The AAMI/FDA Summit on Healthcare Technology in Nonclinical Settings brought together leaders from the medical device industry and regulatory bodies, clinicians from healthcare institutions, researchers, and others to identify, discuss, and formulate strategic initiatives and priorities focused on ensuring the safety and effectiveness of medical technology in nonclinical settings.

With so much going on around human factors in healthcare, I was particularly interested in the challenges surrounding home healthcare, especially since an increasing number of Farm’s clients are developing devices destined for use outside the hospital.

The format of AAMI/FDA summits is more participatory than most, which I like. Only one topic is addressed at a time, beginning with one or more speakers who are experts on the designated topic followed by a moderated brainstorm where the audience participates in answering the following questions:

• What are the key issues regarding the topic;
• What are the barriers to overcoming these issues (including research gaps); 
• What changes need to occur in order to overcome the barriers; and
• Based on the issues, barriers, and what needs to change, what are the top 3‐5 priorities for follow-up assessment and action?

One key takeaway for me was my fellow participants’ heightened awareness of the critical roles played by human factors engineering and user-centered design in solving the issues that were raised during the discussion. 

AAMI just published a report from the summit, titled: A Vision for Anywhere, Everywhere Healthcare.” The five clarion themes from the event were:

1. Deepen all stakeholders’ understanding of use environments, and their remarkable variability. Research, information exchanges, and assessments of nonclinical use environments and practices—in homes, schools, offices, and public venues; in transit and beyond—will help the healthcare community improve patient outcomes.

2. Coordinate multiple and recurring transitions in care to improve patient safety. Delivering seamless care and support services to patients (and caregivers) as they move between clinical and nonclinical settings, interact with service and equipment providers, and adapt to medical technology will help instill a culture of safety.

3. Adopt a systems approach, encompassing people, workflows, therapies, technology, and payment, to redesign the full spectrum of healthcare in nonclinical settings. Synchronizing the disjointed components of healthcare delivery in nonclinical settings will help improve the quality of patient care.

4. Standardize and simplify. Creating consistency and clarity in regulations, data, information, and testing will support integrated products and services and instill confidence in the security and safety of medical equipment.

5. Design with empathy. Attending to human factors in developing medical devices that are “home-ready” and designed to add value from the patient’s perspective will support innovation and safety in healthcare.