Many commonly used medical devices, such as endotracheal and nasogastric tubes, oxygen tubing, non-invasive ventilation masks, urinary catheters, cervical collars and casts, have changed little in decades. It is unsurprising that these traditional devices, which interface with vulnerable skin and soft tissue, are frequently associated with device-related pressure ulcers (DRPUs).
A DRPU involves a device or object that is in direct or indirect contact with skin, or one implanted under the skin, causing focal and localised forces that deform the superficial and deep underlying tissues. It is distinct from a pressure ulcer (PU), which is caused primarily by bodyweight forces.
Patients managed using medical devices are more likely to develop a PU or experience skin breakdown (Black et al, 2010; Yamaguti et al, 2014). For example, in one US hospital setting, the overall rate of PUs was 5.4%, of which 34.5% were DRPUs (Black et al, 2010). Elsewhere, it has been observed that DRPU may account for as much as 61–81% of all hospital-acquired PUs (HAPUs), depending on the care setting and patient subpopulations (Ham et al, 2017; Clay et al, 2018).
Despite this, these wound represent an understudied area. They are commonly hospital acquired and can:
Moreover, as DRPUs almost always develop in healthcare institutions, and in many countries, they are a cause of legal action. The global scale of the problem is considerable, particularly in clinical settings where devices are used intensively, such as in operating theatres, intensive care units and emergency care. Patients of all ages are affected, with the typical scenario involving patients cared for in an environment dense with equipment, tubing, electrodes and wiring. All too often, these devices interact with fragile skin and tissues, such as that of paediatric patients and older individuals.
Expert review
In February 2019, an international group of medical, clinical and bioengineering experts met in London to develop the first international consensus statement on DRPUs. Following a rigorous process of scientific discussion, a statement was drafted. This was then reviewed by an international committee of experts who were external to the panel. Accordingly, this consensus statement (Gefen et al, 2020) is a comprehensive synthesis of current understanding of the aetiology of DRPUs and the technologies and clinical protocols that can be used to mitigate them.
Aimed at generalist and specialist clinicians, as well as biomedical and non-biomedical engineers in academia, research and industry, the consensus statement is an evidence-based review of the aetiology, assessment, prevention and management of DRPUs. It describes how medical devices and objects that come into contact with a patient's skin or apply forces to it can cause deformation damage at cellular and tissue levels.
The consensus statement identifies and discusses devices commonly associated with DRPUs and the biomechanical reasons for the risks they represent. An important and innovative element of the panel's work has been to evaluate which engineering concepts and technologies can be used to protect the skin and deeper tissues from DRPUs and assess whether device-related tissue damage can be reversed. It also outlines strategies for changing the mindsets of health professionals and policymakers on the need for DRPU prevention, including how to increase global awareness about its root causes, the scale of the problem and the financial implications.
Prevention pathway
The consensus document discusses the devices that are associated DRPUs and the biomechanical reasons for the risk to patients. A mnemonic, SECURE, has been devised for a DRPU prevention pathway (seeFigure 1 and Box 1, with SECURE standing for):
|
|
|
This document also presents work on engineering concepts and technologies that can be used to protect the skin from DRPUs and assess tissues that have developed precursor (likely reversible) device-related damage.
Greater awareness of DRPUs will lead to improved adoption of prevention protocols and much-needed new technologies and designs of devices. The consensus statement specifies the requirements that will make medical technologies effective in DRPU prevention.
To guide the medical device industry, the panel has listed design recommendations for the shape, materials and construction of medical devices. The consensus statement discusses how bioengineering design can reduce high pressure and shear points, alleviate frictional forces and stress concentrations on skin and within deeper tissues, and optimise the microclimate. Also discussed is the need for future research work including laboratory tests, clinical trials and computer modelling for DRPU prevention.
Practical application
Multidisciplinary efforts are the key to mitigating DRPUs. The consensus group's team effort provides the cornerstone in working towards this goal. The global scale of the problem is considerable, particularly in clinical settings. Patients of all ages are affected, with the typical scenario for DRPU is an environment dense with equipment, tubing, wiring, all interacting with fragile skin.
The aim of the work to reach a consensus has produced a groundbreaking, comprehensive, international consensus document on DRPUs. For the first time in the literature, detailed advice combines information on how to safely apply medical devices and improve biomechanical and thermodynamic tissue conditions at the skin-device interface. This document allows all clinicians to immediately apply the concepts presented in the document to their practice.