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1. 2006©Medifix Ltd 1 2. All invasive procedures, operations, plastic surgery, transplant surgery, hip or knee replacement, open heart surgery, bypass and minor surgical…
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  • 1. 2006©Medifix Ltd 1
  • 2. All 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 In modern medical practice, up to 80% of hospitalized patients receive intravenous therapy at some point during their admission. Since Dr George W Crile managed shock in 1915, cannulation has become the most commonly performed invasive medical procedure. There is now considerable interest in changing the technique due to problems with antibiotic resistant bacterial infection spreading in our hospitals. Winchester and Eastleigh Healthcare NHS Trust (UK) began prescribing the insertion of cannulae - for giving intravenous fluids. Doctors are able to monitor the tubes more closely for signs of infection. The trust said since the introduction last November there have been no new cases of MRSA infections. This figure covers all forms of MRSA, including bloodstream infections (also known as bacteraemia) and wound infections. This compares to 2007/08 when there was 11 reported bloodstream infections. Cannula insertion is notoriously difficult. It is often complicated in patients who are afraid of needles or have had bad experiences in the past. Fear activates the sympathetic nervous system thereby provoking peripheral vasoconstriction making further attempts to introduce cannulae difficult. Bacteria have also developed resistant to disinfectants and antiseptic wash. This increase the risk of introducing bacteria into the skin and blood vessels. Various studies published since 2006 are all pointing fingers at this simple life saving technique as a major contributor. Cannula have hitherto been arranged for the user to move the cannula forward, over the tip of the needle, using the index finger. This forward movement of the cannula must be performed swiftly once the tip of the needle has entered the lumen of the blood vessel. Any slight movement of the tip of the needle in the blood vessel lumen may result in puncture andfailed cannulation; any withdrawal of the tip of the needle, prior to cannula placement in the lumen, will also result in failure. Multiple punctures is traumatic, increase chances of introducing infection because staff fail to observedrying time and the bacteria are resistant to disinfectants and antiseptic wash. Medical product manufacturers have developed various methods and devices offering protection from needle stick injuries but none claim to reduce the number of attempts. 2006©Medifix Ltd 2
  • 3. We believe reduction of attempts required to successfully introduce cannula in a vein must be our primary task as multiple punctures increase risk of spreading infections. 30% of health people are now colonized with CA-MRSA in their hands. With no new antibiotic and disinfectants not effective, patents life is at risk. Cannula manufacturers are still talking about "Needle-stick Injuries" as a major problem encountered in hospitals. They are aggressively marketing their so called "Safety cannula" despite published data prove the risk of contracting infection due to needle stick injury is considerably low. Sharp Injuries Practice Nurses, July 2006 published statistics about injury & infections between 1996-2004 in UK. 997 healthcare care workers exposed to Hepatitis (9 infected), 551 exposed to HIV (1 infected), & 181 to Hep-B. Safety cannula has no additional benefit to patient care but increase cost and does not reduce introduction of bacterial infections to patients. The number of patients contracting antibiotic resistant bacterial infection is rapidly increasing and is estimated to be as killing 5,000 a year in UK. The number of people colonized with CA-MRSA is said to be 53 million and is rapidly increasing all over the world. We feel it’s is important to start worrying about patients, our children and protect our medical profession from extinction. We must act now and bring in changes that matter not persevere our mission to cut our losses promoting "Needle stick Injury" U-Cann: All about the Product and why is this important? Medifix Limited is proud to present their innovation developed by doctors with a passion to reduce pain, suffering and spreading infections to patients and staff. Our engineers have worked hard to present us this unique product design which can be assembled in two simple stages to help us reduce the cost of manufacture and cost of the end product. We are confident our contribution will help ease this technique and will give the doctors an opportunity to understand more about spreading antibiotic resistant bacterial infections in the hospitals and wound infections and implement changes that could reduce trauma, cost and death of young health adults and children. U-Cannula, invented and patented in 2006 has gone through various changes to help ease manufacture and market this “New Product in a New Category”. We like to classify this device as “The Cannula with Introducer” because the cannula over the needle in the front portion is similar to conventional and safety cannula. The device allow user to insert a cannula using the present technique. The Introducer is a thin plastic strap having a knob on one end and a needle guard on the other. This plastic strap is placed in a casing is used to move the cannula forward once the needle tip punctures the wall of a blood vessel. Using the introducer is optional and is likely to help doctors and nurses to introduce cannula with ease. 2006©Medifix Ltd 3
  • 4. The present method of cannula insertion is to move the cannula forward using the index finger. The pressure applied when the operator tries to move the cannula forward using the index figure will impart pressure making the needle tip move downwards. This downward tilt will result in traumatic damage to the delicate wall of the blood vessels resulting in failure. U-Cannula, strap help to move the cannula over the needle forward. Pressure is applied on bottom & behind the cannula hub. This hypothesis was tested clinically using a hand made spring attachment to the existing cannula. By allowing cannula to move forward using spring, we could demonstrate successful placement in 94% in the first attempt. (Ref KM Srivatsa; Cannulation of blood vessels using a spring loaded device; Anesth Analg; 1992; 75; 859-60) facilitate forward movement Major manufacturers evaluated our technique and conducted feasibility studies, cost, and end users survey. Most doctors who saw our technique complimented our contribution but feared the product is likely to de-skill the doctors and nurses. This was not in the interest of major manufacturer of IV cannula; they also claim doctors find it hard to locate veins and hence high failure rate. We organized observational study to see if doctors find it hard to locate a vein and audit the number of failed attempts required to successfully introduce a cannula. Doctors did puncture veins (blood collection noticed in the blood collecting chamber) in 85% but failed to locate in only 15%. The average attempts required was 2.48 cannula were used to place one. Two cannula are discarded to successfully insert one cannula into a blood vessel. The total number of cannula used in canulate seventy three (73) children was one hundred and seventy seven (177). One hundred and four (104) cannula were discarded due to failed attempt resulting in wasted expense and contaminated hospital waste. Our mission is to reduce wasted plastic disposable medical products to reduce environmental pollution Intravenous cannulation – as well as the word ‘Venflon’ – is hated by all, especially patients and house officers. The former dislike it because it is painful, whereas the latter are repulsed more by the fact that inserting cannulas on a regular basis is such a sub-cortical job. But will it ever be possible to make patients at least more comfortable with them? About two years ago, when I was a PRHO, I successfully inserted about 60% of Venflons at the first attempt. My success rate improved rapidly, and, during my SHO year in Obstetrics and Gynecology, I managed to lift this a further 30% to 90%, (Lilantha Wedisinghe; GMC Today; Issue 11 January 2007) Introducing new technology to doctors working in hospitals is difficult. Introducing an add-on to help ease the present technique will benefit junior staff. We must take care to reduce the cost of manufacture and market this product to gain better penetration. As there are no products in this category, it is likely to benefit manufacturer to market. As doctors working in the hospitals we have evaluated the concept and collected opinions from numerous end users before investing our time and effort developing this product. Most doctors have been envious and have complimented this as a clever, most wanted device for use in the hospital. 2006©Medifix Ltd 4
  • 5. Cannula manufacturers do not acknowledge existing problem of associating IV Cannula and catheters to spreading antibiotic resistant bacteria. Various studies published in medical journals have identified this procedure to be a major risk. Unfortunately, the doctors do not have an alternate method to compare and clearly demonstrate this association. At present the debate is all about how long the cannula can be left in situ, effectiveness of disinfectants and skin preparation and hand washing technique. Spreading antibiotic resistant bacteria is not only threatening human kind but also likely to bring in the sad demise of medical profession. This will not be of interest of pharmaceutical companies, device manufacturers, and doctors. Antibiotic research was abandoned in 1970s by major pharmaceuticals due to poor return in their investments. It’s sad to see new antibiotics introduced in 2001 by two major corporations have now been withdrawn as bacteria have rapidly developed resistance. Antiseptics and disinfectants are found to be useless because the bacterial bio-film is impenetrable. We passionately believe cannula as a major contributor to this devastating scenario. In 1960s doctors have published papers linking cannula with staphylococcus aureus infections and claimed the increase is in tandem with use of intra-vascular device. Medical scientists organized studies in intensive care and published papers linking infection associated with long lines and catheters. Based on their finding, protocols were drawn to manage intra-venous cannulae. Unfortunately the present evidence show that these two procedures are not similar and the danger of introducing bacterial infection can occur before any catheter or long line is introduced. Hampshire hospital in UK introduced a policy and started implementing strict guidelines. Since introduction in 2007, they reduced MRSA infection from eleven to nil. They also claim that they did not encounter post-operation bacterial wound infections. This study clearly demonstrates our hypothesis of associating spreading antibiotic resistant bacterial infection with intravenous cannula. The study also makes raises an important question,” Is post-op surgical wound infection likely to spread via haematogenous route and not due to local skin commensal?” Implementing this policy and staff following protocol may or may not be easy due to practical and ethical (withholding treatment when necessary) issues. Using our device “The U-Cannula” we feel doctors will be in a better position to learn more about post-operative would infections and develop strategy to reduce it. U-Cannula is designed to reduce the spreading infection by helping doctors and nurses introduce cannula in the first attempt. Altering the design of the hub, needless connection could add value and prevent contamination and challenge ported cannula (50% are associated with infection) market. Doctors and nurses use the knob to move cannula forward and so reduce contamination of cannula hub. On average doctors & nurses require 2-3 attempts to successfully introduce one cannula. Subsequent attempts are more difficult because of poor peripheral circulation due to stress. Doctors or nurses fail to adhere to strict aseptic technique as they desperately search using their hands for a good vein to cannulae. Authorities are finding it hard to educate staff and these bacteria have now developed resistance to antibacterial and antiseptic cleaning solutions. We feel it is mandatory to introduce cannula in the first attempt to prevent introducing bacterial into circulation. Organizing clinical studies to assess cannulation technique is very difficult. We find doctors and nurses claim cannula introducing technique is easy yet they fail to introduce one 2006©Medifix Ltd 5
  • 6. successfully in the first attempt. Most doctors are now coming forward to accept there are difficulties and they claim to be successful in the second attempt. Cannula manufacturers claim the problem is to locate a vein because doctors tend to justify their failure by claiming the vein is bad, thrombosed or the patient is obese. In our observational study, we did notice blood collection in the blood collecting chamber when the doctors failed to introduce a cannula. Major manufacturers of IV Cannula invested large sums of their R&D fund to develop “Safety Cannula” to reduce “Needle-stick injury” to staff. These devices are now been aggressively marketed. These companies have been claiming injury from sharp instruments spread Hepatitis C, Hepatitis B, and HIV infections. Bandolier reviewed the result and concluded “This randomised trial could not be blinded. It was unlikely to show any difference in needlestick injuries with only 100 patients, but reminds us that blood contamination can come from other sources”. Occupational health department report the risk of infection occurring due to injury from sharp instrument (including needlestick) to Hep B (1 in 3), Hep C (1 in 30) & HIV (1 in 300). UK the NHS organized a study to identify the number of injuries reported and risk of infection. The study was published and the risk of contacting infection is very low. Between 1996-2004, in England, Wales & Northern Ireland, 9 Hepatitis C, & 1 HIV infection in Health care workers was reported. Based on various published papers and evidence presented we must be prepared to ask an ethical question “How safe is cannula”. If introducing infection when trying to introduce a cannula can result in severe infection result in death because we do not have efficient antibiotics to treat. IV Cannula is said to be more dangerous than drug. Published Articles in Medical Journal Alternative method of cannulation could reduce needlestick injuries and the spread of hospital-acquired infections; Managing Infection Control; March 2006 By Martina Benzing, MRCPCH (UK), PhD, and Kadiyali M. Srivatsa, MD Peripheral Venous Cannula Introducing Technique and MRSA Infection; Dr Kadiyali M Srivatsa Is Cannula Safe? ; Arab Medical Journal; January 2008 Dr Kadiyali M Srivatsa Complication of IV Therepy: Powerpoint Presentation Bacterial Colonization of IV Cannula in Cardiac surgery 2006©Medifix Ltd 6
  • 7. ADVANTAGE • Reduce number of attempts required to insert a cannulae (average 2.48) • Reduced time required to insert a cannulae (average 20 minutes) • New alternative release mechanism. • Add-on to ease existing technique. • Reduce contamination of annular hub • Four methods to choose insert cannula • Needle tip protection in vein reduce traumatic damage of veins • Reduction of Premature withdrawal • Reduction of Double puncture. • Plunger acts as cannula introducer. • Reduction of Needle Stick Injury • Reduce cannula fracture. • Reduce introducing Infection • Manually operated cannula. • Cannula hub move out with no jerks COMMENTS FROM END USERS ment • Easy to use simple but clever • Offer protection from needle stick injury. • May be capable of reducing the number of attempts • No complicated maneuvers to learn • Size of cannula is perfect. • Ingenious, original idea, may help advance our clinical practice of anesthesia • Technique may provide much needed relief to both patients and health care provider • No complicated maneuvers to learn • Good new technology, hope it helps • Very exciting concept, Senior Member, MHRA • Device certainly makes sense, and my opinion is that it will work quite well. Editor, Anaesteis Analgesia. • Novel idea, easy to use and safety profile good. • Why did I not think about this? • Thoughtful and ingenuity 2006©Medifix Ltd 7
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