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Root Cause Analysis of Medical Device Incidents
- 1. Root Cause Analysis Human Error and Medical Device Accidents Semester Project Mariana Hu 12/12/2011
- 2. Root Cause Analysis • Description of Events • Cause and Effect Analysis • Plan of Action and Tracking of Outcomes • Outcomes • Conclusion • References
- 3. Description of Events Hospital’s Medical Surgical Telemetry Unit May 19 May 20 Nurses unable Site Admin. Patients were Nurses unable to obtain Site Admin. to get accurate accurate notified diverted to signals closed unit signals Biomed another unit
- 4. Description of Events Hospital’s Medical Surgical Telemetry Unit May 19 May 20 Nurses unable Site Admin. Patients were to obtain Site Admin. accurate notified diverted to closed unit signals Biomed another unit Noise in waveforms
- 5. Description of Events Hospital’s Medical Surgical Telemetry Unit May 19 May 20 Nurses unable Site Admin. Patients were to obtain Site Admin. accurate notified diverted to closed unit signals Biomed another unit Noise in waveforms False alarms
- 6. Description of Events Hospital’s Medical Surgical Telemetry Unit May 19 May 20 Nurses unable Site Admin. Patients were to obtain Site Admin. accurate notified diverted to closed unit signals Biomed another unit Noise in waveforms Nuisance alarms False alarms
- 7. Description of Events Hospital’s Medical Surgical Telemetry Unit May 19 May 20 Nurses unable Site Admin. Patients were to obtain Site Admin. accurate notified diverted to closed unit signals Biomed another unit Biomed!!! • Site Admin. called Biomed to notify poor signal quality
- 8. Description of Events Hospital’s Medical Surgical Telemetry Unit May 19 May 20 Nurses unable Site Admin. Patients were to obtain Site Admin. accurate notified diverted to closed unit signals Biomed another unit • Site Admin. did not wait for Biomed • Site Admin. initiated process to close the Telemetry unit based on own judgment
- 9. Description of Events Hospital’s Medical Surgical Telemetry Unit May 19 May 20 Nurses unable Site Admin. Patients were to obtain Site Admin. accurate notified diverted to closed unit signals Biomed another unit • Patients were transferred to another Telemetry unit of the hospital
- 10. Description of Events Hospital’s Medical Surgical Telemetry Unit May 19 May 20 Biomed and They found mfg inspected four broken They found antennas and amplifiers in four noisy transmitters antenna transmitters
- 11. Description of Events May 19 May 20 Biomed and They found They found mfg inspected four broken four noisy antennas and amplifiers in transmitters transmitters antenna • The antenna systems were not inventoried and scheduled for PM by Biomedical Engineering • The antenna system was 10 years old
- 12. Description of Events May 19 May 20 Biomed and They found They found mfg inspected four broken four noisy antennas and amplifiers In transmitters transmitters antenna • The transmitters were noisy due to loose internal components • The telemetry transmitters were maintained annually • At the time of the event, 8 months had passed since the last PM
- 14. Analysis Proximal causes Equipment performance
- 15. Analysis Proximal causes Equipment performance Broken antenna Noisy transmitters
- 16. Analysis Proximal causes Equipment performance Staff competency Broken antenna Noisy transmitters
- 17. Analysis Proximal causes Equipment performance Staff competency Broken antenna Noisy transmitters Nurses untrained in applying strategies to avoid poor waveforms
- 18. Cause and Effect Analysis
- 19. Cause and Effect Analysis
- 20. Cause and Effect Analysis
- 21. Cause and Effect Analysis
- 22. Cause and Effect Analysis
- 23. Cause and Effect Analysis
- 24. Cause and Effect Analysis Root Cause
- 25. Cause and Effect Analysis Root Cause
- 26. Cause and Effect Analysis Root Cause
- 27. Cause and Effect Analysis Root Cause Root Cause
- 28. Cause and Effect Analysis Root Cause Root Cause
- 29. Cause and Effect Analysis Root Cause Root Cause Root Cause
- 30. Plan of Action & Tracking of Outcomes Inventory and Train nursing staff on schedule PM of strategies to improve antenna system waveforms in 2 years Track and trend calls Observe results of related to quality of inspection in 2 years signals in Telemetry Retrain Biomed staff Increase PM frequency on effective testing of telemetry procedure of transmitters telemetry transmitters (annual to semiannual) Observe results of the Inspection of transmitters after 6 months
- 31. Plan of Action & Tracking of Outcomes Inventory and Train nursing staff schedule PM of on strategies to antenna system improve waveforms in 2 years Track and trend calls Observe results of related to quality of inspection in 2 years signals in Telemetry Retrain Biomed staff Increase PM frequency on effective testing of telemetry procedure of transmitters telemetry transmitters (annual to semiannual) Observe results of the Inspection of transmitters after 6 months
- 32. Plan of Action & Tracking of Outcomes Inventory and Train nursing staff schedule PM of on strategies to antenna system improve waveforms in 2 years Track and trend calls Observe results of related to quality of inspection in 2 years signals in Telemetry Retrain Biomed staff Increase PM frequency on effective testing of telemetry procedure of transmitters telemetry transmitters (annual to semiannual) Observe results of the Inspection of transmitters after 6 months
- 33. Plan of Action & Tracking of Outcomes Inventory and Train nursing staff schedule PM of on strategies to antenna system improve waveforms in 2 years Track and trend calls Observe results of related to quality of inspection in 2 years signals in Telemetry Retrain Biomed staff Increase PM frequency on effective testing of telemetry procedure of transmitters telemetry transmitters (annual to semiannual) Observe results of the Inspection of transmitters after 6 months
- 34. Outcomes Biomedical Engineering staff Inventory and To be determined schedule PM of antenna in 2 years systems in 2 years Retrain Biomed staff on effective testing procedure of transmitters No defective transmitters found after 6 months Increase PM frequency of telemetry transmitters Reduction of calls related to quality of Provide training to signal in Telemetry. nursing staff on strategies Problems found are to improve waveforms not related to defective equipment
- 35. Conclusion • A reduction in number of calls related to quality of signals already indicates an improvement in performance in the Telemetry unit • Training is acquired gradually
- 36. The End Thank you for your attention!
- 37. References • NASA Root Cause Analysis Presentation • Painter, Frank. Root Cause AnalysisPresentation. October, 2011 • The Joint Commission. Root Cause Analysis in Health Care: Tools and Techniques. Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations, 2003.
Hinweis der Redaktion
- Hello everyone. My presentation is about a RCA on the closing of a Telemetry unit due to inability to obtain accurate signals.This is an outline of my presentation. Now, I’m going to start with a description of the event.
- The event took place in a hospital’s med/surg telemetry unit on may 19 this year.It all started when the nurses were unable to obtain accurate signals from almost all beds.
- They observed noise in the waveforms, there were false alarms (such as reading asystole when pts were alive), and as a result there were a lot of nuisance alarms.
- The site admin in charge called biomed immediately and notified the problem
- After the call she decided to close the unit based on her own judgment
- The next day, Biomedical Eng and the manufacturer inspected the antennas and transmitters and they came to the following result:Broken amplifiers in the antenna. It happens that the antenna was 10 yrs old and had never been maintained. Noisy telemetry transmitters. Although they are maintained once a year, they had loose internal components that caused them to be noisy.
- To begin with the analysis, we identify that there are proximal causes related to equipment performance (broken antenna and noisy transmitters), but after talking to the CE we found out that there is another proximal cause related to staff competency, given by the nurses not trained in applying strategies to avoid poor waveforms: checking/replacing leads, re-prepping the electrode site, etc
- From an analysis we observe that there are proximal causes related to equipment performance (broken antenna and noisy transmitters), but after talking to the CE we found out that there is another proximal cause related to staff competency, given by the nurses not trained in applying strategies to avoid poor waveforms.
- From an analysis we observe that there are proximal causes related to equipment performance (broken antenna and noisy transmitters), but after talking to the CE we found out that there is another proximal cause related to staff competency, given by the nurses not trained in applying strategies to avoid poor waveforms.
- From an analysis we observe that there are proximal causes related to equipment performance (broken antenna and noisy transmitters), but after talking to the CE we found out that there is another proximal cause related to staff competency, given by the nurses not trained in applying strategies to avoid poor waveforms.
- From an analysis we observe that there are proximal causes related to equipment performance (broken antenna and noisy transmitters), but after talking to the CE we found out that there is another proximal cause related to staff competency, given by the nurses not trained in applying strategies to avoid poor waveforms.
- Further I carried out a cause and effect analysis to identify the Root causes. The effect we do not want to recur is the inability to obtain accurate signals in the telemetry unit.The action that caused this effect were nurses placing leads on pt’s chest to monitor heart activity, as part of their daily tasks of telemetry.This action happened under 3 conditions: first, broken amplifiers in the antenna, which was caused by the fact that they were never maintained for 10 years, which was due to Biomed having overlooked their responsibility of maintaining the antenna system because it was in the ceiling and there was no policy written stating that it is Biomed’s responsibility. So a lack of procedural policy Is the 1st root cause.Second, the noisy transmitters due to a deficient testing procedure used by Biomed staff, and at the same time an insufficient pm freq. So here we identify a lack of adequate maintenance as a 2nd root cause. The third conditions is the nurses not being trained to apply strategies to avoid poor waveforms. This is due to a lack of training and education of the nursing staff: 3rd root cause
- An action plan was designed to eliminate the system failures.First, biomed inventoried and scheduled pm for antennas in 2 years. The results of the inspection in 2 years will determine the need for further inspections.Second, the nursing staff was trained on techniques to improve waveformsThird, the biomed staff was retrained on the effective procedure to test transmitters, and at the same time the pm freq was increased from annual to semiannual. The results of the inspection in 6 months determined the effectiveness of these 2 actions.
- - Observe results of inspection in 2 years to determine effectiveness of PM frequencyPrevention starts with implementingstrategies to reduce the number of nuisancealarms. This includes tailoring alarmlimits per patient, appropriate skin prepand lead placement, routine replacementof electrodes and routine replacement oftelemetry transmitter batteries.
- - Observe results of inspection in 2 years to determine effectiveness of PM frequencyPrevention starts with implementingstrategies to reduce the number of nuisancealarms. This includes tailoring alarmlimits per patient, appropriate skin prepand lead placement, routine replacementof electrodes and routine replacement oftelemetry transmitter batteries.
- - Observe results of inspection in 2 years to determine effectiveness of PM frequencyPrevention starts with implementingstrategies to reduce the number of nuisancealarms. This includes tailoring alarmlimits per patient, appropriate skin prepand lead placement, routine replacementof electrodes and routine replacement oftelemetry transmitter batteries.
- Training is acquired gradually, so it is expected that the number of calls in the next months is reduced even more. Skills are not acquired from one day another, so the results of training will be seen in the long-term.