On Feb. 21, 2024, the Colorado Board of Health adopted the request to rescind the requirement for rectangular collimation, mainly due to lack of market availability. Rectangular collimators will not be required by the state but the Board of Health does support the recommendations for their use if practices voluntarily implement them. This rule change will go into effect in April 2024.
The original requirement was added during the 2019-2020 rulemaking with an effective date of Jan. 1, 2025. Colorado was currently the only state to require the use of rectangular collimators for routine dental intraoral imaging. Due to a lack of market availability for universal add-on type collimator devices along with implementation concerns that may be needed to meet FDA requirements when using such devices, implementation and compliance by Jan. 1, 2025 was believed to be unfeasible.
The CDPHE radiation program continues to support the science and principles behind the use of rectangular collimators for most common dental intraoral imaging procedures. However, CDPHE staff members performed a comprehensive search for all distributors and manufacturers of the universal add-on collimator devices and subsequently contacted each one to assess the availability of the devices. The distributors and manufacturers
have universally indicated that the add-on collimator devices envisioned by the current rule have been discontinued, are no longer being manufactured, and are not available for purchase on the open market. While some web sites continue to advertise the devices, the reality is that they are not available.
“[CDPHE] continues to maintain the position that measures taken to reduce dose when reasonably achievable are desirable and consistent with the As Low As Reasonably Achievable (ALARA) concept in radiation protection. However, the current challenges to acquiring the equipment to achieve compliance cannot be ignored. The idea of rule of law should also be considered during the creation and maintenance of regulations and an important aspect of this concept is that a regulated community should be required to comply with regulations with which they can and will comply. Maintaining regulations that cannot and will not be complied with serves to erode the validity of the regulations and the communities respect for the regulatory program as a whole. As a public health agency, CDPHE intends to continue to strive for reductions in radiological dose to all Colorado residents and will encourage all strategies associated with dose reduction through continued education and guidance. As a regulatory body it would be detrimental to the overall program to retain requirements that would result in widespread noncompliance and as such we believe that it is necessary to remove the current rectangular collimator requirement at this time.”
Information in this article was extracted from the Board of Health Hearing Summary from Feb. 21, 2024.
