# Presentation: 075697

## A Cardiology Perspective on the FDA’s Radiological Health Program Plan

- Charles Chambers, MD, FACC, FSCAI
- Representing the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions

## The Role of Cardiology in Protecting Radiological Health

- Cardiologists and their patients are routinely exposed to radiation in advanced cardiovascular procedures
- Invasive and interventional
- Electrophysiology
- Nuclear
- Cardiologists in Training
- Nurses
- Lab and other support personnel

## The Role of Cardiology in Protecting Radiological Health

- We encourage FDA to be mindful that many physician specialists use ionizing radiation – there is no mention of specialties other than radiology in the CDRH Radiological Health Program Plan

## Reaction to CDRH Program Plan

- Does the CDRH Radiological Health Program Plan apply only to diagnostic applications or to both diagnostic and therapeutic applications?

## Reaction to the CDHR Program Plan

- Coordination of program activities with OSHA?
- May 2005 OSHA request for comments on the health effects of exposure to ionizing radiation in the workplace – potential for conflicting and burdensome regulations for catheterization laboratories?

## Reaction to CDRH Program Plan

- Coordination of program activities with NRC?
- Would the FDA plan affect facilities currently regulated by the NRC?
- What is the impact of the CDHR proposal on state regulatory bodies?

## Reaction to CDRH Program Plan

- Voluntary Performance Standards
- What are the current regulatory challenges that lead FDA to the conclusion that legislative adoption and enforcement is necessary?
- How does the Program Plan fit with the FDA’s June 2005 final rule on performance standards for diagnostic x-ray equipment?

## Reaction to CDRH Program Plan

- Need to learn more about the FDA’s thinking on a global approach
- FDA must recognize the long-standing contribution of the NCRP
- How would the agency reconcile the differences between the NCRP and ICRP?
- Differing recommended limits for operator radiation exposure
- No uniformity in Europe on diagnostic reference levels for exposure
-  FDA should engage manufacturers in discussions

## Reaction to CDRH Program Plan

- What does CDRH mean by monitoring?
- Manufacturer inspection and reporting?
- Gathering dose and exposure information?
- Life-long patient follow up?

## Cardiology Data Collection Efforts

- ACC and SCAI have several data collection vehicles
- SCAI, The Heart Rhythm Society, Society for Interventional Radiology (SIR) and ACC are working with the National Cancer Institute to field retrospective and prospective studies on operator radiation exposure in the catheterization laboratory
-  ACC’s National Cardiovascular Data Registry®
-  SCAI/NEMA XR-21 Imaging Phantom

## The Role of Cardiology in Protecting Radiological Health 

- User education and training
- ACC and SCAI encourage FDA to gather information from professional medical societies on user education and training in radiological health
- Clinical care guidelines
- Expert consensus documents
- Competence and training statements
- Quality improvement tools

## The Role of Cardiology in Protecting Radiological Health 

**ACC Expert Consensus Document on Radiation Safety in the Practice of Cardiology** (1998)
**American College of Cardiology Training Statement on Recommendations for the Structure of an Optimal Adult Interventional Cardiology Training Program (1999)**
**ACC/SCAI Clinical Expert Consensus Document on Catheterization Laboratory Standards (2001)**

## The Role of Cardiology in Protecting Public Health 

**ACCF/AHA/HRS/SCAI Clinical Competence Statement on Physician Knowledge to Optimize Patient Safety and Image Quality in Fluoroscopically Guided Invasive Cardiovascular Procedures (2004)**
**ACCF/AHA Clinical Competence Statement on Cardiac Imaging with Computed Tomography and Magnetic Resonance ****(developed in collaboration with the American Society of Echocardiography, American Society of Nuclear Cardiology, Society of Atherosclerosis Imaging, and the Society for Cardiovascular Angiography and Interventions)  *endorsed by the Society of Cardiovascular Computed Tomography (2005)**

## The Role of Cardiology in Protecting Public Health

- Thank you – both ACC and SCAI look forward to assisting the agency in this important endeavor