VA Changes: What You Need to Know About MDE Standards

In January 2017, the United States Access Board released its final rule outlining Standards for Accessible Medical Diagnostic Equipment (MDE).

The rule, which became effective February 1, 2017, is based on recommendations from the MDE Advisory Committee. The Committee was comprised of 24 organizations. They represented a variety of federal sectors, including the U.S. Department of Veterans Affairs (VA).

As a result of this new rule, VA changes are taking place to ensure all patients, including those with disabilities, have access to the MDE they need.

Today, we’re taking a look at the new rule, specifically Section M305, which outlines new regulations on supports.

Ready to learn more? Let’s get started!

VA Changes 101: A Brief Look at the Rulemaking

The Rulemaking on MDE was enacted this year under Section 510 of the Rehabilitation Act. Its official title is “Standards for Accessible Medical Diagnostic Equipment.” It can be found under 36 CFR Part 1195.

Under this legislation, the United States Access Board works with the FDA to ensure all persons have access to specific types of MDE. This equipment includes exam furniture (tables, chairs), scales, radiological/imaging machines, and more.

The rulemaking process, which began in 2012, became complete this year. It brings with it several regulations on MDE accessibility.

Health care providers and device manufacturers are not mandatorily bound by these rules. Yet, the MDE Standards do identify several “enforcing agencies,” including the VA.

These agencies can use the rules to guide policymaking within their jurisdiction, as the VA is doing now.

Section Overviews and Technical Requirements

The recent VA changes are based on the MDE final standards for Medical Diagnostic Equipment. In the final rule Chapter 1 establishes the purpose and the general requirements for the application of the MDE Standards

Following, are the Final Standards section by section analysis:

Section M305.4: New Standards for Leg Supports

Under this rule leg supports shall provide a method of supporting, positioning and securing the patient’s legs

According to the final ruling, the MDE Advisory Committee released the following standard on leg supports:

M301.3.2″ Leg supports. Where stirrups are provided, leg supports shall also be provided and shall comply with M305.4″

M305.4 “The MDE Advisory Committee agreed that, for procedures that use stirrups and require the leg to be stable, there must be a method to support the patient’s legs. The Committee referenced ANSI/AAMI HE75 which recommends that ‘[f]or patients with limited leg strength and control, instead of stirrups that support only the foot and require active user leg strength, leg supports that support both the foot and the leg should be used to assist patients in keeping their legs in the appropriate position.”

Leg Stability and Comfort: Support that Complies

As the VA changes its policies due to these new standards, medical equipment must provide safe, supportive leg support.

The GStirrup® is a foot and leg stabilizing device that fits the bill. It offers future-focused design and the ultimate in patient comfort.

Attaching to an exam table in seconds, the GStirrup® keeps patients’ feet and legs stable and secure during medical exams and procedures.

The GStirrup® was designed specifically to give the needed support to patients with disabilities and the elderly. It also works well for those with back pain, arthritis, knee replacements, and more.

To learn more about our product, feel free to check out some of the GStirrup®’s features. Please contact us with any questions. We’ll help you take the first step toward a more comfortable — and compliant — patient experience.

June 16, 2017 Medical Standards , ,