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DRN NL meeting 10/12/10       Sjirk Boon, PhD          Disclosure:   employee Philips Healthcare
Dose reference levelsRegulatory ‐ Industry – Medical Physicists – Clinical end users:Flying in Formation!
Interventional X‐ray:         Int Rad, Int Card, Int Surg• What is special about interventional X‐ray?  – Physician  opera...
FDA public meeting 30/31 March 2010                                           FDA CDRH websitehttp://www.fda.gov/MedicalDe...
MITA Consensus Answers to FDA        Questions about Fluoroscopic Equipment   (Considerations for an Interventional Equipm...
Mid term future – around 2012 - 2013IEC 60601-2-43: 2010 (all interventional equipment)• Brief audible signal at initiatio...
QUESTION A4Should manufacturers set default imaging protocols for CT and fluoroscopicprocedures so that they incorporate t...
Distribution of DAP (Gy.cm²) for 19 Hospitals for PTCA
QUESTION A6Should manufacturers incorporate into CT and fluoroscopic equipment features toensure that exposure settings, i...
QUESTION A7Should manufacturers incorporate features into CT and fluoroscopicequipment to facilitate transmission of techn...
QUESTION A12What changes should manufacturers make to CT and fluoroscopic devicescurrently on the market in order to reduc...
But what about the time before RDSR is             widely adopted ?• Many initiatives around the world, one example:
Questions ?
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15. drn philips, boon

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15. drn philips, boon

  1. 1. DRN NL meeting 10/12/10 Sjirk Boon, PhD Disclosure:  employee Philips Healthcare
  2. 2. Dose reference levelsRegulatory ‐ Industry – Medical Physicists – Clinical end users:Flying in Formation!
  3. 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
  4. 4. FDA public meeting 30/31 March 2010  FDA CDRH websitehttp://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm201448.htm
  5. 5. MITA Consensus Answers to FDA  Questions about Fluoroscopic Equipment (Considerations for an Interventional Equipment Perspective)Represented manufacturers‐ Siemens‐ Philips‐ Toshiba‐ Shimadzu‐ GE
  6. 6. Mid term future – around 2012 - 2013IEC 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 reportIEC 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. 7. QUESTION A4Should manufacturers set default imaging protocols for CT and fluoroscopicprocedures so that they incorporate the ALARA concept (maintaining dose As LowAs Reasonably Achievable) and utilize or provide for incorporation of diagnosticreference levels into CT and fluoroscopic devices? If so, why and how? If not, whynot?• Appropriate for diagnostic exams to define reference levels• In interventional, the duration of the case is dependent on many factors: diseasestate; case complexity; patient anatomy; so recommendation to just provide alertbased on a user set reference values (refer to A2)• Manufacturers support creation of reference levels by providing Dose StructureReporting data export• Reference levels for diagnostic and interventional can be set on a Hospital,National or International level based on literature
  8. 8. Distribution of DAP (Gy.cm²) for 19 Hospitals for PTCA
  9. 9. QUESTION A6Should manufacturers incorporate into CT and fluoroscopic equipment features toensure that exposure settings, imaging protocols, and metrics of body dose andpeak skin dose are displayed to the operator(s) of the equipment and recorded forphysician review? If so, why and how? If not, why not?• We already display estimation of cumulative skin dose (IEC 60601-2-43) andcumulative 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 ofreconstruction of the peak skin dose from the basic geometrical data (beamincidences, Source to Image Distance, patient equivalent thickness, actual patientposition versus the table position to be determined)• After peak skin dose metrics have been determined, they can be exported usingDICOM Dose SR and accumulated per patient in his/her folder
  10. 10. QUESTION A7Should manufacturers incorporate features into CT and fluoroscopicequipment to facilitate transmission of technique parameters, imagingprotocols, and dose metrics to a patients imaging record, an electronichealth record, or other database? If so, why and how? If not, why not?• For interventional equipment, by means of the DICOM Dose Structured Reportwhich 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. 11. QUESTION A12What changes should manufacturers make to CT and fluoroscopic devicescurrently on the market in order to reduce unnecessary patient exposure toionizing radiation?•It is important to have continuous education of installed base users by requiring atraining program to user facilities also after the initial handover (refer to section B)•Interventional equipment manufactured prior June 2006 and presumably notcompliant with US 21 CFR 1020.30/32 shall be upgraded or replaced prior June2016 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 atypical serviceable product lifecycle• If not upgradeable, replace• DICOM Dose Structure Report: interventional equipment manufactured generallyfrom 2007 on, would require only a minor upgrade
  12. 12. But what about the time before RDSR is  widely adopted ?• Many initiatives around the world, one example:
  13. 13. Questions ?

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