The National Pressure Ulcer Advisory Panel, Reston, Va., a not-for-profit organization comprised of leading professionals who share a commitment to the prevention and management of pressure ulcers, is coordinating the development of uniform terminology, test methods and reporting standards for support surfaces.
As an independent authority on pressure ulcer care in the United States, the NPUAP is coordinating a committee comprised of researchers, clinicians, policy-makers and manufacturers to develop voluntary support surface performance standards, projected to be finalized by October 2003.
“The guidelines will provide an objective means for evaluating and comparing support surface characteristics,” said David M. Brienza, Ph.D., associate professor for the School of Health and Rehabilitation Sciences at the University of Pittsburgh and board member of NPUAP. “Test methods and reporting standards will improve the process of selection and procurement. Clinicians, patients and other users will benefit from having product information and test data presented in a consistent manner,” Brienza said.
“In essence, standards will empower consumers and serve as a product development guide for manufacturers and enhance quality assurance in the manufacturing process,” he added.
In a three-year plan for developing the proposed support surface test methods, NPUAP will be forming working groups in the areas of Terms and Definitions, Tissue Integrity and Device Safety and Lifespan. Test methods will evaluate pressure
The national cost to treat pressure ulcers is estimated at between 1.68 billion and 6.8 billion annually. |
redistribution, temperature and moisture control, patient and product friction, life expectancy of the product, failure modes and flammability.
The support surface initiative will have representation and participation by manufacturers, consumers, clinicians, researchers, health care providers and policy makers.
The national cost to treat pressure ulcers is currently estimated at 1.68 billion to 6.8 billion annually. With the growth of the elder population in the United States, the prevention of pressure ulcers is of critical importance. As a result, pressure ulcer prevention and treatment has become an important health policy issue. Healthy People 2010–a national health promotion and disease prevention initiative–includes a goal to significantly reduce the incidence of pressure ulcers during this decade.
NPUAP’s Support Surface Initiative outlines the need for standardized testing methods due to the lack of information about support surface characteristics and the inconsistent manner in which information is reported. While physicians are typically the providers of support surface information to patients, the range of support surface products on the market makes it difficult for physicians to keep up to speed on the specific products that
Test methods will evaluate pressure redistribution, temperature and moisture control, friction, life expectancy, failure modes and flammability. |
would be ideal for each patient. Developing a method to measure and compare these characteristics is expected to help clarify the support surface selection process and allow the consumer to have the specific product to fit their specific requirements.
Who will benefit?
Not only are the standards expected to benefit clinicians by helping them to sort through products on the market and match characteristics to the needs of a patient, but vendors will benefit by using the standards to easier explain products to clinicians and patients. According to the Support Surface Initiative, cushion testing standards would aid manufacturers by guiding new product development and redesign of existing products.
“The standards’ primary beneficiaries are consumers and other people who to make support surface choices. HME providers and manufacturers benefit by having informed customers. Manufacturers benefit further by having a validated methodology for differentiating their products from inferior products,” Brienza said.
“Standard test methods also provide a tool for use by manufacturers while developing new products,” Brienza added.
The standards are not intended to determine whether a support surface is better or worse than another, but instead are intended to direct health care providers and patients to making an informed decision.
Cynthia Fleck, RN, BSN, ET, CWS and director of global training and education for The Roho Group, Belleville, Ill., said the development of standards will be beneficial to the support surface market. “Without standards, we are like tourists without a map, wondering aimlessly. Further outcome-focused research and randomized controlled studies on the relative effectiveness of specific support surfaces is needed as well as industry standards for evaluating specific criteria such as moisture/heat dissipation capabilities and requirements,” Fleck said.
“The state of the science for determining support surface product effectiveness is growing although a lot of our industry is still based on expert opinion. The process of support surface selection continues to be redefined and clarified as more is discovered about gauging effectiveness,” Fleck said.
Another benefit may come down to dollars and cents. With payer reimbursement driving the market, scientific standards could facilitate reimbursement from funding sources by ensuring that a patient’s needs are met effectively.
“Support surface selection will continue to challenge the health care provider until we develop a ubiquitous master plan or criteria that consistently demonstrates excellent outcomes,” Fleck said.
Products
“It seems that everyday new products are coming to market from high-tech topical wound dressing and recombinant growth factors to negative pressure vacuum closure devices. Wound care has totally evolved in the last 10 to 15 years,” said Cynthia Fleck, RN, BSN, ET, CWS and director of global training and education for The Roho Group, Belleville, Ill.
“Our goal is to prevent the effects of pressure, shear, friction, and moisture on an individual’s soft tissue. If we can provide an environment for healthy blood flow, while diminishing extrinsic risk factors, we can prevent pressure ulcers. Unfortunately, there are many intrinsic factors that we as clinicians and providers cannot control,” Fleck said.
Crown Therapeutics Inc., one of the Roho Group of Companies, offers non-powered preventative and therapeutic support surface overlays. “Our latest product is the Prodigy Mattress System, the first zoned preventative support surface to come to the market.” Fleck said.
Without standards, we are like tourists without a map, wondering aimlessly. |
“It is simple to use yet offers unsurpassed protection for individuals at high risk for development of pressure ulcers.”
Crown Therapeutics also offers Prodigy’s companion product, the Mosaic Cushion. “Since 66 percent of pressure ulcers occur on the pelvis, we must consider continuity of care for the patient or client moving from bed to chair,” Fleck said.
Education of the provider, clinician, end-user and family are important to the marketing and selling of support surface products. “Without a basic understanding of pressure ulcer prevention, development and treatment, educated decisions regarding product choice cannot be made. We offer comprehensive clinical and product education throughout the country via our specialists and sales team,” Fleck said.
Looking Ahead
“This is a one billion dollar plus market. Everyone wants to be a part of it. Important qualifications in a wound care and therapeutic support surface company include initial and on-going education and product support, valid clinical and performance documentation, trial programs and continuity of care,” Fleck said.