This study aimed to evaluate the protection granted by a simple device (X'TENS®, Thiebaud, France) and to provide operators with information on the performance of this new device, which has not yet been assessed. Our assumption is that this device efficiently reduces the radiation dose to the operator. In a prospective clinical study, the radiation dose the operator's hand receives has been assessed using a specific sensor (UNFOR Instrument). Each patient included in the study was to receive at least two injections of cement during the procedure. Exposure was measured with and without the range extender. The data collected were then processed using a Wilcoxon matched pairs test. During 14 interventions, 20 vertebrae were treated with both procedures. Eleven women and three men were included. Seven patients underwent vertebroplasty for metastatic lesions and seven for osteoporotic lesions, bone fractures or vertebral compressions. The average injection time was 1.35 minutes with the device and 1.20 without (p=0.75). The dose to the hand per ml injected was 111.37 vs. 166.91 (p<0.05). Theoretically, the protection granted by the range extender depends on the length of the device. Our results are consistent with the inverse-square law. However, the variations in our results indicate that a proper and rigorous use is mandatory for the device to be effective. Given that radioprotection during fluoroscopy procedures is a frequently raised issue, the need for information for a safer practice increases likewise.

Single-use radio-attenuating gloves are devices protecting the operator's hand by reducing the exposition to scattered radiations during radiological-guided intervention. Expensive, these devices are important, as they contribute to lessen the annual dose to which personals are exposed to. However, inconsistencies in their protection value have been reported between theoretical and clinical practice. In this study, we aim to highlight the normative bias existing in standard norms for radioprotective assessments. Using thermoluminescent captors positioned inside and outside the glove, we designed an EN1331-1 norm-inspired bench test with five brands of radio-attenuating gloves. At 100 keV and 56 cm away from the source, we measured indirect beam and attenuated doses in a clinical setting. From the attenuation index measured, we deduced attenuation rates. We then compared our results to their commercial technical data sheets. The assessed attenuating rates of the tested references were 20%, 30%, 32%, 15%, and 25%. Theoretical rates are, respectively, 38%, 43%, 30%, 26%, and 35%. Only one reference showed no difference between commercial and technical attenuating values (p = 0.12). The inconsistencies between observed and theoretical attenuation value show the importance of the conditions in which protection is assessed. Without complete information, the choice of a protective device as simple as a glove is biased, and this may lead to inappropriate protection of the operator, which should raise concern, as interventional radiology is now widespread in routine practice.

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. Results13 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.