Guest Blog Post by Bob Vogel
Evaluating a product by price alone can be confusing and misleading. Why do two cushions that “look” similar have significantly different prices? This is an important question, especially when it comes time to order your next cushion. In order for a DME (durable medical equipment) cushion to be sold as a medical device in the US it must comply with a specific set of rules and tests set forth by the FDA. These rules and tests are a good thing — I want to be sure that the cushion under my butt has been tested and proven to protect my skin.
However, there is a big difference between doing the minimum required to meet regulations and doing the maximum to ensure that wheelchair users have the best skin protection possible.
The first expense is research and design costs associated with making a cushion before it can be submitted to the FDA for approval to be sold. Companies like ROHO (and other market leaders) spend a tremendous amount of money in this area, while other companies that might make similar looking products spend very little in this area. ROHO continually invests money in research and design in an ongoing effort to make the best product for consumers. Research costs include a prototype tool for every research cushion — something that is very expensive with no guarantee that it will ever reach the consumer — laboratory studies, clinical studies, and support papers for the research. Examples of published ROHO papers and research can be viewed here: http://www.therohogroup.com/roho institute
The FDA has a specific set of rules and tests it requires for DME complex rehab cushion to be sold as a DME product in the US. The manufacturer has to be registered with the FDA and pay associated fees on an annual basis and must meet FDA quality system regulation (QS) manufacturing requirements for designing, purchasing, manufacturing, labeling, storing and servicing medical devices (in this case, cushions). The manufacturer has to have traceability of the product (cushion) and report if there is any kind of recall or adverse event with the product.
The FDA inspects manufacturing facilities and if an inspection or an FDA audit finds there isn’t compliance with its rules, the FDA can shut down the plant.
ROHO takes quality control much further than the FDA model with its quality management systems’ being certified to two ISO standards — ISO 9001:2008 and ISO 13485:2003, which is a medical device quality standard. Manufacturing all ROHO cushions, except the PostureLITE™ by ROHO Cushion at its plant in Belleville, Illinois, ROHO is able to maintain the highest levels of quality control in every aspect of every cushion.
An example of ROHO quality control is the neoprene used to make its cushions. Instead of relying on an outsourced compound, ROHO compounds and mixes its own neoprene and every batch is tested to ensure each cushion maintains the highest standard. To further enhance quality control, each ROHO cushion has a unique serial number that ties it back to the specific date that it was made and processes under which it was manufactured in order to pinpoint any issue regarding quality if needed.
Each and every ROHO cushion goes though multiple layers of quality inspection to ensure each cushion performs to specification before it is shipped.
Another important thing to consider when ordering a new cushion is warranty return policy and customer service — a manufacturer expense that ROHO feels is of vital importance. If you have a problem with a ROHO cushion you call customer service and give them the serial number of the cushion and tell them the problem. Customer service will be able to immediately tell the manufacture date, exact model and size of cushion and warranty information. If it is under warranty, they will send you a new cushion right away, and have you send your old cushion back in a pre-paid shipping box. This enables ROHO to examine the cushion, document the problem and further enhance quality control by gaining knowledge to take steps to work on eliminating problems and improve cushions.
An example of this is, years ago ROHO identified an area of wear on the cushion where the cell met the base of the cushion. To address this, ROHO Engineering spent a great deal of money to redesign the cushion so the cushion cells had a more gradual taper. The redesign meant great expense for re-tooling for all cushions, but the end result was a longer wearing cushion for the customer.
When it comes to qualifying for reimbursement for a DME cushion, most insurance companies follow Medicare guidelines — the product has to meet a Cal-117 Fire safety test, the cushion must have minimum of an 18-month warranty and show that the cushion will pass a Simulated Immersion Laboratory test — a test that measures a cushion’s ability to allow cylindrical devices (meant to simulate a human pelvis) to sink 40 mm into a cushion with a 31-pound load without bottoming out — about 18 months of use. 40 mm is the goal because it simulates immersion of the entire pelvis.
Unfortunately, the Simulated Immersion Laboratory test does not measure pressure, meaning you could end up with a cushion that passes all of the tests, yet puts tremendous pressure on bony areas of the pelvis and puts the user at risk of a pressure ulcer.
Which brings us to another example how ROHO goes the extra mile for consumer safety. ROHO, in conjunction with Sunrise Medical, has spent considerable time and a huge sum of money to develop a superior Simulated Immersion Laboratory test device — one that is in the shape of a pelvis, designed to address the most difficult seating/pressure challenge. The device has eighteen sophisticated pressure sensors imbedded in the indenter at typical pelvic pressure points so you can see the actual pressure readouts on the pelvis. The device is designed to measure all 18 points when immersed at 40 mm in the cushion — the goal is equal pressure distribution on all areas without any high pressure points. An analogy is a scuba diver under water — they have a ton of force applied to them but it is equally distributed so they don’t develop problems.
To make seating safer for all consumers, ROHO and Sunrise have done all of the testing and research on their Simulated Immersion Laboratory test device, and are offering the research and plans for the device to testing agencies for free to try and raise the bar and make seating better and safer for all consumers.
When looking at your next cushion, do your research:
• Where is the cushion manufactured?
• How long is the warranty? (ROHO cushions’ warranties are 24-months and 36-months depending on model).
• What is the warranty policy?
• Is the manufacturer continually improving the product?
• Does the manufacturer include research papers about its product on its website?
The bottom line of all this is, there are a lot of cushions that “look” like a ROHO but cost less — performance, seating and positioning and how a cushion protects your skin, how a cushion protects your bottom, should be the bottom line on cushion choice. And as always, it is vital to ask and make sure the exact make, model and size of cushion are included on all therapists’ and physicians’ prescriptions as in “ROHO® Quadtro Select® High Profile® Cushion, 16″ X 16″.
Bob Vogel, 51, is a freelance writer for the ROHO Community blog. He is a dedicated dad, adventure athlete and journalist. Bob is in his 26th year as a T10 complete para. For the past two decades he has written for New Mobility magazine and is now their Senior Correspondent. He often seeks insight and perspective from his 10-year-old daughter, Sarah, and Schatzie, his 9-year-old German Shepherd service dog. The views and opinions expressed in this blog post are those of Bob Vogel and do not necessarily reflect the views of The ROHO Group. You can contact Bob Vogel by email at email@example.com.