Testing of infusion pumps in healthcare institutions in Bosnia and Herzegovina

Post-market surveillance of medical devices: A review

“…The fact is that standard ISO 13485:2016 [7] requires manufacturers to maintain a PMS system regardless of how their medical device is classified. However, this approach has its limitations which can be seen through variability of MD performance as reported in studies mentioned above [59][60][61][62][63][64], as well as by the number of reported incidents of the patient injuries and deaths including medical devices [65][66][67]. Given these facts, one can conclude that current status of PMS results in duplication of resources and human effort, lack of strategic coordination, mistrust in medical performance and reliability as well as poor responses to global challenges such as the COVID-19 pandemic which only emphasizes the need for harmonization of MD performance evaluation during PMS.…”

“…According to this legal metrology framework, an independent authorized third body measures MD performance through periodic inspections and the results of inspection are reported in the medical device registry developed for this purpose. Particularly, in Republic of Serbia and Bosnia and Herzegovina independent inspection bodies perform performance evaluation of 12 types of MDs: ECG devices, defibrillators, patient monitors, infant incubators, therapeutic ultrasounds, dialysis machines, anesthesia machines, mechanical ventilators, infusomats, perfusion pumps, high-frequency surgical units and blood pressure devices [59][60][61][62][63]. The results of these inspections are reported in medical device registry [49][50][51] and are used for MD surveillance.…”

Evidence-based clinical engineering: Machine learning algorithms for prediction of defibrillator performance

“…These samples were acquired during annual periodical inspections (2015 2017) of defibrillators in healthcare institutions in Bosnia and Herzegovina according to legal metrology framework for medical devices. [30][31][32][33][34][35][36][37] So, this dataset stored in the developed database [29], consists of measurements taken from the same defibrillator three years in a row (2015-2016-2017), measurements taken from the same defibrillator two years in a row (2016-2017) and measurement taken on a single defibrillator once (either 2015 or 2016 or 2017). Performance measurements were taken by Fluke Biomedical Impulse 7000 DP [30] and electrical safety measurements were taken by Fluke Biomedical ESA 620 [31].…”

“…Measurements of following parameters were taken: (1) mains voltage (live to neutral, neutral to earth, live to earth), (2) protective earth resistance, (3) insulation resistance (normal condition, mains to protective earth), 4 Inspection decision is formed based on safety and performance inspection. [32][33][34][35][36][37][38][39] It can be either positive (device passed inspection) or negative (inspection fail faulty device) [32]. Accurate device means that defibrillator based on safety and performance inspection conforms to all technical and metrological requirements defined in national legislation, international standards and medical device directives/regulations.…”

Viabilização técnico-econômica da calibração de bomba de infusão volumétrica peristáltica linear utilizando um analisador de vazão

“…%, o que indica, segundo o autor, a necessidade de programas de controle de qualidade e verificações periódicas de equipamentos médicos.Outro estudo de avaliação de desempenho realizado com 314 bombas de infusão durante o período de um ano em instituições de saúde públicas e privadas na Bósnia e Herzegovina mostrou que aproximadamente 5,7 % dos equipamentos testados estavam fora de especificação. As causas desse desempenho ruim eram, principalmente, o longo período de uso do equipamento, defeitos de hardware, bem como a falta de manutenção sistemática e de inspeções periódicas de segurança e desempenho(GURBETA et al, 2017).No Canadá, 340 hospitais que participaram de um questionamento sobre bombas de infusão responderam que 58 % dos problemas de funcionamento eram relacionados à taxa de vazão requerida(ISMP Canadá, 2004). Um estudo no Reino Unido mostrou que 6770 relatórios de incidentes com equipamentos eletromédicos foram revisados de 1999 a 2000 e problemas com bombas de infusão foram contabilizados em 36 % dos casos(IADANZA et al, 2004).Outra pesquisa realizada com o banco de dados de Serviço Nacional de Relatório eAprendizagem do Reino Unido identificou 606 registros de incidentes, associados a bombas de infusão, ocorridos em pacientes com tratamentos em residência particular de 2005 a 2015.…”