FDA:CT Perfusion Imaging recommendation
2009年 12月 08日
FDA NEWS RELEASE For Immediate Release: Dec. 7, 2009
These recommendations include:
1. Facilities assess whether patients who underwent CT perfusion scans received excess radiation.
2. Facilities review their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study.
3. Facilities implement quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered.
4. Radiologic technologists check the CT scanner display panel before performing a study to make sure the amount of radiation to be delivered is at the appropriate level for the individual patient.
5. If more than one study is performed on a patient during one imaging session, practitioners should adjust the dose of radiation so it is appropriate for each study.
CT Brain Perfusion Scans Safety Investigation: Initial Notification
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186105.htm
mulitiple scanの時、患者ごと・スキャンごとに至適化した投与量が必要とCharles Finder, MD(associate director, Division of Mammography Quality and Radiation Programs, CDRH.)。FDAは、CT perfusion製造会社は、ユーザーのトレーニングをレビューし、再評価、医療施設にその上方を与えること、そして、サーベイランスを行い、過剰放射線暴露を迅速に指摘するべきとした。
(http://www.medscape.com/viewarticle/713492?src=rss)
by internalmedicine | 2009-12-08 11:00 | 動脈硬化/循環器
