Infusion device incidents Lessons learned and recommendations

Transcription

1 HA Convention 8 th May 2007 Infusion device incidents Lessons learned and recommendations Jason Ng, Andy Chung, Bonnie Wong, Becky PY Ho, Kate Choi, Anne Kwan, Joseph Lui, Fred Chan, Ella Ma, David Lau, Lilian Lau

2 Introduction Infusion device Often employed to infuse fluids, nutrients, or medication into patient s circulatory system Widely used for safe and accurate administration

3 Safety of the infusion device Improper use of the equipment can be potentially dangerous or even life-threatening

4 Aim of study Lack of local data addressing on the safety issue of infusion device 1) review the characteristics of the adverse incidents 2) recommend appropriate actions to enhance the safe use of infusion device

5 Method Working Group on Safe Use of Infusion Pump Risk managers of the clusters reported medical incidents Advanced Incident Reporting System (AIRS). Electrical and Mechanical Services Department (EMSD) for checking.

6 2 Stages 1 st :KCC, NTEC, NTWC 2 nd :All clusters (HKEC, HKWC, KCC, KEC, KWC, NTEC, NTWC)

7 Result Period: January 2005 to Sept incidents related to the use of infusion device

8 Types of Infusion device 59 Infusion pumps 11 Infusion syringes

9 Results RESULTS What had been given? How severe were the incidents? Who were involved? Which steps were involved? Why did they happen?

10 Results RESULTS What had been given? How severe were the incidents? Who were involved? Which steps were involved? Why did they happen?

11 What had been given? 9 were used for intravenous fluid replacement 61 infusion devices were used for administering medication Most medications were used for cardiovascular system e.g. thrombolytic agent, vasodilator, vasopressor

12 Results RESULTS What had been given? How severe were the incidents? Who were involved? Which steps were involved? Why did they happen?

13 Severity Index SI = 0 Incident occurred but stopped before reaching patient. No consequence. SI = 1 Incident occurred but no injury sustained. SI = 2 Minor injury SI = 3 Temporary morbidity SI = 4 Significant Morbidity SI = 5 Major permanent loss of function / disability SI = 6 Death May have required monitoring. No investigation is required Required monitoring &/or investigation Required monitoring &/or investigation. Required transfer to a higher care level. No change in vital signs. Some changes in vital signs. Significant changes in vital signs. No treatment required. Required minor treatment (e.g. simple wound care, analgesic). Required simple treatment (e.g suturing). Required emergency treatment / surgical intervention.

14 Severity Index of the Incidents No. of incidents Severity Index

15 Results RESULTS What had been given? How severe were the incidents? Who were involved? Which steps were involved? Why did they happen?

16 WHO were involved? Nurse MO HO Others No. of incidents involved

17 Results RESULTS What had been given? How severe were the incidents? Who were involved? Which steps were involved? Why did they happen?

18 Infusion steps Prescription Calculation Setting up 23 incidents infusion rate Administration Device operation 11 incidents Device tampering

19 Results RESULTS What had been given? How severe were the incidents? Who were involved? Which steps were involved? Why did they happen?

20 WHY did they happen? Human factor Device factor Unknown

21 Factors Human factors Device factors

22 Causes of incidents Human factors Wrong administration Wrong consumables Failure to deliver Calculation errors Human Factors Device tampering Misunderstanding device Incorrect set up

23 Wrong set up (23/70) Intended setting Actual setting

24 Wrong set up 3 incidents Swab between 2 infusion settings

25 Lack of understanding of device operation (11/70) Free flow administration set had been removed from an infusion pump roller was not clamped before opening door (in some models) Persons involved e.g. nurses, health care assistant, radiographer Circumstance e.g. transferal of patient

26 Factors Human factors Device factors

27 Causes of the incidents Device Factors Device Defect Device factors Device Design

28 Device factors (14/70) Device defect 7 incidents Defective pump Defective alarm Damaged electric cord Device design 7 incidents Lack of anti-free flow protection

29 Device design - Free flow 7 incidents (7/70) Models: Drip rate type infusion E.g. Dropmat, Dripwatch, Nikkiso Mechanism: Free flow occurred when the door was opened without clamping the roller Precaution: Not suitable for high risk medications

30 Device without built in anti-free flow mechanism

31 Risk Management of Infusion Pump

32 Recommendation

33 Training Recommendation 1 Human factors To provide adequate education and training to staff. Formal demonstration of commonly used models should be arranged.

34 Safe alert Recommendation 2 Human factors The awareness of the safety issue on infusion device should be raised Ensure 3 checks 5 rights Periodic assessment on the skill and knowledge about operating infusion device may be required.

35 Recommendation 3 Device factors High-risk models Include built-in free-flow protection as standard in the specification in future procurement Require timely and appropriate action on high-risk models e.g. removal from service, safety modifications, add safety tags

36 Recommendation 4 Less is more Standardization of the infusion device to a few models avoid confusion promote user training, equipment maintenance share equipment library and consumable supply

37 1 Significant injury 69 Mild injury Mild / Severe event?? Near Miss Limitation 1: Underreporting

38 Simplistic analysis Human vs Device factor Limitation 2 Reality Multifactorial Consider other factors Staff experience Ward circumstance.

39 Conclusion 70 incidents related to infusion device were captured in 21 months Identify High risk steps High risk models with no free flow protection Error prevention strategy

40 Conclusion Proof of concept Useful data retrieved from AIRS Lessons learned Make recommendation

41 Safe Culture Just culture Flexible culture Reporting culture Sharing and learning culture

42 Learning and sharing It takes a wise man to learn from his mistakes, but an even wiser man to learn from others

43 Acknowledgement Working Group on Safe Use of Infusion Pump Dr Lilian Lau Mr Andy Chung Ms Bonnie Wong Ms Becky PY Ho Ms Kate Choi Mr Kennis IP Dr MY Cheng Dr David Lau Dr Anne Kwan Dr Joseph Lui Mr Fred Chan Ms Jayne Lee Mr YL Cheung Ms Ella Ma

44 Thank you

45 Human Factors Classification Incidents Possible causes Follow up actions No. of cases Incorrect infusion rate setting by users Wrong infusion rate Wrong input Staff training Built-in safety mechanism 5 The use of incompatible consumables Wrong syringe used for patient controlled analgesia Use other brand of syringe Staff training Standardize device 4 Lack of understanding of the device operation Infusion was finished earlier than expected with free flow of fluid Lack of understanding of device operation leading to free flow infusion Staff training Replace high risk models Built-in safety mechanism 3

46 Human Factors Classification Incidents Possible causes Follow up actions No. of cases Calculation errors Over infusion of IVF to a neonate Wrong calculation of prescription Staff training Standardize IVF 3 Over infusion of drug Wrong calculation of infusion rate Staff training Standardize drug concentration Over infusion rate Wrong drug label interpretation Staff training

47 Human Factors Classification Incidents Possible causes Follow up actions No. of cases Failure to deliver drug Battery ran out without power to run the syringe Syringe driver not in proper position Staff was not aware of short life duration (4 days) Staff was not familiar with the set up of infusion pump Lack of monitoring Reminder staff to use new battery for new set-up or check battery level before use Staff training Device tampering Over infusion Tampering Proper placement of infusion device 2 1

48 Device Factor Classification Incidents Possible causes Follow up actions No. of cases Infusion device fault Drug was not infused Defective pump syringe Periodic check by EMSD Pump syringe was repaired 2 Over infusion of the drug Defective sound blast of pump syringe Periodic check by EMSD Sound blast of pump syringe was repaired

49 Root cause analysis Events Proximate causes System factors

50 Content Introduction Aim of study Method Result Recommendation Discussion Conclusion

51 AIRS version 2 Limitation 2 Infusion device template NOT AVAILABLE Free text Information may be missing

52 Device tampering (7/70) Under infusion 5 incidents Nurses Forget to resume setting after reset Over infusion 2 incidents Patients Change setting accidentally