By C.A. Wolski
There are numerous reasons how and why a medical device could cause patient harm. An infusion pump may malfunction and overdose a patient. A defibrillator may not deliver enough of a life-saving bolt of electricity—or simply no electricity at all. A faulty pulse oximeter could misreport a patient’s deteriorating condition until it’s too late. Or an   electrosurgical unit may stop working because it’s plugged into a GCFI circuit that randomly trips open.

“Fully understanding the root cause of a device-related incident requires knowledge about the device, user, patient, building infrastructure, clinical practices, organizational culture, and other factors,” explains Matt Baretich, president of Fort Collins, Colo.-based Baretich Engineering.

A ‘Team Sport’

When an incident occurs, the subsequent investigation should be a multidisciplinary effort, according to Baretich—and for good reason. “No one person is an expert in all facets of the incident,” he says. “It’s a team sport.”

That being said, in most organizations, the risk management department will take the lead in any investigation, gathering experts around them to fully understand the root causes. “Many device-related incident investigations can be handled by in-house HTM professionals; however, it’s okay to call in outside experts for help, especially if [legal action is likely to ensue],” Baretich adds.

Among the decisions that will be left to the risk manager is whether to report the incident to the U.S. FDA under the Safe Medical Devices Act (SMDA) of 1990. Per the SMDA, a report is required within two weeks of an adverse event.

The FDA also has high hopes for its Voluntary Malfunction Summary Reporting (VMSR) Program, which was originally piloted in 2017 and is set to replace the agency’s Alternative Summary Reporting Program. Under the VMSR, manufacturers can report potential, non-life-threatening issues in summary. Even so, they must continue to detail serious injuries or medical device-related deaths in the Manufacturer and User Facility Device Experience, or MAUDEdatabase.

To Baretich, the FDA’s two-week reporting window is a double-edged sword. On the positive side, information is released quickly—alerting administrators, clinicians, risk professionals, and biomeds about potential hazards. On the negative side, “you often don’t know a lot in two weeks,” he says, adding that the FDA has admitted that substantial underreporting exists.

In many cases, the underreporting is not a result of a conspiracy of silence, but simply poor communication. Since the clinical staff is working to address the patient’s well being in the aftermath of an equipment failure, the incident may not be reported to the risk management authority in a timely manner. And that means that the equipment may not be dealt with for a long time.

“The equipment may come down to the shop just saying ‘broken,’ and the HTM professional may not even know there was an incident,” Baretich says. “If they knew, they would sequester the equipment and contact risk management.”

A Glimpse at Best Practices

While good communication is at the heart of a timely and thorough investigation, there are other steps that risk management should take in conjunction with HTM after an incident occurs, Baretich says. In sequence:

  • Step 1: The clinician should make sure the patient is safe and stabilized.
  • Step 2: The clinician should notify risk management.
  • Step 3: The device should be sequestered: taken out of service, put in a safe place, and kept plugged in to maintain all settings and stored data.
  • Step 4: All accessories, disposables, and packaging that show lot numbers should be preserved.

By securing this critical evidence, the multidisciplinary team will have as many facts as possible during their investigation to get to the root cause of the incident.

Getting a Seat at the Table

Key to achieving this ideal is for HTM professionals to be viewed as valuable additions to the risk mitigation process—a task Baretich puts squarely on the shoulders of biomeds. He says it’s up to you—the HTM professionals—to demonstrate your value to risk management team—not the other way around. “Get to know the risk management and patient safety professionals in your organization,” Baretich advises. “Eventually, they’ll ask for your help.” And when they do, he adds, be ready to contribute.

This includes demonstrating your expertise by knowing the basics of root-cause analysis, failure modes and effects analysis, risk assessment, and any other tools that the risk management team uses during an investigation. It’s also important to know how the HTM department fits into risk management’s policies and procedures.

But perhaps most importantly, Baretich says, “understand the difference between ‘user error’—the assumption that the equipment user is at fault—and ‘use error,’ which simply means that a clinician was trying to achieve some clinical object requiring the use of a medical device and was unable to achieve it.”

Tapping HTM’s Expertise

Ultimately, HTM professionals should be an integral part of the equipment procurement process to help stave off device issues down the road, Baretich says. Because of their technical expertise, biomeds can ask important questions about potential equipment, including the device’s failure modes and any problems that the equipment might have from both a technical and user-interface perspective. Such actions will help hospitals select a device that’s reliable and meets their specific needs, Baretich maintains.

After all, he says, “I’ve been involved in several cases in which equipment under consideration for purchase has design flaws that would be obvious to technical experts.”

As an example, he points to a heated surgical mattress that allowed a hot spot to develop—something that could critically burn a patient—if a cable was inserted into the wrong connector. “It was impossible to fully insert the cable into the wrong connector, which is generally a good design feature,” Baretich says. “But it was possible to partially insert the cable and have it stay in place.”

A busy clinician, he adds, may not realize that the cable wasn’t properly connected. But an HTM professional would spot the error immediately, Baretich says, and “recognize that the fit was not right.”

That’s why Baretich recommends that HTM professionals are involved in the process from the very beginning. After all, they can help curb catastrophic events at the best time possible—before they ever occur.

C.A. Wolski is a contributing writer for 24×7 Magazine. Questions and comments can be directed to chief editor Keri Forsythe-Stephens at [email protected]