New VA Center Aims to Partner with Industry on Risk Assessment


By: Martha Vockley

Categories: AAMI News, HTM Professionals, Medical Device Manufacturers

Nurses work with a training dummy in a hospital room.
The Veterans Health Administration (VHA) at the Department of Veterans Affairs (VA) is creating a new center that will support companies in systematically assessing and mitigating healthcare technology risk. This Clinical Systems Performance Evaluation Center (C-SPEC) will be located at the Orlando VA Medical Center, where the VHA’s state-of-the-art SimLEARN National Simulation Center can be used to put products to the test in clinical scenarios.   

C-SPEC is the brainchild of Tandi Bagian, chief engineer at the VA’s National Center for Patient Safety for nearly a decade. She brings an engineer’s mindset, unconventional experience, and considerable clout to the VA’s efforts to improve patient safety.

“I came to the VA knowing nothing about medicine but knowing a lot about complex systems and how you approach them,” Bagian said. She spent the first 20 years of her career at the National Aeronautics and Space Administration (NASA), where she evaluated the risks of complex space technology and trained astronauts and mission control center flight controllers how to work together successfully to achieve mission objectives at Johnson Space Center. Then she spent another 15 years at the Environmental Protection Agency working on advanced technology regulations for fuel cell and hybrid automobiles.

“Healthcare is so much more challenging than going to Mars, because of the variability and the lack of a detailed set of specifications as part of a regulatory framework,” Bagian said. “At NASA, I ran thousands of simulations to identify every failure mode and understand it—and then document what to do with it in the checklist for malfunction procedures. Items that went to space had to meet NASA human systems integration standards for the space shuttle and space station, both of which were derived from Department of Defense human engineering standards, so the crew had the best chance of successfully using them.”

National Patient Safety Center

Building on Years of Patient Safety Initiatives

Since its founding in 1999, the National Patient Safety Center has built a reputation for actively promoting safe use of healthcare technology—within the VHA and beyond. “We’ve encouraged the culture and shown the benefit of proactive enterprise learning,” Bagian said. “As a high-reliability organization, one of our preoccupations is with failure. I’m always asking, ‘What could go wrong?’ People used to ask me why I’m so pessimistic. I’m not pessimistic. I want to be prepared. I want to make sure we can give safe and effective care every time—and I don’t want to have to learn through harming patients.”

Bagian is the point person for the 3,500 reports about medical device and other safety issues submitted every week by the patient safety managers at the VA’s 171 medical centers across the country. Their job is to use standardized root cause analysis tools to assign a risk ranking to every incident, including actual adverse events and close calls, considering the frequency and criticality of hazards of potential adverse events. Most risks can be mitigated locally. But about 15 of these weekly reports rise to the level of national significance—both for the VHA’s 18 regional Veterans Integrated Service Networks and for the wider healthcare community.

Photo portrait of Tandy Bagain
Tandi Bagain, VA

The National Center for Patient Safety further investigates these reported issues, using failure mode and effects analysis to understand the problems. “We learn a lot about what can go wrong in the real world,” Bagian said. “Some of these problems are huge. My team works with our clinical experts and the manufacturer or vendor to understand causes, and then we produce guidance to contain or eliminate vulnerability.” A number of major companies have changed their designs and products because the VA could demonstrate to them what could go wrong.

The National Center for Patient Safety also works closely with the Food and Drug Administration (FDA) to improve medical device safety. For example, the agency asked the VA to share any reports of cracking on the lubricious coatings of catheters. “That’s probably not detectable by my patient safety community,” Bagian said. “They probably wouldn’t report about a little piece of coating on the catheter. They’d probably say the catheter failed.”

Since there is no lab to investigate such issues at the National Center for Patient Safety, Bagian took a different tack. She deployed a crew of summer interns to methodically review and compare the instructions for use for 36 catheters on the market, noting any special instructions for lubricious coatings. “That was very helpful to FDA reviewers,” she said. “They said, ‘We should probably ask manufacturers to comment on this as part of their applications’ for premarket approval or clearance. “Not all manufacturers may have noticed this cracking of the coatings of catheters yet.”

Leveraging CLOUT—and an AAMI Foundation Project

Bagian envisions C-SPEC as a safe space for companies to risk-proof their products—ideally to inform the design and development of their next products. VA human factors engineers, clinicians, and healthcare technology management professionals can partner with companies to comprehensively identify “what can go wrong” with healthcare technology and help mitigate risks early.

Kendra Betz sits on an automated wheelchair.

Evaluation of the iBOT PMB with CLOUT. Credit: VA National Center for Patient Safety

Product designers and developers who take advantage of C-SPEC will benefit from more than 20 years of VA patient safety reporting and insights from watching clinical teams use healthcare technology to perform tasks on patients. They’ll be able to use simulation labs and clinical scenarios in patient environments, such as patient care areas and surgical suites, to see how clinicians really use technology.

“I’m a human factors engineer,” Bagian said. “People are going to make mistakes. They’re tired, they’re doing eight things at once. We want the system to be redundant and robust so that in the worst cases, people still have the opportunity to succeed.”

C-SPEC will build on a process developed in 2018 by the National Center for Patient Safety and the Human Engineering Research Laboratories. The systematic Clinical Limits of Use Tools (CLOUT) process can be used to objectively evaluate products and to improve the design, development, and use of healthcare technology by appropriately classifying its features and limits of safe operation.

In a proof-of-concept project, this partnership applied this process to wheeled mobility devices for adults. The CLOUT process is applicable to all types of wheeled mobility devices, including manual and power wheelchairs, scooters, and power add-on systems. Comprehensive evaluation against established performance criteria, outlined features and functions, and identified limit of use provides objective product information to direct the appropriate prescription, procurement, and safe use of devices in varied environments. The process is directly applicable to all types of wheeled mobility devices, including new and emerging technologies with a multitude of enhanced and unique functions.

“By applying CLOUT, we can evaluate medical technologies based on objective measures, strategic assessment with human factors considerations, and available data instead of relying on product marketing information to guide critical decisions that impact patient safety,” said Kendra Betz, a physical therapist with the National Center for Patient Safety and a co-author of the CLOUT documents. Betz is also a C-SPEC team member.

C-SPEC also will build on a project for the AAMI Foundation’s National Coalition to Promote Safe Use of Complex Healthcare Technology. Bagian, a member of this coalition’s human factors team, brought together pulmonologists, respiratory therapists, and nurses to identify four phases of use for an ICU ventilator and walk through the 15 steps required to complete just one phase of this process. The team used the VHA’s Healthcare Failure Mode and Effect Analysis process to analyze the hazards possible in ventilator setup.

Coming soon!

Complex Technology Solutions, the AAMI Foundation’s anthology of the work of the National Coalition to Promote Safe Use of Complex Healthcare Technology, will be available soon. The anthology describes the failure mode and effect analysis that Bagian led for ventilators.