Wound Care and Support Surfaces
Patients with pressure ulcers or those at risk for developing a pressure ulcer should have a support surface as part of their plan of care. A support surface is defined by the National Pressure Ulcer Advisory Panel's (NPUAP) Support Surface Standards Initiative (S3I) as a specialized device for pressure redistribution designed for management of tissue loads, micro-climate and/or other therapeutic functions. The support surface could be a mattress overlay, mattress replacement, integrated bed unit or variety of seat cushions. The purpose of any support surface is to redistribute a person's weight (load) over the contact areas of the body. This definition replaces the previous terms of pressure relief and pressure reduction.
When a support surface does not match a patient's needs or does not perform properly, it can do more harm than good and it increases the overall cost of treatment. While support surfaces are valuable in all types of patient care settings, there has been no standardization of product testing and reporting by manufacturers. As a result, the clinician is left comparing apples to oranges in matching patient need to the best product available. The research for providing evidence for clinical decision making has been limited. To help eliminate the confusion and improve clinical evidence the NPUAP, manufacturers, clinicians, engineers and researchers came together in January of 2002. Three working groups were started: Terms and Definitions, Tissue Integrity and Lifespan.
Since that time, there have been approximately two meetings a year. The group Terms and Definitions tested the definitions and met in June 2006 to make revisions. The Tissue Integrity and Lifespan groups merged, and a list of appropriate tests is being developed. The product testing has also been presented to the International Standards Organization (ISO) and will become a work group of this international organization.
Several questions remain:
How will this affect practice?
What will it mean for the product manufacturers?
How will any resulting tests and data be used by regulators and payers?
Currently no clear evidence exists to suggest what type, shape or size of wound would benefit from the use of a low air loss, alternating pressure, air-fluidized or a combination product. This is primarily due to the fact that there are no well-defined specifications for each of these terms. By developing clear, consistent definitions and testing methods for the industry, clinicians will know what type of product they are really using and what features are provided by a specific product. The use of some standardized test reporting by manufacturers also will allow products to be compared. For example, if product A has alternating pressure, the clinician will need to know the frequency, duration, amplitude, and rate of change parameters over the "active area" of the surface and how that compares to product B. Product limitations will be documented.
Manufacturers will not be constrained by the use of the proposed consistent testing and will still be able to conduct and report additional test results. Also, manufacturers will be free to develop new products, and S3I may need to decide on additional definitions as this occurs. Product testing may also be updated as technology changes and new products and test methods are developed. The benefit to manufacturers will be a more consistent playing field where everyone internationally will call an apple, an apple and a low air loss, a low air loss.
Standardization of terms and definitions and product testing will further benefit health care and regulatory organizations. Medicare currently recognizes that some pressure ulcers are unavoidable, but the burden of proof is on the health care facility. With no clear evidence that indicates which support surface to use to meet the patient's needs, compliance with federal regulations becomes difficult if not impossible. Some states currently mandate reporting of pressure ulcers as a sentinel event and even have imposed fines. Litigation over a patient's development of pressure ulcers continues to increase, putting organizations under increasing pressure to provide quality care and use evidence-based practice. When no evidence exists, it becomes problematic for everyone.
Further discrepancies exist between levels of care. The support surface that is reimbursed in the acute setting may not be in the home care arena. Without evidence to show the need for a higher priced item, there is no basis for regulatory change. Medicare is currently looking at reimbursement for support surfaces and has started the competitive bidding process. This accelerates the urgency to use consistent terms and definitions for products to ensure that similar products are fairly reimbursed and not compared or categorized with less expensive support surfaces. In the future, it may be imperative to guard against either regulatory bodies implementing rules and reimbursement selectively or payers using data in a way that could inhibit patient access or manufacturer innovation.
Pressure ulcers are costly for the health care system. Healing a wound can cost $35,000 or more. Pressure ulcers are painful for the patient, result in longer length of stay, diminish quality of life and may result in patient mortality. An aggressive wound care program that includes support surfaces can reduce occurrence and enhance healing. The real cost is ignoring the problem.
Support surfaces are an integral part of the patient's plan of care for both the treatment and prevention of pressure ulcers. Standardization of support surface terms and definitions used by clinicians, researchers and manufacturers will ultimately improve patient care. Standardization of product test reporting will allow patients and support surfaces to be better matched for need. This will then become a win-win situation for the patient, clinician, facility and manufacturer.
This article originally appeared in the July 2006 issue of HME Business.