Each year, ECRI produces its Top 10 Health Technology Hazards report to help health care organizations direct their time and energy toward technology management activities that can have the greatest impact on patient safety. The No. 10 topic for 2023, “Underreporting Device-Related Issues May Risk Recurrence,” identifies some common barriers to reporting and offers recommendations to help eliminate, or at least lower, those barriers.
“Too often, when I’m out on the floor I find things that are broken, yet being used anyway.” That was the response from a long-time clinical engineer when asked about underappreciated patient safety concerns.
“Oh yeah, we see that problem all the time, but we figured out a workaround.” That’s how a clinician responded when asked about a device problem that ECRI discovered during its lab testing of the product.
Clinical engineers and biomeds are tasked with keeping patient care areas stocked with well-functioning medical devices. Clinicians are tasked with using the medical devices at their disposal to provide quality patient care. Each group depends on the other to do the job right. A breakdown in communication that leads, for example, to broken, malfunctioning, poorly manufactured, or poorly designed medical devices remaining in use creates the potential for patient harm.
Clearly, patient (and staff) safety is best served when faulty medical devices are reported through appropriate channels and removed from service. That doesn’t always happen, however, as the anecdotes above illustrate. For health technology managers, the question is: Why? And what can be done about it?
Following are some of the barriers to problem reporting that ECRI identified in its 2023 Top 10 Health Technology Hazards report, along with some recommendations to address them.
“I don’t have the time.”
This may be the most common complaint that device users have about problem reporting. It also may be the most valid, and the most important to address. Clinicians frequently are busy with time-sensitive patient care tasks, and it can be difficult for them to interrupt what they’re doing, step away from patient care, and take the time to fill out the appropriate forms to report a problem.
The key to getting buy-in and participation from device users is to minimize the time and effort required to file a report. Facilities need a streamlined, easy-to-use and readily accessible method for staff to report device-related problems. “Reporting needs to be as easy as possible,” advises Mairead Smith, principal project engineer in ECRI’s Device Evaluation group. “Any extra steps in the process will interfere with clinicians performing their primary role of taking care of patients.”
Ideally, a reporting mechanism would include a report form that is easy to access, that offers prompts for key information, that has a minimal number of required fields, and that allows a free-text description of the problem. Also, the system should be structured so that frontline staff need to report an issue only once; that report should then be directed to other recipients as appropriate. For instance, reports should be distributed to clinical engineering and risk management staff who can respond appropriately.
“The more you can make event reporting a fast and easy part of normal workflow, the greater the likelihood of success,” notes Smith.
“I didn’t think a report was needed – nobody got hurt.”
When problems are reported as soon as they are noticed, they can often be remedied before patient care is affected. That’s the goal. So, remind device users that every report is important, even those describing problems that were identified before a device was used on a patient. The reporting of a “good catch” – an incident in which no harm occurred – can be every bit as useful as the reporting of an adverse incident.
There are also instances where staff may not realize that a device issue could have contributed to an event. Users may assume that their own human error caused the problem, when in fact the design of a device may cause many people to make the same mistake. Teach staff how to recognize potential hazards – for example, by providing examples of what can go wrong in various tasks or with various devices – and advise staff to avoid making assumptions about a problem’s cause.
The bottom line here is to communicate to staff that every report can be an opportunity for clinical engineering departments or other investigators to identify and fix or replace damaged or malfunctioning devices. Every report provides an additional data point for health care organizations and risk managers to analyze. Every report helps paint the bigger picture of recurring or system-based problems that may be happening in the background. Using reported information, facilities can redesign systems to protect patients, visitors, and staff.
“I don’t know how to report a problem.”
Staff in each care area will need to be educated about using the organization’s event-reporting mechanism. Further, leadership should communicate the expectation that staff will report any incident in which a device did not function as expected. For their part, supervisors and staff should be encouraged to conduct open discussions (e.g., at staff huddles) to reinforce the process and share wins, good catches and lessons learned to prevent future incidents.
“What’s the point? Nothing happens with the reports anyway.”
Providing feedback to affected staff and other stakeholders can help combat this complaint. For example, thank reporters for their contribution and email them with status updates, as warranted.
“Also look for ways to promote the wins,” adds Smith. “When a report leads to meaningful improvements, advertise that to your organization, and recognize reporters for their contributions.”
“I don’t want to get in trouble.”
An organization’s leadership has the key role here. Staff may be reluctant to report an issue if they fear disciplinary action or other personal consequences, either for themselves or for a coworker. “If staff don’t feel safe reporting, they’re unlikely to do so,” cautions Smith. Leaders can alleviate those fears by promoting a culture of safety and learning that encourages staff to report product safety concerns without fear of reprisal. Consider reframing a report of a problem or issue as a “good catch” – an opportunity to identify a risk before it causes harm to a patient or staff member.
“Somebody else will do it.”
Maybe. But patient safety shouldn’t depend on “maybe.”
Everyone has a role to play in making health care safer. While a culture of safety starts from the top down, implementing that culture depends on contributions from everyone. Ensure that staff feel safe speaking up, help them understand the value in doing so, and look for ways to make reporting a valued and seamless part of their job functions.
To Learn More . . .
This article is adapted from ECRI’s Top 10 Health Technology Hazards for 2023. An Executive Brief version of that report is available for complimentary download at www.ecri.org/2023hazards. The full report, accessible to ECRI members, provides detailed steps that organizations can take to prevent adverse incidents. To learn more, contact ECRI at (610) 825-6000, ext. 5891, or by e-mail at clientservices@ecri.org.
For more information, visit ecri.org.
