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French Sizing of Medical Devices is not Fit for Purpose

  • Laboratory Investigation
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CardioVascular and Interventional Radiology Aims and scope Submit manuscript

Abstract

Purpose

The purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology.

Methods

The labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity.

Results

A total of 200 labels of interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm.

The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average.

Conclusions

Our results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed.

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References

  1. Charrière JFB (1849) “Extrait du catalogue de la maison Charrière, fabricant d’instruments de chirurgie, d’instruments de chirurgie vétérinaire, de coutellerie, fournisseur titulaire de la Faculté de médecine de Paris, des hopitaux civils et militaires, des ministères de la guerre, de la marine etde l’intérieur, de plusieurs universités étrangères, etc.” Conservatoire national des arts et metiers. Chez Charrière, Paris, 1849. Conservatoire numerique http://cnum.cnam.fr/redir?M9856

  2. Norton RA (1971) The history and clinical usefulness of Pi. Arch Intern Med 128:991–992

    Article  PubMed  CAS  Google Scholar 

  3. Medicines and Healthcare products Regulatory Agency (MHRA) One Liners. Issue 88, October 2011

  4. New England Catheters Corp. http://www.necatheter.com/faq.asp

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Acknowledgments

The authors thank Michael McWilliams for translating the French text from the catalogue of the “La Maison Charrière”.

Conflict of interest

Nabil Kibriya, Rebecca Hall, Steven Powell, Thien How, and Richard G. McWilliams have no conflict of interest and no potential benefits in any form from a commercial party related directly or indirectly to the subject of the manuscript.

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Authors and Affiliations

  1. Radiology Department, The Royal Liverpool University Hospital, Prescot Street, Liverpool, L7 8XP, UK

    Nabil Kibriya, Rebecca Hall, Steven Powell & Richard G. McWilliams

  2. Faculty of Health & Life Sciences, University of Liverpool, 4th Floor, UCD Building, Daulby Street, L69 3GA, Liverpool, UK

    Thien How

Authors
  1. Nabil Kibriya
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  2. Rebecca Hall
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  3. Steven Powell
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  4. Thien How
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  5. Richard G. McWilliams
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Corresponding author

Correspondence to Nabil Kibriya.

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Kibriya, N., Hall, R., Powell, S. et al. French Sizing of Medical Devices is not Fit for Purpose. Cardiovasc Intervent Radiol 36, 1073–1078 (2013). https://doi.org/10.1007/s00270-013-0557-7

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  • DOI: https://doi.org/10.1007/s00270-013-0557-7

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