Intercomparison of simulators used for the inspection of non-invasive blood pressure meters and new regulatory framework for medical devices

MAHMUTAJ, ERMIRA (author), Begeš, Gaber (mentor), Geršak, Gregor (comentor)

Medical devices are of extreme importance for diagnosing and treatment of diseases. To ensure the proper diagnosis or treatment, it is of high importance that the devices are in good condition. A problem in the functioning of the device might lead in considerable consequences for the patient. For this reason, medical device verification is very important. This thesis concentrates on the role of metrology in the field of health care and the new regulatory framework for medical devices. Changes regarding the old and new legislation are presented as well. For the experimental part of the thesis, we have compared three different Noninvasive blood pressure (NIBP) simulators for different settings of systolic and diastolic pressure. We used a Clinical Dynamics Smart Arm NIBP simulator from LMK at the Faculty of Electrical Engineering in Ljubljana, Clinical Dynamics AccuSim Handheld NIBP simulator owned by KMA – Kosovo Metrology Agency and Rigel UNI-SIM NIBP simulator owned by a private medical equipment company in Kosovo N.T.SH MAM. Statistical methods according to ISO 13528 were used to compare the three simulators where En number was used to compare the simulators. Three blood pressure monitors: Omron M2, Omron M6, and Microlife BP A100 Plus were used as transfer standards to compare the three simulators. Clinical Dynamics Smart Arm NIBP simulator from LMK Laboratory was considered as reference simulator, therefore at the end of measurements one more cycle of measurements were performed to close the cycle of measurements. In addition, inspection of three NIBP monitors with three simulators were performed according to OIML R 149:2020. We used five different blood pressure settings as follows: 80/50, 100/70, 120/80, 150/100, 180/130. The pulse rate was set at 80 bpm in each case. For each simulator and each of the settings 10 measurements of systolic and diastolic pressure were taken. Our goal was to assess if En it is also suitable to compare NIBP simulators. We used three different transfer standards to compare the simulators, but also to assess how important it is that the transfer standard is in good condition by using a new monitor (Omron M2), used monitor (Omron M6) and worn-out monitor (Microlife). Finally we found out that En number is suitable for comparing simulators when the NIBP monitor used is within the tolerance limits prescribed in OIML R 149:2020. Disadvantages of using En number were found out for evaluation of results when using a worn-out NIBP monitor.

• Language: English
• Keywords: NIBP simulator, blood pressure measurements, NIBP monitors, medical device legislation, medical device regulation
• Work type: Master's thesis/paper
• Organization: FE - Faculty of Electrical Engineering
• Place of publishing: Ljubljana
• Publisher: [E. Mahmutaj]
• Year: 2021
• Number of pages: XVI, 54 str.
• PID: 20.500.12556/RUL-127650
• COBISS.SI-ID: 67677699
• Publication date in RUL: 18.06.2021

Secondary language

• Language: Slovenian
• Title: Primerjava simulatorjev, uporabljenih za pregled ne invazivnih merilnikov tlaka, in nov regulativni okvir za medicinske naprave

Abstract

Medicinski pripomočki so izjemnega pomena za diagnosticiranje in zdravljenje bolezni. Za pravilno diagnozo ali zdravljenje je zelo pomembno, da so naprave v dobrem stanju. Težava pri delovanju naprave lahko povzroči velike posledice za pacienta. Zaradi tega je zelo pomembno preverjanje medicinskih pripomočkov. Taključno delo se osredotoča na vlogo meroslovja na področju zdravstvenega varstva in nov regulativni okvir za medicinske pripomočke. Predstavljene so tudi spremembe glede stare in nove zakonodaje. V okviru eksperimentalnega dela naloge smo primerjali tri različne simulatorje neinvazivnega krvnega tlaka (NIBP) za različne nastavitve sistoličnega in diastoličnega tlaka. Uporabili smo simulator Clinical Dynamics Smart Arm NIBP iz LMK na Fakulteti za elektrotehniko v Ljubljani, ročni simulator Clinical Dynamics AccuSim Handheld NIBP v lasti KMA - Kosovske meroslovne agencije in simulator Rigel UNI-SIM NIBP v lasti zasebne družbe za medicinsko opremo na Kosovu NT SH MAM. Za primerjavo treh simulatorjev so bile uporabljene statistične metode po standardu ISO 13528, pri čemer je bilo za primerjavo simulatorjev uporabljeno število En. Trije merilniki krvnega tlaka: Omron M2, Omron M6 in Microlife BP A100 Plus so bili uporabljeni kot standardi prenosa za primerjavo treh simulatorjev. Clinical Dynamics Smart Arm NIBP simulator iz laboratorija LMK je bil upoštevan kot referenčni simulator, zato smo na koncu meritev izvedli še en cikel meritev, da smo cikel meritev zaključili. Poleg tega so bili opravljeni pregledi treh monitorjev NIBP s tremi simulatorji v skladu z OIML R 149: 2020. Uporabili smo pet različnih nastavitev krvnega tlaka, kot sledi: 80/50, 100/70, 120/80, 150/100, 180/130. Hitrost pulza je bila vedno nastavljena na 80 utripov na minuto. Za vsak simulator in vsako od nastavitev je bilo opravljenih 10 meritev sistoličnega in diastoličnega tlaka. Naš cilj je bil oceniti, ali je En primeren tudi za primerjavo NIBP simulatorjev. Za primerjavo simulatorjev smo uporabili tri različne standarde prenosa, hkrati pa tudi oceno, kako pomembno je, da je standard prenosa v dobrem stanju, z uporabo novega monitorja (Omron M2), rabljenega monitorja (Omron M6) in dotrajanega monitorja (Microlife ). Na koncu smo ugotovili, da je enačba En primerna za primerjavo simulatorjev, kadar je uporabljeni monitor NIBP znotraj tolerančnih meja, predpisanih v OIML R 149: 2020. Pomanjkljivosti uporabe enačbe En so bile ugotovljene za oceno rezultatov pri uporabi dotrajanega monitorja NIBP.

• Keywords: simulator NIBP, meritve krvnega tlaka, monitorji NIBP, zakonodaja o medicinskih pripomočkih, ureditev medicinskih pripomočkov