Health InsuranceNurses File DPH Complaint Over Use Of Life-Threatening Medical Devices At UC Irvine Medical Center
The California Nurses Association/National Nurses Organizing Committee announces that it filed a complaint with the California Department of Public Health (DPH), calling for an urgent investigation into the ongoing use of dozens of narcotic infusion pumps at the University of California Irvine Medical Center that have a history of failure, thereby exposing patients to a dangerous overdose of narcotics.
Nurses have warned UCIMC management repeatedly since February 2009 of the dangers of the Curlin Ambulatory Infusion Pumps, of their failure on the units, and of adverse events caused by this failure. Despite this, UCI only removed a fraction of the pumps and failed to comply with its legal requirements to report each adverse event to DPH.
"UCIMC is endangering countless patients with faulty equipment, and has skirted its legal responsibilities to report and deal with this patient safety issue. We call on the DPH to launch an immediate investigation of this on-going scandal to prevent any further harm to patients from narcotic overdose," said Geri Jenkins, RN, co-President of CNA/NNOC and a nurse at UC San Diego Medical Center.
In February 2009, a UCIMC nurse member of the CNA/NNOC Professional Practice Committee emailed UCIMC Chief Patient Care Services Officer Lisa Reiser of an instance of a Curlin Pump failing by over-delivering narcotics to a patient, resulting in overdosing of the patient, and of the need to immediately address these malfunctioning pumps because of the potential of life-threatening narcotics overdose to patients.
On March 6, 2009, Ms. Reiser sent an email to all UCIMC RNs about the malfunctioning pumps. Nurses were told, "our current pumps do not have software that is now available to protect patients from an error that would expose them to high levels of narcotics and potentially compromise their respiratory status." She concluded, "We know this and we are rapidly moving forward with Smart pump technology to provide you and our patients another level of protectionò€¦.In the meantime please know that you as the nurse are that last level of protectionò€¦.I have confidence that you take this aspect of patient care seriously and understand that you, as the registered nurse, are accountable to the patient to be their advocate and do these double checks as defined."
After receiving this disturbing memo, the CNA/NNOC Professional Practice Committee convened an emergency meeting on March 10 with Ms. Reiser to discuss the dangers of the malfunctioning narcotics pumps and the need to fix or replace the pumps immediately. Hospital administration reported at that meeting that there had been a total of four adverse events resulting from failing narcotic pumps in the prior six months, and that 50 of the hospital"s 158 narcotics pumps had failed mechanical testing last fall and were removed.
Management failed to inform DPH of these adverse events of patients endangered by the faulty pumps, despite legal requirements established in SB 1301 (Alquist), which "requires a General Acute Care Hospitalò€¦to report an adverse event to the department no later that five (5) days after the adverse event has been detected, or if that event is an ongoing [one]ò€¦not later than 24 hours after that adverse event has been detected."
Administration at the March 10 meeting discussed replacing or fixing the pumps.
Near the end of May 2009, however, nurses coming to work on a unit were informed by their nurse manager that another patient had suffered a narcotics overdose from another pump failure and been admitted to the ICU as a result.
Despite this track record of multiple narcotics pump failures, UCI management has refused to act on this danger, leading to the CNA/NNOC to file this DPH complaint against UCIMC, the first DPH complaint CNA/NNOC has filed against UCI in many years.
Rather than act on the original February 2009 complaint by the nurse, UCIMC instead threatened to terminate her. They have withdrawn that threat-but not the pumps endangering the patients.
The federal Food and Drug Administration issued a Class II Recall on the Curlin narcotics pumps September 22, 2008 due to ongoing pump failures. The ECRI Institute, a nonprofit organization that tests the safety of medical equipment, had previously issued a Medical Device Special Report on May 22, 2008 concerning malfunctioning Curlin pumps: "ECRI Institute recently investigated two cases of overdelivery by two PainSmart infusion pumps that were being used at different facilities for patient-controlled analgesia (PCA). In these cases, 50 mL narcotic bags were being used for PCA therapy for postsurgical pain. The bags were found empty in less than an hour after PCA therapy was initiated, despite the pumps being set to deliver far less narcotic in this time frame. If untreated, overdelivery of narcotics can result in respiratory depression, possibly leading to death. In the investigated incidents, we determined that the pumps" doors had become deformed in a manner that permitted gravity flow."
UCI has ample res to replace this dangerous equipment, according to the data it has reported to the state. The California Office of Statewide Health Planning and Development reports that UCI made a profit of $51,174,071 for the fiscal year ending June 30, 2008.
California Nurses Association