Breast Cancer Screening
American Cancer Society's Breast Cancer Information webpage
American Cancer Society's Breast Cancer Early Detection webpage
American Cancer Society's Mammography webpage

  • Joe Melnic, Radiation Control Division Chief

  • Sandra Martin, X-Ray and Accelerator Section Chief

  • John Chippo, Radioactive Materials Licensing Section Chief

FDA Drug Safety Communication:
FDA alerts healthcare professionals to stop
performing heart scans with CardioGen-82
due to potential for increased
radiation exposure in patients

The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals to stop using CardioGen-82 for cardiac positron emission tomography (PET) scans. The manufacturer, Bracco Diagnostics, Inc. has decided to voluntarily recall CardioGen-82.

FDA recommends that healthcare professionals use alternatives to the CardioGen-82 generator when planning nuclear medicine cardiac scans. Patients who have any questions or concerns should talk to their healthcare professional.

FDA continues to work with the U.S. Nuclear Regulatory Commission (NRC) and the CardioGen-82 manufacturer to determine the root cause for the increased radiation exposure detected in the two patients. The extent to which any additional patients may have received inadvertent radiation exposure is also under investigation. FDA plans to notify the public with updates.

FDA Drug Safety Communication dated July 26, 2011

BRP Information Notice 2011-03:
Request for Information Regarding the Feasibility and
Impacts Associated with Potential Changes to
Occupational Dose Limits

This Information Notice (IN) is to request feedback regarding the potential impacts associated with changes to radiation protection standards currently defined in 10 CFR Part 20 and incorporated by reference in Pa. Code Title 25 Sec. 219.5

The U.S. Nuclear Regulatory Commission (NRC) establishes occupational dose limits and is considering lowering the limits to those recommended by the International Commission on Radiological Protection (ICRP) Publication 103. The current dose limit for an occupational radiation worker is 50 mSv/yr (5 rem/yr) and the fetal dose to a declared pregnant worker is 5 mSv (0.5 rem). ICRP is recommending 20 mSv/yr (2 rem/yr) and 1 mSv (0.1 rem), respectively.

The NRC has awarded a contract to SC&A, Inc. to perform a national survey and tabulate potential impacts to licensees and registrants. Please respond via the following link: https://acrobat.com/?d=vraWYERZAnw-gyZlJQewzQ

BRP Information Notice (IN) dated May 18, 2011 PDF
BRP Information Notice 2011-02:
Recent Events Involving Portable Nuclear Gauges

DEP is issuing this information to alert all
portable nuclear gauge licensees of recent incidents
involving violations of radiation safety requirements,
license conditions, and U.S. Department of Transportation (DOT) hazardous material regulations.

During 2010 DEP inspectors observed numerous violations of DEP and DOT regulations by portable nuclear gauge licensees in the following program areas:
Physical Security
Hazardous Materials Transportation
Radiation Protection


Licensees are responsible for compliance with physical security, radiation safety and hazardous materials shipping requirements. If licensees are unsure of specific areas of compliance there are a number of technical resources available.

BRP Information Notice 2011-02 dated March 29, 2011 PDF
BRP Information Notice 2010-01:
Medical Events from Radiation Exposure
During the Use of Computed Tomography,
Fluoroscopy and Medical Accelerator Teletherapy

DEP Urges Medical Facilities to Take Proper Precautions
with X-Ray Equipment to Avoid Health Hazards:
Facilities Asked to Immediately Review
Procedures, Reporting Requirements

The Bureau of Radiation Protection has issued an Information Notice to alert medical facilities of the potential radiological hazards and "medical event" reporting requirements associated with certain patient radiation exposures that may result from unnecessary, inappropriate or improperly calibrated medical diagnostic or therapeutic X-ray or accelerator procedures and devices.

Press Release dated March 3, 2010

BRP Information Notice (IN) dated March 1, 2010 PDF

BRP Fact Sheet: Medical Reportable Events and Other Medical Reports for Radiation-Producing Machines (Used for Therapy or Diagnosis) PDF
DEP Document #2910-FS-DEP4034
DEP Issues Final Technical Guidance Document
Addressing Continuing Education
for Medical X-Ray Operators

Medical X-ray Procedures Operator Training Guide PDF

List of Resources Satisfying Initial and Continuing Education Requirements for Healing-Arts X-ray Operators Involved in High-Risk or Low-Risk Procedures PDF
NRC Information Notice 2009-18:
Performance of Required Shutter
Checks and Reporting of
Gauge Shutter Failures

The U.S. Nuclear Regulatory Commission (NRC) has issued an Information Notice to alert fixed gauge specific and general licensees about the potential for the failure of shutter closure mechanisms on fixed gauges and the requirements for reporting these events to the NRC. It is expected that recipients will review the information for applicability to their facilities and consider actions, as appropriate, to avoid similar incidents.

Since 1990, NRC received numerous reports of fixed gauge shutter closure failures occurring during shutter closure checks performed by licensees. The initial reports indicated that the failures of the shutter open/close mechanisms were sudden and unexpected and most resulted in the inability of the licensee to close the shutter on the device. In addition, most of these reports indicated a breakage of some part of the shutter closure mechanism.

NRC Medical Device Safety Alert, dated September 18, 2009
Click here for full text of NRC Information Notice 2009-18 PDF
Safety Investigation of
CT Brain Perfusion Scans:
Initial Notification

FDA Medical Device Safety Alert, dated October 8, 2009
Click here for full text of FDA alert

The Board of Directors of the Conference of Radiation Control Program Directors, Inc. (CRCPD) strongly recommends that hospitals and CT facilities, review their CT protocols including quality assurance improvements and overexposure prevention to ensure their protocols are appropriate in providing the best possible CT studies while assuring patient exposures are as low as reasonably achievable.

FDA has become aware of radiation overexposures during perfusion CT imaging to aid in the diagnosis of a stroke

Note:  Patients should follow their doctor's recommendations for receiving CT scans. While unnecessary radiation exposure should be avoided, a medically-needed CT scan has benefits that outweigh the radiation risks.
Radiation Control Division Program - Background

Radiation in large doses can cause injury and death. Chronic exposure to lower levels of radiation may cause an increased risk of certain kinds of disease, such as cancer. The major source of radiation exposure to the public is medical and environmental. Medical exposure involves radiation-producing machines such as computed tomography (CT) X-ray imaging devices, high-energy particle accelerators used in cancer therapy and radioactive materials used for internal imaging and therapy. The major source of environmental radiation is radon gas in soil trapped by enclosed buildings and other natural background radiations from building materials, the earth and space. Radiation and radioactive material are also utilized in many common devices such as certain smoke detectors, thickness gauges and chemical analyzers.

The goal of the Radiation Control Division is to prevent avoidable radiation injury from the use of licensed or registered radiation sources and to keep public, environmental and worker exposure to radiation-producing machines and radioactive materials As Low As Reasonably Achievable (ALARA) in order to minimize the potential for long term disease induction. Methods of radiation protection include: public education, regulation, compliance assistance, licensing, registration and inspection of radiation sources, facilities and users.

Specific legislative authority is derived from the Radiation Protection Act (1984-147).

Program Activity: Develop Regulations and Policy

The use of radiation for medical, industrial, and research purposes has increased and evolved significantly since the program was transferred from the Health Department in 1971. The Division develops regulations for the safe use of radiation-producing machines and radioactive material, and continues to revise them over time as necessary. Along with the regulations, guidance and fact sheets are developed to assist licensees and registrants in complying with the regulations and avoiding unnecessary exposure to radiation. The Radiation Control Division provides consultative support to registrants, licensees and the Regional Office program staff in the interpretation of regulations and policy. Procedures are developed and updated to assist regional staff in conducting compliance inspections of registered and licensed facilities.

Program Activity: X-ray Machine Registration and Inspections

The Division is responsible for the registration of over 11,000 facilities possessing over 33,000 X-ray units.

In order to ensure that patients, personnel and the environment are protected, that operators are properly trained, and radiation equipment and facilities meet current protection standards, the Department has a goal to inspect all facilities at least once every four years. Major facilities may be inspected every two to three years. In all, this results in a total of approximately 2,800 inspections per year statewide.

Users of radiation-producing machines are required to register with the Division, to designate an individual to be responsible for radiation protection, and to indicate the number and type of units possessed. Registration allows the Division to maintain an inventory of X-ray equipment in Pennsylvania so that all users can be inspected for compliance with the applicable radiological health regulations. Users pay registration fees based on the type of facility and the number of tubes possessed. The Division oversees the production and issuance of associated registration certificates, renewal letters, invoices, and the collection of initial and annual fees.

Program Activity: Mammography Equipment Inspections

In accordance with the terms of a federal contract with the Food and Drug Administration (FDA), BRP is responsible for inspecting approximately 400 screening mammography X-ray facilities for compliance with the technical aspects of the equipment and quality assurance standards of the federal Mammography Quality Standards Act (MQSA) of 1994. Compliance with these standards enhances the quality of mammograms and increases the likelihood of early detection of breast cancer in women. BRP inspectors receive intensive MQSA inspection protocol training from the FDA. The Radiation Control Division administers the contract and coordinates the inspection program by the regional offices.

Program Activity: NEXT Surveys

The Division has participated in the FDA's National Evaluation of X-ray Trends (NEXT) program since it’s inception in the mid 1970’s. The program tracks exposure to patients from selected diagnostic x-ray procedures over the years. FDA randomly selects the facilities to be surveyed and provides a list to BRP along with the necessary patient equivalent phantoms, survey equipment and protocols needed to conduct the surveys.

Program Activity: Accelerator Licensing

The Division issues specific licenses to medical accelerator and non-medical facilities. In 1998 the regulations were amended to replace the previous registration program for the approximately 141 accelerator facilities and approximately 221 accelerators in the Commonwealth with a licensing program. Unlike registration, licensing requires prior approval for licensed activities. Acceleration operations are complex; information must be provided up-front so the Department can determine on a case-by-case basis what requirements are necessary for the accelerator to be used safely. The Division oversees the production and issuance of associated accelerator license certificates, license renewal letters, invoices and the collection of the license fees. Pre-licensing inspections are conducted by the regional staff in coordination with the central office license reviewer.

Program Activity: Radioactive Material Licensing

Users of all byproduct material are required to obtain a license from the Division prior to obtaining those radioactive materials. This material is used in hospitals, colleges and industries for medical, research and industrial purposes. The Department issues specific and general licenses for the use of radioactive material. The objective of the licensing program is to ensure radioactive material is used safely, disposed of properly and facilities are free from contamination when licensed operations are terminated. Licensees pay fees based on the type of radioactive material being used; thus, the licensing and inspection programs are self-supporting.

In order to more efficiently, uniformly and safely control radioactive material, Pennsylvania has entered into an Agreement with the U.S. Nuclear Regulatory Commission (NRC) to expand its authority over the licensing and regulation of Byproduct, Source and Special Nuclear Material. As a result of the merger of NRC licenses with NARM licenses, the number of radioactive material programs BRP will license and inspect has increased from approximately 460 to about 800. Again, as required by Act 1984-147, licensing fees have been established to provide full financial support for these additional inspection and licensing activities.

Program Activity: Radiation Monitoring of Solid Waste

The Department is responsible for protecting the public and the environment from the disposal of hazardous material contaminants. Hazardous material includes sources of radioactivity. With increasing frequency, radioactive material (RAM) is detected in municipal and residual solid waste by radiation monitors installed at processing and disposal facilities. In 2001, the Bureau of Radiation Protection (BRP) and the Bureau of Waste Management (BWM) jointly developed regulations requiring all municipal and residual solid waste facilities to implement an action plan to monitor all incoming wastes for the presence of radiation and radioactive material. A guidance document was also developed to assist facilities in implementing their action plans. The Division also works with recycling facilities to monitor and prevent the contamination of recycled materials.

Program Activity: Vendor/Service Provider Registration

The Division is responsible for the registration of over 170 service providers/vendors throughout the Commonwealth. Those who provide services for radiation-producing machines (x-ray machines and accelerators) are required to register with the Division. They are also required to provide to the Division information on who, when, where and what equipment or service was provided to the x-ray registrants and accelerator licensees in the Commonwealth. Registrants pay a set registration fee of $100.00. The Division oversees the production and issuance of associated registration certificates, renewal letters, invoices and the collection of initial and annual fees.

Program Activity: Miscellaneous Radiation Control

In addition to the above noted routine activities, staff perform a number of special projects. These projects are related to: special investigations of medical events (misadministration of radiation-producing machines and materials), development of educational materials, training, support of RAM site decommissioning, review of complex proposals for healing arts screening using X-rays (e.g., whole body CT screening), participation in emergency response activities involving nuclear power or radioactive materials, maintaining a Radiation Protection Advisory Committee drawn from the public, regulated and scientific communities, performing outreach to the community on the subject of mammography cancer screening and answering questions regarding non-ionizing hazards from such things as microwaves, power lines and tanning booths.