European standard on usability engineering of medical devices updated to address legacy products
This article was originally published in SRA
The European standard on application of usability engineering to medical devices, EN 62366:2008, has been amended with new requirements pertaining to legacy devices "where the user interface design is of unknown provenance"1.
The amendment EN 62366:2008+A1:2015 supersedes EN 62366:2008, which will be withdrawn on 14 April 2018, a BSI spokesperson explained to Scrip Regulatory Affairs. Until the 2018 deadline, companies can continue using EN 62366:2008.
EN 62366:2008 has also been broken into two parts, with part 1 being a full standard and containing updated normative requirements for the application of usability engineering to medical devices, and part 2 being a technical report and containing guidance on the application of usability engineering2.
"This [breaking up of the standard in to two parts] reduces the size of the normative standard and allows the guidance document to be updated more easily to keep pace with the state-of-the-art in usability engineering without having to republish the normative standard," the spokesperson explained. In the UK, part 1 was published as BS EN 62366-1:20152 and will supersede the newly published BS EN 62366:2008+A1:2015.
Rationale for the amendment
BSI explained that the amended EN 62366:2008+A1:2015 is identical to IEC 62366:2007+AMD1:2014. In addition to defining the term "user interface of unknown provenance (UOUP)", the amendment includes a new normative annex K for evaluation of a user interface of unknown provenance.
Annex K has been created in recognition of the fact that device manufacturers may be interested in applying usability engineering tools to user interfaces of devices that had been commercialized before the standard was published. Such user interfaces were not developed using the processes of IEC 62366 and are therefore of unknown provenance, the amendment explains.
The amendment recommends an "abbreviated" usability process for such devices as it does not include requirements for usability verification and validation, says Yvo Dürr, regulatory senior specialist at medical device company Zimmer GmbH. The amendment is quite important for large medtech companies as they may have many legacy devices, Mr Dürr told SRA.
BSI explained that use errors caused by inadequate medical device usability have become an increasing cause for concern. Many of the medical devices developed without applying a usability engineering process are non-intuitive, difficult to learn to use.
"The design of a usable medical device is a challenging endeavour, yet many organizations treat it as if it were just 'common sense'. The design of the user interface to achieve adequate (safe) usability requires a very different skill set than that of the technical implementation of the user interface… The usability engineering process [described in the standard] is intended to achieve reasonable usability, which in turn is intended to minimise use errors and to minimise use-associated risks. Some, but not all, forms of incorrect use are amenable to control by the manufacturer," the BSI spokesperson explained.
BSI clarified that the use of standards is not mandatory. Standards are voluntary guidance documents that businesses and organizations can implement to ensure they are following best practice within their field. "Where there is a lawful regulatory requirement, it is advisable for them [the standards] to be used in conjunction with that particular directive," BSI said.
References
1. BS EN 62366:2008+A1:2015, Site accessed 19 June 2015, http://shop.bsigroup.com/ProductDetail/?pid=000000000030269446
2. BS EN 62366-1:2015, Site accessed 19 June 2015, http://shop.bsigroup.com/ProductDetail/?pid=000000000030244509