Patients benefit every time a biomed calibrates a piece of equipment or completes a round of preventive maintenance. In many ways, the safety of patients is implicit in the biomedical/clinical engineering mandate to ensure the effective and safe use of equipment and technology in health care. But beyond the basics, what can today’s biomedical/clinical engineers do to improve patient outcomes? And what impact is the current patient safety movement having on their role in today’s health care environment?

Today’s health care providers find themselves caught between shrinking revenue and an increased demand for quality patient care. This trend is not letting up as health care professionals, hospitals, and device manufacturers feel the effects of the recent economic turmoil while also being held accountable for device recalls, medication errors, and hospital-acquired infections.

As a result, despite the resource pressures that many providers currently face, there is a heightened awareness of patient safety issues within the health care community. It is a dilemma that often finds hospital staff—including biomedical/clinical engineers—caught in the middle. The key to remaining relevant and effective in such an environment is for biomeds to be engaged, proactive, and to think outside the box.

With nearly 4 decades of professional biomedical experience, Bryanne Patail, BS, MLS, FACCE, a biomedical engineer with the US Department of Veterans Affairs National Center for Patient Safety (NCPS) in Ann Arbor, Mich, has a clear perspective of what biomeds can bring to the patient safety table.

While the centralization of patient safety efforts at the VA has allowed it to be on the cutting edge, still, “There is a lot of autonomy in the VA,” Patail says. “But we realized that effective patient safety efforts needed to have a common standard to be used as a baseline.” That maxim is true for large or small organizations.

Reaching Out to OEMs

Patail does prospective risk assessment, is involved in several standardization committees, helps write specifications for new equipment acquisition, and creates evaluation tools on how various types of equipment should be used in clinical settings. Sometimes he goes so far as to contact quality assurance managers or engineers at device manufacturers to seek answers—or recommend solutions—when equipment-related problems arise.

“Maybe the manufacturer could have made something less confusing or easier to use,” Patail says. “We want to help the medical device community come up with smart devices, or devices that can use forcing functions, to help improve patient safety.”

Though not all hospital organizations have the centralized database resources of NCPS or the sheer market presence of the VA, similar efforts of reaching out to device manufacturers can still yield results.

A Team Approach

Matt Baretich, PhD, PE, CCE, president of Baretich Engineering Inc in Fort Collins, Colo, has 30-plus years of experience as a clinical engineer. He sees many opportunities for hospital biomedical staff to engage in patient safety efforts by going beyond areas traditionally considered to be the biomed’s domain. One of those areas, according to Baretich, is the no problem found (NPF) report.

It is common for devices to arrive in the biomedical/clinical engineering department for repair without much information about why it is there. “There’s the temptation to just put it on the test stand, test its functionality, and then return it to the floor with a NPF log in the notebook,” Baretich says. “But, why was it really there? Think beyond the technical issues. Yes, the machine worked the way it should, but there was a clinician trying to achieve a certain clinical objective and couldn’t get it done.”

Baretich offers several nontechnical reasons for why devices show up for repair: the clinician does not know how to use it properly, it was not the right machine for the job, or maybe it is difficult to use. He encourages biomedical professionals not to lay blame on clinicians and wash their hands of it.

“If the biomed says, ‘I just check machines,’ then we’re losing an opportunity to speak more broadly and fix problems before they become harmful to a patient,” he says.

Patail agrees that clinical/biomedical engineering professionals should broaden their thinking regarding the roles that they play.

“I cringe when I go in a hospital and ask a clinical engineer what his mission is and he says, on rare occasions, ‘To support the clinicians,’ or a BMET says, on rare occasions, ‘I’m just a repairman,’ ” Patail says. “No, your job should be to be part of a team that cures the sick, heals the injured, and saves lives—to do some good for patients—which is what 85% of surveyed health care workers—including biomeds—indicate.”

He admits that many biomedical professionals often do not get much opportunity to see what happens to the equipment once it leaves their shop, but Patail and his colleagues at the NCPS encourage staff to go and observe clinical activities out on the floor and take part in safety rounds.

“We teach them to do RCAs [root cause analysis] as part of a multidisciplinary process with other staff,” Patail says. “We push to get the work done at the local level, to enable good behavior locally. They can contribute best by working as a team with the rest of the hospital staff.”

That kind of multidisciplinary approach has taken hold elsewhere too. Dennis Minsent, MSBE, CCE, CBET, is the director of clinical technology services at Oregon Health & Science University (OHSU) in Portland. He is one of the few clinical engineers to work as a risk management patient safety officer (PSO), which he said has been invaluable.

When he was a PSO, the risk management staff included himself, a physician, and a nurse. When actual or potential patient safety issues arose, the three of them worked as a team.

“Individually, any one of us could come up with a way to solve an issue,” Minsent says. “But we found that by having a physician, nurse, and engineer working collaboratively, we saw much better results in solving issues because our solutions were much more broadly based.” He cited this multidisciplinary approach as a key to identifying and creating workable solutions.

In his current role, Minsent is actively involved in reaching out across silos to other professionals in order to improve patient safety at his facility. “I currently review all of the incident reports generated during the week, and we then have a multidisciplinary group that looks across the entire organization to see if similar things are happening in other areas,” he says.

The administration at OHSU is now considering establishing a small, multidisciplinary team, including Minsent, which would deploy immediately to investigate any patient incident—a sort of risk management rapid response team.

Baretich agrees that working as a team with staff from other areas is where the biomedical profession is heading. “Medical care is so complex these days that no one person can understand it all,” he says. “So the only way to provide good patient care is to work together as a team. That’s the way the field is going, so if you want to be part of it, you’re going to need to ‘think outside the basement.’ ”

Risk Management First Aid

Baretich adds that biomeds should take the initiative in developing relationships with others in the hospital instead of waiting to be invited. For example, while he believes that risk management should call the biomedical/clinical engineering department for incident investigation and make it a multidisciplinary activity, the reality is that the approach varies quite a bit.

“It’s really up to the biomeds themselves to reach out,” Baretich says. “Risk management usually owns the patient safety process, and once they realize that you can be a contributor, they’ll keep inviting you in.”

Baretich also urges biomedical professionals to educate themselves about the federal regulations related to adverse events reporting in order to help risk management and other administrators sort through those issues.

“That’s an easy way to become valuable,” Baretich says, adding that since The Joint Commission often asks for documentation showing how such federal regulations as the Safe Medical Devices Act are being followed, the efforts of biomedical staff that can help provide such documentation will get noticed.

Taking the initiative is the first step. “Some people in our profession would say, ‘Someone needs to tell those administrators to pay more attention to us.’ But it doesn’t happen that way,” Baretich says. “If you get out there and show them that you’re doing some good and getting involved, that’s the key.”

Like Baretich, Minsent would also encourage biomeds to spend some time with the patient safety officer, risk manager, or whoever is responsible for the patient safety initiatives at their facility and share some helpful ideas.

“Have conversations to let people know you’re interested,” Minsent says. “It would at least raise awareness so that when the PSO sees a situation, they may think to get a different perspective and call on you to get your thoughts and input. If they don’t know you’re interested and can bring value to other problems and issues they’re working on, they won’t even know to ask the question.”

Patail also views reaching out to staff members as vital to adding value, since it is easy enough for hospital administrators to misunderstand the role that biomedical engineering can play in improving patient safety.

“They can see the cost benefit from a repair job done inside versus outside, but the clinical engineers can partner with risk managers and patient safety managers to prevent adverse events from happening,” Patail says. “External repair depots can’t do that.”

He adds that the danger of such attitudes among administrators is greatest when patient safety issues appear to be under control. “The temptation is to say, ‘Why should we have all of these risk management procedures, and why does biomed need to be involved?’ ” Patail says. “But that’s exactly why nothing’s happened. This is not the time to be complacent about medical device-related incidents.”

Care for Nurses

Executives in the C-suite are not the only ones who may face that temptation. Clinicians on the patient floor can also have a narrow view of the biomedical/clinical engineer’s role.

“It’s hard when there’s an uncooperative attitude on the clinical side, but the way to be valuable to others in the system is to do something valuable for them,” Baretich says.

Everyone agrees that nursing staff can benefit from a proactive biomedical engineering department. In Baretich’s words, “The infinitely expandable nurse just doesn’t work. If you can be seen as someone who isn’t adding to their workload, but is helping out, then you become part of the team.”

Like Patail, Baretich recommends regular rounds for biomeds in the various clinical departments. “Show up on a regular basis—weekly, daily—but stop in and ask, ‘What’s working, what’s not working, and is there anything I can do to help you?’ ” Baretich says. “So instead of doing some kind of work order, they can talk to you directly. I’ve really seen that turn some attitudes around.”

According to Patail, in many RCAs that VA staff conducted, nursing staff fatigue was determined to be the real root cause for many situations. He recommends that biomedical/clinical engineering work with the nursing staff to help find ways to prevent fatigue and stress on the nursing floor. One way to do this is to help evaluate the way that equipment is used.

Patail cited an example where nurses at one facility complained about excessive patient monitor alarms. The biomeds and nursing staff studied the problem together and decided to eliminate respiration modules that utilized transthoracic impedance for ventilated patients. The solution dramatically decreased nuisance alarms, which meant less stress and fatigue for the nurses.

Minsent agrees that clinical engineering can play an important role in improving nurse productivity. He says that sometimes it can be as simple as printing specimen labels.

“Nurses might want to label the containers at the bedside instead of running all the way down the hallway to get a label,” Minsent says. “We can help by leveraging available technology to facilitate bringing labels right to the patient’s bedside instead of clinicians having to scatter to get what they need to do their job.”

Another example Minsent cites is being engaged in patient fall reviews. “It’s usually not a piece of equipment causing the fall, but how equipment is situated in a room that may tend to be a tripping or fall hazard to the patient.” He adds that a systematic analysis can help create room layouts and equipment locations that help minimize such risks—for both patients and nursing staff.

Minsent admitted that clinicians have been skeptical that someone who was not a hands-on care provider could provide useful information to improve clinical practice. But once he engaged them in conversation and proposed workable solutions, they realized that thoughts from another discipline can be effective in helping solve their problems.

Adjusting the View

Obviously, it is difficult enough for many biomedical professionals to find enough time to accomplish the basic day-to-day tasks required of them. Although multidisciplinary collaboration is one more thing to have to do and deal with, such efforts have certainly been successful at improving patient safety in many hospitals.

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Patail emphasized that managing resources wisely—especially time—is vital to playing an effective patient safety role for biomeds. He recommends using a management by objectives process (a practice whereby management and employees agree to and understand the organization’s objectives) where one of the basic tenets is “to refuse to be a manager of crisis.”

As a final recommendation for contributing to patient safety, Minsent encourages biomedical professionals to draw on their experience throughout the entire hospital and view problems from a systems-based perspective.

“If we want to be just equipment-focused, we’re missing a great opportunity to help push our profession forward and become a key contributor in the area of patient safety,” Minsent says. “And our respective organizations would miss out on receiving some important perspectives on systems-related issues as well.”


Kent Lupino is a contributing writer for 24×7. For more information, contact .