Reporting medical device-related pressure ulcers: An international consensus and feasibility study

Abstract

Pressure ulcers (PUs) develop when the skin and soft tissues are exposed to prolonged periods of mechanical load. They reduce patients’ quality of life and represent a high cost for the individual and healthcare providers. Recent research revealed that up to a third of PUs are caused by medical devices, where critical care units represent the highest risk areas. Despite raised awareness, medical device-related pressure ulcers (MDRPUs) are not routinely reported, creating a substantive gap in knowledge for both healthcare providers and device regulators.
The doctoral programme of research aimed to systematically develop a MDRPU reporting tool underpinned by an international consensus and followed a sequential mix-methods design. The methodological approach included five phases: (1) a narrative review of reporting practice, (2) an international qualitative study exploring reporting practice with 17 participants from 11 countries, (3) a first–in–kind international consensus study with experts from 23 countries, (4) a preliminary MDRPU reporting form pre-testing using vignettes, incorporating four cognitive interviews and three focus groups with clinical nurses, and (5) a pilot study to evaluate the proposed MDRPU reporting form feasibility with tissue viability teams in two large acute university hospitals.
The findings revealed variation in policy and practice of reporting PUs between countries and organisations. Clinicians in the qualitative study reported that MDRPU data are not routinely collected, and when they are, the device information is extremely limited. The international consensus study facilitated the agreement of thirty items for inclusion in MDRPU reporting across
five themes: medical device care, MDRPU data, device data, ulcer-specific reporting, and general patient data. Cognitively pre-testing of the novel MDRPU reporting form with anticipated end-users confirmed the form’s content and face validity. Subsequently, the form was piloted in two hospitals in England, to assess its feasibility and acceptability. Overall, the participants found the
form clear and comprehensible. However, challenges in the usability of the preliminary reporting form were identified, associated with shortcomings of data availability and time for completion.
The new MDRPU reporting form is an important contribution to the international field of tissue viability. It addresses the lack of a standardised data collection relating to MDRPUs. Furthermore, its use can facilitate cooperation with device regulatory bodies, resulting in improved communication with manufacturers to identify which devices are no longer fit for purpose. The form requires further research to assess its reliability and to identify facilitators to data acquisition, e.g., asset tagging technologies to digitally document devices used in clinical settings.

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Identifiers

ORCID for Ewa Agnieszka Crunden: orcid.org/0000-0002-9814-3696

ORCID for Peter Worsley: orcid.org/0000-0003-0145-5042

ORCID for Lisette Schoonhoven: orcid.org/0000-0002-7129-3766

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