October 27, 1998 SFGate DEADLY NEEDLES Fast Track to Global Disaster Reynolds Holding, William Carlsen, Chronicle Staff Writers- For decades, researchers warned that contaminated syringes could transmit deadly viruses with cruel efficiency. But efforts to defuse the crisis were failed, and today, it has become an insidious global epidemic, destroying millions of lives every year.

UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE STUDY LINKS HEPATITIS C SPREAD IN EGYPT TO INJECTION CAMPAIGNS

Researchers at the University of Maryland School of Medicine have concluded that a high prevalence of hepatitis C infection in Egypt can be traced to mass treatment campaigns to fight a common illness in that country decades ago. The study, conducted in cooperation with the World Health Organization and the Egyptian Ministry of Health and Population, is published in this week's issue of The Lancet.

The study suggests that the hepatitis C virus was transmitted through the contamination of reusable needles and syringes used in the treatment of schistosomiasis, a condition caused by a parasite in the blood.

Researchers say the treatment campaigns may account for the world's largest transmission of blood-borne pathogens resulting from medical intervention.

Hundreds of thousands of Egyptians received the treatment, called parenteral antischistosomal therapy (PAT), from the 1950's to the 1980's. Today, drugs for schistosomiasis are administered in pill form.

"They were given the only available form of treatment for a serious disease, but the treatment was administered with reusable injection equipment, as was the standard in those times," says Christina Frank, a doctoral candidate at the University of Maryland School of Medicine and author of the study. "Doctors meant well, but they were unaware of the dangers associated with inadequate sterilization procedures."

Frank and her colleagues reviewed historical public health records and statistics to determine whether there was a connection between the PAT injections and the hepatitis C rate in different age groups. Researchers found a significant association between exposure to PAT and Hepatitis C infection. A drop in the hepatitis C rate coincided with the gradual replacement of PAT injections with oral medications in the mid-1970's and early 1980's.

The investigators concluded that PAT played a major role in the spread of hepatitis C throughout Egypt. In part because of the high number of people who were infected, the risk of transmission remains high in the Egyptian population today. It is believed that at least 15% of the Egyptian population has been infected with hepatitis C. Liver disease caused by chronic hepatitis C infection is a significant health problem in Egypt today.

"The treatment campaigns were conducted with the best of intentions, using accepted sterilization techniques of the time," says Frank. "Testing for hepatitis C only became available in the early 1990's, years after PAT injection campaigns had ended."

"This situation is somewhat paradoxical," says Thomas Strickland M.D., Ph.D., professor of Epidemiology at the University of Maryland School of Medicine, and the director of the USAID-supported Hepatitis C Prevention Project that coordinated the study.

"Egypt's extensive and dedicated nationwide control program for schistosomiasis was the cause of the current high prevalence of hepatitis C in the country," says Dr. Strickland. "The practice of mass treatment with PAT before the danger of exposure to blood was so well known, and before the availability of disposable syringes and needles, provided a very potent means for transmission of blood-borne infections."

The role of parenteral antischistosomal therapy in the spread of hepatitis C virus in Egypt. 

Lancet 2000 Mar 11;355(9207):887-91 

Frank C, Mohamed MK, Strickland GT, Lavanchy D, Arthur RR, Magder LS, El Khoby T, Abdel-Wahab Y, Aly Ohn ES, Anwar W, Sallam I

University of Maryland, School of Medicine, Department of Epidemiology and

Preventive Medicine, Baltimore, USA. 

BACKGROUND: The population of Egypt has a heavy burden of liver disease, mostly due to chronic infection with hepatitis C virus (HCV). Overall prevalence of antibody to HCV in the general population is around 15-20%.The risk factor for HCV transmission that specifically sets Egypt apart from other countries is a personal history of parenteral antischistosomal therapy (PAT). A review of the Egyptian PAT mass-treatment campaigns, discontinued only in the 1980s, show a very high potential for transmission of blood-borne pathogens. We examine the relative importance of PAT in the spread of HCV in Egypt. METHODS: The degree of exposure to PAT by cohort was estimated from 1961-86 Ministry of Health data. A cohort-specific exposure index for PAT was calculated and compared with cohort-specific HCV prevalence rates in four regions. FINDINGS: HCV prevalence was calculated for 8499 Egyptians aged 10-50 years. A significant association between seroprevalence of antibodies to HCV and the exposure index (1.31 [95% CI 1.08-1.59]; p=0.007) was identified across four different regions. In all regions cohort-specific HCV prevalence was lowest in children and young adults than in older cohorts. These lower prevalence rates coincided with the gradual and final replacement of PAT with oral  antischistosomal drugs at different points in time in the four regions. INTERPRETATION: The data suggest that PAT had a major role in the spread of HCV throughout Egypt. This intensive transmission established a large reservoir of chronic HCV infection, responsible for the high prevalence of HCV infection and current high rates of transmission. Egypt's mass campaigns of PAT may represent the world's largest iatrogenic transmission of blood-borne pathogens.

PMID: 10752705, UI: 20214379

Theory Links Hepatitis C
to Polio Syringes in Italy
Thu April 10, 2003 02:41 PM ET
By Rossella Lorenzi

FLORENCE, Italy (Reuters Health) - Poorly cleaned glass syringes used to administer the polio vaccine in the 1950s and 60s could have spread the hepatitis C virus from person to person in southern Italy, researches from Italy's National Cancer Institute suggested this week.

The accidental spread of the virus might explain why southern Italy has a particularly high rate of the chronic liver disease, suggest Dr. Maurizio Montella and colleagues.

In the mid 1950s and 1960s, an injected vaccine known as the Salk vaccine was used to protect against the crippling disease polio. In southern Italy, reusable glass syringes were used to deliver the vaccine until the new oral version, known as the Sabin vaccine, was introduced in 1965. The authors' theory is that the syringes, if not properly sterilized, may have spread the hepatitis C virus.

Montella told Reuters Health Wednesday there was already some indirect evidence linking the glass syringes used for the older vaccine to high hepatitis C rates.

"The phenomenon is circumscribed to certain areas -- where glass syringes were widely used, there is an increase of hepatitis C cases," he said.

To look closer at the link, he and others drew on a previous investigation that included a sample of 1,908 people aged 30 to 60 years.

The subjects were originally enrolled as healthy "controls" in another study. They were known not to have used intravenous drugs or to have had blood transfusions, both of which can spread the disease.

Tests showed that seven percent of men and five percent of women aged 40 to 49 years had antibodies to hepatitis C, suggesting infection with the virus. People born between the 1940s and early 1960s were nearly three times as likely as younger subjects to have the virus, they reported in this month's Journal of Medical Virology.

Overall, about six percent of older adults had been infected with the virus compared with about two percent of those aged 30 to 39.

The prevalence of hepatitis C is about 1.8 percent in the U.S. and ranges from 0.5 percent to nine percent in Western Europe.

"This is indisputable data, and it is linked to the years when the Salk polio vaccination was administered," Montella said. "The high rate of HCV is most likely attributable to a misuse and reuse of needles and glass syringes being inadequately sterilized."

Because chronic hepatitis C infections may not cause any symptoms, "it will be useful to inform the population of southern Italy about the implication to their future health," the authors write in the article.

About four million people in the United States and 150 million worldwide have hepatitis C, an infection of the liver that is spread by contact with blood and other body fluids.

About 20 percent of people infected with the virus will develop severe and potentially fatal liver damage, or cirrhosis, which in turn increases a person's risk of liver cancer.

SOURCE: Journal of Medical Virology 2003;70:49-50

Federal Safety Needle Legislation

VERNON, Conn.--(BW HealthWire)--May 20, 1999--The momentum toward mandating safe needles to protect health care workers continues to grow. Today in Washington, D.C., Representative Pete Stark (D-California) and
Representative Marge Roukema (R-NJ) introduced a bill in Congress mandating the use safe needles for healthcare workers.

The proposed legislation mirrors the 1998 California law requiring that
hospitals use needles designed with `engineered controls' to protect the
workers from accidental needlesticks. ``Mandating the use of safe needles on a national level will have a tremendous impact in preventing accidental
needlesticks,'' said Tom Sutton, Executive Vice President at Bio-Plexus, Inc. According to Congressman Stark's office, needlestick injuries caused by hollow-bore needles account for 86% of all reported occupational HIV exposures, and every year more than 200 health care workers die of occupationally acquired hepatitis.

``If safety needles are nationally mandated, as it appears they may be, conventional, `unsafe' needles will become obsolete,'' Sutton concluded. In addition to being endorsed by Bio-Plexus, the act is also supported by
organizations including: the American Nurses Association, Kaiser Permanente, the American Federation of State, County and Municipal Employees, the Service Employees International Union, the American Federation of Teachers, and Becton Dickinson, a major medical device manufacturer.

On the state level, legislation mandating the use of safety needles has passed in California and Tennessee. In April, Maryland passed a bill requiring the state to develop recommendations to protect health care workers. Legislation is pending in Texas, New Jersey, Arkansas, Connecticut, Massachusetts, Michigan, and New York.

Bio-Plexus, Inc. (NASDAQ:BPLX - news), designs, develops, manufactures, markets, and holds U.S. and international patents on safety medical needles and other products under the PUNCTUR-GUARD® and DROP-IT® brand names. In a Centers for Disease Control study, Punctur-Guard Blood Collection Needles were found to reduce the rate of accidental needlesticks among healthcare workers by 76%, the highest rate of any device studied. Accidental needlesticks number about one million per year in the United States and can result in the transmission of deadly diseases including HIV and Hepatitis.

Needleless Connectors and Bacteremia: Is There a Relationship?

Needleless connectors, used today as integral components of an infusion system, evolved in response to demands for enhanced healthcare worker safety and as part of the continuing development of infusion technology. At this time, there are three design categories among needleless connectors: split septum connectors, luer activated valves, and luer valves with positive displacement. Numerous branded products are available within each category. Although needleless connectors offer enhanced safety features, there have been recurrent concerns about an increased risk of bacteremia associated with their use. This article reviews the development of these devices, examines the available evidence base, identifies unresolved issues, and suggests strategies to facilitate optimum use of needleless connectors within infusion systems.

During the past two years there has been increasing concern expressed by infection control practitioners, infusion specialists, and epidemiologists that the use of needleless connectors, either generally or specifically according to design category or brand, is directly responsible for increased bacteremia inpatients receiving intravenous therapy.

Bacteremia associated with infusion therapies is known to increase morbidity, prolong inpatient hospitalizations, and significantly increase the economic impact of care.¹ The incidence of catheter-related bloodstream infections is disturbingly high, especially among central catheters, and the mortality risk has been reported as high as 30 percent in ICUs.² Since intravenous therapy is among the most widely used invasive procedures in all healthcare settings, the risk of complications is often also high. If any part of an intravenous system increases patient risks, then the clinician must be aware of it and be prepared to respond accordingly.

First Generation Products
Prior to the 1980s, intermittent access to an intravenous system was accomplished by inserting a beveled, hollow bore needle into a latex cap positioned either along the administration set or at its termination. The needle was often secured with tape and was prone to disconnection. Emerging technology soon combined with engineering controls required under the Occupational Safety and Health Administration (OSHA) Boodborne Pathogens Standard to produce a new generation of connectors.

This first generation of devices featured a split septum that could be repeatedly accessed with a blunt cannula. These connectors were designed to accommodate the need for intermittent access to the intravenous system while simultaneously eliminating the use of needles. The split septum connectors were used in combination with other emerging technology, including safety catheters that typically offered recessed or retractable needles. Although this new technology was neither immediately nor universally adopted and the costs associated with its use often posed a barrier to implementation, these first generation safety products were successful in reducing the exposure incidents reported by healthcare workers.³ However, the first generation split-septum products did not address the problem of catheter occlusion. Split-septum connectors created negative pressure when the blunt cannula was withdrawn. Any negative pressure at the time of disconnection can jeopardize device patency by allowing retrograde flow into the lumen of the catheter.

Second Generation Products
During the 1980s, technology continued to evolve. The second generation of needleless connectors replaced the split-septum design with an anti-reflux valve activated by the use of a malefemale luer configuration. The process of joining the luer components created a locking action that exceeded the stability of the connection possible with the splitseptum product. Since female and male luer mechanisms were already a well-established concept within medical device design, the integration of a luer into a connector was easily understood and accepted by clinicians.

Like the first generation of connectors, the luer devices permitted intermittent access and eliminated the use of needles. However, its unique design was compatible with the use of most syringes and the need for a blunt cannula was eliminated. In addition, the ant-reflux design of the luer activated valve helped neutralize any negative pressure occurring when the syringe (or other luer device) was disconnected from the needleless connector. And when used according to manufacturer guidelines, these products did not demonstrate an increased safety risk.

Unfortunately, the luer compatible design has been demonstrated to pose other, non-infectious safety risks to patients. The serious incidents that have been reported have all involved incorrect product use. For example, in 1996 and 2002 the Institute for Safe Medicine Practices cautioned the healthcare industry about the potential to connect a syringe containing oral medication to an intravenous system by attaching it to a needleless valve.⁴ In 2003, the Food and Drug Administration (FDA) issued a safety alert following a patient death when oxygen was accidentally connected to a needleless luer device.⁵ However, during these years intravenous systems were also evolving. Implanted infusion ports were introduced for patients requiring long-term therapies.

Tunneled central catheters became a viable option for patients no longer candidates for peripheral infusions. Peripherally inserted central catheters (PICCs) offered a safer alternative when therapy was expected to continue for more than several days.

Third Generation Products
With more advanced catheter design and the clinical demand for extended catheter dwell times, the need to maintain patency became a growing clinical concern. Replacement of clotted catheters was expensive and traumatic for the patient. A clotted lumen can also increase the risk of infection. A number of solutions emerged to address this need, including the development of a valved catheter, the use of fibrinoloytics for catheter clearance, and the introduction of a positive displacement connector.

The third generation of connectors combined the existing lueractivated valve concept with a displacement action. This action expels a small amount of the solution used to flush the catheter when the syringe used for flushing is disconnected from the leur. The displacement is a passive feature and occurs automatically. Once this action has occurred, the remaining solution (usually heparin or saline) is retained within the catheter and no further positive pressure exists. The positive pressure luer connector is designed to reduce retrograde flow into the catheter more effectively that either split-septum or standard luer connectors.

However, although the third generation of connectors offered advantages over previous designs, they cannot prevent occlusion completely or under all circumstances. Nonetheless, positive displacement connectors are now widely used to help reduce complications in central catheters. Today, examples of split-septum, luer-activated and positive displacement luer connectors are commercially available and commonly used in intravenous systems (see Table 1).

The gradual introduction of and product diversification within needleless connectors was accompanied in the 1990s by concerns regarding their infection risks. Studies published during this time period revealed a number of issues that could potentially lead to increased infections. For example, needleless connectors were not always used according to manufacturer guidelines. Infection risks increased when connectors were changed less frequently than specified in protocols.^6-8 An increased infection risk was also linked to specific infusates such as TPN or other independent risk factors such as use of multilumen catheter or recent BMT.^9-10

Although a variety of needleless connectors were investigated, no individual products were conclusively associated with either increased risk or national outbreaks. While initial concerns focused on device failure, a better understanding of device use in conjunction with enhanced product design, helped allay clinician fears and allow needleless connectors to remain an integral safety component of most, if not all, intravenous systems. In fact in 2002 the HICPAC IV Guideline stated that “when devices are used according to manufacturer’ recommendations, they do not substantially affect the incidence of CRBSI.”¹¹

Since the 1990s, concerns have lingered about the relationship of needleless connectors to bacteremia. Infection control experts have remained alert to the serious complications that can potentially be associated with these seemingly innocuous devices. But the need for better device-related science remains an elusive goal.

A review of the literature indicates that the studies of the 1990s have not been significantly expanded by subsequent experimental research. In fact, although millions of needleless connectors are used in patient care, the scientific evidence upon which to base their use remains limited. Current studies vary widely in their scope, design, and scientific rigor.

For example, from 1999 to 2004, three new studies attempted to examine the efficacy of positive pressure in maintaining the patency of central venous catheters. These prospective studies show that positive displacement of fluid within central catheters is more effective than negative pressure (or displacement) in preventing occlusions. However, these studies also show that the positive displacement action accomplished with valve technology cannot eliminate the problem of occlusion in all central venous catheters.^12-14

Recent published reports have investigated the issue of infection. Two studies, using different products, have reported a reduced potential for microbial contamination when traditional caps were replaced with a needle-free, luer valve that was been appropriately disinfected prior to use.^15-16

As risks associated with needleless connectors have become an international infection control concern, published reports are now available in non-U.S. based clinical journals. For example, an evaluative study conducted in Britain reported inconsistency of use and routine care of all connectors used with central catheters prior to staff education and standard implementation of a luer valve.¹⁷ A randomized controlled trial conducted in Spain among intensive care patients requiring central venous catheters found a significant reduction in bacteremia when a needleless connector was used in place of a three-way stopcock.¹⁸

In addition to the studies published in scientific, peer-reviewed journals there are also a number of product evaluation studies or reports that have appeared in clinical practice journals, on Web sites, and in trade publications. These articles generally describe an institution’s experience in using a needleless connector or after changing brands. This level of evidence is typically presented either as a quasi-experimental study or as descriptive research and lacks the scientific rigor and control used in the experimental designs. Their lack of control is especially problematic when attempting to infer causation and/or generalize the findings to other practice settings.

Similar to the experiences of a decade ago, reports of bacteremia have resurfaced. The implied cause of these new or increased infection rates appears to be the use of needleless connectors. Concern about the use of needleless connectors has been expressed in presentations, posters, and/or abstracts presented at annual meetings such as the Society of Healthcare Epidemiologists of America (SHEA), the Association for Professionals in Infection Control and Epidemiology (APIC), and other professional organizations since 2004. Simultaneously, some manufacturers have attempted to leverage infection concerns to better position their individual brands. For clinicians struggling to understand the issue, the result is often a confusing jumble of genuine, albeit unanswered, device concerns with product marketing claims, data from bench studies, expert speculation, and over-generalization of findings from institutional reports.

The dilemma remains, as it did a decade ago, the same for all who currently attempt to analyze the infectious risk potential of these devices. There is simply not enough scientifically rigorous evidence upon which to make a conclusion. Although there have been sporadic reports of increased infections, there is insufficient evidence to indicate a trend that can be reliably associated with a specific type of connector or any particular product.

In order to fully understand the risk potential of any type or brand of needleless connector, several important factors need to be clarified.

1. User Error or Device Failure?

Most published reports have not measured the potential for user error. Any break in aseptic technique when using a needleless connector sets the stage for potential infection. At this time, the lack of information related to user error with needleless connectors is a significant barrier in analyzing the underlying cause of actual or presumed increases in bactermia. Although the devices are mechanically simple and their use intuitive, user errors can still occur. For example, clinicians may not disinfect the surface of the connector before accessing the intravenous system. Connectors may not be flushed completely after use or may not be changed according to established protocols. Luer valves may not fully rebound upon disconnection. Split-septum connectors may be damaged by incorrect access with a needle or an incorrectly placed needle rather than a blunt cannula. Extension sets, attached to connectors and intended for intermittent IV access, may not be clamped as required by the manufacturer.

In any study that attempts to identify causation, it is essential that all reasonable contributing variables be identified and controlled. Without this essential step, it is easy to draw the wrong conclusion. Allegations of device failure are often the initial and presumptive cause attributed to sudden increases in bloodstream infections. While concern over device failure is a possibility that must always be considered, it cannot be presumed to the primary cause when insufficient evidence exists to support the claim. At the same time, designing a clinical study that can achieve the necessary level of control is very challenging and can be cost prohibitive for the sponsoring institution. This is particularly problematic when studying needleless connectors since both the number of potential users and opportunities for intentional or accidental misuse is high in all practice settings where infusion therapies are administered.

The potential impact of incorrect use cannot be ignored, especially since the study by Cookson et al. reported that only 60 percent to 70 percent of nurses maintained needleless connectors correctly.⁶ While procedural compliance by clinicians performing infusion therapy has not been thoroughly studied, other aspects of infection control have been. Perhaps the best-known focuses on hand washing where, no matter how frequent or extensive the education provided, clinician compliance rarely exceeds 40 percent.²² If compliance with the use of needleless connectors is similar to compliance with handwashing, user error could emerge as the most important contributing factor in device-related infections. At this time, however, it remains an unknown variable.

2. Device Design In spite of marketing claims to the contrary, the superiority of one type of design for needleless connectors has not been proven. In fact, the impact of residual volumes, dead spaces, and flow rates on infection risk has not been extensively analyzed. Manufacturers will inoculate the access surface and/or the fluid pathway of their device with bacteria to test, under strict laboratory conditions, the efficacy of surface decontamination with an approved disinfectant as well as the possibility of bacterial growth and transfer along the fluid pathway. Such testing is usually limited to seven or eight consecutive days. Longer-term outcomes, especially in less rigidly controlled environments, have not been discussed in the literature.

Part of the current controversy focuses on determining whether split septum or luer-activated valve technology represents the safest approach in preventing catheter-related bloodstream infections. Until more evidence exists regarding the impact of mechanical design aspects on infection risk, none of the three currently available categories of needleless connectors can claim superiority.

3. The Impact of Biofilm Microbial biofilm is the accumulation of polymers excreted by bacterial cells adhering to a device surface. The accumulation of biofilm on medical devices, including intravenous catheters, cannot be prevented and creates clinical management challenges for long-term, indwelling devices. Biofilm accumulates rapidly on central venous catheters and once in place, is difficult to eradicate. Biofilm-related infections often require removal of the device.¹⁹

There has been minimal investigation on the role that biofilm may play in the needleless connector controversy. A study published in 2001 examined needleless connectors used at a bone marrow transplant center. The results of this analysis showed that 63 percent of the 24 needleless connectors tested contained biofilms comprised predominantly of coagulase-negative staphylococci.^20-21 These results suggest additional questions. If biofilm has been detected on central venous catheters is less than 72 hours after placement, is development within needleless connectors equally as rapid? Is the accumulation of biofilm facilitated by mechanical design aspects of these devices? Does biofilm demonstrate an affinity for split-septum products, luer-activated valves, or is there no difference? Answers to these and many other questions will remain unanswered until more research is done.

The lack of reliable evidence, although highly problematic, is not an insurmountable obstacle for ICPs urgently seeking to prevent bacteremia in patients receiving infusion therapies. Awareness of a limited evidence base helps direct decisions and actions along lines of the best available data and objective reasoning. The following list summarizes steps that infection control practitioners can take now.

• Use interdisciplinary collaboration to verify that surveillance systems and collection of epidemiological data for intravenous procedures are adequate. Although device-specific surveillance often focuses on critically ill patients, risks may also be high among those who are less acutely ill but require long-term catheters and therapies. Collaboration is essential in identifying these patient groups and mobilizing the resources to conduct the necessary data collection and analysis.
• Critically examine the impact of intravenous education and training in your institution. Although infusion therapy is among the most commonly performed invasive procedures, most clinicians have received very little formal education about it. While manufacturers can provide excellent in-service programs and training materials, it is the responsibility of the institution to make sure that procedural compliance and infection control standards are maintained, reinforced and reviewed as often as necessary to meet patient care goals.
• Carefully analyze all product literature and studies. Understand the scope of published studies and whether their design, methods, findings, and conclusions meet the standards of scientific evidence. Insist that claims of product superiority be supported with reliable information. Be an informed, skeptical, and objective consumer when confronted with product marketing.
• Remember that while intravenous therapy systems and products are always changing and it is important to keep current with new technology, no product can replace sound clinical judgment, critical decision-making, and rigorous infection control practice.
• Look for new scientific evidence. Research in the use of needleless connectors, and especially the impact of biofilm, continues and clinicians should expect that the current evidence base with be expanded by future studies.
• Involve your patients. This is especially important in patients who require long-term or chronic therapies. These individuals are often experts in managing their catheters and supplies that far exceed that of many healthcare professionals; their feedback can be an important addition to your regular sources of information and evaluation.

Needleless connectors, initially designed to reduce needlestick exposures among clinicians, have contributed to a safer workplace and helped reduce the injury risks associated with performing infusion procedures. Whether or not needleless connectors increase the risk of bacteremia or prevent catheter occlusion is less certain.

Effectiveness of intraluminal fluid displacement triggered by specific valved connectors is suggested by current studies but has not been extensively examined in the literature. At the same time, as needleless connectors have been the alleged cause of infection outbreaks, studies have failed to conclusively demonstrate the link or identify any product trends. Many products have been investigated but none have shown greater or lesser risk for potential infections. Many important variables in the infection equation, including user error, mechanical design, and the role of biofilm, remain unknown.

Like all medical products, needleless connectors present the clinicians with both advantages and disadvantages. And like other products, they are only as safe and reliable as the individuals using them. Until conclusive evidence becomes available to differentiate among existing products or as part of a new generation of products, clinicians must continue to include monitor needleless connectors, evaluate device-related outcomes, and seek to better understand the potential for user error within all practice settings. ICT Marilyn Hanchett, RN, PhD, is director of clinical affairs for IgG America.

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2. Pittet D, Tarara D, Wenzel RP. Nosocomial bloodstream infection in critically ill patients. Excess length of stay, extra costs and attributable mortality. JAMA 1994; 271: 1598-601.

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4. FDA Safety Alert. Subject: Clearlink System. May 13, 2004. Food and Drug Administration, Washington, D.C.

5. Medication Safety Alert, June 17, 2004: Problems persist with lifethreatening tubing misconnections. Institute for Safe Medication Practices, Philadelphia, Pa.

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12. Hoffer EK, Borsa J, Santulli P et al. Prospective randomized comparison of valved vs. nonvalved peripherally inserted central vein catheters. Am Journal Reontgenol. 1999: 173: 1393-98.

13. Hoffer EK, Bloch RD, Borsa J et al. Peripherally inserted central catheters with distal vs. proximal valves: prospective randomized trial. Journal Vasc Interv Radiology 2001: 12: 1173-77.

14. Jacobs BR, Schilling S, Doellman D et al. Central venous catheter occlusion: a prospective, controlled trial examining the impact of a positive pressure valve device. Journal Parenter Enteral Nutrition 2004: 28: 113-8.

15. Bouza E, Munoz P, Lopen-Rodtrquex J et al. A needleless closed device (CLAVE) protects from intravascular catheter tip and hub colonization a prospective randomized study. Journal Hosp Infection 2003 Aug: 54(4(: 279-87.

16. Casey AL, Worthington T, Lambert PA et al. A randomized, prospective clinical trial to assess the potential infection risk associated with the PosiFlow needleless connector. Journal Hosp Infect. 2003 Aug: 54(4): 288-93.

17. Cheesman D. Intravenous care: the benefits of closed system connectors. British Journal Nurs. 2001 Mat 8-21; 10(5): 287-95.

18. Yebenes JC, Vidaur L, Serra-Prat M et al. Prevention of catheter-related bloodstream infection in critically ill patients using a dsinfectable, needle free connector: a randomized controlled trial. Am Journal Infect Control 2004 Aug; 32(5): 291-5.

19. Ryder M. Catheter-related infections: it’s all about biofilm. Topics in Advanced Practice Nursing eJounral 2005; 5(3) 2005 Medscape.

20. Donlan RM, Murga R, Bell M, Toscano CM, Carr JH, Novicki TJ, Zuckerman C, Corey LC, Miller JM. Protocol for detection of biofilms on needleless connectors-attached to central venous catheters. Journal Clinical Microbiol. 2001 Feb; 39(2):750-3.

21. Biolfilms and device-associated infections. Emerging Infect Dis. 2001 Mar-Apr; 7(2):277-81.

22. Kuzu N, Ozer F, Aydemir S, Yalcin AN, Zencir M. Compliance with hand hygiene and glove use in a university-affiliated hospital. Infection Control Hosp Epidemiology 2005 Mar; 26(3): 312-5.

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