Pressure Rescue
- By Ellen Z. Harrison, Bob McCoy
- Mar 01, 2007
To a lifeguard watching from a tower on the shore, the ocean can appear deceptively serene. Yet beneath the greenish blue surface, deadly undertows churn water in a washing-machine-like motion, generating waves powerful enough to crush the toughest swimmer.
In many ways, the formation of pressure ulcers mimics the sea. Unseen forces like pressure, shear, friction, temperature and moisture wreck havoc on the skin of clients who lack sensation and mobility.
To determine a swimmer's distress, lifeguards look for flailing arms and sinking heads. But clients who are unable to move or who have limited mobility offer no such warnings. Clinicians must evaluate the elements that cause pressure ulcers and recommend life-saving prevention in the form of surfaces in foam, gel, air or combination materials, powered and non-powered ™ each surface as unique as the people who use them.
Determining the best surface among the latest technology presents challenges, especially since, much like the ocean, the specialty beds and support surfaces niche of HME speaks its own language. But as the tides of this specialty shift, the mysteries surrounding pressure ulcer management are beginning to unravel.
Learning the Language: Terms for Beds & Support Surfaces
Costly Tidal Wave
Once the integrity of the skin is compromised by a pressure ulcer, the skin never fully recovers its resiliency. Those who get a pressure ulcer are likely to get another. Plus complications from pressure ulcers may have deadly consequences.
The pressure ulcer problem "really cuts across all different care settings, from acute care to post-acute, to rehab, to home care, it's a problem in all of these settings," says David Brienza, former board member of the National Pressure Ulcer Advisory Panel (NPUAP) and professor at the University of Pittsburgh. "Severe pressure ulcers involving deep tissue, like the Stage III and Stage IV ulcers, require significant medical care and therefore are very costly. In the worst case, pressure ulcers can lead to death."
The prognosis for medical costs is equally dim. Figures for the cost of treatment vary, but "according to the CDC, pressure ulcers will annually cost the U.S. health care industry approximately $1.2 billion a year," says W. Darren Hammond, MPT, CWS, director of the department of Training and Education, The ROHO Group Inc., Belleville, Ill.
No one can argue that prevention is the best policy, especially considering these figures. Prevention comes with a much cheaper price tag, estimated at about a tenth of the cost of treatment, says Abbey Daniels, CEO of SenTech Medical Systems, Coral Springs, Fla.
Another factor contributing to the high cost of treating a pressure ulcer is that healing wounds takes time, during which hospital bills can add up. Preventative support surfaces, however, can reduce the total cost to health care by helping to stop a wound before it starts.
Despite these facts, the trend with the Centers for Medicare & Medicaid Services (CMS) has been to only pay for treatment. "What's really sad about that is the majority of all decubitus ulcers are preventable," says Daniels.
Fortunately, CMS is beginning to take notice, says Hammond. "The Centers for Medicare & Medicaid Services have recognized the need for better management of individuals with pressure ulcers," he says. "New regulations have been revised in long-term care and are currently being developed for acute care and rehabilitation hospitals.
"Regardless of diagnosis, age and other co-morbidities, if an individual incurs a pressure ulcer, not only will they incur additional costs to specifically treat the wound, such as dressings and direct clinician hours, but costs may increase due to increases in overall hospital stay, additional diagnostic studies, out-patient visits, and equipment purchases or rentals."
The Geology of Support Surface
Keeping pace with ongoing trends in the HME industry, the beds and support surfaces segment is experiencing many shifts in response to an aging population that demands highly functional products with advanced technology. As the industry gains a broader understanding of what causes pressure ulcers, the segment will likely experience more growth with products that produce better clinical outcomes.
Already the community has banded together to get a few things straight. The Support Surface Standards Initiative of the NPUAP recently defined standard terms and is also working hard to develop a test methodology to compare the different support surfaces available.
All of the progress hinges on the science of pressure ulcers.
"Pressure ulcers are a complicated problem because apparently there are a lot of factors that lead to the development of a pressure ulcer," explains Brienza. "By definition, pressure on the skin is involved, but that's not the only factor involved."
In fact, factors like shear, friction, temperature and moisture play integral roles. So, if current testing methods assess support surfaces only for pressure, then the clinical efficacy of the technology can't be proved across the full spectrum of causes.
Jim Acker, vice president of sales and marketing, Blue Chip Medical Products, Suffern, N.Y., says that since the technology available targets these different aspects of pressure ulcers, the testing methodology must take into consideration all modalities of support surfaces. "They need to come up with testing protocols that will test shear forces and pressure redistribution for all different modalities, not just one that works best for alternating pressure mattresses," he says. "They all have similar outcomes, they just do it differently, and it's hard to just have one test method."
Michael Bredal, vice president of sales, Action Products Inc., Hagerstown, Md., says the lack of standardized testing methods have been a concern for his company. "We have ways to measure how effective our pads are at distributing pressure but they're limited to the vertical pressure readings that you get from using current pressure testing equipment, which just shows one aspect of the effectiveness of a pad," he says. "Right now, there are several initiatives elaborating on the way you test the efficacy of pads, to involve measurements such as shear, heat buildup, water vapor, envelopment, immersion ™ all factors that contribute to the formation of pressure ulcers ™ but some of them are new areas of measurements which have not been explored very well."
Bredal hopes that the work of the NPUAP will prove the virtue of Action's support surfaces. "The National Pressure Ulcer Advisory Panel is trying to standardize tests by using human mannequins and standardizing test methodology, so one can use those tests to explain and compare apples to apples, and say that this mattress meets the guidelines," he says. "I think if one is able to come up with some good standards, that makes it easier for the consumer and those who have not studied this for some time to evaluate if a mattress is good or not."
Brienza concurs. Testing methods, currently under review by NPUAP, would measure envelopment, immersion, shear, and heat and water vapor transmission in addition to pressure.
"We still need to accomplish the development of test methods for these clinically significant performance measures because that's really what's going to allow clinicians to make better decisions," says Brienza. Clinicians "need to know how surfaces perform relative to one another in order to pick the best surface for their client or patient."
Though technology has changed, the methods for determining standards for support surfaces have not evolved. "For example, foam egg crate overlays used to be used years ago more than they are today," explains Hammond. "These simple overlays are made of foam and have limitations in their use. While still effective with some individuals, they are not effective for everyone. Now various technologies exist and offer superior performance over egg crate overlays; some allow for low-air loss to not only effectively submerge the client into the bed thus redistributing forces, but assist in controlling the microclimate of the wound."
With all of the newer technology, testing methods are especially vital. "I support the use of newer technologies; however, these new technologies need to go through rigorous testing, standardization and controlled research to ensure their use is consistent within the industry," Hammond says. "So often new technology hits the market without ever undergoing good randomized, double-blinded clinical trials."
An introduction of testing standards could potentially revolutionize the support surface industry, says Acker. "Having effective test methods in place would probably start a trend in the industry for higher end, better quality systems that have superior outcomes vs. right now the test for an alternating pressure mattress is it's 5 inches of air or greater; that's it," he says. "That allows some really low-quality product to be introduced into the marketplace. These test systems need to make sure that the low-cost imports that really have poor outcomes don't get to sneak through the system because of some loop hole within the test system. "
Bariatric Impact
Recarving the Niche
Efforts are under way to redefine the language associated with beds and support surfaces so that communication will be more effective across the industry.
"There (are) years of inconsistency in how people describe support surfaces and how they describe what effect the support surfaces have on pressure ulcer outcome. This has led to confusion and misinformation," says Brienza.
Responding to that need, the NPUAP has developed standardized terms and definitions. Brienza, one of three board members who led this effort, says, "What we've accomplished so far is this first draft of the terms and definitions, and we're now attempting to get consensus in the community and acceptance of these terms."
In the mean time, the way Medicare defines pressure ulcers still causes significant confusion, for the industry and consumers.
"The whole Support Surface Standards Initiative does not believe necessarily in what's a Class I, a Class II or a Class III," says Daniels. "It's old. Honestly, it's been out there for years and years and years; yet technology has changed."
Part of the problem with the current classification is the wide variety of technology that falls under a given class. "There are products that range in that current Class II device that can be sold anywhere from $400 to just under $5,000," says Daniels. "So, that tells you right there that something isn't right.
"The way the code is written encourages cheaper, perhaps far less effective product or therapy for the patient," she explains.
Acker agrees. "The problem with home care is the nicer preventative type products are not cost effective in home care because Medicare doesn't have the proper allowables attached to the individual HCPCS codes," he says. "So, your clinically viable, positive outcome type, preventative products, you can't use in home care because no one can get reimbursed for them."
Absorbing these products into the codes could definitely help Medicare save money, asserts Acker. "They'd pay a little bit more for prevention, but then they'd save a ton on the treatment side," he says.
Bredal hopes that in time the SADMERC will revisit the codes to determine a more fair classification that also clears up confusion for the consumer.
On the other hand, "our fear is that Medicare will continue to reimburse products based on a few quantifiable standards while there are other measurements, such as shear, heat buildup and water vapor, that are currently not measured in a standardized and quantifiable manner even though most experts in the industry would agree that they do play a significant factor in the formation of pressure ulcers," says Bredal.
"I think there's some hope that the study, it's going on four years now, that the Support Surface Standards Initiative from the NPUAP will help in setting some of those guidelines or at least provide some useful data in setting some of the reimbursement guidelines," says Daniels.
Acker says that Medicare must be careful to listen to all members of the community when rewriting the codes, however. "On paper, you can create this great conceptual thing but in reality it's not feasible or viable to manufacture it, because it's cost-prohibitive," says Acker. "The last go around, Medicare created all this product criteria basics the product had to meet in order to qualify and get a SADMERC letter, but then they didn't increase the allowables. So, we could make it, but then it cost more than the allowable, so therefore the provider wouldn't use it. Everything has to be looked at. And I think what the Support Surface Standards Initiative is doing in conjunction with the National Pressure Ulcer Advisory Panel is crucial in order to come up with something that works … They've been working diligently on it and a lot of manufacturers have been working with them."
Daniels also hopes that the new definitions issued by NPUAP will put everyone in the industry on the same page. "The misuse of terms such as 'pressure relief' and 'pressure reduction' needs to go away, and the Support Surface Standards Initiative (with) the whole list of terms and definitions has said these are being deleted. Instead every support surface, whether it's foam, gel, air, whether it moves or doesn't move, is a 'pressure redistribution' device, and it needs to be thought of that way," she says.
Fortunately, Medicare has been involved in the NPUAP's efforts from the very beginning. "We've kept them in the loop the whole time," Brienza says. "In fact, they were participating in our early meetings so they were aware of the initiative when it began and we've kept them informed throughout the process. But just like the clinicians need the tests, so does Medicare, because Medicare is concerned with making good decisions in terms of paying for support surfaces, which should be consistent with good clinical decisions."
As the NPUAP continues its efforts to develop testing methods, the current definitions and terms are a good foundation for redetermining the reimbursement criteria.
"They're different and they're hopefully better" compared to the current Medicare classifications, says Brienza. "What we assume will happen is that if the community as a whole adopts these terms and definitions, then Medicare as part of that community will also adopt them."
The Power and Limitations of Support Surfaces
Even as the industry expands its knowledge of pressure ulcers and improves products to meet those needs, one fact remains constant: Support surfaces will be instrumental in prevention efforts.
"If we can prevent pressure ulcers from occurring, the cost savings will be huge," says Hammond. "In addition, the overall health and well-being of the client will also be greatly improved. When an individual incurs a pressure ulcer, they may be limited in their vocation, their recreation and lifestyle, and their overall mental well-being. Preventing pressure ulcers is paramount in the overall management of any individual who may present certain risks."
Learning the Language: Terms for Beds & Support Surfaces
On Jan. 29, 2007, the National Pressure Ulcer Advisory Panel (NPUAP) issued revised definitions for support surfaces. Clip out the following glossary of terms to use as a handy reference. The terms are also available for download at www.npuap.org.
active support surface
A powered support surface with the capability to change its load distribution properties, with or without applied load.
air
A low density fluid with minimal resistance to flow.
air fluidized
A feature of a support surface that provides pressure redistribution via a fluid-like medium created by forcing air through beads as characterized by immersion and envelopment.
alternating pressure
A feature of a support surface that provides pressure redistribution via cyclic changes in loading and unloading as characterized by frequency, duration, amplitude and rate of change parameters.
cell/bladder
A means of encapsulating a support medium.
closed cell foam
A non-permeable structure in which there is a barrier between cells, preventing gases or liquids from passing through the foam.
coefficient of friction
A measurement of the amount of friction existing between two surfaces.
elastic foam
A type of porous polymer material that conforms in proportion to the applied weight. Air enters and exits the foam cells more rapidly, due to greater density. (non-memory)
elastomer
Any material that can be repeatedly stretched to at least twice its original length; upon release the stretch will return to approximately its original length.
envelopment
The ability of a support surface to conform, so to fit or mold around irregularities in the body.
fatigue
The reduced capacity of a surface or its components to perform as specified. This change may be the result of intended or unintended use and/or prolonged exposure to chemical, thermal or physical forces.
friction (frictional force)
The resistance to motion in a parallel direction relative to the common boundary of two surfaces.
force
A push-pull vector with magnitude (quantity) and direction (pressure, shear) that is capable of maintaining or altering the position of a body.
gel
A semisolid system consisting of a network of solid aggregates, colloidal dispersions or polymers which may exhibit elastic properties. Can range from a hard gel to a soft gel.
immersion
Depth of penetration (sinking) into a support surface.
integrated bed system
A bed frame and support surface that are combined into a single unit whereby the surface is unable to function separately.
lateral rotation
A feature of a support surface that provides rotation about a longitudinal axis as characterized by degree of patient turn, duration and frequency.
life expectancy
The defined period of time during which a product is able to effectively fulfill its designated purpose.
low air loss
A feature of a support surface that provides a flow of air to assist in managing the heat and humidity (microclimate) of the skin.
mattress
A support surface designed to be placed directly on the existing bed frame.
mechanical load
Force distribution acting on a surface.
multi-zoned surface
A surface in which different segments can have different pressure redistribution capabilities.
non-powered
Any support surface not requiring or using external sources of energy for operation. (Energy= D/C or A/C)
open cell foam
A permeable structure in which there is no barrier between cells and gases or liquids can pass through the foam.
overlay
An additional support surface designed to be placed directly on top of an existing surface.
pad
A cushion-like mass of soft material used for comfort, protection or positioning.
powered
Any support surface requiring or using external sources of energy to operate. (Energy=D/C or A/C)
pressure
The force per unit area exerted perpendicular to the plane of interest.
pressure redistribution
The ability of a support surface to distribute load over the contact areas of the human body. This term replaces prior terminology of pressure reduction and pressure relief surfaces.
pressure reduction
This term is no longer used to describe classes of support surfaces. The term is pressure redistribution.
pressure relief
This term is no longer used to describe classes of support surfaces. The term is pressure redistribution.
reactive support surface
A powered or non-powered support surface with the capability to change its load distribution properties only in response to applied load.
shear (shear stress)
The force per unit area exerted parallel to the plane of interest.
shear strain
Distortion or deformation of tissue as a result of shear stress.
solid
A substance that does not flow perceptibly under stress. Under ordinary conditions retains its size and shape.
support surface
A specialized device for pressure redistribution designed for management of tissue loads, micro-climate, and/or other therapeutic functions (i.e. any mattresses, integrated bed system, mattress replacement, overlay, or seat cushion or seat cushion overlay).
viscoelastic foam
A type of porous polymer material that conforms in proportion to the applied weight. The air exits and enters the foam cells slowly, which allows the material to respond slower than a standard elastic foam (memory foam).
viscous fluid
A fluid with a relatively high resistance to flow of the fluid.
water
A moderate density fluid with moderate resistance to flow.
zone
A segment with a single pressure redistribution capability.
Bariatric Impact
As technology advances to meet client needs, the obesity epidemic is playing a more significant role in the development of support surfaces. "Probably the most challenging product that we have launched recently is our bariatric lateral rotation product," says Abbey Daniels, CEO of SenTech Medical Systems. The new product, capable of turning users up to 1,000 pounds from side to side, was designed to keep the user on the center point of the surface. "A lot of times if you turn, you kind of shift to the side and shift and shift and the next thing you know you're at the side rail," says Daniels. "Keeping that patient centered and effectively moving them or turning them from side to side was a challenge." Daniels says today's market also demands support surfaces that offer caregiver assistance, much like this one.
Blue Chip Medical Products has also devoted more time to specialized bariatric products. "We focus on creating a product line that works specifically for bariatrics, just like we do for pediatrics, vs. just taking our current standard product and just making it a little bit wider," explains Jim Acker, vice president of sales of marketing. "We actually try to address the bariatric needs, the heat and moisture buildup (and) the transferring issues of bariatric patients, and adapt that into a bariatric line of product vs. just creating a 42" of our standard alternating pressure mattress."
The Power and Limitations of Support Surfaces
Support surfaces help control the extrinsic risk factors of pressure ulcer formation, says W. Darren Hammond, MPT, CWS, director of the department of Training and Education, The ROHO Group Inc. Pressure ulcers form because of lack of blood flow, as a result of factors such as pressure, shear, friction and moisture.
"The correct use of support surfaces helps manage these extrinsic risks," says Hammond. "A support surface may redistribute forces over a larger area so there is a reduction of peak forces in one specific area. A support surface may also assist in reducing shear and friction forces. Finally, some support surfaces will also affect the microclimate of the skin (and wound) to decrease the amount of moisture at the skin level."
But support surfaces have limitations as well. An individual might also have intrinsic risk factors such as age, mobility, nutrition and disease that do not respond to support surfaces.
"Support surfaces, unfortunately, cannot help with these intrinsic factors," says Hammond. "Hence, someone can have the best support surface, the best care, the best turning schedule and they will continue to break down due to their body or system not being able to support the skin."
This article originally appeared in the March 2007 issue of HME Business.