Radiology Department, The Royal Liverpool University Hospital, Prescot Street, Liverpool, L7 8XP, UK.
Cardiovasc Intervent Radiol. 2013 Aug;36(4):1073-8. doi: 10.1007/s00270-013-0557-7. Epub 2013 Jan 26.
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.
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.
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.
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.
本研究旨在量化介入放射学中使用的各种制造商生产的一系列医疗器械的法国尺寸的度量等效值的变化。
检查了一系列导管、导引器、引流管、球囊、支架和血管内移植物的标签。选择了各种制造商生产的不同法国尺寸的产品，以实现广泛的范围。为了评估制造精度，使用激光测微仪对 8 种设备进行了测量选择。对每个设备的三个样本进行了测量，在设备长度上每隔厘米测量一次外部直径，以确保均匀性。
共检查了 200 个介入放射学设备的标签。结果表明，法国尺寸的度量等效值存在很大差异。标签产品在产品范围内的直径变化可达 0.79mm。用非接触式激光测微仪选择的用于测量的设备显示出可接受的制造一致性。平均而言，外部直径相差 0.05mm。
我们的结果表明，不同医疗器械制造商对法国刻度的解释存在很大差异。这可能导致使用同轴系统出现问题，尤其是当产品来自不同制造商时。建议所有制造商采用标准标签，传达设备的具体细节。鉴于对法国刻度的解释存在广泛差异，我们认为该刻度要么需要放弃，要么需要严格定义并遵循。
