When it comes to healthcare, even software can be considered a medical device! And with the potential gains in patient safety that can be achieved by the use of computerization in the health field, it’s no wonder we’ve seen an explosion of new applications in the last 10 years. But the widespread adoption of networked products and computer-aided instruments can have some unintended consequences as well. With patients’ safety at risk, those entering this arena must be vigilant to avoid adverse outcomes. It’s for these reasons that the new ISO/TR 17791, “Health informatics – Guidance on standards for enabling safety in health software,” has just been released.
Part of the reason for the technical report is the realization that products that have been developed as stand-alone devices actually operate in a environment that contains any number of systems, technologies, and other infrastructure components. This may mean the need to configure these products to meet a customer’s clinical and/or business processes.
Thus the ISO/TR 17791 discusses the issues surrounding software safety in this context, as well as a description of the relevant standards. Then it gives you an analytical perspective so you can determine which standards are appropriate for each stage of your software cycle.
The beauty of this document is that it discusses the inclusion of software within the medical device product domain and uses the referenced standards to show how they support improved processes and outcomes. It has three standards assessment maps giving a visual reference for it’s recommendations.
Another feature of this report is that many gaps that are identified, places where existing standards do not address the specific requirements of health care software. The goal of the document is to help you identify standards for your software lifecycle (design, development, implementation, operation and decommission). Where there is no standards support, the authoring committee points out the situation. For example, the committee notes that there is a need at the international level for guidance on clinical workflow documentation, analysis and redesign, and safe practices.
While there is little hard information on software safety within the healthcare environment, a proactive incident management process has been put into place at the National Health Service in England. During 2006 to 2010, 708 incidents were documented and investigated. It was found that about 80% had some potential risk to patient safety.
This is a very new field, filled with as yet unknown risks. The use of ISO/TR 17791 provides a map of the known and unknown world for software developers. We suggest that any organization involved in developing, manufacturing and marketing medical device software, whether stand-alone or integrated into another device, needs to review this report. It will help you to understand the territory you’re now entering.
Of course, all current ISO standards (and many obsolete ones) can be purchased at Document Center’s webstore, www.document-center.com. And you are always welcome to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re a licensed dealer of standards from many organizations (including ISO) and we’re here to improve the way you collect and use technical documentation. Make us your Standards Experts!
