Höss Angelika, Lampe Christian, Panse Ralf, Ackermann Benjamin, Naumann Jakob, Jäkel Oliver
Heidelberg Ion-Beam Therapy Center (HIT), Im Neuenheimer Feld 450, 69120 Heidelberg, Germany.
Radiat Oncol. 2014 Mar 21;9:79. doi: 10.1186/1748-717X-9-79.
According to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of medical device software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture).
The EN 62304 standard outlines minimum requirements for each stage of the software life-cycle, defines the activities and tasks to be performed and scales documentation and testing according to its criticality. The required processes were established for the pre-existent decision-support software FlashDumpComparator (FDC) used during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates compliance with the EN ISO 14971 standard on the application of risk management to medical devices, a risk analysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels.
The EN 62304 standard is difficult to implement without proper tools, thus open-source software was selected and integrated into a dedicated development platform. The control measures yielded by the risk analysis were independently implemented and verified, and a script-based test automation was retrofitted to reduce the associated test effort. After all documents facilitating the traceability of the specified requirements to the corresponding tests and of the control measures to the proof of execution were generated, the FDC was released as an accessory to the HIT facility.
The implementation of the EN 62304 standard was time-consuming, and a learning curve had to be overcome during the first iterations of the associated processes, but many process descriptions and all software tools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of small and medium-sized medical software can be carried out by a small team with limited resources in a clinical setting. This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to harmonize and tighten the current legal requirements for all European in-house manufacturers.
根据《医疗器械指令》的最新修订案，独立软件在制造商打算将其用于医疗目的时即被视为医疗器械。在此背景下，适用EN 62304标准，该标准定义了医疗器械软件开发和维护的生命周期要求。启动了一个试点项目，以获取在医院环境（内部制造）中实施该标准的技能。
EN 62304标准概述了软件生命周期各阶段的最低要求，定义了要执行的活动和任务，并根据其关键性对文档编制和测试进行分级。针对在治疗相关射束参数质量保证期间使用的现有决策支持软件FlashDumpComparator（FDC）建立了所需流程。由于EN 62304标准意味着要符合关于医疗器械风险管理应用的EN ISO 14971标准，因此进行了风险分析，以识别潜在危害并将相关风险降低到可接受水平。
如果没有合适的工具，很难实施EN 62304标准，因此选择了开源软件并将其集成到专用开发平台中。风险分析产生的控制措施得到独立实施和验证，并对基于脚本的测试自动化进行了改造，以减少相关的测试工作量。在生成了所有有助于将指定要求追溯到相应测试以及将控制措施追溯到执行证明的文档之后，FDC作为医院信息系统设施的附件发布。
EN 62304标准的实施耗时较长，在相关流程的首次迭代过程中必须克服学习曲线，但许多流程描述和所有软件工具都可在后续项目中重复使用。事实证明，一个资源有限的小团队可以在临床环境中对中小型医疗软件进行符合标准的开发。这一点尤为重要，因为预计即将修订的《医疗器械指令》将协调并收紧目前对所有欧洲内部制造商的法律要求。
