APPENDIX 11
Memorandum by KCI Medical Ltd (MT 43)
INTRODUCTION
Founded by an emergency room physician in 1976,
Kinetic Concepts Incorporated (KCI) is a global corporation providing
leading edge innovation in wound care, pulmonary care, bariatric
care, and circulatory improvement in all care settings. KCI manufactures,
delivers and services one of the largest offerings of speciality
beds and related medical devices. The company is dedicated in
taking an active role in the healing process, helping to save
a patient's life, helping to improve the quality of a patient's
life, and reducing the cost of healthcare along the way.
KCI Therapies have been clinically proven and/or
financially justified in, collectively, more than 110 articles
published in peer-reviewed clinical journals. Through research-based
protocols and a clinically trained support team, KCI helps ensure
that the right patient receives the right therapy for the right
length of time.
KCI welcomes the Health Select Committee's inquiry
into the use of medical technology in the NHS and the opportunity
to submit evidence.
KCI'S VIEWS
ON THE
INQUIRY'S
TERMS OF
REFERENCE
1. Recommendations of the Healthcare Industries
Task Force (HITF) report
1.1 As an active member of the Healthcare
Industries Task Force, KCI hopes the Government will ensure that
the recommendations of the report are implemented as quickly as
possible. KCI welcomed the opportunity to work with the Department
of Health on this important project and presses the Government
to ensure that the good work that has been started by this process
continues.
1.2 The recommendations from the HITF report
pertaining to device evaluation and procurement are of particular
interest to KCI. It is essential for the uptake of new technologies
that the purchase of medical devices is best aligned with the
relevant NHS providers to ensure the quickest possible benefit
to patients. This is especially true where the use of a medical
device will cross the boundary between secondary and primary care.
KCI's concerns regarding this issue are outlined further in the
section on barriers to uptake of new technology (paragraph 2.2).
1.3 The Device Evaluation Service (DES)
as outlined in the HITF report should go some way to providing
a single point of reference for NHS bodies and individuals relating
to new medical devices. KCI therefore recommends that the legislative
process to enable the move of this body from the Medicines and
Healthcare Products Regulatory Agency (MHRA) to the Purchasing
and Supply Agency (PASA) commence as soon as possible. However,
due to the fast paced introduction of both new and evolving medical
technology, it will be essential that the DES has the capability
to handle the constant updating and diverse nature of these products.
In the first instance, it is not clear whether consideration has
been given to how technology will be prioritised in terms of assessment
by the DES, as all technologies will not be able to be assessed
at once. If it will, for example, be based on clinical and/or
financial importance, then it is essential that Industry is made
aware of this or any other process as soon as possible.
1.4 Training and Education of NHS staff
for new medical devices is an essential element of patient access
to this technology. Of particular concern is the prevention of
the use of new devices, which improve patient outcomes and quality
of life, due to a lack of understanding or awareness of a technology.
KCI would encourage the implementation of the recommendations
in the HITF report on Training and Education, but also recommend
that further attention and consideration (particularly in relation
to funding decisions for new technology) be paid to the value
that medical device companies can offer for the direct training
of NHS staff. It is also essential that healthcare professionals
are given the time to train appropriately, not only on the use
of new technologies, but also the updated newest technologies,
otherwise the patient benefits of these can be lost.
2. The speed of, and barriers to, the introduction
of new technologies
2.1 Medical technology is often purchased,
or not purchased as the case may be, on the basis of the initial,
short-term cost of the equipment. Factors such as the ability
to shorten hospital stay, reduce waiting lists and hospital admissions
are often not taken into account. The long-term social and economic
benefits of medical technology must be evaluated when making procurement
decisions. For example, KCI is a world leader in the development
of therapeutic medical devices that help promote wound healing
in acute care settings, such as trauma and surgically created
wounds, amputations, burns, serious pressure ulcers and skin grafts.
In 1994, KCI introduced V.A.C.® TherapyTM which is effective
in treating the most challenging trauma and abdominal wounds,
by applying a vacuum force across a sealed wound using a reticulated
foam interface. The vacuum effect and the mechanical forces generated
at the interface of the foam positively influence the healing
process allowing patients who have to be hospitalised for wound
management to be healed and discharged home earlier, thus shortening
the length of stay in the hospital and freeing up the bed space
for another patient. In addition, V.A.C.® TherapyTM dressings
are changed every two days rather than multiple times in one day,
which, again, must be taken into consideration.
2.2 Funding in the community also presents
a barrier to the introduction to new technologies. KCI has recently
launched a variation of the above therapy which allows for the
continued treatment in the community. The V.A.C.® FreedomTM
has recently won an Independent Living Award for its ability to
enable the disabled and debilitated more freedom, mobility and
choice:
"With the new VAC Freedom I feel that
civilisation has returned and I can unobtrusively rejoin society[19]"
However, present procurement mechanisms prevent
PCTs paying for the device through FPI0. This means that although
the therapy is often clinically recommended, patients are denied
access to the treatment in their own home and remain in hospital
to continue treatment. KCI cannot understand why primary and secondary
care providers will not work together to formulate specific commissioning
arrangements for technologies that cut across PCT and Trust boundaries.
The use of such technologies not only benefits patients, but they
can also result in financial savings for both providers. It is
unacceptable that a patient, although well enough to continue
their care at home, should be denied such treatment when a medical
professional has made such a recommendation.
2.3 The Drug Tariff is presenting a further
barrier to the introduction of new technologies. As more and more
devices fail to be funded through the Drug Tariff, manufacturers
are creating products that will ensure inclusion in the Tariff,
rather than developing innovative products for the benefit of
patients. KCI believes that a complete review of the Drug Tariff
in relation to medical devices is needed to ensure that patients
are not being denied the latest products because of commissioning
concerns.
2.4 A lack of clear guidance from the National
Institute of Clinical Excellence (NICE) presents a barrier to
the introduction of new technology. For example, in the area of
woundcare, NICE is focusing on creating clinical guidelines for
particular areas of wound management rather than undertaking individual
technology appraisals. This is unfortunate as lack of specific
guidance from NICE can lead to a variation in service and therefore
patient choice and treatment. KCI would recommend that all products
receive technology appraisals and that the uptake of products
following such recommendations is monitored.
3. The effectiveness and cost benefit of
new technologies
3.1 New technologies, such as those produced
by KCI, bring benefits to the patient, the NHS and society as
a whole. As previously mentioned, they are effective by helping
to reduce waiting lists, shortening the length of stay in hospital,
relieving bed-blocking, enabling patients to be cared for in their
own home and, most importantly, improving the quality of life
of patients.
3.2 The cost benefit of medical technology
must be considered in the long rather than short-term. For the
patient, a shorter stay in hospital and care in the community,
coupled with significantly reduced risk in readmission can only
have positive consequences. Medical technology like the V.A.C.®
FreedomTM has allowed patients to return to their lives more quickly
and, in most cases, return to work. This has implications not
just for the patient who can continue to earn a living and perhaps
provide for a family, but society as a whole as it reduces reliance
on social security and other State benefits.
3.3 The effectiveness and cost benefit to
the NHS is considerable in terms of bed days saved and helping
to achieve waiting targets. For example, a recent case study (October
2004) by Claire Campbell, Macmillan Gynaecology Oncology Clinical
Nurse Specialist at Northampton General Hospital, demonstrated
that for the treatment of women with wounds, as a result of vulval
surgery, that have broken down, using VAC machines reduced length
of stay in hospital by 7-14 days.
3.4 However, medical technology is also
effective in helping to reduce the risk of hospital-acquired infection
and the costs associated with bacterial infection such as MRSA.
The Rapid Review Panel set up by the Department of Health and
the Health Protection Agency is currently considering technologies
which will help prevent hospital-acquired infections. Again, products
such as V.A.C.® TherapyTM (which is about to be considered
by the Panel), can make a contribution to the problem; while at
the same time produce considerable cost benefits to the NHS as
a whole.
4. Key recommendations
— That the Device Evaluation Service,
once transferred to the Purchasing and Supply Agency, is provided
with the capability and resources to carry out its role across
the diverse and rapidly changing medical technology field to ensure
that patients receive the best possible treatment in a timely
fashion. That a review of the scope for assessment of technology
by the DES takes place and that industry is provided with both
this process and the process for prioritising technology assessments
as soon as possible.
— That prior to the commencement of
any major purchasing initiative involving medical technology,
a survey of stakeholders takes place to ensure that any changes
will not impact on the viability of NHS services.
— That long-term social and economic
benefits of medical technology for both patients and the NHS are
considered when making procurement decisions.
— That a complete review of the Drug
Tariff in relation to Medical Technology is needed to ensure that
patients are not being denied the latest treatments, in the most
appropriate setting.
— That there is a permanent mechanism
for the rapid review and uptake of technologies that will have
a major impact on achieving Government priorities and targets
for NHS patients.
19 John Hume, Nursing Times-"The VAC Freedom
portable would healing system", Nov/Dec 2004. Back
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