Monday, August 13, 2012

Joint Commission Issues Sentinel Event Alert on Opioid-Induced Respiratory Depression -- IRVINE, Calif.


IRVINE, Calif., -- Masimo (NASDAQ: MASI) announced today that The Joint Commission has issued a Sentinel Event Alert on safe use of opioids in hospitals with recommendations to implement better dosing along with oxygenation and ventilation monitoring in post-surgical patients. The Masimo Patient SafetyNet System, consisting of Measure-through Motion and Low Perfusion oxygenation monitoring (Masimo SET Pulse Oximetry or rainbow SET Pulse CO-Oximetry), choice of easy-to-use ventilation monitoring with rainbow Acoustic Monitoring or standard capnography, and remote monitoring and clinician notification to keep clinicians connected to patients, can help hospitals comply with The Joint Commission recommendations. The Patient SafetyNet System is also the only technology clinically shown to reduce rapid response activations, intensive care unit (ICU) transfers, and deaths related to opioid-induced respiratory depression.

While opioid use is safe for most patients, opioid analgesics are associated with adverse effects and cause respiratory depression in 0.5% of post-surgical patients, who often receive them for pain management. Opioid analgesics rank among the drugs most frequently associated with adverse drug events, the Sentinel Event Alert noted. Of opioid-related adverse drug events – including deaths – that occurred in hospitals and were reported to The Joint Commission's Sentinel Event database (2004-2011), 47% were wrong dosing medication errors, 29% were related to improper monitoring of the patient, and 11% were related to other factors including excessive dosing, medication interactions, and adverse drug reactions.

Similar to the 2011 Anesthesia Patient Safety Foundation's recommendations, the Sentinel Event Alert recommended continuous monitoring (instead of spot checks) of both oxygenation and ventilation.  Oxygenation monitoring is possible with Masimo SET Measure-through Motion and Low Perfusion pulse oximetry, which is ideal for the general floor where patients are often moving and the nursing staff does not have the time to respond to false alarms.

Ventilation monitoring is possible with Masimo's rainbow Acoustic Monitoring, which provides continuous respiration rate through an acoustic sensor on the neck, or standard capnography, which provides continuous respiration rate and end-tidal carbon dioxide (EtCO2) through a nasal cannula. While capnography is considered the clinical standard for unconscious, mechanically ventilated patients undergoing surgery, in conscious patients the nasal cannula is often not well tolerated. In addition, the nasal cannula can be become dislodged or unable to pick reliable signals when patients breathe through their mouths, requiring additional nursing staff time to manage.

In a 2010 landmark study published in Anesthesiology, clinicians at Dartmouth Hitchcock Medical Center reported that use of Masimo SET pulse oximetry and Patient SafetyNet in a single orthopedic post-surgical unit led to a 65% decrease in rapid response activations and a 48% decrease in ICU transfers. A follow-up analysis appearing in the Spring-Summer 2012 issue of the Anesthesia Patient Safety Foundation newsletter validated the original findings by showing similar clinical results on two additional post-surgical floors.  Importantly, Dartmouth Hitchcock also reported that no patients on the original orthopedic unit have died or suffered irreversible brain injury as a result of respiratory depression from opioids since the Patient SafetyNet system was instituted in December of 2007.