Infusion Insight: The AAMI Foundation’s National Coalition to Promote the Safe Use of Complex Healthcare Technology

To Err is Human . . .

Mistakes happen—and of course healthcare professionals are no exception. In today’s rapidly evolving hospital environment, the risks of technology-related errors are greater than ever before because new innovations introduce challenges to clinicians almost daily. But is the problem really human error, process or machine . . . or all of the above?

In April, Ivenix participated in a two day kick-off meeting addressing the challenges associated with introducing, using, and upgrading complex healthcare technologies. In this context, complex technology is defined as “technology that cannot be fully mastered for safe and reliable use in a very quick in-service.” The event brought together thought leaders from health systems, industry associations, regulatory bodies, and the medical device community to further the goal of avoiding errors and enhancing patient safety.

Healthcare, as we all know, tends to rely on user initiatives such as training to improve performance and demonstrate competency, and proper training is important. However, as Marilyn Neder-Flack, Executive Director for the AAMI Foundation, notes: “We have found that there are limitations in most training programs because of the lack of time afforded to the clinicians for the training. The full breadth of what they need to know is not covered. Additionally, work must be done to improve the usability of many of the medical devices’ interfaces so they are easier to learn and to use.”

Many risk management theorists agree and rate the impact of these behavioral interventions aimed solely at users as limited in impact. They advocate broad systemic changes—changes that cut across device design, administrative, cultural and hospital environmental perspectives. The committee also agreed and believes providers can’t go it alone. All technology stakeholders must play a role to ensure success.

In particular, vendors must employ user-centered design and rely on principles of human factors engineering to develop equipment based on clinician workflow and the hospital environment with an understanding of the user’s mindset. Hospitals must also define workflow, develop troubleshooting scenarios during the implementation process, and put mechanisms in place to assess competency and proficiency on an ongoing basis. And that’s just the beginning.

How will the Coalition address these challenges? During the next two years, several initiatives have been identified to provide health systems and the industry with the resources needed to take a systems approach to improving the safe use of complex medical devices throughout their lifecycle. This includes:

• Best practices for selecting and purchasing complex technology
• Best practices for educating and training for the use of complex technology
• Best practices for establishing minimal levels of proficiency and for assessing that proficiency
• The business case for allocating financial resources to improve how clinicians are prepared for safe use of complex technologies
• Design & development considerations for medical devices

In Neder-Flack’s words: “Through this new coalition, the AAMI Foundation and its partners want to tackle this on the technology side, to see what we can do to better prepare clinicians and discuss what the healthcare industry should be doing overall to mitigate this risk. I am thrilled that Ivenix is partnering with us on this incredibly important effort!”

Ivenix is proud to partner with the AAMI Foundation on this important initiative.

Julie Kuhlken is Director of Product Marketing for Ivenix, Inc.