Memorandum from Deltex Medical
SUMMARY
— Deltex Medical is a small British
company which produces an innovative medical device called the
CardioQ which accurately monitors changes in blood flow in critical
care and during surgery. Numerous independent clinical studies
have shown that the CardioQ reduces the number and severity of
post-operative complications leading to improved outcomes and
reduced hospital stays.
— The CardioQ is an ideal tool for
helping to stabilise injured patients and deal with the sorts
of wounds commonly encountered in combat situations.
— The US Army has quickly recognised
the potential of the CardioQ to save lives in military situations.
The US Army first bought CardioQ in 2005 and is now assessing
protocols for its use in Iraq to improve care given to wounded
soldiers.
— Progress towards wide-scale adoption
of the CardioQ by the US military is in marked contrast to the
UK where the CardioQ is not available at all in combat situations.
— NICE's Interventional Procedure Programme
(IPP) has declared the CardioQ technology "standard clinical
practice" yet this has done little if anything to encourage
uptake in the UK military or wider NHS.
— The potential to develop Deltex Medical's
new wholly non-invasive SupraQ for wider use, including on the
battlefield itself, has already been recognised by the US military;
in the UK it has not been possible to find out who in the MoD
might be responsible or even interested.
INTRODUCTION: ABOUT
DELTEX MEDICAL
AND CARDIOQ,
AND ITS
USE IN
COMBAT SITUATIONS
1. Deltex Medical is a small innovative
British healthcare company which has developed a device, the "CardioQ"
Oesophageal Doppler monitor (ODM), to accurately monitor blood
flow during surgery and in critical care. Reduced circulating
blood volume is known as hypovolemia, which leads to insufficient
oxygen being delivered to the organs, causing medical complications
including peripheral and major organ failure resulting in longer
hospital stays and in some cases death. Using the CardioQ allows
the clinical team to better manage the patient during this time
(haemodynamic optimisation), reducing complications and mortality.
2. Clinical evidence has shown that there
are approximately 1 million NHS patients each year who would derive
a clear clinical benefit from haemodynamic optimisation. If lengths
of hospital stay for these patients were reduced by two days each,
the NHS would free up about 5,500 beds, with a saving of at least
£350 million a year. Were NHS managers to embrace the CardioQ
technology and work with their clinical colleagues towards implementing
it effectively they would significantly improve the experience
of hundreds of thousands of their patients undergoing operations.
By freeing up hospital beds they could choose whether to treat
more patients, close beds or redeploy resources to meet local
priorities.
3. In August 2006 the British Journal of
Surgery published the results of a major new randomised controlled
clinical trial of the CardioQ during surgery. The study on bowel
surgery patients at the Freeman hospital in Newcastle-Upon-Tyne
was funded by the Royal College of Surgeons and was the seventh
high quality CardioQ outcome study to be published in a leading
peer-reviewed journal. It demonstrated that in those patients
whose circulating blood volume was optimised using the CardioQ,
serious post-operative complications, emergency post-operative
admissions to critical care units and emergency readmissions to
hospital were almost entirely eliminated. The study found that
CardioQ patients were also fit to go home three days earlier than
non-CardioQ patients.
4. Routine use of the CardioQ during surgery
is now a core part of the Freeman hospital's "enhanced recovery"
or "fast-track" programme for major bowel surgery. This
programme delivers amongst the lowest mortality rates, the lowest
readmission rates and the shortest lengths of stay not just in
the UK but in the whole of the developed world.
5. The effectiveness of the CardioQ and
the quality of the scientific evidence behind it have been confirmed
by the results of both an independent clinical meta-analysis and
by a US Government funded Health Technology Assessment.
6. The benefits shown from using the CardioQ
in emergency trauma surgery and critical care in NHS hospitals
are particularly applicable to combat situations, where patients
frequently suffer from hypovolemia due to blood loss and shock.
Using the CardioQ would also enable medical staff to make an early
identification of internal bleeding.
DELTEX MEDICAL'S
EXPERIENCE OF
UPTAKE IN
THE UK AND
THE US
7. Deltex Medical is a British company which
has brought to market a British technology: the vast majority
of the clinical and "real-world" evidence supporting
the CardioQ comes from British hospitals. Yet the company has
found its dealings with the Department of Health and the NHS consistently
frustrating over many years. Our recent experiences with the equivalent
bodies in the USA have been in marked contrast. In the USA the
decision making process is more transparent, faster and considerably
less bureaucratic with clearly defined roles for the various bodies
and agencies involved.
8. The Centers for Medicare & Medicaid
Services (CMS), the US Federal Government body responsible for
determining coverage for the reimbursement of medical technologies
in the US, recently (26 February 2007) published a favourable
draft decision on ODM following an application originally submitted
on 22 August 2006. If a technology is "covered" it is
possible for hospitals to receive a payment (reimbursement) that
covers the costs associated with the purchase and use of that
technology.
9. In reaching its proposed decision, CMS
had commissioned a Health Technology Assessment (HTA) on ODM from
the US Government Agency for Healthcare Research and Quality (AHRQ).
The AHRQ report was delivered to CMS on 16 January 2007 and published
on CMS's website on 14 March 2007. It grades evidence whether
a technology does or does not work into four categories: "strong",
"moderate", "weak" and "inconclusive".
Strong evidence is where "it is highly unlikely that new
evidence will lead to a change in this conclusion". The HTA
concluded that in "patients undergoing surgical procedures
with an expected substantial blood loss or fluid compartment shifts
requiring fluid replacement" the clinical evidence for ODM
was "strong" in respect of the following three statements:
(a) "Doppler-guided fluid replacement
during surgery leads to a clinically significant reduction in
major complications";
(b) "Doppler-guided fluid replacement
during surgery leads to a clinically significant reduction in
the total number of complications"; and
(c) "Doppler-monitored fluid replacement
leads to a reduction in hospital stay".
10. The US Army first bought CardioQ in
2005. Following a satisfactory evaluation in the William Beaumont
military hospital in Texas, the US Army has purchased a further
six monitors for use in one of its mobile field hospital posted
to Iraq. Amongst other applications, the CardioQ is being used
to stabilise wounded patients before they are flown back to the
USA for treatment. Doctors associated with using the device in
Iraq have already indicated that they expect it to enable them
to save servicemen and women's lives.
RECOMMENDATIONS
11. The UK Armed Forces should be actively
seeking to help develop and deploy innovative new medical technologies
which will benefit its front line troops.
12. The MoD should apply equivalent development
and procurement processes to technology aimed at caring for wounded
personnel as it has long done for the development and procurement
of weapons for the same personnel to use in combat.
14 May 2007
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