(IRI) 07-00 September 2007

(IRI) 07-00 September 2007
MARYLAND DEPARTMENT OF THE ENVIRONMENT
1800 Washington Boulevard • Baltimore MD 21230
410-537-3000 • 1-800-633-6101
Martin O’Malley
Governor
Shari T. Wilson
Secretary
Robert M. Summers, Ph.D.
Deputy Secretary
Anthony G. Brown
Lieutenant Governor
DATE:
September 19, 2007
TO:
All State Licensed Private Inspectors and Registered Service Providers
THRU:
Roland G. Fletcher, Manager III, Radiological Health Program (RHP)
FROM:
Eva Nair, Acting Division Chief, Radiation Machine Division
Jerry Adams, Section Head, Radiation Machines Division
SUBJECT:
Information and Regulatory Interpretation Memo (IRI) 07-00, September 2007
Meeting Location at Maryland Department of the Environment (MDE)
A combined meeting of licensed private inspectors and service providers will be held on December 13,
2007 at 10:00 a.m. in the Aqua and Terra Room on the 1st Floor of the Montgomery Park Executive
Office Building at 1800 Washington Boulevard. Please park in the visitor lot (marked Red Lot) and come
to the lobby area where someone will escort you to the meeting. A tentative agenda and directions are
attached.
Introduction
The RHP is proud to announce the filling of a position effective September 2007:
Mr. Andrew Hurst – Health Physicist Trainee
Ms. Renee Fizer has temporarily accepted a leadership assignment for the Regional Greenhouse Gas
Initiative (RGGI). In the interim Ms. Eva Nair has been named Acting Division Chief.
2007 Mid-Atlantic States Radiation Control Program Regional Meeting
The 2007 meeting of the Mid-Atlantic States Radiation Control Programs will be held on October 16 and
17, 2007 at the Inn at Lambertville Station in Lambertville NJ. The meeting is hosted by the New Jersey
Department of Environmental Protection's Radiation Protection Programs and co-sponsored by the New
Jersey Chapter of the Health Physics Society. There will be MQSA training on October 16 and 6.5
MQSA CEU’s will be offered. Agenda topics include Digital mammography Medical Physicist QC tests,
MQSA compliance Overview, Access to MQSA for Women, among other topics. The States meeting
will be held on October 17 and will cover new detection equipment technology, CBCT units, dental
initiatives, nuclear medicine technology, ionizing radiation exposure, amount other topics. Please contact
Recycled Paper
www.mde.state.md.us
TTY Users 1-800-735-2258
Via Maryland Relay Service
Paul G. Orlando, Bureau of Radiological Health, N.J. Dept. of Environmental Protection at (609) 9845634 or Deborah Hrabinski at (732) 445-2550 for further details.
Updated Area Survey and Plan Review Form
Effective October 1, 2007, the RHP will be introducing an updated Area Survey form (RX-22) and Plan
Review Form (RX-21) which will be located on the MDE website. On the RX-22, you will be required to
submit a facility signature and the facility registration number, and an email address for the inspector or
service provider. On the RX-21, you will be required to submit an email address for the inspector or
service provider. The RMD will be notifying inspectors or service providers via email as a temporary
acknowledgment that the submission has been received and approved and a formal letter will follow in the
mail. Contact Mr. Jerry Adams for further information.
Interpretation of COMAR 26.12.01.01E.5(b)
COMAR 26.12.01.01E.5(b)(3) states that the registrant shall perform an evaluation, at intervals not to
exceed 1 year, to determine conformance with D.301 of these regulations. If such a system is a certified
cabinet-x-ray system, it shall be evaluated at intervals not to exceed 1 year to determine conformance with
21CFR 1020.40. Records of these evaluations shall be maintained for inspection by the Agency for a
period of 3 years after the evaluation. The RMD’s interpretation of this regulation is that if a facility has
film badges that will demonstrate an evaluation that the dose to the general public is less than the allowed
amount of D.301. If you are interpreting this regulation differently, please let us know.
Submittal of the FDA’s 2579 “Report of Assembly” and the MDE RX-24 “Report of Assembly”
The RMD notes continued deficiencies with registered service providers submitting required paperwork
within the fifteen (15) day period stated in COMAR 26.12.01.01B.12. The RMD has a tracking system to
determine which registered service providers are in compliance with this requirement. Escalated
enforcement action will be considered for those service providers that do not comply. In order for the
RMD to modify a radiation machine facility’s number of invoiced x-ray tubes or to cancel a facility
registration, it is necessary to have documentation from the service companies.
Manufacturer Specifications for Dental and Veterinarian X-Ray Machines
The State of Maryland continues to experience an increasing number of digital dental devices in
Maryland. There is a need to establish a requirement that dentists use the recommended exposure
technique ranges suitable to the new technology. The RMD’s inspectors have noted that while many
offices are using digital equipment, some are keeping their exposure time at or near pre digital installation
levels. Beginning in August 2007, the RMD started collecting and compiling exposure ranges suggested
or recommended by equipment manufacturers. An educational instrument will be developed to
demonstrate to dental digital equipment users that reduction of exposure can be achieved with little or no
impact to overall image quality. Any dental office found to be using film exposure settings in a digital
environment would be appropriately educated as to the expectation of reduced exposures/doses.
Important RHP web pages:
http://www.mde.state.md.us/Programs/AirPrograms/Radiological_Health/index.asp
http://www.mde.state.md.us/Programs/AirPrograms/Radiological_Health/xray_applications/index.asp
Attachments: Agenda
Directions
Recycled Paper
www.mde.state.md.us
TTY Users 1-800-735-2258
Via Maryland Relay Service
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