Facing Ventilator Technology Issues Openly: Upcoming AAMI/FDA Summit Will Help Lead Change

By Robin S. Baum

Here’s the good news: ventilator innovation has advanced at a breakneck pace in recent years, and has helped many at-risk patients survive and even thrive with the help of more sophisticated assistive breathing devices. The bad news: the complexities and wide variations of design, application and operation of these technologies has sometimes challenged healthcare providers and become a safety risk for patients, for a huge variety of reasons. The list of 10,000-plus reported ventilator adverse events documents a wide assortment of major and minor issues; from ventilator-associated pneumonia (VAP) that caused illness or death; to human factors (such as an unreleased pause button or an alarm that was missed) that caused temporary or minor injury; to computer or technical glitches or voluntary recalls that did not impact patient health at all. Concerned stakeholders have acknowledged that this is an appropriate point in time to discuss the most pressing of these challenges in order to develop solutions that help assure optimal patient safety and outcomes.

One such high-level gathering of influencers is the AAMI/FDA Ventilator Technology Summit, which is planned for Sept. 16-17, 2014, in Herndon, Va. This will be the sixth joint event hosted by the Association for the Advancement of Medical Instrumentation (AAMI) and the Food and Drug Administration (FDA). It builds on the knowledge gained from earlier summits, but is different in that it will address a breadth of issues related specifically to one technology – ventilators – in clinical areas (operating rooms, critical care units and other higher risk healthcare delivery settings). The previous summit, in comparison, dealt with multiple healthcare technologies, including ventilators, in the nonclinical setting. As with all previous AAMI/FDA summits, the Ventilator Technology Summit will be professionally moderated and will follow the same successful format, to engage attendees in fair and balanced discussion and help them prioritize and achieve consensus on the most pressing issues and potential solutions.

“Two days is a very short time when there is so much to discuss, so this will be a jam-packed event,” says Scott Colburn, MS, BSN, RN, commander, U.S. Public Health Service and director of the CDRH Standards Program. In spite of the time crunch, Colburn is looking forward to what FDA can learn from the subject matter experts who participate, and what the attendees can potentially achieve. “My hope is that the scope of this summit will allow the group to be more granular in their discussions, and will enable tangible solutions,” he adds.

Deborah Reuter, senior vice president of education for AAMI, is equally optimistic. “The professionals involved in these summits attend because they want to make a difference,” she says. “They typically get charged up by the experience and want to take the information back and use it to make meaningful change happen. I expect that this interaction of thought leaders will be as successful as our other joint summits have been.”
 
An Objective Resource
AAMI is an international alliance of more than 7,000 members that includes healthcare individuals and professionals representing healthcare institutions, research and teaching facilities, government agencies, manufacturers, testing operations and trade associations. AAMI is a neutral party, a convener of diverse healthcare stakeholders and a producer of high quality, objective information. It is “dedicated to supporting the healthcare community in the development, management and use of safe and effective medical technology,” and is not involved in advocacy. Within this neutral culture, it’s all in a day’s work for AAMI to convene thought leaders who share knowledge and achieve consensus that helps create positive change. In addition, AAMI produces a formal summary publication of each summit’s consensus decisions and makes it publicly available at no charge, to assure that high quality information on issues and solutions is widely shared among those who can use it best.

A Willing and Engaged Collaborator
Government agencies are well represented among AAMI members, and are active participants in the work of the organization. The FDA, part of the Department of Health and Human Services, is responsible for ‘assuring the safety, efficacy and security of human and veterinary drugs, biological products and medical devices…” among many other responsibilities. In this sense, FDA’s mission aligns well with AAMI’s and has a number of similar goals. “The agency is genuinely interested in helping develop workable, realistic solutions to urgent health and safety issues that address the needs of patients, healthcare providers and medical device manufacturers,” stresses Colburn. “We see ourselves as a customer (of manufacturers and other industry providers) that also serves customers (the American public), so we are aware of the needs of both sides of this relationship.” As such, the agency is a fitting partner for these joint summits.

Clarion Themes: Another Value-Added Takeaway
In addition to the free AAMI publication, a valuable end product of each AAMI/FDA summit is the establishment of clarion themes, which are consensus-built, immediate calls to action that are derived from the issues that were discussed and prioritized. For example, two of the clarion themes derived from the 2013 AAMI/FDA Summit on Healthcare Technology in Nonclinical Settings are:
1. Deepen all stakeholders’ understanding of use environments and their remarkable variability. Research, information exchanges and assessments of nonclinical use environments and practices … will help the healthcare community improve patient outcomes.
2. 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.

Although the clarion themes for this summit will not be known until the event ends, Colburn and Reuter have identified some of the issues that are being considered for the agenda. These are based on information received from numerous stakeholders, adverse event reports and other relevant sources, and they could contribute to the clarion themes of the 2014 summit. They include:
• Infection risks (VAP)
• Interoperability issues (lack of communication capability with other systems in an integrated clinical setting)
• Biocompatibility testing (biological evaluation of components that come into direct or indirect contact with the human body to assess sensitivities, toxicity issues)
• Lack of standard terminology/graphics used on the systems and in instructions for use (causes confusion)
• Power and battery concerns (how to test them, back-up concerns, environmental conditions that may affect them)
• Alarms, alarm fatigue and other related human factor issues
• Instructions for use (inconsistent, poorly written, or not comprehensive)
• Design control issues (failure to cycle, poor human factor design, inconsistent operation)
• Quality systems engineering issues
• Developing general performance requirements
• Global approach to design (harmonization across borders)
• Design-related human factors (ease of use, training ease, unintended consequences of human interaction with the devices)
 
These topics and others that may be brought forward by summit leaders will be prioritized and organized into the agenda for the two-day event. As more information on participants, the agenda and other details becomes available, it will be posted on the AAMI Ventilator Technology Summit site, at http://www.aami.org/summit2014/index.html.

Catalyzing Change
Ventilator-associated pneumonia, one of the most serious consequences of ventilator use, has been reported to occur in patients at a rate of up to 4 per 1,000 ventilator days, and in some neonatal and surgical patients at up to 10 per 1,000 ventilator days. VAP has also been estimated to have a potential mortality rate of greater than 10 percent. Ironically, patients with VAP also tend to require prolonged time on a ventilator, extended hospital stays, prolonged antibiotic use, and significant additional medical costs.

If this one preventable consequence of ventilator use could be eliminated, it would greatly reduce unnecessary suffering and significantly improve patient outcomes. Imagine the exponentially higher patient safety gains that could be made if all the listed issues were addressed successfully.
Realistically, working through healthcare issues is a complex process that requires balanced consideration of the needs of several constituencies: patients, healthcare providers, manufacturers, and regulating and standards bodies. In addition, people are inherently resistant to change, so it does not happen overnight. Regardless of these obstacles, the potential is there for 2014 AAMI/FDA summit participants to become the catalysts for progress toward optimized ventilator design, quality, function, biocompatibility and interoperability, and toward much improved patient health and safety.

Robin S. Baum is a healthcare writer with 13 years of experience writing for medical device manufacturers, research scientists, sterile processing professionals, perioperative professionals, hospital executives and other healthcare providers. She is based in the Cleveland, Ohio area.

References

1. FDAble search results: http://www.fdable.com/basic_query/maude/1bcd144f6911a91e7b3792f2e08f5e84 
2. About AAMI: www.aami.org
3. AAMI Standards Philosophy and Strategy - Key Elements: http://www.aami.org/standards/philosophy.html
4. Take Precautions with Audible Alarms on Ventilators; http://www.fda.gov/medicaldevices/safety/alertsandnotices/tipsandarticlesondevicesafety/ucm270894.htm
5. A Vision for Anywhere, Everywhere Healthcare: Priority Issues from the 2013 AAMI/FDA Summit on Healthcare Technology in Nonclinical Settings: http://www.aami.org/publications/summits/HomeHealthcare.pdf
6. National Healthcare Safety Network (NHSN) report, data summary for 2012, Device-associated module; http://www.cdc.gov/nhsn/PDFs/2012-data-summary-nhsn.pdf
7. Ventilator-associated Pneumonia (CDC); http://www.cdc.gov/hai/vap/vap.html
8. Infection Control & Hospital Epidemiology: Strategies to Prevent VentilatorAssociated Pneumonia in Acute Care Hospitals; http://www.jstor.org/stable/10.1086/591062