Farfán-Vargas Harold M, Espinoza-Morriberon Dante, Moya-Salazar Marcia M, Contreras-Pulache Hans, Moya-Salazar Jeel
School of Biomedical Engineering, Faculty of Engineering, Universidad Tecnológica del Perú, Lima, Peru.
Digital Transformation Center, Universidad Norbert Wiener, Lima, Peru.
Front Med (Lausanne). 2024 Jun 21;11:1281199. doi: 10.3389/fmed.2024.1281199. eCollection 2024.
Metrology plays a crucial role in small healthcare service businesses to ensure the quality of products and services. While legal metrology in healthcare exists in some regions, it lacks harmonization. In other countries, there is limited presence of metrology in medical and biomedical engineering. We aimed to evaluate the implementation of metrological assurance systems for medical devices in Latin America.
A systematic review was conducted following PRISMA 2020 guidelines and registered with PROSPERO (CRD42022359284). Searches were performed across 13 databases from October 30th to November 3rd, 2022. The search equation was "(((quality assurance) AND (metrology)) AND (medical devices))." A total of 7,789 documents were identified, of which only 16 met the inclusion criteria.
The majority of studies (75%) were conducted in Colombia, with a significant portion being undergraduate theses. The primary normative references used in the analyzed studies were ISO 10012 and ISO 17025, with the majority (68.75%) relying on national legislation for their approach. One study in Colombia referenced eight standards, and one in Brazil analyzed user involvement in medical device management. Among the included studies, 56.25% were conducted in healthcare institutions, mainly clinics. Most studies provided implementation guidelines, with ISO 10012 being prominent, alongside ISO 17025, which implicitly addresses ISO 9001 elements. Global bias was low across all studies.
Our results underscore the importance of metrological assurance in managing medical devices in Latin America. The utilization of international standards and national legislation illustrates the diverse approaches adopted by different institutions. Future research should focus on optimizing metrological practices to enhance quality and safety in healthcare.
计量在小型医疗服务企业中起着至关重要的作用，以确保产品和服务的质量。虽然医疗领域的法定计量在一些地区存在，但缺乏协调性。在其他国家，医疗和生物医学工程中的计量应用有限。我们旨在评估拉丁美洲医疗器械计量保证体系的实施情况。
按照PRISMA 2020指南进行系统综述，并在PROSPERO（CRD42022359284）上注册。于2022年10月30日至11月3日在13个数据库中进行检索。检索式为“(((质量保证) AND (计量)) AND (医疗器械))”。共识别出7789篇文献，其中只有16篇符合纳入标准。
大多数研究（75%）在哥伦比亚进行，其中很大一部分是本科论文。分析的研究中使用的主要规范性参考文献是ISO 10012和ISO 17025，大多数（68.75%）在其方法中依赖国家立法。哥伦比亚的一项研究引用了八项标准，巴西的一项研究分析了用户在医疗器械管理中的参与情况。在所纳入的研究中，56.25%在医疗机构进行，主要是诊所。大多数研究提供了实施指南，其中ISO 10012较为突出，同时还有隐含涉及ISO 9001要素的ISO 17025。所有研究的整体偏倚较低。
我们的结果强调了计量保证在拉丁美洲医疗器械管理中的重要性。国际标准和国家立法的使用说明了不同机构采用的不同方法。未来的研究应侧重于优化计量实践，以提高医疗保健的质量和安全性。
