministry/category/ochi-malumotlar/. |
| 31 | Uzbek National Institute of Metrology. Available at: https://nim.uz/en/about-us/generalinformation/. |
| 32 | State center for expertise and standardization of medicines, medical devices and medical equipment. Available at: https://uzpharm-control.uz/en/. |
| 33 | On approval of the official list of measuring instruments and measurements subject to legal metrological control. Decree of the Government of the Republic of Moldova September 13, 2016, No. 1042. |
| 34 | On the list of measuring instruments, the veriication of which is carried out only by state regional metrology centers accredited in the prescribed manner in the field of ensuring the uniformity of measurements. Decree of the Government of the Russian Federation April 20, 2010, No. 250. |
| 35 | On approval and enforcement of the Regulations on metrological support of healthcare institutions of the Republic of Belarus. Decree of the Ministry of Health of the Republic of Belarus November 29, 1996, No. 255. |
| 36 | On approval of the list of categories of measuring equipment subject to periodic verification. Decree of the Cabinet Ministry of the Republic of Ukraine June 4, 2015, No. 374. |
| 37 | On measures to implement the Law of the Kyrgyz Republic “On ensuring the uniformity of measurements”. Decree of the Government of the Republic of Kyrgyz September 27, 2012, No. 664. |
| 38 | On approval of the List of medical equipment, which is a means of measurement. Decree of the Ministry of Health of the Republic of Kazakhstan November 24, 2009, No. 765. |
| 39 | Wong W.-P. A Global Search Method for Inputs and Outputs in Data Envelopment Analysis: Procedures and Managerial Perspectives. Symmetry, 2021, no. 13, p. 1155. DOI: 10.3390/sym 13071155/. |
| 40 | Gurbeta L., Badnjević A., Kurta E. eVerlab: Software Tool for Medical Device Safety and Performance Inspection Management. Badnjevic A., Škrbić R., Gurbeta Pokvić L. (eds). CMBEBIH 2019. IFMBE Proceedings, 2020, vol 73. Springer, Cham. |
| 41 | Hrvat F., Spahic L., Gurbeta P.L., Badnjevic A. Artificial Neural Networks for prediction of medical device performance based on conformity assessment data: Infusion and perfusor pumps case study. Proceedings of the IEEE 9th Mediterranean Conference on Embedded Computing (MECO), 08–11 June 2020, Budva, Montenegro. |
| 42 | Spahić L., Kurta E., Cordic S., Becirovic M., Gurbeta L., Kovacevic Z., Izetbegovic S., Badnjevic A. Machine Learning Techniques for Performance Prediction of Medical Devices: Infant Incubators. In: Badnjevic A., Škrbić R., Gurbeta Pokvić L. (eds). CMBEBIH 2019. IFMBE Proceedings, 2020, vol 73. Springer, Cham |
| 43 | Gurbeta L., Džemic Z., Badnjevic A. (2018) Establishing Traceability Chain of Infusion and Perfusor Pumps Using Legal Metrology Procedures in Bosnia and Herzegovina. Lhotska L., Sukupova L., Lacković I., Ibbott G. (eds). World Congress on Medical Physics and Biomedical Engineering, 2018. IFMBE Proceedings, Springer, Singapore, vol. 68/2. |
| 44 | Gurbeta L., Vukovic D., Džemic Z., Badnjevic A. Legal Metrology Procedures for Increasing Safety and Performance Characteristics with Cost Benefits Analysis: Case Study Dialysis Machines. In: Lhotska L., Sukupova L., Lacković I., Ibbott G. (eds) World Congress on Medical Physics and Biomedical Engineering 2018. IFMBE Proceedings, Springer, Singapore, 2018, vol. 68/2. |
| 45 | Badnjević A., Gurbeta P.L., Hasičić M., Bandić L., Mašetić Z., Kovačević Ž., Kevrić J., Pecchia L. Evidence-based clinical engineering: Machine learning algorithms for prediction of defibrillator performance. Biomedical Signal Processing and Control, 2019, vol. 54, p. 101629, ISSN 1746-8094. DOI: 10.1016/j.bspc.2019.101629/. |
| 46 | Xamidova Z.A., Nishonov V.X Tibbiyot sohasida foydalanilayotgan asbob-uskunalarda yuzaga kelishi mumkin bo‘lgan xavflarni boshqarish. Standard, Tashkent, 2018, no. 1, pp. 15–17. |
| 47 | Juraev Z.B., Nishonov V.X. Metrology service in the field of medicine. Problems of modern science. Proccedings of the International scientific-practical conference. Economics and Finance, Namur, Belgium, 2018, pp. 97–100. |
| 48 | Muminov N.Sh., Nishonov V.X. Metrological support system in the field of health care of the Republic of Uzbekistan. European Journal of Research Development and Sustainability, Ispaniya, 2021, February, no. 2. |