Prophylactic Dressing Standards Initiative Announced

The National Pressure Injury Advisory Panel (NPIAP) and the European Pressure Ulcer Advisory Panel (EPUAP) are pleased to announce the launch of the joint NPIAP-EPUAP Prophylactic Dressing Standards Initiative (PDSI) and the establishment of a dedicated international task force to lead and develop this initiative.

No accepted standards exist for prophylactic dressings, despite their international widespread and growing use. Performance standards based on bioengineering laboratory testing generate critical information that is needed to guide effective medical product selection and practice. Testing standards and consistent manufacturing practices are established for all types of medical devices and serve different stakeholders in multiple ways, including industry itself, by providing benchmarks for development purposes or instructions for use. Testing standards further serve regulatory bodies and reimbursement policy-makers to evalute safety and efficacy as well as to qualify existing or new products for use with patients who have specific needs. Ultimately, testing standards support informed clinical decision-making by objectively and quantitatively characterizing pros and cons of available technologies and products.

The new PDSI Task Force will include expert representatives of all relevant stakeholder groups and apply a transparent policy for the balance of influences among those groups (eg, industry, clinicians, researchers, policy-makers, etc.). The first priority of the task force will be to develop a consensus on the scope of prophylactic dressing standards and prioritize specific elements of this scope; that is, select the specific topics and standards for initial development efforts. Next, they will develop these testing standards over a 3-year period, validate the developed standards, and submit them for accreditation through international and national standard organizations. An unrestricted development fund will be developed for resourcing the activities of the PDSI, and all stakeholders are invited to support the initiative through this mechanism.

According to Dr. Amit Gefen, a Professor of Biomedical Engineering at Tel Aviv University, Israel, and a Co-Chair of the NPIAP-EPUAP Task Force for the PDSI, the work of the task force will shape the future of design, regulation, and clinical decision-making with regard to dressings with an intended prophylactic use on a global scale. The prophylactic value in any dressing used for pressure ulcer/injury prevention is its ability to effectively alleviate the sustained skin and subdermal soft tissue loads, perform adequately to prevent excessive heat accumulation on the skin and within deeper tissues, and absorb shearing loads caused by static or dynamic frictional forces. A dressing that successfully accomplishes the above goals at an anatomic site needs to continue to do so at a steady level of effectiveness over time, even when exposed to a changing environment (eg, when a patient is incontinent and therefore the bedsheets become wet). Although manufacturers of prophylactic dressings claim that dressings meet some or all of these goals, there are no standardized, quantitative testing protocols and laboratory methods that evaluate whether the above goals are, in fact, being met and to what extent. The development of a set of testing standards and their validation will enable 1) objective, standardized, and quantitative measurements of the biomechanical efficacy of preventive dressings in achieving the above aims and 2) systematic comparisons of the performances of any prophylactic dressings, existing or new, to allow informed decisions by clinicians, health care policy makers, regulators, hospital purchasing teams, and others. 

Gefen goes on to say that the wound care field has traditionally been hindered by a lack of quantitative, advanced bioengineering methods to evaluate the performances of technologies and products (dressings included), which as a result may compromise patient safety, clinical outcomes, and overall quality of care. “We as a community of bioengineers with an interest in delivering better wound prevention and healing are acting jointly, on a global level, to change that and bring the level of technology and its implementation in wound care to the level now set as standard in other advanced medical fields, such as orthopedics and cardiovascular medicine,” he said. 

In the near future members of the PDSI Task Force will reach out to relevant industry networks with additional information and details. At this time, however, all potential stakeholders who wish to be listed in the databases for the PSDI, regardless of whether they have existing connections with the NPIAP or EPUAP, and irrespective of their geographical location (ie, including entities or individuals outside Europe and the United States), are invited to share their interest in the PDSI initiative. For additional information and expression of interest, please contact the two Co-Chairs of the PDSI Task Force directly: Professor David Brienza at the NPIAP (DBRIENZA@pitt.edu), and Professor Amit Gefen at the EPUAP (gefen@tauex.tau.ac.il).

The opinions and statements expressed herein are specific to the respective authors and not necessarily those of Wound Management & Prevention or HMP Global. This article was not subject to the Wound Management & Prevention peer-review process.