iPlan RT Image / iPlan RT and BrainSCAN 의 안전성 경고

Safety alert

2015-10-22

2015-10-22

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20151022a.html

Medical device safety alert: brainlab iplan rt image / iplan rt and brainscan medical device manufacturer, brainlab ag, has issued a medical device safety alert concerning its iplan rt image (below v.4.1.2) / iplan rt; and brainscan (all lot; discontinued in 2002). according to the manufacturer, except for computed tomography (ct) or positron emission tomography (pet) normalised to standard uptake value (suv), the brainlab software supports only image sets that contain a uniform calibration of pixel values assigned by the imaging device (scanner) for all images, i.E. for all slices of the set. the only image sets that are supported by the brainlab radiation treatment planning software even when containing varying calibrations of pixel values in between image slices are: ct image sets, and pet image sets normalised to suv with suv also loaded in and displayed by the brainlab sw. the only other image modality than the above that the manufacturer has ever observed to actually contain different pixel value calibrations of different slices within one image set, is pet (without suv). there has been no negative effect on a patient treatment due to this specific issue reported to the manufacture by user site. if such an unsupported image set is used with the brainlab software, the brainlab software applies the same pixel value calibration as contained in the middle image slice of the set to all slices. in a pet image set such uniform calibrated pixels might then have a different activity value, thus displayed with a different brightness and colour, compared to the image slices as displayed by the scanner using varying calibrations. if this effect occurs when using an unsupported image set, it can be misleading to the user during treatment planning and, for example, result in an incorrect definition of volumes of interest in the planning software. the objects created for these volumes of interest might differ in location or dimension from the actual desired definition of the structure. if not detected by the user during treatment planning, as a consequence target volumes could be erroneously defined for an irradiation plan. this could ultimately result in ineffective treatment, serious patient injury or even death of the patient. the manufacturer will provide a software solution with the corresponding new feature for affected iplan rt / iplan rt image customers to prevent the described scenario from occurring. in the interim, the manufacturer advises customers as follows: except for ct and pet used with suv, only load and use image sets in iplan rt / iplan rt image that have the same pixel value calibration for all images of the set. before using image datasets loaded into the brainlab radiation treatment planning software, always compare the images displayed in the brainlab application to the images as displayed by the imaging device (scanner). delete and do not use the image sets within iplan rt in case any deviation is detected and contact the manufacturer for support. the manufacturer will not provide a software update for brainscan. the manufacturer strongly recommends customers still using brainscan clinically to phase out the use of this software as soon as possible but in no event later than january 2016. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 22 october 2015.