By working closely with key decision makers at William Beaumont Hospital, the CE department has formed solid partnerships that have led to new opportunities.

Collaboration could easily be the motto at Optim—an organization in Royal Oak, Mich, that supplies clinical technology services to the health care industry—and the facilities in which it operates. Take the impact of high definition television (HDTV) on telemetry.

A much-publicized case occurred in February 1998, when a Dallas television station activated its HDTV transmitters and promptly drowned out the signals being sent to the telemetry system at nearby Baylor University Medical Center, Dallas.

When the Federal Communications Commission later allocated a dedicated bandwidth for wireless medical-telemetry devices, it meant that all existing telemetry equipment

needed to be either upgraded or replaced. While William Beaumont Hospital (WBH), Royal Oak, Mich, was not the only facility at the turn of the century evaluating the best way to transfer to the protected band, a unique approach set it apart.

“We wanted to include all stakeholders who needed to be a part of that group to ensure a decision was made that benefited all areas of the hospital,” says Izabella A. Gieras, MS, MBA, clinical engineering manager for Optim and president of the American College of Clinical Engineering. Its first step involved establishing a comprehensive group of representatives from nursing, administration, purchasing, communication, information services, and other biomedical engineering groups, among others. “The multidisciplinary approach makes sure everybody is involved and up to date, including the users, because they’re the ones who will be dealing with it on a day-to-day basis.”

The clinical engineering department Optim has in place at WBH has formed a close partnership with hospital personnel. This collaboration helps ensure that the facility stays ahead of the curve.

“We were already aware of the phenomenon when it happened at Baylor, so we had a task force working to resolve the problem,” says Salil Balar, MS, MBA, one of the four clinical engineers from Optim who service WBH. “We were in a replacement cycle for our equipment; and that, combined with the need to move into the wireless medical telemetry service (WMTS), led us to the decision that it was time to replace everything.”

After forming the internal committee, Optim and WBH followed a familiar path: distributing requests for proposals and reviewing vendor responses. But that is where the standard approach ended.

“We selected four manufacturers to perform 1-month clinical trials in our hospital so we could compare their systems and collect user input—how they liked it, if there were any technical problems—based on their real-world use of the system,” Balar says.

While this series of mini-installations did add time to the vetting process—as well as some additional funding—the Beaumont team feels the results warrant any extra effort.

“This type of equipment is very expensive, and you want to do whatever it takes to evaluate it before you sign on the bottom line for a multimillion-dollar project,” Gieras says, acknowledging that budgetary constraints can limit access to this type of testing. Exactly which pieces of equipment are involved also plays a role, as the sheer size of many fixed imaging systems, such as magnetic resonance imaging and computed tomography, for example, can preclude on-site testing. “Based on what we’ve gone through with the telemetry system, we definitely recommend, wherever you can, performing a clinical trial and a technical evaluation on medical equipment prior to purchase.”

Improved Systems and Patient Care
Even with a diligent selection process, the installation—which began early in 2003 and took the majority of the year to complete—was not without its complications.

“There were some bugs because a lot of the new systems were coming out in the WMTS band, but vendors had only tested them in their own labs, not in an actual environment,” Balar says. “Contingency plans need to be implemented with all major installations of this nature to make sure backup systems are available and to ensure patients are being monitored.”

System issues were not the only hurdle that had to be cleared. The new telemetry system was designed around a centralized monitoring station: one room equipped with numerous monitors and telemetry-monitoring-system (TMS) techs overseeing signals from more than 300 patients on all floors of the hospital.

When an alarm sounds, a TMS tech would immediately page a nurse in the patient’s unit and, per protocol, continue to page every 3 minutes until confirmation of the alarm was received.

“It sometimes took as long as 12 minutes before the alarm-communication loop was closed,” Balar says. A new multidisciplinary group, focused on patient safety, was assembled and found that the average response time was 9.5 minutes. “We did not think this process was optimal and found another technology we believed had the potential to improve the process, so we started testing in one unit.”

The voice-activated, two-way-communication device proved successful, dropping the average response time to roughly 39 seconds. The success of this technology solution is currently being tested for application in the facility’s busiest units.

Administrative Support
Beaumont began evaluating telemetry systems in early 2001, and during the 2 years of evaluation it took a measured approach to accumulating not only research but funding. The request to replace all medical-telemetry equipment at once was a tall order financially. Making it happen took patience.

“As we moved through the vendor-selection process, available capital budget would be earmarked for the new equipment,” Balar says. “We had to be flexible, so we actually waited until the end of 2002 to purchase all the equipment.”

This type of close collaboration with medical administrators not only aids in the implementation of large projects, but it also keeps the clinical engineering department in the loop on many critical issues.

“Beaumont is really focused on safety and quality, so everything we do is centered around the safety of patients, caregivers, and visitors,” Gieras says, emphasizing the department’s goal of becoming leaders in the medical-device-technology-management and patient-safety initiatives. “That includes the quality of medical equipment we choose, with respect to procedures and treatments.”

The commitment to safety also extends to in-house initiatives geared toward preventing adverse events whenever possible. One such example is Beaumont’s proactive approach to the issue of tubing- and catheter-misconnection errors.

The topic was recently addressed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), which names tubing misconnections as “a persistent and potentially deadly occurrence.”1

“In the medical device industry, some of the tubings, catheters, stopcocks—among other disposable devices designed for single-patient use—have a universal luer lock connection,” Gieras explains. Although they are attached to different systems and are intended for different clinical applications, many of the connectors fit easily together. “One of the adverse events that is well documented is a hose connector from a noninvasive blood pressure cuff being inadvertently connected to an intravenous line connector delivering medications, which resulted in air being infused into the patient’s vein.”

According to the JCAHO, eight of the nine reported cases resulted in patient death. Tubing and catheter types involved include “central intravenous catheters, peripheral intravenous catheters, nasogastric feeding tubes, percutaneous enteric feeding tubes, peritoneal dialysis catheters, tracheostomy cuff inflation tubes, and automatic blood pressure cuff insufflation tubes.”1

Since 2004, the Misconnections Task Force, led by the clinical engineering department, has been working at Beaumont to catalog all types of connections and associated devices used by the pediatric intensive care unit.

In addition to creating an inventory of more than 160 different connectors and tubings, the team also labeled each type of connector, as well as assigned a “severity level” to each combination identifying the potential danger involved. Completion is projected for summer or fall of this year, when the task force hopes to publish its findings.

“The initiative is designed to make our staff aware when they are connecting different types of tubing and to make sure they follow the recommendation from the Joint Commission to always trace the line and verify where it’s coming from and what it’s connected to,” Gieras says. “But the ultimate goal is to create unique connectors for the different clinical applications with a forcing function that will not physically allow you to put misconnections together.”

While industry standards dictating these types of design changes do not currently exist, Beaumont’s clinical engineering staff is working with the US Food and Drug Administration (FDA). Additionally, several standards committees, including the Association for the Advancement of Medical Instrumentation and the European Committee for Standardization, are in the process of developing guidelines.

Gieras acknowledges that inspiring manufacturers to transfer from universal connectors to application-specific ones will be an uphill battle, but she is optimistic about the possibility.

“We have been communicating with the FDA regarding this, because we know we will need a regulatory body to enforce any mandates to the manufacturers,” she says.

Building a Better Future
This same type of proactive involvement led to the development of the Beaumont Technology Usability Center (BTUC), which helps manufacturers develop superior medical devices. Focused on leveraging Beaumont’s skills in medicine and clinical engineering, the BTUC provides a venue for manufacturers to conduct usability testing and apply human-factors engineering—a process that assesses the human-technology interface—in the design stages of medical equipment.

Located in Royal Oak, Mich, the facility also performs product and process risks assessments, develops and implements testing protocols, provides prototype-development services, and simulates hospital environments to aid in preparation for clinical trials.

This cooperative approach extends beyond the facility’s walls. Several department members work together to teach a course on clinical engineering at a local university, and as of last winter, Beaumont began offering real-world experience to college students through a semester-long internship.

While such tasks are outside the parameters of the average clinical engineer’s job description, Gieras believes that being involved not only strengthens existing partnerships, but helps create new relationships and, along with them, new opportunities.

“Our partnerships have been very successful, including the support we have from the administration. It’s very important to have the clinical engineers facilitate and deliver the different services we provide, making us visible to the hospital,” she says. To that end, department members are active in professional organizations and attend and speak at conferences. “Like many clinical engineering departments,” Gieras says, “We continue to leverage our projects to enhance our visibility and show the benefits of having clinical engineering on board, so the next time somebody needs help, they know exactly who to call.”

Dana Hinesly is a contributing writer for 24×7.

Reference
1. Sentinel Event Alert, Issue 36, April 3, 2006. Available at: www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_36.htm Accessed May 25, 2006.