1. ©ECRI 2007 1 XIX. Drug Delivery Pumps TRAINING SEMINAR ON MEDICAL DEVICE ACCIDENT INVESTIGATION for Kingdom of Saudi Arabia Saudi Food & Drug Authority Riyadh 11-14 February, 2007 Presenter: Mark E. Bruley Vice President, Accident and Forensic Investigation ECRI 5200 Butler Pike, Plymouth Meeting, PA, 19642 USA Tel: +1 610-825-6000, ext. 5223 E-mail: mbruley@ecri.org Web Sites: www.ecri.org www.mdsr.ecri.org

2. ©2007 ECRI 2 Drug Delivery Pumps Infusion Pumps and Accessories Patient Controlled Analgesia Pumps Implantable Pumps Implantable Reservoirs/Medication Ports Pharmacy Medication Pumps Special Testing Considerations/Equipment Safety During Testing

3. ©2007 ECRI 3 An error waiting to happen!

4. ©2007 ECRI 4 Infusion Pump Technology Pump technology has been relatively stable over the past few years Pump models are now distinguished by ability to reduce common infusion hazards Free-flow IV medication errors

5. ©2007 ECRI 5 Free-Flow Solution flows freely by gravity, uncontrolled pump = over infusion Can happen when tubing set is removed pump Use tubing sets with anti-free-flow mechanisms

6. ©2007 ECRI 6 IV Medication Errors Delivery of an incorrect dose Operator programs pump incorrectly Physician or pharmacist issues incorrect order Can be reduced through several strategies Have clear ordering protocols Use pumps with automatic dose calculation Get dose error reduction systems (new) Get bar-coding technology (new)

7. ©2007 ECRI 7 Dose Error Reduction Systems Warn of potential over- or under-delivery Check programmed dose against stored preset upper and lower limits Display drug name, concentration, and limit- exceeded warnings during infusion Logs events that trigger dose limit warnings

8. ©2007 ECRI 8 Bar-Coding Technology Used with dose error reduction system Bar-code scan of solution label Pump software interfaces with HIS, PhIS Emerging technology

9. ©2007 ECRI 9 Safe Use of PCA Pumps Entails more hazards than does the use of standard infusion pumps, most notably an increased risk of overmedication Narcotic administration may require special controls Needs careful patient, family, and staff education

10. ©2007 ECRI 10 Case Reports Infusion Devices –Free flow over- infusion (Lidocaine) –Programming errors –PCA Pumps (default concentration; tampering) –MedSUN Case 9

11. ©2007 ECRI 11 Implantable Pumps Mostly epidural Pneumatic or pneumatic/electronic Free flow (shim or tubing problems) Refilling in wrong spot (into tissue or into vessel) Catheter/pump separation Who owns: permission to test

12. ©2007 ECRI 12 Implantable Reservoirs/ Medication Ports Catheter separation Catheter crushing/failure Refilling in wrong spot (into tissue or into vessel) Clotting off/Tissue growth Instructions issues

13. ©2007 ECRI 13 Pharmacy Medication Pumps Case 14: Improper Mixing –Solution compounder –Software problem –Other incidents –Loss of device history –Programming error

14. ©2007 ECRI 14 Special Testing Considerations/Equipment Save device history Pumping time Precision scale for small volumes Graduated cylinders for large volumes Computer monitoring Need for pump programmer Temperature issues with fluorocarbons

15. ©2007 ECRI 15 Safety During Testing Use of water in place of drugs Contamination, surface & interior Retained solutions

16. ©2007 ECRI 16 QUESTIONS? XIX. Drug Delivery Pumps