Co-operative Research projects for SMEs - European Commission ...

Sharp system for safer surgery
“The number of people who actually have
The challenge for the Co-operative Research
to handle potentially contaminated sharp
project Disblade is to develop a new type of disposable
instruments will be significantly
surgical blade. There is a pressing need for disposable blades
reduced.”
as a result of the dangers of contamination by the ‘prion’ pathogens,
responsible for Creutzfeldt-Jakob disease, which can only be destroyed using
expensive specialised sterilisation procedures. The new polymer-based blades must
meet the exacting specifications required to match conventional steel scalpels. The project
is also developing a safe disposal system to blunt each blade immediately after use. Commercial
exploitation of the system will make the project an effective business proposition for all partners, displacing
currently imported products.
One of the most prominent health stories of recent years has been
the discovery that infectious proteins known as prions (proteinaceous
infectious particles) are responsible for Creutzfeldt-Jakob disease
(CJD) in humans and bovine spongiform encephalopathy (BSE) in
cattle. An outbreak of BSE, popularly known as ‘mad cow disease’,
brought the dangers of prion diseases to the notice of the European
public.
One of the biggest problems with such diseases is that the infectious
particles are resistant to the conventional procedures used to
sterilise surgical blades and tools. This has generated widespread
concern about the dangers of transmitting fatal diseases such as CJD
by the reuse of surgical instruments. Effective destruction of prions
requires expensive specialised sterilisation processes. Consequently,
there is great interest in developing cost-effective methods for
making disposable instruments.
The disposable instruments that exist today are of low quality, still
rely on steel blades, and are not popular with surgeons. The primary
objective of the Disblade project is to develop an automated
and economically viable method to prepare disposable surgical
blades that can match steel blades in the key criteria of
sharpness, surface hardness and stiffness. A second objective is to
develop a disposal system based on fast heating of the blades, to
render them blunt and suitable for straightforward disposal without
any remaining danger of sharp injuries and the associated risks
of contamination. Use of this system within the operating theatre,
immediately after use, will ensure contaminated sharp blades
never leave that controlled environment.
High-value partnership
The Disblade partners are a consortium of five SMEs in Ireland,
Denmark, UK, Italy and the Czech Republic, working with one large
enterprise (Rosti AS of Denmark) and two RTD performers (Pera
Innovation Ltd, UK and The National Institute of Technology of
Norway). This structure will allow the innovative technology to be
channelled through a trusted and large-scale supplier to the general
medical market. The SMEs (small and medium-sized enterprises)
have expertise in medical instrument design, moulding technology
and machinery, and sterilisation techniques. But these small
specialised companies would find it difficult to bring a new
innovation to the mainstream European and global market if they
had to do so on their own. While the SMEs gain the marketing
benefits of working with Rosti AS, this larger partner gains the
advantage of direct access to the combined talents and ideas of
several SMEs spread across Europe.
By working together as part of a Co-operative Research project, the
partners hope to produce a new high-value and high-technology
product, which is exactly the sort of thing the European Union needs
to compete successfully against the low-labour-cost countries.
Without EU assistance, getting the system developed could prove
much more daunting.
Midway through the project, the partners have already proven the
principles of their system, but are working to optimise it and to
achieve the most useful and appealing product designs.
A lasting impact
The long-term hope of the Disblade partners is that the system
they are developing will bring a higher level of routine safety into
the surgical procedures used across Europe. At present, the costs
of the sterilisation processes that are effective against prions mean
that they are not widely used. They can only be justified for specific
procedures or for patients who have been previously identified
as ‘high-risk’ as regards prion contamination.
The problem with
such a selective system is
that some patients
carrying infectious
prions inevitably
slip through
the net.
The effects of CJD on
the human brain.
DISBLADE