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1. Reducing Infusion Pump Errors A Saudi Food & Drug Administration Program
January 2008
Tim Ritter
Senior Project Engineer
2. An error waiting to happen! Copyright 2008
3. State of the Technology Pump technology has been relatively stable
rate entered in mL/hr
no feed-back for erroneous programming
Some models can now reduce common infusion hazards
gravity free-flow
dosing errors Copyright 2008
4. Free-Flow Fluid flows freely under the force of gravity when pump’s infusion set is removed unclamped
Can occur when infusion set is removed from pump
by a nurse changing patient’s gown clearing air from the set
by the patient or a visitor attempting to stop an alarm
Risk can be greatly reduced by pumps that cause the set to be closed before it can be removed
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5. IV Medication Errors Delivery of an incorrect dose
operator incorrectly programs a pump
physician or pharmacist issues an incorrect order
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6. IV Medication Errors
Can be reduced through several strategies
establish clear protocols for ordering infusions
standardize drug concentrations
use pumps with a dose error reduction system
bar-coding technology (in development) used in conjunction with dose error reduction system
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7. Dose Error Reduction System Definition
An advisory function that produces alerts for potential over- or under-delivery of a selected drug or electrolyte
Programmed dose is compared to preset limits
Devices with this capability are being referred to as “smart pumps” and associated with the terms medication safety or surveillance software Copyright 2008
8. Dose Error Reduction System Criteria
System should be able to link drugs, their concentrations, dosing units, and dose limits to =8 clinical locations/applications
System should also include maximum patient weight, VTBI, and rate limit for each location/application
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9. Dose Error Reduction System Criteria
System should permit limits for
manually-entered concentrations
Boluses (volume and time limits)
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10. Dose Error Reduction System Criteria Soft and hard limits
it should be possible to set limits that can and cannot be overridden
it may be desirable to have both for some drugs
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11. Dose Error Reduction System Criteria System should encourage consistent use
simple to use and few additional steps
usable with minimal-risk infusions
Display should clearly indicate
when the system is not in use
when the pump is operating outside a limit Copyright 2008
12. Dose Error Reduction System Criteria When the pump is turned on it should
be in dose error reduction system mode
require user to confirm if same or new patient and to select current clinical location/application
Display should identify drug/electrolyte and dose infusing in each channel
TALLman letters (DOPamine / DOButamine)
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13. Dose Error Reduction System Criteria Multichannel pumps should trigger an alert if same drug is programmed on 2 channels
System should permit batch programming of facility’s drug library and dose limits Copyright 2008
14. Dose Error Reduction System Criteria Pump should have a separate log to record
limit overrides
programming changes that resulted from limit alerts
Log should retain data for >1 year and be downloadable for spreadsheet analysis
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15. Dose Error Reduction System Criteria Manufacturers should provide facility-based support with implementation
Coordinate decision-making staff
Develop a drug library consistent with the facility’s ordering and delivery practices
Develop dose limits and other clinical location/application-specific parameters
Train clinicians in the effective use of the pump and its dose error reduction system
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16. Evaluation Ratings Free-flow protection
Pumps that lack this protection are Unacceptable
Dose error reduction system
Pumps that lack this feature are Not Recommended
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17. ECRI Evaluations
General-Purpose Infusion Pumps Health Devices evaluation
October 2007
Syringe Pumps
Health Devices evaluation
January 2008
Infusion Pump poster Copyright 2008
18. Setting Up for Infusion Use sets and accessories with Luer-lock connectors for all central venous and arterial lines
Purge air from lines to prevent embolisms, nuisance alarms, and flow errors
Use dose error reduction system on pumps so-equipped
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19. During Infusion To prevent call-back alarms, verify that device is infusing after starting
Check device operation and IV site as often as with gravity sets. Occlusion alarms cannot reliably detect infiltration
Note changes in flow or pressure indicator if present
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20. During Infusion Don't repeatedly restart pump after an alarm
Wipe spills off equipment before they dry
Always close manual clamp before removing infusion set Copyright 2008