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Heather Weir, MA, RGN, is research associate
Patricia Grocott, PhD, RGN, is senior research fellow; Mala Bridgelal Ram, MSc, RGN, is research associate; all at King's College LondonNurses increasingly use a range of medical devices, simple and complex, in a variety of clinical and community settings. Patient safety, delivery of optimum care and professional accountability all hinge on nurses having the knowledge to ensure safe and effective device use. This extends to having the skills to educate, train and supervise patients and carers in care involving medical devices. Given the constraints within the clinical environment in relation to workload, staffing and time, many would feel that any deeper consideration around the issue of medical devices is unrealistic and not a priority.
Nurses increasingly use a range of medical devices, simple and complex, in a variety of clinical and community settings. Patient safety, delivery of optimum care and professional accountability all hinge on nurses having the knowledge to ensure safe and effective device use. This extends to having the skills to educate, train and supervise patients and carers in care involving medical devices. Given the constraints within the clinical environment in relation to workload, staffing and time, many would feel that any deeper consideration around the issue of medical devices is unrealistic and not a priority.
We suggest, however, that the nursing role would be enhanced by an understanding of the broader issues around medical devices. This paper looks at medical devices in the context of UK and global markets and the roles of the stakeholders in the UK field. The medical device technology cycle is illustrated to provide a framework for discussing key findings from a review of the literature. The processes around development, regulation, procurement and evaluation raise pertinent issues and have the potential to affect the nurse in her or his clinical role, and some of these are explored.
The medical device sector
It is estimated that more than half the UK population have contact with a medical device on any one day (Healthcare Industries Task Force, 2004). Biomedical advances and technological change will ensure that the number of devices to support diagnosis, treatment and care will continue to grow.
Acute hospital care is increasingly complex and sophisticated as a result of the increasing use of innovative devices on general wards to deliver what was once considered to be high dependency care.
Demographic factors, changing illness patterns and the concept of patients as consumers of healthcare will act as drivers to the delivery of both acute and intermediate care in the community setting, where sophisticated device usage will become increasingly routine (Department of Health, 2002; Morris, 1999).
The NHS is the world's largest healthcare delivery organisation and the main customer for healthcare products in the UK. The UK-based healthcare products industry plays a significant role in contributing to patient care, public health and the national economy. The Healthcare Industries Task Force (HITF) was set up to help bring innovative medical devices and procedures to the market, and to stimulate investment from the industry in the UK economy (HITF, 2004). It reports the value of the UK market to be EUR5.8bn (£4bn) (Eucomed reports) compared with EUR170bn worldwide.
Definitions, classes and risks
The term 'medical device' means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other related article. Devices can be used alone or in combination for one or more specific purposes, for example diagnosis, prevention, monitoring, treatment or alleviation of disease (World Health Organization, 2003). Thus they include everything from highly sophisticated computerised medical equipment to simple wooden tongue depressors, reflecting this field's complexity, diversity and innovation. There are over 10,000 families of medical devices with potentially over 400,000 devices on the market at any time (Pammolli et al, 2005).
External and internal medical devices are classified according to potential areas of hazard. These include the degree of invasiveness, duration of contact, the body system affected, and local versus systemic effects. Bandages, for example, are classified as low risk in class I. A removable contact lens is classified as class II, as opposed to an implantable intraocular lens which is class III. All internal devices are classified as class III. In addition, there are diagnostic devices, for example X-ray machines (class II). Assistive technologies, such as aids for people with disabilities, are viewed as being in a separate category by organisations such as the WHO (WHO, 2003) and the Global Harmonisation Task Force (GHTF, 2000).
Table 1 lists key stakeholders involved in medical devices and access through the NHS in the UK. These organisations focus on safety, clinical effectiveness and cost. The Medicines and Healthcare products Regulatory Agency (MHRA) works with the public, healthcare professionals, medical device manufacturers and legislators to ensure that medical devices used in the UK are as safe as possible. The new Centre for Evidence-based Procurement (CEP) is intended to function not only as an advisory and coordinating body but also as an active participant in the ongoing modernisation of the purchasing and supply of healthcare products within the health service. The emphasis on evidence-based practice and clinical effectiveness is underpinned by the work done through bodies such as the Health Technology Assessment programme (HTA) and the National Institute for Health and Clinical Excellence (NICE). The HTA programme makes recommendations on the use of new and existing technologies within the NHS based on clinical and economic evidence, and supports the work of NICE.
The importance of medical device technologies is reflected through funding bodies such as the Engineering and Physical Sciences Research Council (EPSRC), which operates to meet the needs of industry and society by working in partnership with universities to invest in people, scientific discovery and innovation (www.epsrc.ac.uk). The knowledge and expertise gained through projects funded by the EPSRC helps to maintain a technological leading edge, build a strong economy and improve quality of life. In addition, NHS Innovations, working through a network of regional hubs, is the technology transfer arm of the NHS. It provides a route by which nurses in the NHS can generate problem solving solutions to aspects of care, including medical devices, which could lead to devices that can be patented and commercially exploited.
We are involved in the Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH), an EPSRC-funded collaboration between five UK universities (www.match.ac.uk). MATCH was established to develop and test methodologies to substantially reduce the time and cost of healthcare devices from concept to market acceptance. One strand of MATCH, consistent with policy drivers relating to choice and patient-centred service delivery, is concerned with ascertaining how far and to what extent users are involved in medical device development, along with the methods used to determine their level of involvement. The first step involved in undertaking an extensive survey of the literature and some of the pertinent findings are drawn on in this paper (Bridgelal Ram et al, 2005).
Locating the user
All medical devices go through a developmental process, which constitutes a complete life cycle that involves several phases (Fig 1). These include: concept; design; testing and trials; production; marketing and use (including post-market surveillance); and ends with decommissioning.
An initial concept leads to the designing of a new or improved device followed by a testing and trials phase. This comprises prototype testing in a laboratory setting, after which controlled clinical trials are undertaken. An important component of the final marketing and use phase is post-market surveillance (PMS). This takes place in the real world of medical device use and broadly describes the range of activities undertaken by medical device manufacturers, national regulators and clinicians to ensure the ongoing safety, effectiveness, performance and compliance of medical devices in the market. Such activities may include testing, surveys, surveillance audits and clinical studies.
Defining medical device users
One of the issues we wrestled with was getting a clear picture of who was perceived to be the medical device user. The work done by Browne et al (2004) found that manufacturers tended to view users as NHS purchasers and procurers. For the purposes of our review, we defined users as professional users (predominantly clinicians) and lay users (predominantly carers). They are individuals who use devices for or on behalf of end-users. We also included patients, clients and consumers who have conditions and disorders that require medical devices within the definition of the end-users.
It was clear from the review, however, that clinicians were predominantly perceived to be the users. In addition the different stakeholders engaged in different ways throughout the development process. In general any involvement by patient or clinician, including nurses, tended to occur in the PMS phase. Nursing involvement in this process was mainly found during this phase and occasionally in the testing and trials phase. Therefore, although the purpose of medical devices is to benefit patients, they generally had little voice in relation to device development and evaluation.
Consulting clinicians regarding device use and effectiveness is clearly important. However, so is consulting end-users. The clinician will focus on the function of the device in relation to the clinical problem. The end-user will be concerned about the function of the device and the clinical problem within their daily life. From the clinical perspective, the information will comprise objective measures of physical function derived from the end-users. What appeared to be lacking from our literature review was important subjective end-user reports of symptoms and experiences that were not picked up by the physical measurements.
Logically, users and end-users should be involved in the concept, design, and testing and trials phases. Involvement in these early phases means products can be checked for suitability and performance before they are launched in the market, at a point when it is possible to make changes. In the literature we found examples where this lack of user and end-user engagement led to problems in relation to ineffective, inappropriate and discarded equipment or indeed repeated clinical procedures.
The following example illustrates the consequences of not taking end-user needs into account in the design, development and supply of a medical device. This example is powerful in a number of ways. It demonstrates the effective use of clinical observation leading to positive action to improve end-user outcomes. It also shows the value of engaging with experienced end-users in the process of device design and development.
Sethi (1982) was an orthopaedic clinician in rural north India who observed that amputees issued with western-style artificial limb prostheses discarded them in favour of crutches. The western design was culturally and environmentally insensitive, failing to take account of a rural lifestyle that included working barefoot in irrigation channels and sitting cross-legged. Sethi engaged with the amputees in the complete redesign of their limb prostheses. This population was not insignificant, comprising over 5,000 individuals. These end-users were involved in a variety of ways, especially in the early phases, in developing a culturally and environmentally sensitive prosthesis: the Jaipur limb. Local products and artisans were engaged in the process, keeping down production costs. The Jaipur design takes 45 minutes to make and costs around £20 (www.disabilityanddevelopmentpartners.org/index.htm and www.jaipurfoot.org).
The Sethi approach is in line with the principles of user-centred design (UCD), which takes a needs-driven approach to device development. This contrasts with a technology-driven process, where the starting point for device development is a technology looking for a home in the form of a clinical problem. The UCD philosophy has at the start the needs and interests of the user and end-user and emphasises making products usable and understandable (Norman, 2002).
This movement towards a user focus can be seen in UK-funded projects such as: the EPSRC-funded Woundcare Research for Appropriate Products (WRAP) study (Cowley et al 2004); the Design for Patient Safety study comprising a research team from the universities of Cambridge and Surrey and the Royal College of Art (DH, 2003); and the Helen Hamlyn Research Centre for the study and practice of socially inclusive design for people with disabilities (www.hhrc.rca.ac.uk). These are just some examples of the movement towards client-centred health and social services, including medical devices.
Focusing on a needs-driven rather than a technology-driven approach can open doors that will allow nurses to use their experience and skills. The adoption of a problem-solving approach has resulted in nurses inventing devices that benefit both themselves and patient care. For example, one nurse invented a plastic hook (£7) that attaches to the curtain rail around a bed, replacing the traditional free-standing drip stand (£130) and has signed a deal to mass-produce his invention (www.hee.org.uk/innovation_showcase.php).
Another example, designed by a former nurse, is the Uni-line, a small plastic device shaped like a horseshoe that can be clipped on to IV lines, holding them securely and thus preventing occlusion when the patient moves (www.centralinnovation.net/news/newsdetail.php?nid=583). The easy-to-use, low-cost system eliminates the tendency for IV lines to bend and stabilises the IV pipe in the vein.
Applying the findings
We are embarking on a piece of work that uses this needs-driven approach. This work will engage both users and end-users in developing a novel product for a specific population with a clearly defined clinical need. It is underpinned by findings from the literature survey and includes a model used by the American Veterans Association. This organisation has a track record in developing devices to improve treatment, management and rehabilitation of veterans with a range of physiological and cognitive disabilities (Sheredos and Cupo, 1997).
The process begins and ends with a clinically defined need, elicited from the end-users and their carers through a variety of methods. This need drives the design of prototypes, which are then tested by the end-users and carers. These prototypes can be redesigned as often as necessary in response to user and end-user input.
Two key aspects of this model have the potential to ensure end-users needs are met. First, the concept and prototype phases are funded independently of commercial interests. Second, manufacturers are locked in to the process, through procurement contracts, when the device shows marketing promise, to ensure their commitment to future production and marketing.
In our study, user and end-user needs will be ascertained through a series of workshops. The findings from these will be used to inform round-table discussions with designers and scientists from different disciplines. From these discussions innovative solutions will be formulated and early prototypes developed.
Our purpose was to explore issues in relation to medical devices that are relevant to nurses. Clearly this is a vast, complex and multifaceted area that can be difficult to unravel. We hope this paper has:
- Given an overview of the medical device field;
- Raised awareness of issues and difficulties and how these may be overcome;
- Demonstrated a role for nurses in using clinical skills to highlight unmet need in relation to devices;
- Demonstrated a role for nurses in finding solutions, which could be done through evaluating device effectiveness or inventing and commercially exploiting new devices through NHS innovation hubs.
This article has been double-blind peer-reviewed.
For related articles on this subject and links to relevant websites see www.nursingtimes.net