Background Materiovigilance aims to monitor the risk of incidents resulting from the use of Medical Devices. What is its role in the establishment of a QMS in the hospital pharmacy?
Purpose To identify materiovigilance notifications within our hospital, to analyse them, to identify measures taken in each case and to establish a QMS that incldes the traceability of medical devices.
Material and methods Materiovigilance statements that were collected between June 2012 and May 2014 were analysed. Decisions that had been taken were collected in order to make a synthesis of QMS implemented in our pharmacy. Incidents were classified into three categories according to the severity of the event (3 is the worst) and measures taken were classified into three categories (corrective, preventive and palliative).
Results 75 notifications were collected, 27 (36%) first degree, 24 (32%) second degree and 24 (32%) the third degree of dangerousness. 24 notifications were from surgery units (gloves, sutures, infusion tubing), 19 from the haemodialysis service (vials of bicarbonate), 12 from ophthalmology (ocular implants) and 7 from the Intensive Care Unit (catheters, tracheal intubation tube, pressure sensors). Similar results have been found and published in EJHP by other national teams. The measures that have been taken were corrective in 16 (21%) of cases (definitive change of medical device), preventive in 6 (8%) of cases (compliance test before use) and palliative in 53 (71%) of cases (exchange of defective device).
Conclusion All notifications were selected and sent to suppliers to request information and to exchange defective devices. Some incidents were very serious (coils and stents breaking). Materiovigilance is necessary for the traceability of adverse events related to the use of medical devices. It is essential for the adoption of the QMS that we introduced in our pharmacy. This is particularly important in the absence of a national medical devices industry and specific regulation for these products.
References and/or acknowledgements Acknowledgements for Zakia Cheikh.
No conflict of interest.
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