U-Cannula

Invented by Doctors to Reduce Needle Stick Injury &

Spreading Antibiotic Resistant Bacterial Infection in Hospitals
Emerging New Infections Are Threatening Mankind

Advances in medicine was made possible after Penicillin (1940s) and venous access (1950s) was
introduced. Since disposable plastic device IV Cannulae was used, antibiotic resistant strains (
MRSA, CA-MRSA, Panton-Valentine Leukocidin (PVL), Clostridium and Ecoli) has in tandem
increased. Noskin and others report that a patient infected with MRSA is five times more likely to
die than other patients. Wyllie et al. report a death rate of 34 percent within 30 days among
patients infected with MRSA, while among CA-MRSA patients the death rate was similar at 27%
and is said to be increasing in risk groups.

"Number pharmaceutical companies, there were active decisions taken that antibiotic research was
not going to be profitable enough to meet their obligation to shareholders," says Talbot, an
infectious-disease specialist and consultant to drug companies. "So they decided to go for drugs
that would be taken for a lifetime — drugs for diabetes or high blood pressure — rather than drugs
to be taken for a week." (Ref: USA Toady; Super bug spread fear far and wide)

Harmless bacteria that people carry on their skin, has now suddenly becomes a dangerous predator
immune to antibiotics, chemical wash and antiseptic is threatening us all. Community-Acquired
Methicillin Resistant Staphylococcus aureus (CA-MRSA) entering blood with helpless white blood
cells unable to stop them. HA-MRSA occurs most frequently among people with weakened immune
systems-possibly 1 in 20 patients may have MRSA, according to a study conducted by the
Association for Professionals in Infection and Epidemiology (APIC). HA-MRSA is often responsible
for surgical wound infections, urinary tract infections, and pneumonia in hospitals. CA-MRSA, on
the other hand, strikes in otherwise healthy people and children in the community. They manifests
itself in soft-tissue infections, also in such skin conditions as boils, pimples or an abscess, whose
initial appearance mirrors a insect bite and is often dismissed as trivial.

It’s occurred to us yet again that microbes just might be more determined to survive than we are.
And that they were here before we were, and that maybe our hard-hitting pre-emptive war on bugs
—with the many vaccines and antibiotics routinely used—is only making things worse.

This may sounds like a B-movie on the Sci-Fi Channel, but the CA-MRSA scare is all too real - one
of several health alerts this year that proved just how vulnerable we are despite all our scientific
know-how and advances in medicine. Invasive procedures, operations, plastic surgery, transplant
surgery, hip or knee replacement, open heart surgery, bypass and minor surgical procedures will
come to a grinding halt. This is the year we learn that the very technology we’ve created to help us
live more comfortable and, yes, often healthier lives will turn around and bite us-hard.
Intra-Venous Cannula

The use of intravenous cannula is an integral part of patient care in hospitals. These devices are
used for the administration of fluid, nutrients, medications, blood products and to monitor the
haemodynamic status of a patient.

Peripheral venous cannulae and catheter introducing device are the devices most frequently used
for vascular access. Insertion of cannula and catheter into a blood vessel in patients and veterinary
medicine is probably the most common invasive medical procedure performed. In modern medical
practice, up to 80 percent of hospitalised patients receive intravenous therapy at some point during
their stay. There is a growing awareness in the medical community that the cannulation technique
needs to be reviewed.

However, intravenous devices provide a potential route for micro-organisms to enter the blood
stream resulting in a variety of local or systemic infections. Our hypothesis “ Multiple punctures to
introduce cannula is a major cause of spreading hospital infections” was proved by doctors in
Winchester, UK. No new cases of MRSA have been reported at the Royal Hampshire County
Hospital in Winchester and the Andover War Memorial Hospital since the use of cannulae has had
to be authorised by a specialist and signed off by a doctor to ensure that they are used only when
absolutely necessary. Once in place, the tubes are flushed with a saline solution and inspected
daily. No MRSA bloodstream & wound infections since November 2007 when compared to 11
MRSA during the same period before last year.

If this same practice were adopted nationwide by the NHS, MRSA levels would fall sharply but is
not practically possible and could be ethically un acceptable.

These cannularelated infections were often said to be associated with prolonged hospitalisation,
increased morbidity and mortality. In order to minimise the risk of infection associated with these
devices CDC produced the guidelines on “Prevention of infections related to peripheral intravenous
devices” to all healthcare practitioners involved in the care of adult patients. These guidelines aims
to serve as a guide for practitioners who are involved in caring for or treating adult patients with
peripheral intravenous devices. The recommendations are based on the available research findings.
However, there are some aspects in which there is insufficient published research and, therefore,
consensus of experts in the field has been utilised to provide guidelines specific to conventional
practice.
What are the Problems?

Cannula (small plastic tube) insertion through vein is particularly difficult in certain cases,
including in intravenous drug users, patients having repeated courses of chemotherapy, children,
dark-skinned and obese patients. It is often complicated in patients who are afraid, as fear activates
the sympathetic nervous system, provoking peripheral vasoconstriction. Once an initial attempt at
cannulation has failed; nearly all patients experience a degree of sympathetic activation that makes
subsequent attempts increasingly difficult.

Failed attempts are expensive, also embarrassing for the provider, causing a degree of nervousness
that also hampers further attempts. It is therefore important that a cannula is inserted quickly the
first time. Many doctors claim a high success rate for inserting cannulae, but may still require
several attempts to get it right in certain cases. Cannulation can prove problematic and time
consuming, which causes difficulties in urgent situations. In emergencies optimal attention to
aseptic technique is not always feasible and multiple punctures are more likely to result in
infection, including septic thrombophlebitis, endocarditis and other metastatic infections (e.g.,
lung and brain abscesses, osteomyelitis and death).

Ultrasound guidance has been shown not to decrease the number of attempts at cannulation or the
time taken to do it successfully. Neither does it lead to improved patient satisfaction. Currently
doctors and nurses often try to recannulate by re introducing the needle tip through the hub. In
fact some cannula manufacturers recommend reusing cannulae up to three times to save costs.
However, reusing or re introducing cannula needles increases the risk of introducing infection,
cannula tip fracture and embolisation. NHS (UK) continue to use ported cannula despite warning
from clinicians that 50% of patients are said to colonise skin commensal in the port.

The incidence of Staphylococcus aureus infections acquired in hospitals has raised in tandem with
increased use of cannulation since the Braunule (cannula) was introduced in 1962. Making several
attempts increases costs and the risk of introducing infection into the patient. Discarded used
needles also pose a risk of needle stick injury to staff, increasing their chances of contracting HIV,
Hepatitis and other blood borne infections.

If a cannula is used for an extended period of time, a patient may be colonized with hospital-
acquired organisms. Information is now available on CA-MRSA in the community, but it is
estimated that up to 64% percent of people in USA are now carriers. The incidence of community-
acquired MRSA infections appears to be rising, although little is known about their epidemiology.
Most reported cases are uncomplicated skin infections, although some are more severe, including
necrotising pneumonia, and bloodstream infections. Risk factors for infection with MRSA in health
care settings include prolonged hospital stay, time spent in an intensive care or burns unit,
exposure to multiple antibiotics or prolonged broad-spectrum anti microbial therapy, proximity to
patients colonized or infected with MRSA, use of invasive devices, surgical procedures, underlying
illnesses and MRSA nasal carriage.

The frequency of the procedure means that resultant infections do lead to considerable annual
morbidity. MRSA (methicillin-resistant Staphylococcus aureus) infections are becoming
increasingly common in health care settings. In certain circumstances - for instance, if a person has
breaks or puncture wounds in their skin or they are particularly vulnerable to infection due to their
medical condition or treatment-MRSA may enter the body, where it can cause infections of varying
degrees of severity.

Discarded cannulae increase hospital waste and environmental pollution, pose a risk of needle stick
injury and encouraging the spread of infections. Growing concern about this issue has led to a
desire to reassess cannulation techniques. Various cannula manufacturers now offer devices
designed to reduce needle stick injuries. However, none have claimed to reduce the number of
attempts required to cannulate. Unsuccessful attempts not only cause distress to the patient and
make cannulation more difficult, but each unnecessary puncture wound provides an access route
for MRSA or other drug-resistant organisms into the bloodstream.

Cannulation is a valuable skill and has many advantages for practitioner and patient. Most doctors
assume the currently used technique is safe and therefore continue to use it, tolerating the
frustration of failure and the sadness of causing distressing to patients. Some doctors learn to
accept failure while others blame the vein, but few think to assess their own technique or that of
others.

Most related studies have looked into issues such as cannula-associated infections, pain relief or
needle stick injuries, rather than insertion techniques or the number of attempts needed to
cannulate a vein. IV Cannula was hailed as the most important advances and accepted for use
without proper clinical evaluation or trial. Cannulae manufacturers did not make any effort to
introduce alternative technique nor did they fund clinical evaluation of the technique used.

Dougherty (1998) suggests that only two cannulation attempts should be permitted before
deferring to a more experienced practitioner, but this is rarely practiced as the doctors feel
incompetent and the patients also start loosing trust in the doctors managing them. Doctors claim
to be very competent and questionair studies give us wrong information.
The result of our observational study establish our claim and the data prove experienced
practitioners are not as competent as we expected but are more confiedent. On average doctors are
using 2.58 (1-6 attempts) cannula to sucessfully introduce onne cannula and the time taken was 0-
20 minutes.

Number of Attempts
30

25

20

15

10

0
ONE TWO THREE FOUR FIVE SIX

Junior Doctors Registrar Senior Doctors

SIX Number of cannulae used

ONE
14% 14%

FIVE
TWO
8%
21%

FOUR
16%
THREE
27%

ONE TWO THREE FOUR FIVE SIX

Current Cannulation Trends

There is currently a trend in the United Kingdom and the United States to train nurses and
paramedic to cannulate to reduce time for doctors. However, nurses and paramedic may lack the
skill or experience to cannulate in complex cases. Nurses are advised to be aware of their own
limitations in relation to experience and skill (Ref: Scales K (2005) vascular access: a guide to
peripheral venous cannulation. Nursing Standard. 19, 49, 48-52.). There may be times when the
nurse should decline to attempt cannulation if patient history or assessment suggests that
cannulation is too complex (Ref: Jackson A (2003) Reflecting on the nursing contribution to
vascular access. British Journal of Nursing. 12, 11, 657-665. There is also some concern that
allowing other staff to carry out cannulation could, over time, de-skill doctors, possibly resulting in
inadequate care in difficult cases.

Cannulae manufacturers have invested large sums of their R&D funds and are agressivly marketing
their “Safety Cannula” claiming them to reduce needlestick injury. In USA, they have successfully
encouraged governamanet to impliment law, making it mandatory to use safety cannula in the
hospitals. Healthcare Commission in UK published their report “Surveillance of occupational
transmission of blood borne virus associated with sharps injury” in 2005. From 1996-2004, 997
healthcare workers in UK were exposted to Hepatitis C, only nine contracted the infection and one
was said to be infected with HIV infection. (Practical nurse, July 2006,; 38).

NHS in UK is at present investing large sums of their tax payer’s funds (£ Billion) to clean the
hospitals to reduce spreading hospital infections (MRSA, MSSA & C Defficalis) and have not been
successful. They are now investing in education; prepare protocol, special local sterilizing
technique prior to introducing cannula. This increase time and cost of providing medical
treatment, especially in an emergency situation. UK Department of Health " Low cleanliness score,
NO longer have significantly higher MRSA infections": Hospitals with high bed occupancy rates,
high levels of temporary staff or cleanliness. Increasing spend on cleaning by 10% is estimated to
reduce MRSA rates by less than 1%. In the final 2 years. (Hospital organisation, specialty mix and
MRSA, Dec 2007)

Intravenous devices provide a potential route for micro-organisms to enter the blood stream
resulting in a variety of local or systemic infections. Our hypothesis “ Multiple punctures to
introduce cannula is a major cause of spreading hospital infections” was proved by doctors in
Winchester, UK. No new cases of MRSA have been reported at the Royal Hampshire County
Hospital in Winchester and the Andover War Memorial Hospital since the use of cannulae has had
to be authorised by a specialist and signed off by a doctor to ensure that they are used only when
absolutely necessary. Once in place, the tubes are flushed with a saline solution and inspected
daily. No MRSA bloodstream & wound infections since November 2007 when compared to 11
MRSA during the same period before last year.

If this same practice were adopted nationwide by the NHS, MRSA levels would fall sharply but is
not practically possible and could be ethically un acceptable.
What Did We Do?

In 1980s MRSA infections were reported from various pediatric departments in UK hospitals.
During this period, HIV was also becoming a major problem and attracted media attention.
Staphylococcus was not seen as a major threat by doctors and often dismissed blood culture results
as normal commensal. Some babies were very ill and so were treated with vancomycin. These
babies should have been treated in isolation but the guidelines were not strictly followed.

We initially noticed an increased infection rate in babies who were very ill, very preterm or when
multiple punctures to introduce cannula or catheters. Due to lack of support, funding and
encouragement, we could not organize a study to prove our hypothesis. We decided to identify
reasons we fail to cannulate in the first attempt, and hoped we could produce an alternative
cannula introducing technique to reduce the number of attempts.

After studying the our video recordings and on after close observation we identified two important
mistakes resulting in failure rate. The operator was either moving the needle forward (double
puncture) or withdrawing (pre-mature withdrawal) prior to cannula entering the lumen of blood
vessels.

We constructed the first cannula introducing

device to help ease the forward movement of
cannula to reduce double puncture. We were
allowed to test the cannula introducer only after
SHO & Registrar failed to cannulate. The results
of this study were published in Anaestesia
Analgesia hoping some plastic disposable product
manufacturer will produce a device to help us ease
this life saving technique to reduce the rate of
spreading MRSA infection in hospital.

A cannula company contated us and were initially entusiastic to produce the spring loaded cannula.
After completing end users servey, they abandon the project due to fear of de-skilling doctors.
Medifix Limited

Medifix Limited, a company registered by two doctors working in UK. They are striving to make
common surgical procedures simple, easy to perform and less traumatic to reduce stress to doctors,
cost to health care providers and spread antibitic resistant strain of bacteria to patients.

As doctors working in NHS hospitals they have been using a number of plastic disposable medical
products (syringes, cannula, needles, and long lines, blood collecting bottles, phlebotomy set, et-
tubes and fluid administration lines), and believe this contributed to the origin of new strains of
bacteria in hospitals. These products are used and discarded in providing the best health care. Con-
taminated hospital waste increase spreading resistant strains of bacteria in the community. Global
warming will encourage survival of bacteria and help breed new strains of bacteriae and fungus
which may threaten our existence.

Healthcare costs are spiraling to catastrophic proportions. Most countries are struggling to offer
comprehensive health care to their populations. Plastic disposable products are imported from
USA and are expensive. Health care providers including NHS, spend 60% of their health care cost
on medical equipment and disposable products. Politicians promise changes, and are keen to im-
plement them, but are unable to deliver. We are thinking ahead and working towards changing the-
oretical idealism into practical reality.

Medical product manufacturers claim to reduce cost of healthcare and encourage single use dispos-
able devices to reduce cross infection. Medifix aim to reduce cost of providing the best health care
by reducing wasted expenses.

Doctors established Medifix to improve upon the existing technology, by designing to serve a need
that is clearly defined and acknowledged by medical professionals. Each technology will fill a
current need in medical procedure by improving upon an existing technology.

These products shall be realistically priced to appeal to the healthcare provider market and patients
that stresses lowest costs of total treatment parameters.

Our mission is to provide the best possible available health care products and techniques which are
simple, easy to use and safe. Our team of experts will work with the health care providers in the
UK, and are planning to offer successful models globally.
The U-Cann®

The first cannula introducing device designed to help doctors reduce the number of attempts
required to sucessfully introduce cannula & prevent invasive MRSA spreading in the hospitals.

In 1997, we conducted our own observational study to assess cannulation technique, looking at
failure rates and the time taken to cannulate successfully. The average number of attempts
required by doctors to successfully cannulate a vein was 2.84 (0 to 6 attempts). Junior doctors were
reluctant to cannulate obese people, children or patients suffering from edema or shock. We also
found, perhaps surprisingly, that senior doctors were not noticeably better at inserting cannulae,
although they were better at acknowledging their own failure. Their failure rate was higher because
they were cannulating children after two doctors failed to cannulate these critically ill children.

Doctors have now independently published information that their success rate (this may not
necessarily be in the 1st attempt) to introduce a cannula is around 60% which increase to 90% in the
subsequent years.

Various hospitals have started using nurses as phlebotomy and cannula introducing technicians.
These nurses were trained and have resulted in doctors not often getting an opportunity to
introduce cannula. Nursing Association (UK) published paper recommending their member to pass
on the responsibility to cannulate in emergency situation and if the patient is said to be critical or
the nurse felt the technique will be difficult.

Based on this initial work, we invented the First catheter introducing device, organized clinical
trials and published our results. The technique of doctors using the device to cannulate 50 infants
(92 percent weighing less than 4Kg) was assessed. Cannulation was successful at the first attempt
in 94 percent of these cases.

With the cannulae currently in common use the sharp end of the needle is exposed, which can
result in accidental injury to medical staff and patients. Major cannula manufacturers have been
concentrating on developing method to cover needle tip but not tried to alter the main technique.
In Medifix, we developed a new simplified technique to reduce the number of attempts, pain and
trauma to patients and incorporated needle tip protection. We have named and registered our First
Cannula Introducer designed to help doctors and nurses as “U-Cann”.
How Does the U-Cann® Work?

The U-Cann® has a knob, connected internally to a plunger. Once the cannula has been placed in
the right position in the vein, retracting the knob moves the needle guard, allowing the cannula to
move forward in a controlled manner into the lumen of the blood vessel. He has also developed
another device (patent pending) incorporating needle withdrawal linked to cannula moving
forward. This eliminates the accidental jerky forward thrust of the needle tip, reducing the risk of
double puncture. After use, the guard protects the needle tip, preventing accidental needle stick
injuries to the practitioner. For the safety of the patients, forward movement of the knob is blocked
to reduce cannula fracture and embolisation.

The U-Cann® can be used in a variety of ways, requiring varying levels of skill. This will make
cannulation easier while avoiding deskilling practitioners. Patent examiners have acknowledged
that they could not identify any device to challenge our concept. This device is unique and has been
developed to over come various problems encountered by doctors when performing cannulation.

U-Cann® is the only device which allow doctors/nurses to choose one of four different methods
(no other cannula can offer this option). Users are given option to switch over to present method if
they find it hard to use our new retraction technique. Medifix feels that doctors and nurses will
soon realize the new technique is easy to perform and their success rate will drastically improve
and help them to succeed in the first attempt.

We are currently working to bring the product to market and determined to make it affordable to
developing countries, where it could make an enormous impact, reducing hospital waste, cutting
the transmission of HIV, hepatitis and other serious infections to health care workers through
needle stick injuries.

Using our past experience and knowledge of cannula introducing technique, we re-designed and
invented U-Cannula to simplify and successful introduce cannula in the first attempt. Our
contribution was published in the medical journal.

We believe we have a simple solution to optimise the technique, thus reducing the number of
attempts, incorporating needle tip protection, and blocking re-introduction of needle into the
cannula. U-Cann® is especially designed to help doctors to cannulate with ease and reduce the
number of attempts to cannulate successfully. The U-Cann® prevents accidental needle stick
injuries and cannula fracture.
Major cannula manufacturers have developed new safety cannula but they are all based on present
technique. These cannula are expensive, complicated to use and are not designed to reduce wasted
cannula. Discarded cannula threaten environment and encourage spreading resistant strains of
bacteria.

Cannula is often administered into a vein in the hand of a patient, so the product can infect
endanger the life of the patient due to CA-MRSA & other bacterial being introduced. Good hand
washing technique may reduce the incidence of serious bacteraemia in most but will not totally
prevent it.

Multiple punctures will increase time required to cannulate, stress for doctors and the chances of
doctors hand becoming unitarily. This device has been proved to be a major risk factor for
introducing MRSA infection in hospitals in UK and proved to be associated with bacteraemia.

In a study that focused solely on wipes, researchers concluded that instead of preventing hospital-
acquired infections like methicillin-resistant Staphylococcus aureus (MRSA ) the wipes could
actually be spreading bacteria when used improperly by hospital staffers.

Disinfecting wipes and alcohol-based hand gels are now widely used in hospitals, schools, and
other public settings to kill the pathogens that cause infectious disease. Americans now spend an
estimated $1 billion a year on these and other antibacterial products, but their direct impact on the
spread of infectious disease is not well understood.

Major benefits of U-Cann®

1. New easy insertion technique to reduce attempts.

2. First cannula to offer four methods of introduction.
3. Only cannula offering existing technique with alternate methods to choose
4. Smaller size compared to other safety cannulae.
5. Needle tip protection in vein greatly increases success
6. Reducing premature withdrawal or double puncture.
7. Plunger acts as cannula introducer and protects the needle tip.
8. Reduction of needle-stick injury and cannula fracture.
9. Reduction of multiple puncture, stress to doctors and trauma to patients.
10. Blood-collecting chamber offers better visibility to reduce failure rate.
11. Prevents reuse and re-introduction of the needle through the cannula hub.
12. Reduce cost to healthcare providers, wasted time and stress to doctors
Competitive Comparison

We have none! This is the first “Cannula Introducer” in the market designed to reduce the number
of attempts taken to introduce cannula . Classified as “The Cannula Introducer” is straight with and
without wings. We are different and have various features which have not been documented or
invented. UK Patent office examiner accepted all our claims and we have successfully patented this
concept and device in six months. We have this unique opportunity to be the market leaders in the
cannula and catheter market because the evidences demonstrate cannula associated with spreading
antibiotic resistant bacterial infections.

The product currently available in the safety cannula and catheter market are Adivec (Medikit),
Autogurd, Angiocath (Becton Dickinson), Protectiv, Acuvance and IV Safe (Johnson & Johnson)
and Introcan (B Braun). These devices are at present marketed as safety cannula in USA and have
an estimated 15% market share. Market penetration has not been good as the cost of this device is
very high. NHS in UK is still debating on choosing a safety device for use in the hospitals. Since
1996-2004, only 9 healthcare workers contracted Hepatitis C and one developed HIV during this
period (HPA Report 2005).

U-Cann® was developed based on our initial work which was published in reputed medical journal
Anaesthesia & Analgesia and hailed as the much needed technology by the Anesthetists and the
readers of the journal.

We are aware of both its strengths and shortcomings. The U-Cann® is a much improved product in
a rapidly growing market application. Cleaning hand and washing in the only option available but
there is no guarantee that the hand is completely sterile or the disinfectant helps to remove
bacteria from the skin. In hospitals we have observed doctors and nurses forget to change gloves
and use the alcohol wipes on various areas, repeated puncture sites in the skin allowing entry of
bacteria into the blood stream.
Video Presentations

IV Cannulae

1. Introducing IV Cannula (Present Method)

2. Spring-loaded Device to Ease Introducing IV Cannula
3. Introducing IV Cannula Made Easy
4. U-Cann : Reduce Multiple Puncture to Reduce MRSA Infection

MRSA:

1. MRSA: Why, How and What Happened

2. How MRSA can enter your body in hospitals
3. Spreading CA-MRSA
4. Why MRSA spread in UK
5. MRSA Infection Threatens Us

Our Websites
1. Medifix Limited
2. Safe Cannula

Publications

1. All about CA-MRSA

2. Compare CA-MRSA with HA-MRSA
3. U-Cannula: Article published in Medical Journal
4. How Safe are Cannulae?
5. Peripheral Venous Cannula Introducing Technique and MRSA infection
6. Reducing Medical Waste by revalutionising blood test
7. Combining Cannula with Test strips, Medica
8. U-Cann™ Brochure (Large file)
9. Spring-loaded Cannula Introducer
10. Instruction on How to use U-Cann™
11. Brochure for Medica 2006
12. U-Cann TS™ Information sheet
13. Doctors at war with Infections