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NP-008 Case report: single-use cranial drills, high-risk devices!
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  1. A Barusseau,
  2. L Ruesche,
  3. L Gueneret,
  4. Y Lurton
  1. Pharmacie, CHU de Rennes, 2 Rue Henri Le Guilloux, 35000 Rennes, France

Abstract

Background and Importance Single-use cranial drills are used in neurosurgery to perforate cranial bones. From June 2018 to October 2020, 18 adverse events (AEs) were recorded in our hospital, seven of which resulted in a material safety (MS) declaration to the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) for risk of cerebral damage.

Aims and Objectives We aimed to analyse the causes of these AEs in order to propose corrective and preventive measures.

Materials and Methods MS data were analysed chronologically, and the various people involved in the circuit were contacted. Other healthcare establishments were questioned in order to obtain feedback on the management of this type of AE. At the same time, a search of MS data via the American MAUDE database was carried out for the period, targeting the devices used in our centre. We then performed a causal analysis using the 5M method and an Ishikawa diagram.

Results We identified several modes of possible failure: (i) connection between chuck and motor may be loose; (ii) different types of material for the connection tip may influence the behaviour of the device; (iii) an added manual rotation movement during the surgical gesture; (iv) non-perpendicular placement of the device; (v) inappropriate rotation speed, and the thickness of the cranial bone.

Research via MAUDE showed 13 notifications of incidents of non-disengagement over the period.

Conclusion and Relevance Single-use cranial drills require careful handling for optimum disengagement. The material causes have been identified, but the human component cannot be ruled out. Corrective measures have been implemented to reduce the risk of these AEs, including a change of supplier and training for the medical team. Preventive measures also need to be developed such as revised selection criteria for the next call for tenders, or best practices audits in the operating room.

The impact of these corrective and preventive measures will be assessed though AEs monitoring.

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