The potential benefits of moving point of care into the homes of patients, as seen in the US, should mean the accompanying challenges to health professionals are faced head on, according to Sagentia colleagues Peter Brady and Stewart Fox.

Long before the current austerity measures hit hospital and other medical budgets, there were signs of a significant divergence between the cost of healthcare provision and growth in the economies of developed countries. This has put us in an unsustainable and unaffordable position, where significant reductions in healthcare spending have become inevitable. 

The challenge for the healthcare industry is to provide the devices, systems and equipment which will improve, or at least maintain, outcomes for patients at the same time as reducing the cost of provision for society as a whole. 

One effective means of reducing this cost is to move the point of care out of high cost clinical centres, and into the home. The process is already underway in the United States where home healthcare is the fastest growing sector in the general healthcare market.

The point-of-care and home diagnostics market is currently worth $4.9bn in the U.S. and spending levels of $178 per person in 2007 are predicted to almost double to $343 per person by 2016. Disparate telehealth projects are also being introduced in the UK.

The transition to home-based healthcare is not just about cutting costs; there are benefits for patients also. In home dialysis, for example, patients can expect to see improvements in their quality of life and achieve greater control over their condition.

However, the transitioning point of care comes with challenges too. Sophisticated equipment which was designed for use by trained professionals in a clinical centre does not always translate easily into a home use device; particularly if the device is to be operated by unskilled patients who may also have co-morbidities resulting in sensory, cognitive and manual dexterity impairments, in addition to a lack of knowledge concerning their condition and handling medical emergencies. 

As a result, it is likely that medical devices used in the home may have to be able to make clinical decisions under certain circumstances. For example, whether or not to alert the emergency services. 

The good news is that inclusive design principles, commonly used in the consumer electronics industry to shape the design of a product so that it is usable by its target end users, can also be applied to the development of medical devices to ensure they are safe, effective and easy to operate for a wide range of users. 

This is particularly important when the target end-users are people with chronic and acute conditions or their caregivers, who may be elderly and also have impairments that may affect their vision, hearing, cognitive processes, communication, locomotion or dexterity.

In April 2010, the United States Food and Drug Administration launched the Medical Devices Home Use Initiative. Through this initiative, the FDA hopes to address the challenges associated with the use of medical devices in the home and provide greater protection for patients receiving healthcare at home. However, the design of medical devices alone cannot ensure patient safety.

In addition to the challenges presented by device usability and human factors, the home environment can also serve to conspire with a patient’s impairments to create hazardous situations. For example, low lighting and background noises may impede the user’s interactions with a device. This environment, in contrast to a hospital, is also much less controlled in terms of temperature, humidity and electromagnetic interference sources, all of which can affect the performance of a device. 

Single-use, disposable devices and consumables are also unlikely to run out in a hospital setting where stocks are managed, whereas the risk of a home user re-using single-use, disposable devices is much higher. This significantly increases the risk of infections and associated complications.

The issue of connectivity should also be considered. Many medical devices being used in patients’ homes do not exist in isolation and may be connected to control centres where patients and the devices themselves can be monitored by trained professionals. The fact that landlines are disappearing from homes in the developed world introduces new challenges for reliable connectivity between devices, particularly in areas where there is poor mobile network coverage.

These challenges are not insurmountable, but it’s important that they are known and understood by all stakeholders in the provision of healthcare – from those designing and developing devices and infrastructure through to those commissioning healthcare services and, ultimately, the patients and care givers at the front line.

The economic imperative is likely to continue to push the point of care out of high cost clinical settings and into the home. If the challenges for healthcare industry professionals are overcome, the potential benefits for both patients and payers are likely to be significant.