Institute of Global Health Innovation, Imperial College London, London, United Kingdom.
Department of Pharmacology and Toxicology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.
J Med Internet Res. 2021 Dec 13;23(12):e31333. doi: 10.2196/31333.
Pediatric drug calculators (PDCs) intended for clinical use qualify as medical devices under the Medical Device Directive and the Medical Device Regulation. The extent to which they comply with European standards on quality and safety is unknown.
This study determines the number of PDCs available as mobile apps for use in the Netherlands that bear a CE mark, and explore the factors influencing the CE marking of such devices among app developers.
A scoping review of Google Play Store and Apple App Store was conducted to identify PDCs available for download in the Netherlands. CE accreditation of the sampled apps was determined by consulting the app landing pages on app stores, by screening the United Kingdom Medicines and Healthcare products Regulatory Agency's online registry of medical devices, and by surveying app developers. The barriers to CE accreditation were also explored through a survey of app developers.
Of 632 screened apps, 74 were eligible, including 60 pediatric drug dosage calculators and 14 infusion rate calculators. One app was CE marked. Of the 20 (34%) respondents to the survey, 8 considered their apps not to be medical devices based on their intent of use or functionality. Three developers had not aimed to make their app available for use in Europe. Other barriers that may explain the limited CE accreditation of sampled PDC apps included poor awareness of European regulations among developers and a lack of restrictions when placing PDCs in app stores.
The compliance of PDCs with European standards on medical devices is poor. This puts clinicians and their patients at risk of medical errors resulting from the largely unrestricted use of these apps.
儿科药物计算器（PDC）旨在用于临床，根据《医疗器械指令》和《医疗器械条例》，属于医疗器械。它们在多大程度上符合欧洲关于质量和安全的标准尚不清楚。
本研究旨在确定荷兰可作为移动应用程序使用的、带有 CE 标志的 PDC 数量，并探讨应用程序开发者对这些设备进行 CE 标记的影响因素。
对 Google Play 商店和 Apple App Store 进行了范围界定性审查，以确定可在荷兰下载的 PDC。通过查阅应用商店上的应用程序登陆页面、筛选英国药品和保健产品监管局（Medicines and Healthcare products Regulatory Agency）在线医疗器械注册处、以及对应用程序开发者进行调查，确定了抽样应用程序的 CE 认证情况。还通过对应用程序开发者的调查，探讨了 CE 认证的障碍。
在筛选出的 632 个应用程序中，有 74 个符合条件，包括 60 个儿科药物剂量计算器和 14 个输液速度计算器。有 1 个应用程序带有 CE 标志。在对调查做出回应的 20 个（34%）开发者中，有 8 人认为他们的应用程序并非基于其使用意图或功能的医疗器械。有 3 位开发者并没有将他们的应用程序定位于在欧洲使用。可能解释抽样 PDC 应用程序 CE 认证有限的其他障碍包括开发者对欧洲法规的认识不足，以及在将 PDC 放置在应用程序商店时缺乏限制。
PDC 符合欧洲医疗器械标准的情况不佳。这使得临床医生及其患者面临因广泛不受限制地使用这些应用程序而导致的医疗错误风险。
