Addressing Infusion Pump Risk: A Mandate for Capnography

FDA recommends etCO2 monitoring for patients receiving opioids through infusion pumps

Recent reports from the Food and Drug Administration (FDA) have spotlighted the alarming safety risks of external infusion pumps, and, specifically, patient-controlled analgesia (PCA) pumps. To protect patients from this risk, the FDA has joined leading patient safety organizations in recommending that patients receiving opioids through infusion pumps be monitored with etCO2 when applicable.

The Oridion white paper Addressing Infusion Pump Risk: A Mandate for Capnography highlights the performance problems related to external infusion pumps and the strategies recommended by the FDA to reduce risk to patients. You can download it here.

FDA joins patient safety organizations with capnography recommendation

The FDA report was released in the wake of adverse patient events that demonstrate the risk of respiratory depression associated with infusion pumps.

In addition, leading patient safety organizations have highlighted the value of capnography in reducing patient risk:

• The APSF (American Patient Safety Foundation) emphasized guidelines recommending continuous ventilation monitoring in patients receiving PCA or neuraxial opioids in the postoperative period.

  “We recommend consideration of the use of technology to continuously monitor ventilation in all patients receiving postoperative PCA or neuraxial opioid pain management … (which) would improve the detection of progressive or unrecognized hypoventilation.” (APSF Newsletter, Summer 2009)

• The American Society of Anesthesiologists established new guidelines recommending that post-anesthesia patients be monitored for ventilation, and patients receiving epidural or spinal opioids be monitored for depth of respiration, not only pulse oximetry and respiratory rate.

  “All patients receiving neuraxial opioids should be monitored for adequacy of ventilation (e.g., respiratory rate, depth of respiration [assessed without disturbing a sleeping patient]), oxygenation (e.g., pulse oximetry when appropriate), and level of consciousness.” (American Society of Anesthesiologists, Practice Guidelines for the Prevention, Detection, and Management of Respiratory Depression Associated with Neuraxial Opioid Administration, 2009)