Launch of the joint NPIAP-EPUAP Prophylactic Dressing Standards Initiative (PDSI)
Tuesday, November 3, 2020
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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 known standards exist anywhere in the world for prophylactic dressings, despite their international widespread and growing use. Performance standards based on bioengineering laboratory testing generate critical information which is needed to guide effective medical product selection and practice. Testing standards and consistent manufacturing 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 in evaluating safety and efficacy and in qualification of existing and 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 the different stakeholder groups (e.g. industry, clinicians, researchers, policy-makers etc.). The immediate and first priority of the PDSI 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, we 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.
In the near future we will reach out to the relevant industry networks of the two organizations with additional information and details. At this time, however, we invite all potential stakeholders who wish to be listed in our databases for this PSDI, regardless of whether they have existing connections with the NPIAP or EPUAP, and irrespective of their geographical location (i.e. including entities or individuals outside Europe and the US), to inform us of their interest in the above 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
);
Professor Amit Gefen at the EPUAP (gefen@tauex.tau.ac.il
)
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