The last couple of weeks we’ve been focusing on the process of developing ISO and ANSI/RESNA standards, along with the benefits and limitations of these test methods. Today’s blog focuses on the relationship between the standards and clinical practice.
How do standards tie to clinical practice? We have ISO and RESNA standards which are mechanical testing methods, and we currently have the new Prevention and Treatment of Pressure Ulcers / Injuries: Clinical Practice Guideline (CPG) recently published by the National Pressure Injury Advisory Panel (NPIAP), European Pressure Ulcer Advisory Panel (EPUAP), and the Pan Pacific Pressure Injury Alliance (PPPIA). The CPG offers guidance about the best clinical practices, informed by the current understanding of the etiology of pressure injury, published scientific literature, and expert opinion. Using the guidelines and the standards together can help narrow the field of cushion choices for trialing with a client. These tools, in combination with clinical reasoning, can help identify a solution that best meets the individual’s needs.
Let’s take a closer look at the CPG, thinking about pressure injury in particular. The CPG was published at the end of 2019, as an international effort by over 250 globally recognized experts in pressure injury from Europe, US, and the Pan Pacific region. The experts critiqued and vetted over 3500 research studies with input from over 1000 stakeholders. It’s quite an achievement to have a global agreement about the state of the science and the understanding of how to best prevent and treat pressure injuries.
This document is key to us as we develop standards, and we take our guidance and input from this clinical practice and level of understanding that exists today in 2020. The guidelines have extensive definitions, especially for pressure injury. To paraphrase, a pressure injury is localized damage to the skin and/or underlying tissue as a result of pressure or pressure in combination with shear. Tolerance may be affected by microclimate, perfusion, age, health conditions, co-morbidities, and conditions of the soft tissue. Pressure, shear, and microclimate can all be measured in a laboratory environment, so developing these standardized test methods is important to help us better understand cushion performance.
The CPG talks specifically about the role of support surfaces in the prevention and treatment of pressure injuries. The guideline describes support surfaces as devices for pressure redistribution, designed for management of tissue loads, microclimate, and/or other therapeutic functions. The characteristics of the surface include immersion, envelopment, and microclimate. The CPG notes that the way these properties are achieved and the level they achieve does vary substantially between devices within and across categories. Not all support surfaces are designed the same way, and they don’t perform the same way. Having standardized tests that can quantify those performance characteristics is extremely helpful in understanding how the surfaces are different. As a complement to your clinical reasoning, when you know the properties you’re looking for your client, the results of standardized tests can help you find a solution to meet the client’s needs.
Join us next week as we take a closer look at the specific ISO and RESNA standard test methods for wheelchair seating and positioning.
Kara Kopplin, B.Sc.Eng,
Chair of the ANSI/RESNA Wheelchair and Related Seating Committee, Director of Regulatory Science for Permobil
Kara Kopplin holds a B.Sc. in Ceramic Engineering from the University of Missouri-Rolla, U.S.A., bringing a unique and complementary materials engineering perspective to seating solutions. In her role as Director of Regulatory Science for Permobil, Inc., Ms. Kopplin actively contributes to the efforts of the International Organization for Standardization (ISO) and European Committee for Standardization (CEN) to develop object test methods for wheelchair systems and components. She is honored to chair the ANSI/RESNA Standards Committee on Wheelchair and Related Seating (WRS) in the US and encourages everyone to contribute to the development of these critical evaluation tools.