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OHP-052 Infusion Device Evaluation: A Metrological Approach to Device Clinical Performance and Safety
  1. H Garnier1,
  2. A Murez1,
  3. JV Chauny2,
  4. R Ait Alik1,
  5. L Nguyen-Kim2,
  6. J Jerome2,
  7. J Vernois3,
  8. M Bernard1,
  9. M SInegre4
  1. 1AGEPS – Pole Etablissement Pharmaceutique, Quality Control Laboratory Unit, Paris, France
  2. 2AGEPS – Pole Pharmacie Hospitaliere, Medical Device Purchasing Evaluation Unit, Paris, France
  3. 3AGEPS – Pole Pharmacie Hospitaliere, Quality And Hospital Trial Unit, Paris, France
  4. 4AGEPS – Pole Pharmacie Hospitaliere, Therapeutic Evaluation Unit, Paris, France

Abstract

Background Gravity Infusion Devices (GIDs) are Medical Devices requiring European Conformity (CE) marking and have to comply with mandatory norm ISO8536–4, stating that an ‘effective’ GID has to permit the infusion of 1 L of NaCl 0.9% in less than 10 min. Considering their major importance for drug administration, this requirement is not satisfactory.

Purpose In addition to the normative tests, we designed an approach based on efficiency tests and statistical tools. Our aim was to provide users with rational data on their performance and safety, and help buyers to choose the appropriate one.

Materials and Methods We designed an in vitro study in which each GID was connected to a NaCl bag at a height of 70 cm and supplied the fluid at a rate of 2.7 ml/min. The rate was calculated by weighing NaCl bags at 15, 60, 120 and 180 min. Data were processed with XLSTAT for flow rate linearity (linear regression), stability (regression slope test), accuracy (student test) and precision (variance analysis). Cross comparison and Principal Component Analysis (PCA) enabled us to rank the GID in a 4 dimensional analysis.

Results 13 GID references were analysed. For each GID reference, 3 batches of 3 units were investigated. Mean flow rates ranged from 2.0 to 2.8 ml/h. Mean intra-reference rates varied from 7% to 31% and cross comparison analysis identified 4 different ratings in linearity, stability, precision, accuracy. Flow was not linear for 3 references, 3 were not satisfactorily accurate and 1 was not satisfactorily precise. PCA clustered 3 different groups, and we identified a group of 4 references suited for clinical use.

Conclusions In this study, we designed a repeatable method that will allow clinicians and buyers to assess GID performance. We demonstrated a large variability in performance between giving sets. The use of statistical tools appears suitable and important to select the best GIDs and for patient safety.

No conflict of interest.

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