Reducing Infusion Pump Errors

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Reducing Infusion Pump Errors

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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 Copyright 2008

5. IV Medication Errors Delivery of an incorrect dose operator incorrectly programs a pump physician or pharmacist issues an incorrect order Copyright 2008

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 Copyright 2008

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 Copyright 2008

9. Dose Error Reduction System Criteria System should permit limits for manually-entered concentrations Boluses (volume and time limits) Copyright 2008

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 Copyright 2008

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) Copyright 2008

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 Copyright 2008

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 Copyright 2008

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 Copyright 2008

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 Copyright 2008

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 Copyright 2008

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

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