Compilation About Adverse Events Recorded in FDA/ USA and ANVISA/Brazil Databases Through Models Available in the Literature Concerning Analysis and Prioritization of Actions for Medical Devices
Main Article Content
Keywords
Adverse events, ANVISA, ECRI’s top ten health hazards, FDA, Medical devices
Abstract
The use of medical technologies has grown steadily in all health fields, offering numerous benefits to patients. However, related adverse events, which may cause severe consequences for patients, also have increased. Technical factors and human aspects that cause dangers to patients may be related to the complexity of the devices, quality control in manufacturing, software used, maintenance procedures, materials, and mode of use. Thereby, our objective is to present the main alerts, dangers, and failures related to medical equipment and ways to attenuate them. For that purpose, we performed an analysis of adverse events reported for medical equipment in the Food Drugs Administration (FDA/USA) and the Brazilian Health Surveillance Agency (ANVISA) databases, since 2016. Finally, we classified the events into different categories, according to similarity. The results show a total of 3,100 cases registered in the FDA for six types of equipment at the study and 75 cases in ANVISA for two of these equipment. Based on the top ten health hazards (2016-2020) provided by the Emergency Care Research Institute (ECRI) we were able to understand which equipment most offers hazards and the main ways to mitigate them. We found that the risks are common to medical devices, therefore, it is crucial that there are preventative measures to avoid them, for example, training users to use the products, maintenance, improving quality, and reporting adverse events to manufacturers.
Downloads
Abstract 4454 | PDF Downloads 709
References
2.Nota Técnica Nº 01/2020. Orientações para enfrentamento à pandemia de Covid-19. ABEClin, 2020. Available at: https://ced.ifmbe.org/images/COVID-19_ENGENHARIA_CLI%CC%81NICA-Equipamentos_e_infraestrutura.NOTA_TE%CC%81CNICA_N%C2%BA_01_ABECLIN_Bahia_2.pdf
3.Freitas E V S, Artega M A P, Cardoso P A, et al. A Review About Equipment for Mechanical Ventilation in Intensive Care to Combat COVID-19 and the Role of Clinical Engineers. In: XXVII Brazilian Congress in Biomedical Engineering, 2020, Vitoria. Proceedings CBEB2020, 1054-1059.
4.ANVISA. RDC nº 02: Gerenciamento de tecnologias em saúde em estabelecimentos de saúde, 2010.
5.Gao X, Wen Q, Duan X, et al. A hazard analysis of class I recalls of infusion pumps. JMIR Human Factors 2019;6(2):e10366. doi 10.2196/10366
6.United States Food and Drug Administration. Data Mining at the Center for Devices and Radiological Health. FDA; 2018. Available at: https://www.fda.gov/science-research/data-mining/data-mining-center-devices-and-radiological-health
7.United States Food and Drug Administration. Medical Device Reporting (MDR): How to Report Medical Device Problems. FDA, 2020. Available at: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
8.United States Food and Drug Administration. OpenFDA. FDA, 2019. Available at: https://www.fda.gov/science-research/health-informatics-fda/openfda.
9.Electronic Code of Federal Regulations. DC-defibrillator (including paddles)., 2021. Available at: https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=3dfaca70be1507ca8fdb5029de41c3d7&mc=true&r=SECTION&n=se21.8.870_15300.
10.Electronic Code of Federal Regulations. Automated external defibrillator system., 2021. Available at: https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=7d33d575fa607c396a47d06b8b5faa0b&mc=true&r=SECTION&n=se21.8.870_15310.
11.Golpaygani AT, Movahedi MM, Reza M. A study on performance and safety tests of defibrillator equipment. J Biomed Physics Engineering 2017;7(4):397.
12.Infusion Pumps. FDA, 2018. Available at: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/infusion-pumps
13.Bonafide CP, Localio AR, Holmes JH, et al. Video analysis of factors associated with response time to physiologic monitor alarms in a children’s hospital. JAMA Pediatrics 2017;171(6):524-531. doi 10.1001/jamapediatrics.2016.5123.
14.Pham JC, Williams TL, Sparnon EM, et al. Ventilator-related adverse events: a taxonomy and findings from 3 incident reporting systems. Respir Care 2016;61(5):621-631. doi 10.4187/respcare.04151.
15.Crispi CP, Crispi Jr CP, da Silva Reis Jr, et al. Hemostasis with the ultrasonic scalpel. J Soc Laparoendosc Surg 2018;22(4). doi 10.4293/JSLS.2018.00042.
16.Schabacker M. Awareness Alone Won’t Improve Medical Device Safety. ECRI; 2018. Available at: www.ecri.org/press/improve-medical-device-safety.
17.Avendaño G. Critical importance of multilateral studies related with adverse events in medical devices. Health Technol 2016;6(3):213-227.
18.Amoore JN. A structured approach for investigating the causes of medical device adverse events. J Med Engineer 2014.
19.Shepherd M. A systems approach to medical device safety. In: Clinical Engineering Handbook, Ed. J. Dyro Pub: Elsevier Academic Press; 2004:246-249.
20.Reason JT. Human error: models and management. Bmj, 2000;320(7237):768-770.
21.ECRI. Top Ten Technology Hazards for 2016. Health Devices, 2015. Available at: https://www.ecri.org/Resources/Whitepapers_and_reports/Top_Ten_Technology_Hazards_2015.pdf.
22.ECRI. Top Ten Technology Hazards for 2017. Available at: Health Devices, 2016. https://www.ecri.org/Resources/Whitepapers_and_reports/2016_Top_10_Hazards_Executive_Brief.pdf.
23.ECRI. Top Ten Technology Hazards for 2018. Health Devices, 2017. Available at: http://www.ecri.org/Resources/Whitepapers_and_reports/Haz17.pdf.
24.ECRI. Top Ten Technology Hazards for 2019. Health Devices, 2018. Available at: https://www.draeger.com/Library/Content/Haz_18.pdf.
25.ECRI. Top Ten Technology Hazards for 2020. Health Devices, 2019. Available at: https://www.ecri.org/Resources/Whitepapers_and_reports/Haz_19.pdf.
26.Evans R S, Johnson K V, Flint V B, et al. Enhanced notification of critical ventilator events. J Am Med Inform Assoc 2005;12(6):589-595. doi 10.1197/jamia.M1863.
27.Ruppel H, Funk M, Whittemore R. Measurement of physiological monitor alarm accuracy and clinical relevance in intensive care units. Am J Crit Care 2018;27(1):11-21. doi 10.4037/ajcc2018385.
28.Peng M, Meng Z, Yang Z H, et al. The ultrasonic harmonic scalpel for circumcision: experimental evaluation using dogs. Asian J Androl 2013;15(1):93. doi 10.1038/aja.2012.67.
29.Ferri E, Armato E, Spinato G, et al. Harmonic scalpel versus conventional haemostasis in neck dissection: a prospective randomized study. Internat J Surg Oncol 2013. doi 10.1155/2013/369345.
30.Otani M, Machado W V. A proposta de desenvolvimento de gestão da manutenção industrial na busca da excelência ou classe mundial. Revista Gestão Industrial 2008;4(2):1-16.
31.ABNT, NBR 5462. Confiabilidade e Mantenabilidade; 1994.
32.ABNT, NBR 15943. Diretrizes para um programa de gerenciamento de equipamentos de infraestrutura de serviços de saúde e de equipamentos para a saúde; 2011.
Article Sidebar
Article Details
This work is licensed under a Creative Commons Attribution 4.0 International License.
Author(s) must obtain all parties consent [co-author(s), others if applicable] and submit the acceptance of Copyright Agreement with their paper. Written permission must be obtained by the author for material that has been published in copyrighted material; this includes tables, figures, and quoted text that exceeds 150 words. A copy of all permissions must accompany the manuscript when published in copyrighted material. The author(s) hereby represents and warrants that the paper is original and that he/she is the author of the paper, except for material that is clearly identified as to its original source, with permission notices from the copyright owners where required. Author(s) must clearly indicate that approval for publication has been received in cases of institutional ownership.
In all submitted material authors retain all copyrights; however, the GlobalCE Journal reserve the right to reprint all or portions of the article and to post all or part of the article online. GlobalCE Journal reserves the right to edit manuscripts as required to publish in the journal. Authors are responsible for obtaining any and all clearances as appropriate. Unless stated otherwise, all articles are open-access and distributed under the terms of the Creative Commons Attribution License (CC BY 4.0) which permits unrestricted use, distribution, and reproduction in any medium, provided the original author(s) and original work (e.g. first published in the Global Clinical Engineering Journal) is properly cited with the original URL and bibliographic citation information. The complete bibliographic information, a link to the original publication on www.Globalce.org well as the copyright and license information must be included. No use, distribution or reproduction is permitted which does not comply with these terms.
