[Editor's note: The IEC 60601-1 standard is an international standard for electro-medical equipment safety. The third edition, issued in 2005, had a compliance deadline of June 2012 for the European market (EN 60601-1:2006), and July 2013 for the U.S. market.]
The third edition of IEC 60601-1 requires that manufacturers circumvent the risks of poor usability that can arise in identification, marking and documents by applying usability engineering to medical devices in compliance with IEC 62366.
Enhancing usability for safety and competitiveness
Wherever medical devices are used there is a responsibility to make sure all such products available on the market are well-designed and ergonomic. The simpler and more intuitive a medical product is to use, the safer it will be for patients. Consequently, safer and easier to use products are more competitive.
In 1999, a report entitled ĎTo Err is Human: Building A Safer Health Systemí Was issued by the Institute of Medicine. The report stated that at least 44,000 people die annually in US hospitals from preventable medical errors, and that perhaps this is as high as 98,000 people. It concluded that rather than being due to individual carelessness, most medical errors are caused by faulty processes, conditions, and systems that either lead people to make mistakes or fail to avoid making them.
The European MDD and United States FDA both demand that medical devices are developed by taking into account the errors arising from risks of use and human factors. The 3rd edition of IEC 60601-1 (specifically IEC 60601-1-6) is an example of an international standard that seeks to minimize the risks of poor usability by applying usability engineering.
The usability engineering cycle
Questioning and observing users to iteratively discover how they actually use the equipment or software with early prototypes is a valuable part of the tuning process of product development.
Extensive guidance about how best to minimize the risks with usability engineering is provided in IEC 62366 including a user-interfaced medical design cycle as follows:
Click on image to enlarge.
Proposal 62A/799/DC seeks to address the problem of existing products lacking usability engineering by initiating a fast-track amendment to IEC 62366 compliance. The proposed amendment introduces an evaluation of User Interface Of Unknown Provenance (UOUP) and a new Annex K to ensure engineering processes include usability in legacy devices, minor revisions of devices and standard components embedded in medical devices. Designing for good usability
Usability engineering is best incorporated from the outset and the process should be continuously documented to comply with IEC 62366. Good usability offers competitive advantages as a very good differentiator under conditions of market saturation.
If users are able to use a product intuitively without needing workarounds, your product design is on target. If you have also designed an appealing medical device or application, you are sure to reap the rewards.About the authorSeppo Vahasalo
is Medical Devices Group Manager at SGS Fimko. He has earned his Ph.Lic. Degree from the University of Helsinki, with a major in Physics, IT and Measuring Technology. Vahasalo has over 20 years of experience in the area of medical electrical equipment technology and joined SGS
* in 2011.
*SGS is an inspection, verification, testing and certification company with 70,000 employees in over 1,350 offices and laboratories around the world.