Building off a state health department report showing that, as The Morning Call‘s Tim Darragh wrote, “Nurses at St. Luke’s Hospital three times in 2010 and 2011 improperly programmed patient-controlled pumps to deliver pain medication, causing patients to overdose themselves,” Darragh dug deep into each incident, uncovering patient details and adding perspective to the errors, which were severe enough that the feds decided the hospital’s patients were in “immediate jeopardy” until steps were taken.
In each of those cases and in three others, the nursing staff failed to document the errors properly, state investigators found.
Employees told the investigators that St. Luke’s did not require annual competency training on the pumps. Unnamed employees offered conflicting statements about when and whether all the staff had received retraining in 2010.
For their part, hospital officials say they have bought new patient-controlled pumps, developed a restricted dosage plan and retrained staff.
“When St. Luke’s nursing staff members identified the dosing pump programming issues, the events were promptly reported to all the appropriate individuals and regulatory agencies as outlined in our Network Patient Safety Plan,” said Carol Kuplen, chief nursing officer for St. Luke’s Hospital & Health Network.
“There was complete transparency in these events,” she said in an interview Thursday.
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, appeared at a newsmaker briefing at Health Journalism 2010 to announce an FDA initiative to reduce risks associated with infusion pumps. Log in to the AHCJ website to see his presentation and listen to his announcement.
- Press release: FDA Launches Initiative to Reduce Infusion Pump Risks
- FDA page on infusion pumps and FDA’s new safety initiative
- White Paper: Infusion Pump Improvement Initiative
- Guidance for Industry and FDA Staff – Total Product Life Cycle: Infusion Pump – Premarket Notification [510(k)] Submissions
- Letter to Infusion Pump Manufacturers
- Public Meeting: Infusion Pump Workshop, May 25-26, 2010
- Generic Infusion Pump Project