APPENDIX 8
Memorandum by Medtronic Ltd. (MT 30)
1. SUMMARY
Medtronic welcomes the opportunity to submit
evidence to the Health Select Committee, addressing the important
issue of the utilisation of telemedicine, and its future potential
for improving services within the NHS. Medtronic provides advanced,
implantable medical devices for patients in the United Kingdom.
Our most recent innovations in the area of telemedicine have the
potential to significantly advance not only the quality of care
for chronic disease patients, but also improve the efficiency
of overall health care delivery within the NHS. The purpose of
this submission is to provide the Committee with evidence of some
of the benefits of telemedicine in chronic disease management,
and to highlight some of the barriers to adoption.
2. We would like to offer the following
evidence, appropriate to the Committee's terms of reference. The
evidence reflects our experience in the use of telemedicine applications
throughout the world.
3. The utilisation of telemedicine and its
future potential for improving services.
3.1 Telemedicine is broadly defined as the
use of electronic information and communications technologies,
to provide and support health care when distance separates the
participants. [12]The
applications of telemedicine are increasingly important in the
context of chronic disease management. Medtronic is advancing
such applications for the remote monitoring of patients with cardiac
rhythm management devices (implantable pacemakers and defibrillators),
diabetes patients using insulin pumps and in patient data reporting
for its emergency response systems (external defibrillators and
ambulance based monitors). Remote monitoring allows medical professionals
to access clinical information from devices without the patient
having to be present in the surgery or clinic. This submission
will focus on evidence concerning the remote monitoring of implanted
cardiac rhythm management devices.
3.2 Cardiac arrhythmias, where the hearts
beats abnormally slowly, quickly or in an irregular manner, are
a chronic condition affecting millions of people in the UK, including
the 110,000 who die from sudden cardiac death each year. Many
of these patients can be effectively treated with implantable
medical devices such as cardiac pacemakers for bradycardia (slow
heart rates), implantable defibrillators for tachycardias (fast
heart rates), and cardiac resynchronisation therapy for heart
failure. It is estimated, that in the U.K. there are currently
more than 200,000 patients with implantable cardiac rhythm management
devices[13]
and approximately 40,000 new implants are performed every year[14].
The U.K. is well behind other developed nations in its level of
device therapy utilisation, a fact being addressed by the Cardiology
community, and additional increases in the number of new implants
are expected in order to meet the recommendations from various
technology appraisals and clinical guidelines, either published
or in preparation by the National Institute for Clinical Excellence
(NICE)[15].
All device patients are required to have periodic follow-ups,
to review their condition, device parameters and to adjust the
therapy if appropriate. Each such visit lasts about 30 minutes
and is a considerable inconvenience for patients, as it requires
travel to and from the hospital, usually during normal working
hours and, in many cases individuals require an escort. Additionally,
the periodic routine checks create significant demand for hospital
resources (physicians, cardiac technicians and facilities). As
many follow-up checks are routine and no action is required, more
efficient patient screening would enable the shifting of resources
to other activities. This might be focusing on patients who require
more attention, or the redeployment of highly qualified clinical
staff to other functions within the cardiology department, making
better use of their skills and. It is widely acknowledged that
there is an acute shortage of trained technicians in the NHS.
Any reduction in the number of, and attendees at follow-up clinics
also has obvious benefits from a capacity perspective.
3.3 In 2002 Medtronic introduced a remote
device monitoring solution called Carelink Network, a telemedicine
application enabling data stored in the memory of implanted devices
to be retrieved by medical professionals in locations removed
from those individuals with the devices . This system allows patients
to download the information from their device to a secure server,
making it available to clinicians for review almost instantaneously.
Remote monitoring of implantable pacemakers and defibrillators
provides benefits in three key areas.
3.4 Quality of care—better patient
outcomes and improved quality of service delivery. CareLink Network
service was assessed in a multi-center study[16]
as a practical tool for routine device management, which may also
allow timely identification of clinically important issues. Clinicians
involved in this study found the quality of this service comparable
to a device interrogation carried out in a clinic.
3.5 Efficiency in clinics—resource
utilisation and workflow efficiency. Remote device monitoring
allows for a reduction in the number of hospital visits and better
access to device data. The implications of these improvements
are a reduction in waiting time in clinics, a streamlined device
follow-up process and the ability to free up resources used in
clinics for other activities[17].
3.6 Additional reassurance for patients.
Patients using remote follow-up technologies have the additional
reassurance of being able to rapidly send data for investigation
in times of concern. The discharge of a potentially life saving
shock from an implantable defibrillator can be an alarming experience
for an individual. Yet the overwhelming majority of shocks are
entirely appropriate, the defibrillator merely having done its
job. The ability of a patient in this situation to quickly and
easily verify that the shock was necessary, and that the device
needs no alteration, has obvious advantages for that individual.
Additionally, patients have to make fewer trips to clinics, and,
with many device patients being elderly, this has a major impact
on the transport requirements for ambulance services, family and
friends, as well as being more convenient for the individual themselves.
Finally, remote monitors are portable and allow patients to travel
freely.
3.7 Note: Carelink Network does not carry
a CE mark and is not currently available in the UK.
4. THE SPEED
OF, AND
BARRIERS TO,
THE INTRODUCTION
OF NEW
TECHNOLOGIES
4.1 Whilst the benefits of telemedicine
applications such as CareLink have been well recognised and documented
during the two years of successful use in the USA, the introduction
of this type of technology is not straightforward in the United
Kingdom. There are three principal obstacles to adoption.
4.2 Funding. Current funding methods do
not adequately recognise the value of telemedicine. Whilst Medtronic
is encouraged by the attempts of the Payment by Results team to
capture appropriate tariffs for telemedicine, there must be clear
methodologies described to collect data in a meaningful way to
create appropriate HRG labels, and realistic tariffs attached
to them subsequently. Both the NHS and industry need to have proper
incentives to develop productivity-enhancing technology.
4.3 Guidance. There are presently no guidelines
advocating the use of telemedicine applications within the NHS.
The development of, for example, NICE guidelines in this area
would be welcome, and it will also be important to follow any
such recommendations with an adequate set of measures to properly
track their implementation.
4.4 Value recognition. Due to nature of
their delivery, telemedicine applications provide benefits to
various stakeholders. Whilst such benefits undoubtedly occur,
they are not always recognised in their entirety, and as such
the value of the technology may be underestimated. For example,
travel costs and inconvenience incurred by patients are largely
not recognised in hospitals, or, indeed, the wider NHS, but their
societal impact is significant.
5. THE EFFECTIVENESS
AND COST
BENEFIT OF
NEW TECHNOLOGIES
5.1 Remote patient management technologies
improve the quality of care. Telemedicine applications provide
clinicians with timely access to information about acute events,
which require immediate attention. Remote patient management may
also provides savings for patients by reducing the burden and
cost of travelling to a clinic and spending time away from work.
5.2 The use of telemedicine is an important
way of modernising services in clinics. The expected growth in
the device patient population could either require extensive investment
in resources and clinic capacity, or the additional resource requirement
could be minimised through the application of technologies such
as CareLink.
6. RECOMMENDATIONS
6.1 Telemedicine has the potential to improve
the quality of patient care. Clinical and practical benefits of
applications should be considered by NICE and appropriate guidance
issued, and measures should be in place to track implementation.
6.2 The use of telemedicine within the NHS
should, through favourable tariffs and other appropriate mechanisms,
be incentivised, thus focusing efforts on ensuring rapid adoption.
6.3 Introduction of telemedicine technologies
can help the NHS to achieve waiting list reductions and other
goals set in the National Service Frameworks, NHS Plan and other
guidance documents. Investments aimed at achieving current NHS
goals should include monies targeted for advanced telemedicine
applications.
6.4 The cost of introducing telemedicine
technologies can be rapidly offset through the reconfiguration
of services across the health economy, and non-healthcare impacts
on individuals. It is important to capture the true benefits of
such technologies. A wider societal perspective, as well as the
costs to the NHS should be considered when assessing the benefits
of telemedicine.
6.6 Telemedicine is a rapidly developing
field. A clear pathway for the introduction of telemedicine into
the NHS should be defined, such that the potential these technologies
have is fully realised.
7. COMPANY OVERVIEW
7.1 Medtronic provides lifelong solutions
for people with chronic disease. During the past year alone, Medtronic
technologies treated more than five million patients throughout
the world. Products include those for bradycardia pacing, tachyarrhythmia
management, heart failure, atrial fibrillation, coronary and peripheral
vascular disease, heart valve replacement, extra corporeal cardiac
support, minimally invasive cardiac surgery, malignant and non-malignant
pain, diabetes, gastroenterological ailments, urological disorders,
movement disorders, spinal disorders, hydrocephalus, and ear,
nose and throat (ENT) surgery. Founded in 1949, the company's
world headquarters is in Minneapolis, USA, with research, manufacturing,
education and sales premises in more than 120 countries. Medtronic
employs approximately 31,000 people worldwide. [18]
7.2 Medtronic has been present in the UK
for over 15 years, and all its businesses have sales, marketing,
customer services and distribution operations here. Now employing
over 200 people, Medtronic Ltd. is based in Watford, where there
is also one of the company's Bakken Education Centres, a facility
used by employees, medical professionals and patient groups. Medtronic's
Clinical, Technical and Education groups have strong links with
the programmes of numerous professional bodies, including the
British Cardiac Society, providing, amongst other things, tuition
for technicians taking professional exams. The Medtronic Foundation
has supported the work of various Patient Advocacy Groups in the
UK.
12 M. Field, J, Grigsby "Telemedicine and Remote
Patient Monitoring", JAMA, 2002 Vol 288 No 4. Back
13
Source: Dr. David Cunningham, Central Cardiac Audit Database. Back
14
Estimate, Medtronic Ltd. Back
15
National Institute for Clinical Excellence, Technology Appraisals
on Implanatable Cardioverter Defibrillators (2000 and currently
in review), Dual Chamber Pacemakers (expected Jan 2005) and Cardiac
Resynchronisation Therapy (expected March 2007). Clinical Guidelines
on Chronic Heart Failure (July 2003) and Myocardial Infarction-Secondary
Prevention (tbc). Back
16
M Schoenfeld et al "Remote Monitoring of Implantable
Cardioverter Defibrillators: A Prospective Analysis", PACE
June 2004. Back
17
R Owen "Pacer/Arrhythmia Clinic Improves Patient Satisfaction"
EP Lab Digest, October 2003, Vol 3, No 8. Back
18
Medtronic, Inc. Annual Report 2004. Back
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