Background The European Regulatory Framework of Medical Devices is constantly evolving. Soon, hospitals will have to issue to patients traceability support for the medical device they receive. Since 2015 in France, this criterion has been evaluated by health authorities. In a previous study, we observed that few suppliers insert an implant card in the packaging of their implantable medical devices (IMD) (only 28% of references contained an implant card). Therefore, hospitals have to create their own implant card.
Purpose In order to evaluate the suppliers’ knowledge and involvement about the traceability intended to patients, we conducted a supplier survey.
Material and methods An online questionnaire was produced (Google Forms) and sent by electronic mail to 47 of the 60 IMD suppliers of our hospital. The 11 questions allowed assessment of the supplier’s offer and opinion about traceability of IMDs. The survey lasted 45 days (September to October 2015).
Results 23 (49%) on the 47 suppliers requested answered. 44% of the suppliers admitted that none of their implants contained support for patient traceability, 32% assured that all their implants were delivered with this support whereas 20% declared that only a few of their implants were provided with it. For the number of labels for traceability available on the box, 36% declared they supplied 4 or less labels, which can be a brake in fast transmission of information. More than one-third of the suppliers (40%) were not aware of this obligation of traceability intended for patients. A minority (12%) believed that they were not ready to provide this support. Many of the suppliers were interested in the survey and were ready to improve the situation.
Conclusion A minority of the suppliers provided an implant card in their packaging. A very small number of suppliers felt concerned by the transmission of information to the patient, although it will soon be an obligation. This survey made them aware of the situation and some are ready to help us to improve the situation.
References and/or acknowledgements Instruction No DGOS/PF2/2015/200 of 15 June 2015 (French Health Ministry).
No conflict of interest
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