Recommendations on Standards for the Design of Medical Diagnostic Equipment for Adults with Disabilities, Advisory Committee Final Report

5. Recommendations
5.3 Diagnostic Imaging Equipment

One type of equipment stood out as unique are systems used for interventional X-Ray and breast prone biopsy procedures. Both interventional procedures and biopsies are technically considered “diagnostic” because they can provide diagnostic information. These systems however, frequently require all patients to under some form of sedation prior to transfer. Because of the use of sedation, their invasiveness, and that these exams are a secondary follow-up to a primary diagnostic finding, they seem more related treatment and hence the subcommittee and the full advisory committee believes they should be considered out of scope for these standards and hence exempted.

As discussed in Section 4.3, the requirements for diagnostic imaging equipment do not apply to patients in a seated (chair or wheelchair) when the imaging system is provided with and/or intended to be used for patients in prone, supine, or Side-Lying Position. Some X-Rays exams are performed with a wall stand in use where the patient is asked to stand. In these situations M304 would apply. However it is likely that the standing supports may need to be an accessory or a mounting in the room. Additionally, given that these supports may also need to serve the diagnostic purpose of a positioning aid some of the dimensions proposed in M305.3 may need to be adjusted in order to maintain diagnostic efficacy.