The story of how one respiratory therapist’s discovery brought about product safety changes nationwide.
Jacque Kelchen, BS, RRT, says she did a double-take while educating respiratory therapists about a new airway pressure monitor that was being rolled out for use in University of Iowa Stead Family Children’s Hospital.
“We were going to use the monitor in the NICU, PICU and on the other intermediate hospital floors,” she says. “During the in-service with staff, however, I noticed that the monitor suddenly zeroed out the pressure when I silenced an alarm.”
For young neonate patients, it’s critical for airway pressure monitors to function correctly. Proper airway pressure eases the strain of breathing and promotes stability. Too low or too high pressures can cause adverse effects, such as breathing difficulties or damage to the lungs, making the pressure monitor vitally important to patient care.
A startling situation
Wondering if it was a fluke or a true design flaw, Kelchen showed the device to a few other respiratory therapists in the PICU. They were also perplexed when the same problem occurred.
“What we discovered was that if you pushed the silence alarm button just a bit too long on the new device, it would not only shut off the alarm, it also would zero out the pressure reading, something the monitors shouldn’t do,” explains Kelchen, who serves as the day shift supervisor for the Department of Respiratory Care. “That could have caused multiple complications in our patients because once the monitor was re-started, it could lead to double the pressure being delivered.”
If the pressure suddenly becomes too high or too low for a patient, the monitor alarms, alerting staff of a potential problem. Typically, respiratory therapists silence the alarm as they respond to the situation.
“We went through it several times because we couldn’t believe what we were seeing,” she says. “We knew then that we had to alert hospital management and the manufacturer.”
A hospital-wide Safety-Gram was sent out immediately to halt the introduction of the new monitor. The issue was then put on a National Reporting Dashboard and reported to the Emergency Care Research Institute.
Once that was done, a report was submitted to the Food and Drug Administration (FDA) and the equipment manufacturer, which rapidly issued a national safety alert. The notice, which went out to hospitals across the country, clearly highlighted what Kelchen discovered at the children’s hospital:
- It has been determined that depressing the alarm silence button continuously for more than one second will cause the unit to re-zero.
- This unexpected zero calibration will be obvious to the user. If encountered, a zero calibration will need to be conducted with the unit sample line open to atmosphere.
The manufacturer immediately released enhanced software to correct the malfunction and sent representatives to upgrade all units.
“This entire experience showed me that if we notice equipment that doesn’t function properly or doesn’t seem quite right, we should double-check, talk with colleagues, and say something,” says Kelchen. “And because we spoke up and alerted everyone, we’ve now helped young patients not only here, but all over the country.”