Main problems identified through the pathway mapping and suggested improvements
| Problems identified through pathway mapping | Suggested improvements to the existing system | Lean six Sigma principles applied |
| 1. Multiple methods of reporting 2. Methods not inclusive of each other—pathways 1 and 3, 1 and 2, 1,2 and 3 occur simultaneously in different combination with no recommendation on the best pathway to follow for each event | 1. Simplify the existing system by removing multiple pathways | Remove non-value added steps |
| 3. No guidance on the best pathway(s) to follow | 2. Improve staff training | Involve staff and Improve staff training |
| 4. Not all events reported by clinicians via Datix are reported to MHRA via yellow card 5. Clinical information is interpreted and summarised by a non-clinician before reporting to MHRA 6. Variability and bias in the events reported to MHRA from manufacturers | 3. Reporting data directly from the end user to MHRA/manufacturer 4. Increased transparency of reporting and process 5. Increase awareness of yellow card among clinical teams | Involve staff and Improve staff training Manage by fact and reduce variation (use of accurate data) |
| 7. Maintenance contracts often not available | 6. Organisation of maintenance contracts | Manage, improve and smooth the process flow |
| 8. Devices not reparable internally, are thrown away if no maintenance contract is in place (with often no record) 9. Reporting directly to manufacturer is the most common pathway followed in operating theatres with no log of events reported and inability to carry out trend analysis | 7. Create a log of all devices in use 8. Improve data sources | Manage by fact and reduce variation (use of accurate data) |
| 10.Lack of data leads to decision making in the absence of evidence | 9. Improve data sources 10.Improve data access to clinical teams 11.Move away from incident reporting only and include near misses | Manage by fact and reduce variation (use of accurate data) Identify and understand how the work gets done |
| 11.Unreported events—the extent is unknown with no log of events 12.Unreported events—removes possibility for improvement from manufacturer | 12.Improve data sources 13.Move away from assessment and surveillance into prevention | Manage by fact and reduce variation (use of accurate data) Identify and understand how the work gets done |
| 13.Feedback from MHRA stops with medical device safety officer and Trust safety committee and does not reach the end user. | 14.Increased transparency of reporting and process 15.Improve communication between MHRA, clinicians and manufacturers | Focus on patients and staff Manage by fact and reduce variation Undertake improvement activity in a systematic way |
MHRA, Medicines and Healthcare products Regulatory Agency.