3. Interventional X‐ray:
Int Rad, Int Card, Int Surg
• What is special about interventional X‐ray?
– Physician operates machine
– Large dose levels can occur: deterministic effects
can be an acceptable side effect of treatment
– Different risk – benefit balance (treatment of
stroke, acute coronary blockage etc etc )
– Usage more important than machine for patient
dose
– Training
5. MITA Consensus Answers to FDA
Questions about Fluoroscopic Equipment
(Considerations for an Interventional Equipment Perspective)
Represented manufacturers
‐ Siemens
‐ Philips
‐ Toshiba
‐ Shimadzu
‐ GE
6. Mid term future – around 2012 - 2013
IEC 60601-2-43: 2010 (all interventional equipment)
• Brief audible signal at initiation of irradiation
• Adjustable threshold for visual warning when provided and when exceeding a
threshold value of cumulative reference air kerma
• Removable anti‐scatter grid for pediatrics
• Storage of the LIH
• Additional filtration of 0.1 mm Copper or equivalent available for pediatrics
• Radiation dose structured report
IEC 60601-2-54: 2010 (all non interventional equipment)
• Removable anti‐scatter grid for pediatrics
• Additional filtration of 0.1 mm Copper or equivalent for pediatrics
• Note: No Radiation dose structured report will be required
7. QUESTION A4
Should manufacturers set default imaging protocols for CT and fluoroscopic
procedures so that they incorporate the ALARA concept (maintaining dose As Low
As Reasonably Achievable) and utilize or provide for incorporation of diagnostic
reference levels into CT and fluoroscopic devices? If so, why and how? If not, why
not?
• Appropriate for diagnostic exams to define reference levels
• In interventional, the duration of the case is dependent on many factors: disease
state; case complexity; patient anatomy; so recommendation to just provide alert
based on a user set reference values (refer to A2)
• Manufacturers support creation of reference levels by providing Dose Structure
Reporting data export
• Reference levels for diagnostic and interventional can be set on a Hospital,
National or International level based on literature
9. QUESTION A6
Should manufacturers incorporate into CT and fluoroscopic equipment features to
ensure that exposure settings, imaging protocols, and metrics of body dose and
peak skin dose are displayed to the operator(s) of the equipment and recorded for
physician review? If so, why and how? If not, why not?
• We already display estimation of cumulative skin dose (IEC 60601-2-43) and
cumulative DAP
• Regarding the peak skin dose (expected to be localized), the stakeholders
(AAPM; SIR; SCAI; ACR; etc) should decide on the importance of a method of
reconstruction of the peak skin dose from the basic geometrical data (beam
incidences, Source to Image Distance, patient equivalent thickness, actual patient
position versus the table position to be determined)
• After peak skin dose metrics have been determined, they can be exported using
DICOM Dose SR and accumulated per patient in his/her folder
10. QUESTION A7
Should manufacturers incorporate features into CT and fluoroscopic
equipment to facilitate transmission of technique parameters, imaging
protocols, and dose metrics to a patient's imaging record, an electronic
health record, or other database? If so, why and how? If not, why not?
• For interventional equipment, by means of the DICOM Dose Structured Report
which is proposed for interventional equipment manufactured from June 2012
(DAP and air kerma)
• In future, if a universal unit is proposed to accumulate CT and XRAY equipment,
it will be accommodated by an update of the DICOM SR Report
11. QUESTION A12
What changes should manufacturers make to CT and fluoroscopic devices
currently on the market in order to reduce unnecessary patient exposure to
ionizing radiation?
•It is important to have continuous education of installed base users by requiring a
training program to user facilities also after the initial handover (refer to section B)
•Interventional equipment manufactured prior June 2006 and presumably not
compliant with US 21 CFR 1020.30/32 shall be upgraded or replaced prior June
2016 according to the 2006 US Regulation
• Upgrade or replace according to features brought by 21CFR 1020.30/32 (2006)
and IEC 60601-2-43: 2000 & 2010 and IEC 60601-2-54: 2009 (e.g. DAP) within a
typical serviceable product lifecycle
• If not upgradeable, replace
• DICOM Dose Structure Report: interventional equipment manufactured generally
from 2007 on, would require only a minor upgrade
