Background Since 2011, according to the good practice contract (CBUMPP), our University Hospital is committed to writing reports tracing named cochlear implants (devices, indications) which are submitted to the Regional Health Agency.
Purpose To organise a prospective database to monitor the conformity of indications with the national recommendations and to justify off-label prescriptions (HR).
Materials and methods Since the start of 2012, a multidisciplinary team (surgeons, pharmacists, speech therapists, Department of Medical Information (DIM)) have been required to identify the possible sources for retrieving the requested data (patient clinical data, implant traceability, indication), to organise a database, to analyse it and to validate it biannually.
Results 3 sources were identified, but the data extraction from each single source was not exhaustive. It was therefore necessary to manually perform a more complete collection by exploiting the 3 sources.
In 2012, of the 58 implants, 95% were in accordance with the national recommendations and 5% were HR but justified (N = 3). Over the first 8 months of 2013, of the 39 implants, 92% were in accordance with the national recommendations and 8% were HR but justified (N = 3). Regarding the 6 HR indications, 5 corresponded to a unilateral implantation for severe deafness in adults when the discrimination was over 50% during vocal audiometry tests and 1 was for an acoustic neuroma.
Conclusions The full traceability of implantable medical devices and their indications under the CBUMPP is complex in the absence of a suitable tool. The majority of cochlear implant indications in our hospital are in accordance with the national recommendations. In 2012 some inconsistencies were encountered due to financial coverage modalities. Therefore, since 2013, we monitor reimbursed cochlear implants with the DIM physician. Finally, multidisciplinary collaboration is essential to obtain complete data and reasons for implants, along with a continued improvement in practice.
No conflict of interest.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.