MRSA-Why and How MRSA Moved Into Community | Methicillin Resistant Staphylococcus Aureus | Intravenous Therapy

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 hospitalacquired 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 communityacquired 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 020 minutes.

Number of Attempts
30 25 20 15 10 5 0 ONE TWO THREE FOUR FIVE SIX

Junior Doctors

Registrar

Senior Doctors

SIX 14% FIVE 8%

Number of cannulae used

ONE 14% TWO 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, ettubes 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. Contaminated 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 implement them, but are unable to deliver. We are thinking ahead and working towards changing theoretical idealism into practical reality. Medical product manufacturers claim to reduce cost of healthcare and encourage single use disposable 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 hospitalacquired 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

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