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CIN2011

Control of hepatitis C virus transmission in dialysis units; should we isolate? Adel Afifi, Hayam Aref and Lina Khedr. Nephrology dept. Ain Shams University, Cairo, Egypt. Abstract: Hepatitis C virus (HCV) infection is a significant cause of morbidity and mortality in hemodialysis (HD) patients. The reported prevalence of HCV among the HD population has varied greatly from 1.9 to 84.6% in different countries in recent years. The length of time on HD is generally believed to be associated with HCV acquisition. Nevertheless, several recent reports failed to recognize any significant role of blood transfusion. Several studies of viral isolates suggested nosocomial patient-to-patient transmission of HCV among HD patients for which the main potential source is believed to be contaminated hands and articles. However, isolation of HCV-infected HD patients and use of dedicated machines are currently unjustified, while strict adherence to universal precautions seems to be enough to control disease spread in HD units. Introduction and review of literature: Hepatitis C virus infection (HCV) is a major public health problem and a leading cause of chronic liver disease. An estimated 180 million people are infected worldwide. Hepatitis C virus (HCV) is a leading cause of liver cancer and cirrhosis. Some calculations suggest that mortality related to HCV infection (death from liver failure or hepatocellular carcinoma) will continue to increase over the next two decades (1) The prevalence of HCV infection in patients on hemodialysis is highly variable but clearly much higher than in the general population of the respective countries. The high incidence and prevalence of HCV antibodies among patients on dialysis can be attributed to several risk factors including the number of blood transfusions, duration of dialysis (the interval since beginning dialysis has been reported to be significantly longer among anti-

HCV-positive patients) (2,3) and mode of dialysis (lower HCV prevalence among peritoneal dialysis patients) (4). The prevalence of HCV infection is lower in those who began their replacement therapy with PD than in those who started with HD, ranging from 2% to 29.7%. Patients on peritoneal dialysis (PD) are at lower risk of HCV infection and, in contrast to haemodialyzed patients, the duration of PD does not appear to be a risk factor for acquiring HCV infection. In addition, the majority of anti HCV positive PD patients may have acquired HCV infection while they have been on hemodialysis (3,5). One or more of the following factors can account for the lower risk of HCV infection among PD patients: 1) PD patients have a lower requirement for blood transfusion than hemodialysis patients. 2) The absence of access site and extracorporeal blood circuit reduces the risk of parenteral exposure to the virus. 3) PD offers a more isolated environment since it is a primarily home procedure. Patients treated in hemodialysis units with high prevalence of HCV infection are at increased risk of acquiring infection. Among units with a prevalence of less then 19%, the annual incidence of seroconversion for anti-HCV was 2.5%. By comparison, among units with a prevalence of HCV infection greater than 60%, the annual incidence of seroconversion was 35.3% (3). Several of the following factors may affect the risk of transmission of HCV to patients and staff in dialysis units: 1) The risk of transmission of HCV from infected patients to medical staff by needle-stick injury ranges from 2.7 to 10% (6). 2) Physical proximity to an infected patient: The Portuguese Society of Nephrology survey found the lowest incidence of HCV infection in dialysis units that used isolated rooms to treat anti-HCV-positive patients (3,7). 3) Breakdown in standard infection control practices: Several outbreaks of HCV infection in dialysis units have been associated

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with a failure to rigidly enforce universal precautions and standard infection- control measures, such as sharing of a multi-dose heparin vial between patients with and without HCV infection and failure to change gloves between patients while performing dialysis treatments. HCV RNA has also been detected on the hands of some dialysis staff despite apparent adherence to standard precautions. This observation raises the possibility that dialysis staff could be a potential vector for HCV transmission between dialysis patients. Savey described a large outbreak of 61 patients in a French HD centre mainly supported by patient-to-patient transmission via health care workers hands (8) . Indirect evidence suggesting that infection results from breaks in infection- control practices was also provided by an Italian study of 58 dialysis units (3,9). A multicentre prospective study from Belgium unequivocally demonstrated that enforcement of universal precautions alone could fully prevent transmission of HCV in dialysis units (3,10). In addition, a recent systematic review on transmission of HCV in healthcare settings in USA between 1998 and 2008 reported that inappropriate use on multiple patients of single use vials and failure to store and prepare medications under aseptic conditions were responsible for HCV transmission in 15 outbreaks occurring in nonhospital healthcare settings (6 of which were HD units (11). As a consequence, to prevent transmission of blood borne viruses in HD settings, Center for Diseases Control and Prevention (CDC) recommend that all single-use injectable medications and solutions should be dedicated for use on a single patient and should be entered one at a time only (8). 4) Dialysis machines Several reports have linked a high incidence of HCV infection in dialysis patients who shared dialysis machines in dialysis unit. In addition, the use of dedicated machines and isolated areas for antiHCV-positive patients along with strict enforcement of universal precautions was associated with a decrease in the incidence of seroconversion. Similarly, a survey by the Portuguese Society of Nephrology found a significantly lower incidence of HCV infection in units that used dedicated machines for HCV-positive patients (3,10). However, the need for isolation and the use of dedicated machines for anti-HCV-positive patients has been challenged. In a multicentre study from Belgium, for example, no new cases of HCV

CIN2011

infected patients occurred over a 54 month study period, despite the observation that none of the participating dialysis centers used dedicated machines for anti-HCV-positive patients, and over 70% of the patients were dialyzed in units whose monitors were not disinfected after each session (3). Currently, the best available evidence on the impact of isolation measures on HCV transmission to hemodialysis patients derives from two large prospective observational studies. The DOPPS and an Italian study concur that, after multivariate adjustment for potential confounders especially the prevalence of HCV infection within each hemodialysis unit, isolation does not protect against HCV transmission in hemodialysis patients. Some prospective observational studies have reported a reduction of HCV transmission after the reinforcement of basic hygienic precautions, without any isolation measures. In particular, one Belgian prospective multicenter study showed a reduction from 1.4 to 0% of the yearly incidence of seroconversion for HCV. This demonstrated that complete prevention of HCV transmission to hemodialysis patients was possible in the absence of any isolation policy(12). Additional arguments against relying on the use of isolation to prevent transmission of HCV include the possibility of increased risk of HCV infection with more than one genotype and the time between infection and seroconversion. The seroconversion time (window) can be over a year and has a median length of 5 months in hemodialysis patients even with third-generation EIA tests. This will result in inadequate selection of patients to be isolated, unless costly NAT is performed frequently. If nosocomial transmission continues to occur, despite reinforcement of the precautions, a local isolation policy may be necessary. HCV-infected patients should be treated by dedicated staff in a separate room, area, or shift (morning, afternoon, or evening), as there is no rationale for using dedicated machines. It should be realized that accepting the need for isolation equates to accepting the impossibility of full implementation of basic hygienic precautions, a regrettable situation that entails the risk of transmission of pathogens other than HCV (12). At the present time, the Center for Disease Control and Prevention (CDC) does not recommend isolation of patients with HCV (13). The evaluation of this problem is difficult because of the paucity of prospective studies and the scarce data about patient-to-patient transmission in settings other than HD centers (14).

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A study done in the year 2003 at Ain Shams university hospital in Cairo, Egypt, demonstrated that in the absence of adherence to standard infection control precautions, isolation alone was ineffective for prevention of HCV transmission as the seroconversion rate was 37% among HCV negative patients. Neither the use of single use dialysers nor single pass machines nor the policy of stopping blood transfusion proved to be efficient in prevention of HCV transmission within HD units without adherence to infection control precautions. Only after continuous reinforcement of infection control program the incidence of HCV infection dropped from 37 % to 27% to 7.8% in the second and third years respectively (15). Theoretically, the passage of HCV through intact dialyzer membranes seems improbable as the viral particles have an estimated diameter of 35 nm, much higher than the pores of the most permeable dialysis membrane. Nevertheless, the passage of the virus into the dialysis compartment could result from any alteration in pore size or disruption of the membrane integrity associated with the process of filter assembly, the dialysis session itself, or with dialyzer reuse (3). Two studies have reported that neither low-flux nor high-flux dialyzers permit contamination of the dialysis ultra filtrate with HCV RNA. In similar reports, other investigators suggest that lower trans-membrane pressure should be used in anti HCV positive patients to minimize the risk of HCV transmission. In contrast, others have detected HCV RNA by the PCR method in the dialysate of apparently intact polyacrylonitrile membranes but not in cellulose membranes (3,16). It is important to emphasize that detection of HCV RNA in the dialysate by PCR may only imply the presence of fragments of viral RNA, not the infective virus itself, a situation which may not lead to transmission of the infection (3,17). Reprocessing the dialyzers: The main risk for HCV transmission associated with the reprocessing of dialyzers is to the staff involved. Theoretically, contaminated blood could be transferred if dialyzers or blood port caps that have not been sterilized effectively are switched between patients, but this should not occur if procedures are followed correctly (12) . Dialyzer reuse was not identified as a risk factor for seroconversion for HCV in the CDC surveillance data or in the Belgian prospective multicenter study.

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KDIGO guidelines for prevention of HCV transmission in HD units: Guideline 1: Hemodialysis units should ensure implementation of, and adherence to, strict infection-control procedures designed to prevent transmission of blood-borne pathogens, including HCV (Strong). Isolation of HCV-infected patients is not recommended as an alternative to strict infection-control procedures for preventing transmission of blood-borne pathogens (Weak). The use of dedicated dialysis machines for HCV-infected patients is not recommended (Moderate). Where dialyzer reuse is unavoidable, it is suggested that the dialyzers of HCV-infected patients can be reused provided there is implementation of, and adherence to, strict infection-control procedures (Weak). Guideline 2: Infection control procedures should include hygienic precautions that effectively prevent the transfer of blood - or fluids contaminated with blood - between patients, either directly or via contaminated equipment or surfaces. (Strong) It is suggested to integrate regular observational audits of infectioncontrol procedures in performance reviews of hemodialysis units (Weak). General hygienic precautions for hemodialysis units Hand hygiene: During the process of hemodialysis, exposure to blood and potentially contaminated items can be routinely anticipated; thus, gloves are required whenever caring for a patient or touching the patients equipment. To facilitate glove use, a supply of clean nonsterile gloves and a glove discard container should be placed near each dialysis station. Hands always should be washed after gloves are removed and between patient contacts, as well as after

CIN2011

touching blood, body fluids, secretions, excretions, and contaminated items. A sufficient number of sinks with warm water and soap should be available to facilitate hand washing (18). Staff should wash their hands with soap or an antiseptic hand-wash and water, before and after contact with a patient or any equipment at the dialysis station. An antiseptic alcohol gel rub may be used instead when their hands are not visibly contaminated. In addition to hand washing, staff should wear disposable gloves when caring for a patient or touching any potentially contaminated surfaces at the dialysis station. Gloves should always be removed when leaving the dialysis station. Where practical, patients should also clean their hands, or use an alcohol gel rub, when arriving at and leaving the dialysis station (12). Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Such protective clothing or gear should be changed if it becomes soiled with blood, body fluids, secretions, or excretions. Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. However, patients can be served meals or eat food brought from home at their dialysis station. The glasses, dishes, and other utensils should be cleaned in the usual manner; no special care of these items is needed (18). Any item taken to a patients dialysis station could become contaminated with blood and other body fluids and serve as a vehicle of transmission to other patients either directly or by contamination of the hands of personnel (18). Single-use items required in the dialysis process should be disposed of after use on one patient. Non disposable items should be disinfected after use on one patient. Items that cannot be disinfected easily (for example, adhesive tape, tourniquets) should be dedicated to a single patient. The risks associated with the use of physiologic monitoring equipment (e.g., blood pressure monitors, weight scales, access flow monitors) for groups of patients should be assessed and minimized. Blood pressure cuffs should be dedicated to a single patient or made from a light-colored, wipe clean fabric.

CIN2011

Medications and other supplies should not be moved between patients. Medications provided in multiple-use vials, and those requiring dilution using a multiple-use diluent vial, should be prepared in a dedicated central area and taken separately to each Patient. Items that have been taken to the dialysis station should not be returned to the preparation area. CDC recommends that all single-use injectable medications and solutions be dedicated for use on a single patient and be entered one time only. Medications packaged as multidose should be assigned to a single patient whenever possible (19). Equipment management: After each session, all potentially contaminated surfaces at the dialysis station should be wiped clean with a low-level disinfectant if not visibly contaminated. Surfaces that are visibly contaminated with blood or fluid should be disinfected with a commercially available tuberculocidal germicide or a solution containing at least 500 p.p.m. hypochlorite (a 1:100 dilution of 5% household bleach). For each chemical cleaning and disinfectant agent units should follow the manufacturers instructions regarding appropriate dilution and contact time (20). Waste management: Wastes generated by the hemodialysis facility might be contaminated with blood and should be considered infectious and handled accordingly. These solid medical wastes should be disposed of properly in an incinerator or sanitary landfill, according to local and state regulations governing medical waste disposal (18). Needles should be disposed of in closed, unbreakable containers that should not be overfilled. A no-touch technique should be used to drop the needle into the container, as it is likely to have a contaminated surface. If this is difficult due to the design of the container, staff should complete patient care before disposing of needles. The used extracorporeal circuit should be sealed as effectively as possible before transporting it from the dialysis station in a fluidtight waste bag or leak-proof container. If it is necessary to drain the circuit, or to remove any components for reprocessing, this should be done in a dedicated area away from the treatment and preparation areas. Implementing these precautions will require a

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plentiful supply of protective equipment, adequate handwashing facilities and adequate nursing and cleaning staff. Particular attention should be paid to the layout of the dialysis unit, lighting and the flow of traffic (21). Every effort should be made to avoid staff rushing clinical care, to minimize the opportunity for accidental transmission of blood from one patient to another. Studies in Italian and Saudi Arabian haemodialysis centres revealed a significant association between the incidence and prevalence of HCV and the nurse patient ratio, suggesting that staffing plays a role in transmission (20). Implementation of these simple measures described above has been shown to be effective in preventing transmission when a patient has contracted BBV outside the renal unit and dialysed in the unit until BBV was detected by surveillance (20). References 1-Ghany M, Strader D, Thomas D, et al: Diagnosis, Management, and Treatment of Hepatitis C; An Update : Hepatology 2009; 49(4). 2-Natov SN., Lau JY., Bouthot BA. et al. (1998): Serologic and virologic profiles of hepatitis C infection in renal transplant candidates. New England Organ Bank Hepatitis C Study Group. Am J Kidney Dis; 31(6): 920. 3-Polenakovic M, Dzekova P, Sikole A: Hepatitis C in dialysis patients Sec. Biol. Med. Sci., MASA, XXVIII, 2007 239 265 . 4-Cusumano A, Poratto F, Del Pino N, et al: Identification of Hepatitis C virus RNA in peritoneal dialysis fluid of patients with viremia. Perit Dial Int 2005; 25:478482. 5-Pereira BJ., Levey AS (1997): Hepatitis C virus infection in dialysis and renal transplantation. Kidney Int; 51(4): 981

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6-Bergman S, Accortt N, Turner A, et al: Hepatitis C infection is acquired pre-ESRD. Am J Kidney Dis; 2005: 45(4): 684. 7-Mitsui T., Iwano K., Masuko K. et al. (1992): Hepatitis C virus infection in medical personnel after needlestick accident. Hepatology; 16(5): 1109 8-Savey A, Simon F, Izopet J, Lepoutre A, Fabry J, Desenclos JC: A large nosocomial outbreak of hepatitis C virus infections at a hemodialysis center. Infect Control Hosp Epidemiol 2005, 26:752-60. 9-Petrosillo N., Gilli P., Serraino D. et al. (2001): Prevalence of infected patients and understaffing have a role in hepatitis C virus transmission in dialysis. Am J Kidney Dis; 37(5): 1004. 10-Jadoul M., Cornu C., van Ypersele de Strihou C. (1993): Incidence and risk factors for hepatitis C seroconversion in hemodialysis: a prospective study. The UCL Collaborative Group. Kidney Int; 44(6): 1322 11-Thompson ND, Perz JF, Moorman AC, Holmberg SD: Non hospital healthcare-associated hepatitis B and C virus transmission: United States, 1998-2008. Ann Intern Med 2009, 150:33-9. 12-Kidney disease : improving global outcomes. KDIGO clinical practice guidelines for prevention , diagnosis ,evaluation and treatment of hepatitis c in chronic kidney disease: kidney international (2008) 73 (suppl 109),siii-siv\ 13-Shamshirsaz, Kamgar M, Bekheirnia MR, et al: The role of hemodialysis machines dedication in reducing Hepatitis C transmission in the dialysis setting in Iran: A multicenter prospective interventional study. BMC Nephrology 2004; 5:13. 14-Knoll A, Helmig, Peters, et al: Hepatitis C virus in a pediatric oncology ward: analysis an outbreak and review of the literature. Laboratory investigation 2001; 81 (3):251-262.

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15-Kamel M, ElMasry S. : Value Of Use Of Dedicated Dialysis Machines In Prevention Of HCV Infection Amongst Hemodialysis Patients : Egyptian Journal of Hospital medicine,2008,vol.31 16-Hubmann R., Zazgornik J., Gabriel C., Garbeis B., Blauhut B. (1995): Hepatitis C virus--does it penetrate the haemodialysis membrane? PCR analysis of haemodialysis ultrafiltrate and whole blood. Nephrol Dial Transplant; 10(4): 541. 17-Lombardi M., Cerrai T., Dattolo P. et al. (1995): Is the dialysis membrane a safe barrier against HCV infection? Nephrol Dial Transplant; 10(4): 578 18-Centers for Disease Control and Prevention (CDC): Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients. MMWR. 2001v 50 / No. RR-5. 19-Centers for Disease Control and Prevention (CDC): Acute hepatitis C virus infections attributed to unsafe injection practices at an endoscopy clinicNevada, 2007. MMWR Morb Mortal Wkly Rep 2008, 57(19):513-7.-21 20-Geddes C , Lindley E et al : UK renal association guidelines for prevention of transmission of blood borne viruses in dialysis units 21-Kroes A, van Bommel E , Klutymans J , et al. Hepatitis B and hemodialysis :the impact of universal precautions in preventing the transmission of blood bourne viruses. Infection control & hospital epidemiology 1998 ; 19:508-510(UK RENAL ASSOCIATION GUIDELINES 2008)

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