A good place to start is the EU MedDev on Vigilance Reporting, MedDev 2.12-1 Rev. 8. It has a section on Trend Reporting and says, "Appendix C of GHTF SG2 document N54 'Global Guidance for Adverse Event Reporting for Medical Devices' provides useful guidance."
You should expect that every adverse event and nearly all complaints are associated with at least one row in your ISO 14971:2007 Hazard Analysis (assuming the typical Excel workbook approach). The row will have steps from Hazard, Sequence of Events, Hazardous Situation, to Harm. For each harm you would have estimated the severity and its frequency of occurrence.
For the analysis, I recommend classifying each complaint or adverse event by the unique identification number assigned in the Hazard Analysis. Part of the implementation of ISO 14971:2007 Clause 9 determines if the frequency of occurrence (this is a rate not the number of events), is greater than your initial estimate.
An SPC like approach is a good technique to start. Using the GHTF guidance, set the baseline at the estimated rate from the Hazard Analysis. Set the threshold high enough to detect signals, while reducing false alarms. Start with the threshold at 1.5 times the baseline rate. Also, consider using a moving average (three months) to smooth out spikes in the data. For example, some reporters may send reports in a batch instead of when they occur. This would cause a false alarm from the spike. Plot the monthly (smoothed data) as a time series along with the baseline and threshold. Apply "Shewhart rules" to detect a signal. (While not technically correct, the method is pretty robust for signal detection.)
------------------------------
Dan O'Leary
Swanzey NH
United States
------------------------------
Original Message:
Sent: 07-Nov-2017 19:08
From: Rashmi Pillay
Subject: Complaints /Adverse events trend analysis
Hi ,
Does anyone have experience with performing trend analysis for complaints and /adverse events. Could you share the best practices / guidance for the same.
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
.............................................................................
One Powerful Vision.
Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document.