What the rules will mean for providers, manufacturers and distributor reps moving forward.
Repertoire spoke to several manufacturers about the MDE Standards that healthcare providers will have to adhere to following the recent final rules issued by the Department of Justice and Department of Health and Human Services.
Brewer commends DOJ and HHS on adopting recommendations
Brewer commended the DOJ and HHS for adopting the 2017 Access Board recommendations, which enhance accessibility in healthcare settings for patients with mobility challenges.
“All our power exam tables – including the FLEX High-Low Exam Table, Access High-Low Exam Table and Assist procedure table – are fully compliant with these important standards, ensuring greater access for all patients,” the manufacturer said.
Clearing up confusion about low seat height standards
There has been some recent confusion regarding low seat transfer heights that Brewer wanted to address.
“To clarify, the Department of Justice (DOJ) and Health and Human Services (HHS) have adopted the 2017 Access Board standards, which require a 17-19 inch low transfer height,” Brewer noted.
Additionally, these standards specify that only 10-20% of covered medical equipment needs to meet compliance requirements, not all equipment.
“However, contrary to some claims, the DOJ and HHS have not adopted the newer 2024 Access Board recommendation of a 17-inch height,” Brewer said. “This updated 17-inch recommendation carries no legal enforcement by any government agency at this time. If the DOJ and HHS ever do adopt the 2024 Access Board recommendation, we will ensure our products fully meet those new standards.”
Midmark: New Regulations Present Opportunity for Innovation
The new US Access Board Standards for Accessible Medical Diagnostic Equipment (MDE) will significantly impact healthcare providers, particularly in terms of providing accessibility to all patients, said Brian Vierra, Vice President, Medical Sales, Midmark Corporation. Providers will need to ensure that their examination and procedure chairs meet the new minimum required specifications, which include having a low seat height of no more than 17 inches to facilitate transfers for individuals with disabilities.
“Most examination and procedure chairs in use in the market do not meet this standard,” Vierra said. “The Midmark 626 Barrier-Free® Examination Chair is currently the only chair available that meets the new requirement.”
Providers will need to assess their current equipment and plan for new chairs that comply with these standards. It is also recommended that training for their staff take place to educate them on using the new equipment and ensuring a safe, accessible and positive experience for all patients.
Meanwhile, manufacturers will need to align their product designs with the new Access Board standards, Vierra said. “This creates an opportunity for manufacturers to innovate and develop new products that prioritize accessibility requirements, ultimately enhancing the experience between patients and caregivers.”
Equipment manufacturers may also want to consider increasing marketing and communication efforts to educate healthcare providers about the new standards and the products that are compliant.
To help ensure customers are compliant with the new rule, distributor reps can ask the following questions:
1. Are you aware of the new US Access Board standards for Accessible Medical Diagnostic Equipment that went into effect in September?
2. Have you evaluated your current examination chairs and diagnostic equipment for compliance with the new seat height and transfer support requirements?
3. Are your current examination chairs able to lower to a low seat height of 17 inches or less?
4. Do your examination chairs have the required transfer supports that meet the new design specifications for accessibility?
5. Have you made plans to replace or upgrade to equipment that complies with the new standards?
6. What training have you implemented for your staff to ensure they can safely and effectively use compliant equipment?
Pelstar: Take Steps Now to Ensure Compliance
Pelstar LLC, the manufacturer of Health o meter® Professional Scales, said the new MDE regulations define standards for providers to follow that ensure equal care across a patient population. “This means they should have medical equipment that meets the new MDE standards as well as follow new guidelines for how the patient approaches the equipment.”
For example, a piece of equipment that meets the MDE standards would be an exam table with a lower transfer height or a wheelchair scale that has ramps with easy egress. A facility’s layout should also ensure there is sufficient room around a piece of equipment to be able to wheel the patient up to and around it.
Budgets will be affected as customers may need to purchase new equipment or adjust equipment purchases for future builds and allocate space differently. Though not in the regulations, providers should also make efforts to train staff to be able to support and work safely with disabled patients to ensure a comfortable healthcare experience, Pelstar said. “These new regulations apply to all types of medical facilities including public hospitals, whether state or federally funded, and any facility receiving Medicare or Medicaid assistance.”
For facilities that do not already comply, the rules state, “Beginning October 8, all MDE (Medical Device Equipment) that state and local government entities purchase, lease, or otherwise acquire must be accessible until the entities have the amount of accessible MDE that the rule requires.” Facilities have until Aug. 9, 2026 to have at least 10% of their equipment units meeting the standards. For example, a hospital with ten scales must have at least one unit that meets the standards. If the facility has patients that are primarily struggling with mobility issues, such as a rehab center, the % required is higher at 20% of units.
To help ensure customers are compliant with the new rule, Pelstar said distributor reps should take the following steps:
- First, the rep can ask the customer if they are aware of the new regulations. If not, they should be educated on the requirements and the upcoming deadlines.
- Next, they can discuss if the facility has evaluated its equipment and the space requirements to determine what new equipment needs to be purchased or what plans need to be modified.
- Reps can alleviate their customers’ fears, assuring them there is adequate time to meet these deadlines and that they should take their time planning before making any impulsive purchases. The equipment market will take some time to develop new products to meet the MDE standards, and buyers should be patient. To be certain if a product is compliant, buyers should look for third party certification assuring the product meets the new MDE standards.
- Most importantly, the facility needs to check with its own legal and regulatory teams before making any decisions.