Background
Regulatory frameworks around medical devices require that devices placed on the market or put into service are both safe to use and perform as the manufacturer claims they should. The supply of clinical evidence in support of these safety and performance requirements begins with the initial conformity assessment procedures and, in the context of post-market surveillance, continues for the life cycle of the device. Essential to both the initial evaluation and subsequent post-market surveillance is the identification and accumulation of information pertaining to possible adverse effects of the medical device.
Golder et al (see References below) have developed and validated search filters for adverse effects of medical devices in Ovid MEDLINE and Embase. They have shown that the developed searches are able to achieve over 80% relative recall in both databases. Additionally, that such recall can be extended to 90% where the searches are supplemented with specifically named adverse effects.
This Focused Search presents the Embase search filter for adverse effects of medical devices in Embase on Ovid. For the equivalent search in Ovid MEDLINE, please see Adverse Effects of Medical Devices – Ovid MEDLINE.
Both of these search filters can be easily viewed and run, as well as imported into your My Workspace area on Ovid. And this, for re-use and further fine-tuning to meet your own specific needs. These search filters can be linked to a medical device of your choosing and further refined. Implemented also as an AutoAlert, the information subsequently delivered from such routinely run searches, will be an important contribution to your post-market surveillance activities.
Search Stategy
1. co.fs.
2. complicat*.ti,ab.
3. safe*.ti,ab.
4. failure*.ti,ab.
5. exp medical device complication/
6. adverse.ti,ab.
7. failed.ti,ab.
8. exp postoperative complication/
9. problem*.ti,ab.
10. side effect*.ti,ab.
11. discomfort.ti,ab.
12. loosen*.ti,ab.
13. removal*.ti,ab.
14. complications.kf.
15. migration.ti,ab.
16. ae.fs.
17. device related events.ti,ab.
18. adverse effects/
19. device safety/
20. safety/
21. peroperative complication/
22. tolerated.ti,ab.
23. failing.ti,ab.
24. Or/1-23
Reviewers
Primary: Michael Fanning
Secondary: Charlotte Viken
Review Date: 2024-05-08
Expiry Date: 2025-05-08
Original search produced by:
CRD
References:
Golder S, Farrah K, Mierzwinski‐Urban M, Wright K, Loke YK. The development of search filters for adverse effects of medical devices in MEDLINE and EMBASE. Health Information & Libraries Journal. 2019 Sep;36(3):244-63. OA article available at https://onlinelibrary.wiley.com/doi/pdf/10.1111/hir.12260.
Note: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. See reference above on page 244.
Citation:
Ovid Customer Support, Adverse Effects of Medical Devices – Embase, Ovid Expert Searches Portal, Version: 8th May 2024, Visited: 11th May 2024.