PCA-related device events are three times as likely to result in injury or death. As Tim Ritter (Senior Patient Safety Analyst, Pennsylvania Patient Safety Authority) reminds us, “Over the six-year period from June 2004 to May 2010, data collected by Pennsylvania Patient Safety Authority revealed that there were approximately 4,500 reports associated with PCA pumps. Moreover, U.S. Food and Drug Administration’s (FDA) Manufacturer and User Device Experience (MAUDE) database demonstrates that PCA-related device events are three times as likely to result in injury or death as reports of device events involving general-purpose infusion pumps.”

Michael Wong, executive director for PPAHS, says these 10 reminders are the decided recommendations of health experts who have commented in the past year for PPAHS on PCA: “PPAHS encourages all hospitals to observe these reminders to ensure there are no further adverse events and deaths with patients managing their pain using PCA.”

Reminder #1: Respiratory depression may happen with any patient receiving opioids

Dr. Jason McKeown (Associate Professor, Medical Director – Inpatient Pain Service, University of Alabama School of Medicine), “While PCA may be the safest mode of opioid delivery it is true that regardless of the route of administration, respiratory depression may still occur. To help prevent such incidents from happening, it should be remembered that some of the most significant strides in medicine and surgery are directly attributable to anesthesiology’s advances in patient monitoring.”

Reminder #2: Using periodic checks and pulse oximtery are not enough

Matthew Grissinger (Director, Error Reporting Programs, ISMP), “… a “periodic check” and pulse oximetry would only catch an error, not prevent the error.”

Mr. Grissinger explains further “… there’s too much reliance on pulse oximetry readings, which can offer a false sense of security since oxygen saturation is usually maintained even at low respiratory rates, especially if supplemental oxygen is in place. As ISMP President, Michael Cohen has said, “Capnography measures the end tidal volume of carbon dioxide, which is a more reliable indicator of respiratory depression and has previously been employed in limited areas such as critical care units.”

Reminder #3: Adverse events can happen even when no human error has occurred

Pat Iyer, MSN, RN, LNCC (President, avoidmedicalerrors.com), “a misunderstanding on the part of nurses that if a PCA pump is ordered and the patient can receive, for example, half of a milligram of Morphine every hour that the patient cannot develop respiratory depression if the order is followed and the pump is setup correctly. That is certainly not true because of the variables, the other medications, or the way the patient is clearing anesthesia out of her body after surgery. You can still end up with respiratory depression even if the instructions are followed on the pump …

Reminder #4: Eliminate adverse events by using a forcing function 

Bryanne Patail (biomedical engineer at the U.S. Department of Veterans Affairs, National Center for Patient Safety), “Use of PCA pumps is a process, and improving that process is an area that involves many stakeholders. In looking at fixes, they can be categorized as strong, intermediate or weak fixes. The strongest fix for PCA pumps is a forcing function, such as an integrated end tidal CO2 monitor that will pause the pump if a possible over infusion occurred. So, healthcare providers should first look at these strong fixes. There they will see the most impact on reducing errors and improving patient safety.”

David Watson (VP, ECRI Institute) concurs, “We have previously recommended the development of an action plan to implement effective physiological monitoring of patients on PCA therapy.  As such, I would concur with the VHA recommendations on this [to use PCA pumps with integrated capnography].”

Reminder #5: Monitoring patients with capnography save lives

Dr. Carin Hagberg (professor and chair of anesthesiology at the University of Texas Medical School at Houston, and executive director of the Society for Airway Management). “The key finding of the UK study was that 70% of airway-related deaths occurred in the ICU at least partly caused by failure to use capnography in ventilated patients. The researchers noted that increasing use of capnography in ICU patients is the single change with the greatest potential to prevent deaths such as those reported to NAP4. Perhaps we should follow suit with the Association of Anaesthetists of Great Britain and Ireland, which recently published a statement urging that continuous capnography be used in all patients whose airways are being maintained.”

Reminder #6: Continuously monitor all patients to prevent respiratory depression

Dr. Frank Overdyk (Executive Director for Research, North American Partners in Anesthesiology, and Professor of Anesthesiology at Hofstra University School of Medicine), “Patient surveillance systems that use continuous monitoring with oximetry and capnography would facilitate early recognition of patient deterioration.”

Dr. David Crippen (Associate Professor of Critical Care Medicine, University of Pittsburgh Medical Center) explains further, “To prevent respiratory depression, patients need to be monitored in real time, and not just when caregivers periodically check on their patients. Capnography is the only way to assess adequacy of ventilation (not oxygenation) for patients on controlled mechanical ventilation. If patients on a ventilator become hypoxic for whatever reason, and the pCO2 stays constant, they do not necessarily become agitated (hypercarbia induced catecholamine release and agitation). They simply go to sleep. The pulseox will not alarm in hypercarbic or hypocarbic states in the face of normal oxygenation. Therefore, capnography is necessary to assess whether ventilation is proceeding normally in real time. It also assesses possible bronchospasm, thumbnail guesses of deadspace and of course, whether the patient has air entering the trachea after intubation. It gives a tremendous amount of useful information at a glance and also allows troubleshooting in real time.”

Reminder #7: Get smart about monitoring alarms. Use monitors to save patients, don’t turn them off.

Dr. Paul M. Schyve (Senior Advisor, Healthcare Improvement, The Joint Commission) says, “There is uniform agreement that alarm fatigue is a major problem.  Alarm systems are built into many medical devices, such as infusion pumps and ventilators. When they work as intended, they alert caregivers that a decision or action is required for the patient’s health and safety. However, too many alarms, including false alarms, can fatigue, confuse, and overload clinicians.”

Maria Cvach, RN, MSN, CCRN (assistant director of nursing and clinical standards at The Johns Hopkins Hospital), “Nurses in intensive care units stated that the primary problem with alarms is that they are continuously going off and that the largest contributor to the number of false alarms in intensive care units is the pulse oximetry alarm. A ‘smart alarm’ that analyzed multiple parameters, like oxygenation and adequacy of ventilation, in a patient’s condition, may be a solution. This would increase patient safety by making it easier for nurses to assess a patient’s condition and reduce the frequency of false alarms.”

Reminder #8: Continuously electronically monitoring all patients is not “extra work”. It’s the right thing to do.

Tammy Haslar, RN, an oncology advanced practice nurse at St Francis Hospital (Indianapolis, Indiana), “Although monitoring all patients using PCA can be seen as ‘extra-work,’ our facility decided that we could not make the ethical decision of saying which patients should or should not be monitored, and our facility made the decision that all patients with PCA would be monitored with capnography.”

Reminder #9: Using monitors reinforces the need for and helps nurses.

Anne Miller, RN, an assistant professor at Center for Research and Innovation in Systems Safety at Vanderbilt University Medical Center (Nashville, Tennessee), “In my opinion, the solutions lie closer to the bedside. For example, real-time monitoring has benefits beyond simple patient monitoring. For the nurses in our study, the major revelation was that their patients had changed and that they needed to be doing things differently. Continuous electronic monitoring gave them feedback about the effectiveness of their actions on these patients.”

Reminder #10: Use the PCA Safety Checklist for greater patient safety and to save lives

Frank Federico, RPh (Patient Safety Advisory Group at The Joint Commission and Executive Director at the Institute for Healthcare Improvement), “Use and adherence with standardized processes for eligible patients leads to better clinical outcomes. The PPAHS PCA checklist lays out essential steps to be taken to initiate patient-controlled analgesia (PCA) with a patient and to continue to assess that patient’s use of PCA. Following these steps will help to increase patient safety and save lives.”

• Alarm Fatigue
• Opioid Safety
• Respiratory Compromise