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Other Hospital Pharmacy topics (including: medical devices)
Vigilance system for medical devices: the experience of an Italian hospital
  1. M. Dall'Aglio,
  2. G. Bellavia,
  3. C. Allegretti,
  4. A. Luoni,
  5. G.P. Venturelli
  1. 1A.O. Ospedale Niguarda Ca' Granda, Pharmacy, Milano, Italy
  2. 2A.O. Ospedale Niguarda Ca' Granda, Medical Division, Milano, Italy


Background The pharmacovigilance on Medical Devices (MDs) and In Vitro Diagnostic Medical Devices (IVDs) represents a relevant system for improving the protection of patients and health workers. In our hospital, according to Italian law implementing European Directive 2007/47/CE and MEDDEV guidelines, the activity is performed by a multidisciplinary team (pharmacists, physicians, clinical engineers).

Purpose To evaluate the impact of the pharmacovigilance system on the correct use of MDs in our hospital.

Materials and methods In 2004 the Pharmacy set up a database to record every event (Incidents, Field Safety Notices – FSNs, reports from users) related to the use of MDs and IVDs. For each event, information about the device, warning procedures, subsequent actions from manufacturers or the Ministry and corrections put in place by the hospital team have been recorded.

Results Over the January 2009-September 2011 observation period 636 records were made: 33 incident reports (13 were near misses), 596 FSNs, 7 reports of non-conformity. In 12 cases, the reports involved non-specialist devices (extension cables, catheters, dampers, etc); in 20 cases specialist products (cardiac, obs/gynae, ophthalmic devices, etc.), in 1 case an IVD (test tube baby). Whenever possible, the device involved was retained and later returned to the manufacturer; if an incident occurred, stock of the same batch was collected and withdrawn from wards.

Conclusions Pharmacovigilance represents an important element in the management of MDs. In this context, Pharmacy plays a key role, as 1) it acts as first interlocutor for users, 2) withdraws the product involved 3) takes part in editing the reports to the Ministry and 4) cooperates in training activities for health workers. Data collected over the years represent an important support in all activities linked to the use of MDs: evaluation/selection, acquisition, troubleshooting, handling of incidents.

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