Improving the Safety of PCA with Smart IV Technology and Continuous Respiratory Monitoring

1
Improving the Safety of PCA with Smart IV
Technology and Continuous Respiratory Monitoring

• Carolyn K. Williams, R.Ph.
• St. Josephs/Candler Health System, Inc.
• Savannah, GA
• williamsc_at_sjchs.org

2
Objectives

• Understand the risk associated with patient
  controlled analgesia (PCA)
• Describe benefits of smart IV technology to
  reduce PCA programming errors
• Describe benefits of continuous respiratory
  monitoring for patients receiving PCA

3
PCA Has Inherent Dangers

• Drug product mix-ups
• Device design flaws
• Inadequate patient/family education
• Pump misprogrammings
• PCA by proxy
• Inadequate monitoring
• Improper patient selection
• ISMP Medication Safety Newsletter, July 10, 2003
  Vol 8, no.14

4
Statistics from the FDAMAUDE Database
2004 LVP Deaths/ADEs 17 Deaths 9
programming errors 1 user error 5
unknown if device related 2 not related
to device 390 ADEs 74 programming errors 138
device malfunctions 133 unknown if device
related 38 user error 7 others ( e.g.
bolus) 407 total reports
2004 PCA Deaths/ADEs 22 Deaths 4
programming errors 5 not related to device
10 unknown if device related 3
device malfunctions 106 ADEs 4 PCA by
proxy 2 user error 21 programming errors
24 unknown if device related 55 device
malfunction 128 total reports
MAUDE Manufacturer And User Facility Device
Experience Database
Source FDA MAUDE Database January 2004
December 31, 2004
5
Smart Technology PCA Pumps

• Best Practice data set with standardized
  concentrations
• Prevents programming errors
• Integrated with continuous respiratory monitoring
• Measure effect of opioid on respiratory function
• Alarm ranges customized
• Medication pauses

6
66 PCA Programming Errors Prevented December
2004 to June 2005
7
PCA Programming Error Prevented
8
PCA Programming Error Prevented
9
Patient Controlled Analgesia with Continuous
Respiratory Monitoring
10
Patient Controlled Analgesia with Continuous
Respiratory Monitoring
11
The Respiratory Cycle has two separate
physiologic processes Ventilation Oxygenation

• EtCO2 Monitoring
• (Measures Ventilation)

• SpO2 Monitoring
• (Measures Oxygenation)

• Measures oxygen saturation (O2 attached to
  hemoglobin)
• Reflects oxygenation
• Detects hypoxia
• Should be used with capnography

• Measures carbon dioxide
• Reflects breath-to-breath ventilation
• Detects hypoventilation/apnea immediately
• Should be used with pulse oximetry

Both assist in non-invasive monitoring of
physiological status.
12
PCA Monitoring Trend Data Opioid Induced
Respiratory Depression
? alarm
13
Initial Findings with Combining Monitoring and PCA

• Multiple high risk situations identified
• Included narcotic overdose, no breath alarms,
  obstructive airway disease, OSA, CHF, PE
• Initial reaction to monitoring possible
  monitoring inaccuracy
• Perceived nuisance alarms were real events
• Patient status can change quickly

14
Conclusions

• Internal external evidence that PCA is a high
  risk therapy.
• Smart pump platform improves safety of
  programming PCA dosing
• PCA with continuous respiratory monitoring
  averted gt15 serious potential outcomes in 6 month
  period
• EtCO2 gt sensitivity than SpO2 for impending
  respiratory problems
• Multidisciplinary team must include respiratory
  therapists
• Continuous monitoring improves outcomes by
  reducing morbidity, mortality, and costs for
  hospitalized patients on PCA