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Accuracy and Precision of the SynchroMed II Pump
Reza Farid1, Kirstin Binz1, Jane Anne Emerson1
1Department of Physical Medicine and Rehabilitation, University of Missouri, Columbia, MO, USA.
Summary
SynchroMed II pumps accurately deliver intrathecal baclofen within specifications, though at a slightly lower rate than predicted. Pump flow rate accuracy decreases over time, warranting further study for patient safety.
Area of Science:
- Neurology
- Biomedical Engineering
- Clinical Pharmacology
Background:
- Severe spasticity requires precise medication delivery.
- Intrathecal baclofen is a common treatment for spasticity.
- Programmable infusion pumps are used for continuous drug delivery.
Purpose of the Study:
- To evaluate the accuracy and precision of SynchroMed II infusion pumps for intrathecal baclofen delivery.
- To assess pump performance in patients with severe spasticity.
Main Methods:
- Retrospective chart review of 149 patients over 2.5 years.
- Analysis of baclofen pump refill data, including drug concentration, dose, and pump volumes.
- Calculation of flow rate accuracy and precision based on manufacturer specifications for 20mL and 40mL pumps.
Main Results:
- SynchroMed II pumps demonstrated accuracy and precision within manufacturer specifications.
- Drug delivery rate was slightly lower than predicted for both 20mL and 40mL pumps.
- A statistically significant decrease in flow rate accuracy was observed over the pump's lifespan; no over-infusions occurred.
Conclusions:
- SynchroMed II pumps reliably deliver intrathecal baclofen within specified limits.
- A gradual decline in pump flow rate accuracy over time was noted.
- Further research is needed to understand the clinical implications of this flow rate decrease on patient treatment and safety.
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