105 CMR, § 120.410 - Bone Densitometry

(A) Bone Densitometry Systems shall be:

(1) Certified by the manufacturer pursuant to the Medical Device Act and Subchapter C - Electronic Product Radiation Control (EPRC) of Chapter V of the Federal Food, Drug and Cosmetic Act.;

(2) Registered in accordance with 105 CMR 120.020;

(3) Maintained and operated in accordance with the manufacturer's specifications.

(B) Equipment Requirements. Systems with stepless collimators shall be provided with means to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond 2% of the SID.

(C) Operators of Bone Densitometry Systems shall be:

(1) Licensed as a radiologic technologist [by the Agency]; or

(2) A licensed physician; or

(3) International Society For Clinical Densitometry certified as a bone densitometry technologist; or

(4) ARRT certified in Bone Density

² For the purpose of determining the CTDI, the manufacturer's statment as to the nominal tomographic section thickness for that particular system may be utilized.

(D) During the Operation of any Bone Densitometry System:

(1) The operator, ancillary personnel, and members of the general public shall be positioned at least one meter from the patient and bone densitometry system during the examination.

(2) The operator shall advise the patient that the bone densitometry examination is a type of x-ray procedure.

(E) The Manufacturer's Quality Assurance and Quality Control programs shall be followed.

(F) The registrant of the facility shall keep maintenance records for bone densitometry systems. These records shall be maintained for inspection by the Agency for three years.

(G) Bone Densitometry on Human Patients Shall be Conducted Only:

(1) Under a prescription of a licensed practitioner of the healing arts; or

(2) Under a screening program approved by the Agency.

(H) Any person proposing to conduct a bone densitometry screening program shall submit the information outlined in 105 CMR 120.421: Appendix B and include the name and address of the individual who will interpret the screening results.

(I) 105 CMR 120.010 includes CT units that are designed for bone density.

Notes

105 CMR, § 120.410