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OHP-038 Traceability of implantable medical devices: a retrospective study from 2010 to 2013
  1. E Grandeau,
  2. N Dumont
  1. General Hospital of Boulogne Sur Mer, Pharmacy, Boulogne Sur Mer, France


Background In 2009, our general hospital purchased software (Genois) for tracking implantable medical devices (IMDs). Tracing IMDs after implantation not only involves nurses but also pharmacy assistants when problems occur.

Purpose To identify and analyse traceability errors and provide the appropriate solutions and improvements.

Material and methods Each year, an audit is performed to compare the actual stock of IDMs to our computerised database. A first rate is calculated after the inventory phase and a second one results from the pharmacist and nurse reassessment, which consists of comparing different sources of available information from the Genois and Blocqual systems and from operating room logbooks. Audit results were analysed retrospectively and errors were pointed out.

Results Between 2010 and 2013, the number of IDMs tracked increased from 1,089 to 4,346 implants. This rise reflects progressive computerization of traceability and the increased workload of operating rooms. The intermediate rate of untraced IDMs remains stable (about 2%) over the period while the final rate shows a significant decrease from 1.1% (2010) to 0.2% (2013). This difference is owed to improvements in input errors (34 in 2013) and computer traceability oversights (52 in 2013).

A new version of the software compatible with current interfaces will include a barcode scanner, to decrease the number of input errors. IMDs traceability structure will be reviewed: the 3 different recording medias actually in use will be reduced to one, through the Genois software.

Errors on untraced and lost IDMs are mainly due to packaging issues (batches containing 2 or more IDMs) or related to implanted life-long IDMs (implanted subcutaneous ports): a method of traceability to the single unit has been set up.

Conclusion Traceability of IDMs has been improved thanks to the close collaboration between the pharmacy and the nurses. The next step in management of IDMs is the computerised input of IDMs indications.

References and/or acknowledgements Art L.5212–3 CSP.

No conflict of interest.

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