MRSA-Why and How MRSA Moved Into Community

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U-Cannula Invented by Doctors to Reduce Needle Stick Injury & Spreading Antibiotic Resistant Bacterial Infection in Hospitals

Transcript of MRSA-Why and How MRSA Moved Into Community

Page 1: MRSA-Why and How MRSA Moved Into Community

U-Cannula Invented by Doctors to Reduce Needle Stick Injury &

Spreading Antibiotic Resistant Bacterial Infection in Hospitals

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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.

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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.

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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

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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.

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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

0

5

10

15

20

25

30

ONE TWO THREE FOUR FIVE SIX

Junior Doctors Registrar Senior Doctors

Number of cannulae usedSIX14%

ONE14%

TWO21%

FIVE8%

FOUR16%

THREE27%

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

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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.

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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.

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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.

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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”.

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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.

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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

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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.

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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 Websites1. 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