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OHP-007 Medical device vigilance improving professional practices: The example of huber needles
  1. M Le Barbu,
  2. O Chauvel,
  3. B Le Fahler,
  4. A Debonne,
  5. JM Descoutures
  1. Centre Hospitalier Victor Dupouy, Val d’Oise, Argenteuil Cedex, France


Background A new model of safety Huber needles was referenced to meet the recommendations of positive pressure withdrawal. Despite preliminary nurse training and assessment organised by the pharmacy and operational hygiene team, various incidents were reported connected with the use of this medical device (MD).

Purpose To define the cause of these incidents and establish a corrective action plan preventing repetition of such incidents.

Material and methods After an analysis of medical device vigilance reports, a survey of nursing practices was conducted among the different departments based on the device instructions for use.

Results 7 reports were recorded in the oncology inpatient unit and the onco-haematology day care unit for 230 needles distributed between May and June 2015. Two reports were rated ‘minor’, two ‘significant’ and three ‘major’. There were 2 cases of lack of safety activation, 4 cases of needles retracting from the implantable port septum (IPS) and 1 of extravasation. These reports were more frequent in the inpatient unit, despite a lower use of these MD. After meeting the unit nurse manager, it was shown that nurses were connecting these incidents with a lack of training (dissimilar manipulations, unadapted needle lengths, hasty change with few preliminary evaluations). These criticisms were expressed during initial assessments along with instability and higher pain during needle insertion and removal. The nursing practice survey highlighted various misuses, such as non-perpendicular insertion and withdrawal, misuse of the foam wedging the needle, ineffective pulsed flushing technique and unadapted needle lengths. The 19 mm needles, previously used for most of the patients, had no strict equivalent in the new model. 20 mm needles were initially chosen but proved to be long, causing needle retracting from IPS. A corrective action plan was implemented: 17 mm needles are recommended for standard patients while the 20 mm needles are reserved for corpulent patients. Traceability of needle size is now mandatory in the patient file.

Conclusion This work outlines that what first appeared to be a quality default was a professional practice problem. A new training campaign on good use of the MD was organised in September 2015 and allowed us to check the application of the action plan.

No conflict of interest.

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