Study of the mechanical properties of rachianesthesia needles as part of materiovigilance

IJMDAT 2021; 4: e298
DOI: 10.32113/ijmdat_20213_298

  Topic: Anesthesiology     Category:

Abstract

Objective: Spinal anesthesia needles are sterile medical devices used during cesarean procedures such as lumbar punctures with the administration of a local anesthetic in the cerebrospinal fluid. It is a simple and reliable anesthesia technique. However, it can be complicated by difficult needle removal. This complication is an event estimated to have an incidence between one in 20,000 and one in 30,000. Difficult removal can sometimes be due to a broken needle. This rupture can be manifested by a break in the needle tube, but also by a dislocation of the connection between the hub and the needle tube.

Materials and methods: Following complaints from healthcare establishments relating to difficulties in removing spinal anesthesia needles due to a dislocation of the connection between the base and the tube, we evaluated the breaking force of the base / tube connection of the implicated needles. Thus, we compared the breaking strengths of two different lots of spinal anesthesia needles (test lot and reference lot) using ISO standard 7864 as a technical reference. This standard requires a minimum breaking force of the needles of dimension 25G equal to 22 Newtons.

Results: Regarding the test batch, more than 50% of the samples tested did not comply with the specifications of the standard. On the other hand, concerning the reference lot, all the samples tested showed values ​​of the breaking force higher than the minimum breaking force required by the standard. Compared to the needles from the reference lot, we can say that the needles from the test lot have an increased risk of rupture of the connection between the hub and the tube when the needle is withdrawn at the end of the procedure medical.

Conclusions: Thus, a systematic control of the breaking force, as carried out in our study, should be carried out on all lots of spinal needles in particular and on lots of single-use, non-reusable needles in general, in accordance with the standard ISO 7864. This is in order to avoid exposing patients to severe risks which can go as far as neurological complications and financial losses for the patients.

To cite this article

Study of the mechanical properties of rachianesthesia needles as part of materiovigilance

IJMDAT 2021; 4: e298
DOI: 10.32113/ijmdat_20213_298

Publication History

Submission date: 26 Jan 2021

Revised on: 11 Feb 2021

Accepted on: 19 Mar 2021

Published online: 23 Mar 2021