Using Human Factors Engineering to Improve Medical Device Safety
On June 24, Louise Underdahl, faculty member at University of Phoenix School of Advanced Studies and risk analyst with UCLA Health System, will present at the 2010 Regional FDA MedSun (Medical Product Safety Network) Conference. The conference provides opportunities to share lessons learned and clarifies potential problems encountered by other participating hospitals.
Her presentation will be on UCLA Health System's experience with the tag and sequester aspect of medical device reporting. She hopes to identify possible solutions during the discussion that may identify strategies for encouraging medical device manufacturers to rethink design.
Underdahl stated that UCLA’s medical device safety initiative began in 2004 when the university accepted the FDA’s invitation to participate in the MedSun project to improve medical device safety. She says the goal was to streamline the reporting process in order to encourage user participation, increase data accuracy and identify potential vulnerabilities associated with human factors. She clarified the last point, stating that human factors engineering (HFE) is “the science and the methods used to make devices easier and safer to use. When applied to medical devices, HFE helps improve human performance and reduce the risks associated with use” (FDA, 2009).
Underdahl admitted that, initially, staff members were reluctant to report issues with medical devices for several reasons. One, they were unfamiliar with the online event reporting system. Two, they feared punitive consequences. And three, they suspected it would ultimately be an exercise in futility.
Device-Reporting Reluctance Turns into Acceptance
This reluctance eventually began to turn around. “Risk management representatives and unit directors attended rounds and department meetings to educate staff on the rationale, procedure and benefits of reporting device issues,” said Underdahl. Participation gradually increased as clinicians began seeing results. They realized that reporting actually created positive changes and even generated a sense of pride in making a difference.
“Alerting manufacturers to potential vulnerabilities with device design and use is a significant incentive for staff reporting,” said Underdahl. “For example, when the head of an operating room bed drops suddenly and causes the patient's neck to snap, the manufacturer must be informed. When a pump delivers too much or too little medication and the patient experiences cardiac arrest, the manufacturer must be informed. Both UCLA Health System staff and MedSun representatives collaborate to target the specific device and identify factors contributing to malfunction so that the manufacturer may assess design and functionality.”
Medical Device Manufacturers Resist Necessary Change
Since 2004, medical device event-reporting has improved through ongoing education initiatives. The device is retained—tagged and sequestered—instead of being discarded, identifiers—including model, serial and lot numbers—are provided, and underlying circumstances are documented in online and verbal reports.
Even with these achievements, manufacturers' resistance to change is a formidable challenge. Underdahl related a real-life instance that illustrates this challenge. “A dysfunctional skull clamp lacerated a patient's head during surgery, necessitating stitches. Expeditious reporting to MedSun triggered an investigation of ancillary issues, all of which were completed in a timely manner so that the involved clinicians remembered the event. Yet, the manufacturer failed to link the reported details with the dysfunctional skull clamp, sent follow-up correspondence to the incorrect hospital and ultimately concluded that ‘the root cause may be related to user error.’”
FDA: Design with Device Use in Mind
According to Underdahl, FDA research indicates that the “frequency and consequences of medical device use errors far exceed those arising from device failures. Therefore, product developers must consider device use and use-related hazards to ensure that their devices will be safe. FDA's human factors program evaluates manufacturers' design validation documents required by the Quality System Regulation, develops guidance documents to help manufacturers understand and use human factors engineering, and educates manufacturers about the need for human factors programs” (FDA, 2009).