Patient Monitoring: The New Revolution Gathers Pace as Novel and Innovative Technologies Re-Stimulates the Patient Monitoring Market

As the health sector of every country faces the need to provide expanded and equitable access to quality healthcare services they are also having to face the need to reduce, or at least control, the rising costs of healthcare services.

Irrespective of whether the patient is suffering from a chronic debilitating condition or whether they are critically ill it seems little will stop the remorseless requirement to collect, store and retrieve data to support an informed decision about that patient. Important technological advances have been made over the last decade culminating in the introduction of a variety of new and innovative patient monitoring solutions.

Both telemedicine, in particular remote patient monitoring (RPM) and the wireless monitoring of patients have come to the fore in recent years. These technologies are perceived by healthcare professionals as methods which allow a degree of liberation from the traditional constraints of place and time, whilst also empowering these individuals with the ability to make informed choices about their patients’ treatment pathways. Similarly, the formulation of new programmes are designed to involve the patient in undertaking aspects of the management of chronic illnesses. Progress in the area of remote patient monitoring is thus setting the stage for a paradigm shift from an institution-centred to patient-centred treatment model in healthcare.

Telemedicine and Remote Patient Monitoring Come of Age

Advances made in wireless and Internet technology mean that the days when patient monitoring was thought of being the preserve of the high acuity areas in hospitals are long gone. Products and technologies are now converging to revolutionise distance monitoring within the home environment.

Figure 2 provides a basic diagram of the major components of a remote patient monitoring system and highlights the interrelationship between the hardware components and the patients and the healthcare professionals.

Clearly there are considerable variations on this schematic diagram as a result of the wide variety of hardware and software products which are available from an expanding array of suppliers from the largest multinationals through to small specialised software developers.

Expanding Application List Offers Considerable Scope and Market Potential

Numerous studies have explored the clinical application of novel home monitoring devices. For example, a whole blood prothrombin time monitor, a portable sleep monitor, an electronic spirometer and a variety of other clinical applications have found usefulness, as identified in Figure 1. Telephone and videoconferencing equipment can be used for the measurement of mobility, sleep patterns, and self care behaviours (such as cooking, washing, and toilet visits) and can properly identify changes in the functional health status of patients at home.

Similarly, computerised home distance monitoring in the management of diabetes has been found to improve patient outcomes. Home monitoring of pregnant women at risk of preterm labour and foetal mortality illustrates the difficulty of researchers in some clinical applications. To achieve appropriate blood glucose control in diabetic women during pregnancy frequent admission to hospital has been recommended, particularly in the third trimester.

Table 1: Use of wireless technology to support applications

Source: HBS Consulting

Other applications such as web-based monitoring services for electrocardiograms have been developed to collect clinical data from patients' homes and with computerised electrocardiography and the provision of decision support programmes different and appropriate reminders and suggestions for actions can be generated. Wireless electronics and digital processing have also revolutionised heart monitors so that now they can be connected to personal computers making it appreciably more convenient for people to track their own heart rates and other vital information at home and then transmit data to their health-care providers.

A recent innovation marketed by France Telecom at the beginning of 2004 has been the introduction of a wireless diagnostic unit for monitoring the health of a patient while they are in transit in an ambulance. The system monitors the patient and transmits the health data to the emergency medical services headquarters informing health professionals there of real-time changes in the condition on the patient. Information can also be received about transport conditions with regard to the destination that the patient is being taken to. The service utilises the GPRS network from the telecoms operator Orange.

One of the most interesting ongoing developments has been the creation of the Oxford Telemonitoring Centre in the UK (Figure 3). This initiative was originally established in 1994 to investigate the sleeping patterns of infants and children in their normal environment and to overcome the demand for, and the cost of, hospital beds in the Oxford region. Since then the Centre has expanded dramatically to encompass a wide range of other clinical conditions, primarily for infants within the home environment. It has also evolved by extending the services provided to incorporate JANET (The United Kingdom academic and research computer network) and JVCSS (JANET VideoConferencing Switching Service).

The multinational suppliers of medical equipment including Philips, GE Medical Systems (GEMS) and Siemens have been keen to exploit these new market opportunities. These major suppliers have been at the forefront of new and novel technologies and product R&D and have been keen to introduce their products in what is seen as a prerequisite to improved healthcare delivery and an expanding and dynamic market place. However, one notable drawback to this prolific R&D output is that there is a wide variety of different communication protocols and a number of companies pushing different proprietary technologies.

Communication and Computerised Decision Support or "Expert Systems"

Although there are similarities between telemetry and wireless monitoring, the two are ultimately very different. Telemetry and remote patient monitoring technologies are linked to the hospital information systems either hardwired through the Ethernet and Token Ring systems or through using wireless encryption and compression technologies to transmit medical data over cellular telephone networks, which then pipe the data by modem into the hardwired networks.

The introduction of the Wireless Ethernet by the then Spacelabs in the late 1990s integrated wireless and hardwired monitors with ambulatory patient telemetry transmitters. Using this technology, hospitals were able to network wireless portable monitors, hardwired bedside monitors, and telemetry transmitters into one central station monitor. It is anticipated that in the future all forms of patient information coming from wireless monitoring will be fully integrated with the hardwired clinical information systems and hospital information systems using some form of hybrid hardwired and wireless network. Patient data and information could then be remotely accessed via computer and modem by tapping into a physician workstation.

As a complimentary technology, computer decision support and “expert” systems are being constantly developed. They were originally introduced and designed to aid clinical decision-making through the analysis and interpretation of the data and information received. More advanced technologies have however added a new dimension to these original objectives. These are now able to provide pre-emptive support, have the potential to drive reminders, provide alerts for prescribing interactions or test results, interpret complex investigations (or electrocardiograms), predict mortality on the basis of epidemiological data, aid diagnosis, and calculate drug doses.

Computerised decision support has been defined as the provision of assessments or prompts specific to the patient and selected from a knowledge base on the basis of individual patient data. Although once used exclusively in hospitals and general practices these technologies have advanced so far that they are now available for use in the home and are a critical factor in the continuing evolution of remote patient monitoring systems. Communication and computerised decision support are thus becoming an integral part of the transfer of data and information generated by the monitoring systems to healthcare professionals at a centralised location.

There are a plethora of wireless communication technologies which help prompt preventive care, generate patient data feedback and help support patient education. However, choosing the right technology and implementation strategy for a given institution is crucial. Failure to do so will not only be extremely expensive but it will also result in insufficient functionality, low reliability, and interference from other medical equipment together with the possibility that it could breach current regulatory and licensing conditions.

Issues, Concerns and Problems Associated with Implementing Telemedicine and Remote Patient Monitoring Systems

In addition to the general selection criteria for the implementation of a telemedicine or remote patient monitoring system discussed earlier there are several reasons affecting the general acceptance and widespread use of such systems:

• Initial set up costs are high. The cost of networked medical data acquisition systems (home-based patient monitoring systems) prevents them being used as a widespread solution in both the developed as well as the under-developed countries. Cash strapped healthcare systems may wish to prioritise their healthcare budgets for specific targeted diseases or for developing other infrastructure areas. In addition, certain sections of the community, especially the homebound elderly in developing countries, may not be considered as a high priority and given the same level of funding.
• Regulatory and Licensing Issues. There are a large variety of wireless patient monitoring devices currently available and which have to operate under the regulations governing the allocation of the radio-spectrum used for wireless devices, i.e. Wireless Medical Telemetry Service (WMTS) and Scientific and Medical (ISM) bandwidths and issues concerning the medical safety and privacy of transmitted data as required by Health Insurance Portability and Accountability Act of 1996 (HIPAA) in the US.
• Industry standardisation and product connectivity. Despite standards introduced by The Institute of Electrical and Electronics Engineers (IEEE) for two-way wireless communications (IEEE 802.11) in 1997 some manufacturers of patient monitoring equipment are reluctant to allow another vendor’s monitors to be connected to their monitors or to a central station. In addition, if equipment is introduced into a network which they cannot control, then some manufacturers will not be able to guarantee total system reliability. Also, even though communication is on an Ethernet system, the format in which each manufacturer sends data is complex, proprietary, subject to change, and often timing sensitive.
• “Human factors” and system design limitations. "Human factors" is the science of interactions between people and technology, and involves designing a device with the users' abilities, limitations, and operating environments in mind. As technological developments become more complicated, so do the requirements for their design to ensure that they can be used safely and effectively in the home. The ability of patients to operate a medical device, for example, can depend on medical training and experience, language barriers, literacy, memory, learning ability, dexterity, vision, and hearing. Difficulties using certain devices can be caused by advanced age, medications, or the actual medical condition that requires use of a product. Medical device design problems can lead to errors when there is inadequate consideration of the fact that some consumers can become easily confused using devices in the home.

  Distractions, such as children or other family members, variations in lighting and noise levels, and the demands of using the device exceeding the user's capabilities, all can contribute. A patient receiving oxygen, for example, died when a pressure hose loosened from the unit. The alarm was not loud enough to be heard over the drone of the device. Dropping a device or using it in changing temperatures or high humidity (such as a bathroom or shower) also may affect its performance.

• Primary care local community healthcare facilities have limited budgets. Local community healthcare facilities typically do not have the amount of funding to purchase systems to monitor at least the vital signs required for informed clinical decision making.