Fostering an enhanced culture of safety is a necessary condition for addressing challenges with ventilator technology, according to a comprehensive new report from AAMI. The report, “Creating a Culture of Safety, Priority Issues from the 2014 AAMI/FDA Summit on Ventilator Technology,” sheds light on the complex challenges associated with the use of ventilator technology and sets forth a series of ideas for addressing them.
More than 160 multidisciplinary stakeholders brought their expertise, personal experiences, and wisdom to the AAMI/ FDA Summit on Ventilator Technology, which was held Sept. 16-17, 2014, in Herndon, Va. Participants and presenters at the summit shaped a vision of a safer and more effective environment of care for patients who depend on ventilators — remarkable, life-saving equipment that could be even better.
The summit report, sponsored exclusively by Philips Healthcare, describes six “clarion themes” that will be vital to achieving this vision. Patients and the entire healthcare community would benefit from:
1. Clear, standardized language for mechanical ventilation and ventilation modes, used broadly and consistently to improve patient care and enhance clinical information.
2. Shared understanding of biocompatibility expectations for ventilator technology — and a safer, clearer, faster path to market.
3. Clinicians who are consistently trained, competent, and certified to care for ventilated patients and operate the ventilators they use.
4. Integrated devices and systems, including alarm systems, that provide clinicians with comprehensive, actionable information about ventilated patients.
5. Intuitive and consistent user interfaces that make it easy to set up and operate ventilators in clinical and nonclinical settings.
6. A strong and transparent culture of cooperation, coordination, and collaboration in which shared information spurs improvements in the safety and outcomes of mechanical ventilation.
As described in the summit report by Anya Harry, branch chief of the FDA Center for Devices and Radiological Health (CDRH) Respiratory Devices Branch, work is needed to improve patient safety and outcomes, including:
• Balancing adequate gas exchange and avoiding lung injury associated with positive airway pressure and oxygen exposure
• Minimizing the duration of mechanical ventilation with protocol-driven, spontaneous breathing trials and autonomous weaning functionality
• Improving visual and auditory alarm signal functionality
The report is available at www.aami.org/publications/summits/2014_Ventilator_Summit_Report.pdf.
Committee Explores Interaction Between EAS Gates, Medical Devices
With a growing number of patients receiving implantable electronic medical devices, there is increased concern about their exposure to electronic article surveillance (EAS) gates, which are designed to deter shoplifting. AAMI’s Cardiac Rhythm Management Device Committee recently met to discuss the potential risks patients face when they are exposed to these surveillance systems.
The FDA has taken notice, issuing guidance in 2000, titled “Labeling for Electronic Anti-Theft Systems” and summarily referred to as “don’t lean and don’t linger.” The guidance recommends “that all manufacturers of electronic anti-theft systems develop labeling or signage to post on or near all new and currently installed systems, indicating that an electronic anti-theft system is in use.”
At the meeting, committee members discussed whether this guidance was becoming ineffective. A primary concern of the committee, which is co-chaired by Bob Stevenson, senior scientist at Greatbatch Medical in Clarence, N.Y., and Roger Carrillo, MD, thoracic and cardiac surgeon at the University of Miami Hospital, was that many retailers are obfuscating EAS gates. Examples of how EAS gates may be hidden include the following:
• Advertisements and other signage, vending machines, coffee stations, and other attractive elements can cause individuals (including patients with medical devices) to potentially “linger and lean” near EAS gates.
• High-end retailers placing chairs and lounge-type furniture in close proximity to the gates.
• Under-the-floor EAS systems are becoming more prevalent. Because they are not visible, patients may not be aware of their presence.
• Signs alerting people of the presence of EAS gates typically are quite small — typically 3-by-5-inch — and can be easily hidden from view by advertisements or other objects.
To help gain insight into the topic, the committee heard the views of physicians, representatives from pacemaker manufacturers, and scientists who have performed extensive EAS gate testing. In addition, representatives from EAS system manufacturers offered their perspectives.
Hubert Patterson, Tyco vice president and chief technology advisor at Sensormatic in Boca Raton, Fla., provided an EAS manufacturer’s perspective. Patterson said Sensormatic takes the “don’t lean and don’t linger” guidance very seriously and has a policy of “zero harm.” He noted that electromagnetic field (EMF) levels for EAS gates have not changed in 20 years; that Sensormatic is not going to make larger, more powerful systems; and that it does not wish to raise EMF levels, but only maintain current ones.
Furthermore, Sensormatic is revamping its guidance to retailers to mitigate the risk of patients lingering around EAS gates, Patterson said. In addition to sending letters to retailers, the company is educating its front-line sales employees about the dangers of attractive factors that can increase the probability of customers lingering near EAS gates.
Mitchell Shein, branch chief for pacing and defibrillation devices at the FDA, recommended that industry conduct human factors testing to determine whether patients are able to determine whether EAS systems are in place, given a variety of factors (e.g., presence or lack of signage on or around gates). Such research, he said, could provide better data on the likelihood of customers/patients to “lean and linger.”
Shein noted that although this is a not a public health crisis, interactions do occur between EAS gates and medical devices, and more research is needed to improve the understanding of these relationships.
Expert Warns Healthcare Facilities: Watch Guest Access
Healthcare facilities need to perform a real balancing act with wireless applications. If management doesn’t constantly evaluate facility needs in terms of apps, something will break, warned Bob Zemke, healthcare solutions manager at Extreme Networks and member of AAMI’s Wireless Strategy Task Force (WSTF).
Zemke made these comments during a WSTF session of the mHealth Summit 2014, just outside Washington, D.C. The meeting brought together a range of stakeholders to examine collaboration in the use of mobile health, including members of the pharmaceutical industry and telecom.
During the WSTF session, titled “Everything You Wanted to Know About Wireless but Were Afraid to Ask,” Zemke reminded the audience that healthcare facilities are unique environments, quite different from the typical office.
Troubleshooting the various wireless applications throughout the hospital is a huge concern. Managers have to ensure that mission-critical applications, such as HVAC and security systems, remain functional. They also have to make sure that life-critical applications, such as telemetry and infusion pump systems, deliver safe and effective care. With the rise of online social media platforms, managers have a new concern: how patients will portray their facilities on social media. “Guest access is an increasing challenge,” he said, “it used to be a nice-to-have.” However, “what we’ve seen happen is that it’s mandatory to have this type of service.”
Patients want to have access to high-speed downloads and streaming videos, putting an additional strain on the wireless network. Facilities need to think of the network holistically and evaluate the number of devices already in the building, as well as those being brought in by patients.
And it’s not just the patients that management needs to account for: “We have to understand the real workflow of our clinicians,” Zemke said. “We have to understand how they’re communicating and where.” For example, doctors and nurses might do their work in stairwells; facilities need to be ready to take the mobile clinician into consideration.
AAMI’s work in the wireless arena took off at the October 2012 Wireless Workshop, during which 75 attendees created a list of priority wireless issues. These priorities include clarifying roles and responsibilities in the wireless arena; managing spectrum to improve safety and security; designing wireless infrastructure for high reliability; learning from other industries; and managing risk and preventing failure. The findings from that workshop paved the way for the development of the WSTF — a group of about two dozen representatives from hospitals, companies with wireless expertise, the medical device industry, and the U.S. Food and Drug Administration.
