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

Hologic, Inc.

Hologic, Inc.
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MINORITY REPORT: CONSIDERATIONS FOR THE APPLICATION OF ACCESSIBILITY STANDARDS TO PRONE BREAST BIOPSY TABLES

John LaViola, GVP, Women’s Health Group, Product Development, Hologic, Inc.
Michelle Lustrino, Mechanical Engineer, Product Development, Hologic, Inc.

Prone breast biopsy tables were considered by the “Imaging Equipment with Transfer Surfaces” sub-committee and are described in Section 4.3.2 of the full committee report. As discussed in the report, prone breast biopsy tables are one of several equivalent clinical options used for specialized interventional breast biopsy procedures. Minimally, they require local anesthetics, and at times require some level of patient sedation. Section 4.3.3 of the full committee report states, “The Committee viewed imaging systems used for interventions and biopsies in patients who are typically sedated as outside the scope of the accessibility standards.” Although, in many cases prone biopsy procedures require only local anesthetics, prone breast biopsy tables should be exempt from the related transfer height and lift compatibility requirements under consideration by the committee’s standards and rules determination processes. Therefore, Hologic is submitting this report to support this exemption by describing the relevant clinical use cases and the practical application of the committee’s consideration of alternative lift compatibility requirements.

The process of detecting breast cancer begins with regular mammography screening exams. If an area of concern has been detected, then the patient may be asked to have more images of their breast taken in what is considered a diagnostic mammogram. It is only after these images are taken and a region of interest (e.g., calcifications or suspicious architectural distortion) has been detected that a patient will be required to go for a minimally invasive image-guided breast biopsy procedure. A breast biopsy is a minimally invasive surgical procedure used to sample tissue from a region of interest, and is the last of multiple steps required to diagnose breast cancer. While it is an important step in the diagnosis, it is the screening mammogram that is used to determine suspicious regions of interest and begin clinical work-up of these regions. It is critical that women have independent access to screening mammography equipment and that they can be examined with as much ease as possible, as independent access will impact their likelihood to get their regular mammograms. However, breast biopsy procedures are prescribed in response to a specific clinical concern with multiple healthcare and accessibility considerations jointly evaluated by the patient and the care provider. Accordingly, independent patient accessibility to breast biopsy procedures is not the overriding clinical concern and would not likely interfere with the patient’s access to health care.

Breast biopsies may be performed with the patient in a prone, seated, or decubitus position. A dedicated prone breast biopsy table is used only for biopsy procedures in the prone position. Equivalent care can be provided with biopsy accessories attached to upright mammography equipment with patients in seated or decubitus positions. It should be noted that for lesions that can be readily localized with ultrasound imaging, supine breast biopsies are typically performed. Additionally, some clinical situations may indicate an open surgical biopsy with the patient under general anesthesia.

It is critical that there be a method by which all patients can safely access medical diagnostic equipment. During a prone biopsy procedure (Figure 1), the patient lies in the prone position on a cushioned table, with her breast positioned beneath the patient support surface while the physician works underneath the table, out of sight of the patient. This configuration increases patient comfort and thereby is an advantage for the use of prone biopsy tables.

Figure 1. Example prone breast biopsy table. The patient is lying in the prone position on a cushioned table, with her breast positioned beneath the patient support surface while the physician works underneath the table.

Because the procedure takes place underneath the patient support surface, provisions are needed under the table for imaging and biopsy equipment and for a drive mechanism to move the table to a height that allows comfortable physician access, while also maintaining access to the patient from the front and back of the machine. As a result of these technical and clinical use constraints, the minimum possible table height in the table shown in Figure 1 is 37 inches. With the table surface at these heights, all patients are assisted in getting onto the table either with a step stool or with a supplemental patient transfer device (e.g., a stretcher). While future redesign may be able to decrease this height by a few inches, it would be cost prohibitive (and technically infeasible through practical means) to redesign the system to achieve any of the transfer heights described by Section M301 (even with the accessibility configurations discussed in Section 7 of the full Committee report).

This, however, does not mean that the prone biopsy table is inaccessible to patients in wheelchairs. While they may not be able to independently transfer onto the breast biopsy table, they can still access the table through transfer via an accessible stretcher (or other supplemental transfer device). In this case, the patient can independently transfer onto the stretcher, the stretcher will be raised to the height of the biopsy table, and the patient will transfer laterally onto the prone biopsy table. While this process will likely require the assistance of a technologist, the patient will be supported throughout the entire lateral transfer, unlike when they are transferring from their wheelchair to the stretcher, thus minimizing the safety concerns for the technologist and the patient. The technologist can utilize slip/slide sheets, boards, or other aids, to assist with lateral transfers.ⁱ Furthermore, if there are no obstructions to the transfer surface, the top of the stretcher and the top of the biopsy table can act as one continuous surface on which the patient positioning takes place, giving the patient ample space to use to turn over into the prone position. Once the patient is safely in position, the stretcher can be moved out of the way. Hologic understands the tremendous benefits of independent transfers, but due to the nature of this particular procedure, transfer via an accessible supplemental patient transfer device appropriately manages patient accessibility and use risks, and provides enhanced patient comfort during the procedure.

The above transfer procedure is an example of how using a supplemental patient transfer device provides a valuable method of assisted transfer as an alternative to the use of portable or overhead lifts. In the case of prone biopsy, this method is a safe, effective, and efficient way to transfer and position the patient. In cases such as these, where a stretcher-assisted transfer is used for its positioning and safety benefits, provisions for portable and overhead lifts are not required. If a patient requires a lift to transfer out of her wheelchair, she can use one for the initial transfer to the stretcher. In these cases especially, it will be important that the patient has ample space to move into the prone position, which will be made possible by the stretcher-based transfer method.

Seated position breast biopsies with an upright device provide the same efficacy and accuracy as prone biopsies,ⁱⁱ and therefore are equally effective in diagnostic work-up of the patient. If there are concerns of patient vasovagal response with the seated breast biopsy, they can likely be mitigated by decubitus positioning of the patient. Since these procedures take place using a screening mammography system, all patients will be able to achieve independent access to an upright biopsy and thus patients who are unable to access a prone biopsy table, even with the help of a supplemental patient transfer device, can still have a breast biopsy. However, it would be detrimental to the patients and to the healthcare system to rule prone biopsy systems inaccessible due to the technical constraints that minimize the ability for purely independent transfer.

All breast biopsy cases should be evaluated for their individual clinical and accessibility needs. When a breast biopsy is prescribed, the physician must work with the patient to ensure that the right biopsy procedure is chosen for them, taking into account any benefits or risks of that particular procedure. In order to maximize patient care, it is important that the prone biopsy table is included as an accessible option by this standards-setting process, provided that there is a plan in place to safely complete the assisted transfers at any site where this technology is used.

Hologic is fully committed to ensuring that our products are accessible to all patients and we appreciate the opportunity to work with the Access Board during this process. If you have any questions or need further information regarding the information presented here, please do not hesitate to let us know.

^i. U.S. Department of Justice, Disability Rights Section. U.S. Department of Health and Human Services, Office for Civil Rights. “Americans with Disabilities Act: Access To Medical Care For Individuals With Mobility Disabilities.” Part 4: Accessible Medical Equipment. 15-16.

^ii. Wunderbaldinger P, Wolf, G, Turetschek K, Helbich TH. “Comparison of Sitting Versus Prone Position for Stereotactic Large-Core Breast Biopsy in Surgically Proven Lesions.” American Journal of Roentgenology. 2002. 178:5, 1221-1225.