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Assessing the Efficacy of Professional Healthcare Antiseptics: A Regulatory Perspective

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Article
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Infection at or near surgical incisions within 30 days of an operative procedure contributes substantially to surgical morbidity and mortality each year. The prevention of surgical site infections encompasses meticulous operative technique, timely administration of appropriate preoperative antibiotics, and a variety of preventive measures aimed at neutralizing the threat of bacterial, viral, and fungal contamination posed by operative staff, the operating room environment, and the patient's endogenous skin flora. It is the latter aspect of contamination, and specifically mechanical methods of prevention, on which this review focuses.
Article
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Cross-transmission of microorganisms by the hands of health care workers is considered the main route of spread of nosocomial infections. To study the process of bacterial contamination of health care workers' hands during routine patient care in a large teaching hospital. Structured observations of 417 episodes of care were conducted by trained external observers (S.T. and V.S.). Each observation period started after a hand-cleansing procedure and ended when the health care worker proceeded to clean his or her hands or at the end of a coherent episode of care. At the end of each period of observation, an imprint of the 5 fingertips of the dominant hand was taken and bacterial colony counts were quantified. Regression methods were used to model the intensity of bacterial contamination as a function of method of hand cleansing, use of gloves during patient care, duration and type of care, and hospital ward. Bacterial contamination increased linearly with time on ungloved hands during patient care (average, 16 colony-forming units [CFUs] per minute; 95% confidence interval, 11-21 CFUs per minute). Patient care activities independently (P<.05 for all) associated with higher contamination levels were direct patient contact, respiratory care, handling of body fluid secretions, and rupture in the sequence of patient care. Contamination levels varied with hospital location; the medical rehabilitation ward had higher levels (49 CFUs; P=.03) than did other wards. Finally, simple hand washing before patient care, without hand antisepsis, was also associated with higher colony counts (52 CFUs; P=.03). The duration and type of patient care affect hand contamination. Furthermore, because hand antisepsis was superior to hand washing, intervention trials should explore the role of systematic hand antisepsis as a cornerstone of infection control to reduce cross-transmission in hospitals.
Article
von Ignaz Philipp Semmelweis.
Article
From January 1980 to July 1990, the Hospital Infections Program of the Centers for Disease Control conducted 125 on-site epidemiologic investigations of nosocomial outbreaks. Seventy-seven (62%) were caused by bacterial pathogens, 11 (9%) were caused by fungi, 10 (8%) were caused by viruses, five (4%) were caused by mycobacteria, and 22 (18%) were caused by toxins or other organisms. The majority of fungi and mycobacterial outbreaks occurred since July 1985. Fourteen (11%) outbreaks were device related, 16 (13%) were procedure related, and 28 (22%) were product related. The proportion of outbreaks involving products, procedures, or devices increased from 47% during 1980-1985 to 67% between 1986 and July 1990. Recent outbreaks have shown that packed red blood cell transfusion-associated Yersinia enterocolitica sepsis results from contamination of the blood by the asymptomatic donor; that povidone-iodine solutions can become intrinsically contaminated and cause outbreaks of infection and/or pseudoinfection; and that rapidly growing mycobacteria can cause chronic otitis media, surgical wound infection, and hemodialysis-associated infections. These and other outbreaks demonstrate how epidemiologic and laboratory investigations can be combined to identify new pathogens and sources of infection and ultimately result in disease prevention.
Chapter
IntroductionSkin floraStrategies of hand hygieneStrategies to prevent transmission of transient floraStrategies against transmission of resident floraThe clinical impact of hand hygiene and the role of compliance with itDisinfection of operation sitesAntisepsis in burnsUse of antiseptics on skin and mucosaePractical aspects of disinfectants and antisepticsConclusions References
Article
by Oliver W. Holmes. Cover title. "Read before the Boston Society for Medical Improvement, and published at the request of the Society"--P. 1. Reprinted from: New England quarterly journal of medicine and surgery, Apr. 1843.
Article
To examine evidence of a causal link between handwashing and risk of infection, a review of published literature from 1879 through 1986 was conducted. In the 107 years studied, 423 articles specifically related to handwashing were found. Articles were categorized as studies to evaluate products (50.8%), review articles (29.1%), behavioral studies (10.9%), methodologic studies (2.8%), studies linking handwashing to infection (3.3%), and other (3.1%). There was an increase in the proportion of handwashing articles published in the 1980s with the rate (9.4/10 citations/year) being almost double that of any other period studied. Nonexperimental and experimental studies related to handwashing were reviewed and evidence for a causal association evaluated. Except for specificity, all the elements for causality, including temporality, strength, plausibility, consistency of the association, and dose response were present. It was therefore concluded that emphasis on handwashing as a primary infection control measure has not been misplaced and should continue.
Article
From January 1980 to July 1990, the Hospital Infections Program of the Centers for Disease Control conducted 125 on-site epidemiologic investigations of nosocomial outbreaks. Seventy-seven (62%) were caused by bacterial pathogens, 11 (9%) were caused by fungi, 10 (8%) were caused by viruses, five (4%) were caused by mycobacteria, and 22 (18%) were caused by toxins or other organisms. The majority of fungi and mycobacterial outbreaks occurred since July 1985. Fourteen (11%) outbreaks were device related, 16 (13%) were procedure related, and 28 (22%) were product related. The proportion of outbreaks involving products, procedures, or devices increased from 47% during 1980-1985 to 67% between 1986 and July 1990. Recent outbreaks have shown that packed red blood cell transfusion-associated Yersinia enterocolitica sepsis results from contamination of the blood by the asymptomatic donor; that povidone-iodine solutions can become intrinsically contaminated and cause outbreaks of infection and/or pseudoinfection; and that rapidly growing mycobacteria can cause chronic otitis media, surgical wound infection, and hemodialysis-associated infections. These and other outbreaks demonstrate how epidemiologic and laboratory investigations can be combined to identify new pathogens and sources of infection and ultimately result in disease prevention.
Article
A prospective epidemiological survey was carried out over a period of seven weeks in a medical intensive care unit. Bacteria from patients, staff and air were monitored and the transmission of isolated microorganisms was followed. Handwashing samples revealed pathogenic bacteria in 30.8% of physicians (average number of colony forming units: 71,300 per hand) and 16.6% of nurses (39,800 cfu per hand). Air cultures yielded pathogens in 15% of sampling periods and nine of 53 patients were found to be colonized with Gram-negative bacteria, Staphylococcus aureus or Candida spp. The spectrum of bacteria recovered from patients and air was generally different, whereas strains recovered from patients and their attendants' hands were indistinguishable on multiple occasions. The results of this study confirm that direct contact is the principal pathway of microbial transmission, whereas little evidence for a significant role of airborne transmission is shown. The call for more extensive air-filtering and ventilation systems in medical intensive care units is not supported by the results shown in this communication.
Article
A single strain of Staphylococcus epidermidis caused an outbreak of postoperative wound infections and endocarditis during a 6-month period. Infections caused by the epidemic strain developed more frequently in valve surgery patients than in those undergoing coronary artery bypass graft surgery (P = .03) and occurred only in patients operated on by surgeon A. None of 17 members of the cardiac surgery team carried the epidemic strain in their anterior nares, axillae, or inguinal folds. Hand cultures were performed on 8 surgical personnel, and only surgeon A carried the epidemic strain on his hands. Isolates from cardiac surgery patients, bypass pump blood cultures, and the hands of the implicated surgeon all had identical antimicrobial susceptibility patterns, plasmid profiles, and EcoR1 restriction endonuclease digest patterns. In the 24 months after control measures were implemented, no infections caused by the epidemic strain occurred among open heart surgery patients. The findings suggest that the common-source outbreak of infections among cardiac surgery patients was due to carriage of a strain S. epidermidis on the hands of a cardiac surgeon.
Article
Numerous studies have shown that the major reservoir of nosocomial infection in the hospital is the infected or colonised patient and the major mode of spread of organisms between patients is on the hands of medical personnel. A prolonged preoperative scrub with an antiseptic is one of the most time-honoured rituals of surgical asepsis. Hygienic handwashing in the hospital or clinic, to remove transient contaminants acquired from patients or the environment and prevent cross-infection to vulnerable patients, is similarly regarded as one of the most fundamental infection control measures, yet is done infrequently by personnel in most hospitals. Following a typical brief (7.10 second) handwashing with a nonmedicated soap, the number of organisms that can be transmitted from the person's hands may, paradoxically, actually increase. Use of chlorhexidine for handwashing or application of an evaporative alcohol-based lotion has been found to reduce shedding of bacteria-laden skin squames. Routine use of antiseptic-containing handwashing agents is clearly more effective than nonmedicated soaps for microbial removal, can enhance the value of the handwashings that are done and might further confer protection against contaminants acquired between handwashings. In a sequential comparative trial of three handwashing agents in a surgical intensive care unit--a nonmedicated soap, 10% povidone-iodine solution, and 4% aqueous chlorhexidine, each used exclusively for approximately six weeks--the incidence of nosocomial infection was 50% lower during the use of the antiseptic handwashing products than during the use of nonmedicated soap (P less than .001). Novel approaches are needed to improve the frequency of hygienic handwashing.(ABSTRACT TRUNCATED AT 250 WORDS)
Article
A dramatic increase in the incidence of methicillin-resistant Staphylococcus aureus at a teaching hospital was documented to be due to three factors: a hospital-wide outbreak of 32 cases caused by an epidemic strain, an increase in the number of nosocomial cases caused by several other strains, and an increase in the number of patients admitted carrying strains acquired at other institutions. Case patients with the epidemic strain were significantly more likely than control patients to have had previous exposure to a respiratory therapist (P = .005) who had chronic sinusitis due to the epidemic strain. The plasmid DNA of isolates from the implicated respiratory therapist and affected patients yielded the same patterns on restriction endonuclease digestion. Implementation of general control measures and eradication of the respiratory therapist's sinusitis and nasal carriage terminated the epidemic. Establishing the importance of the infected health care worker by epidemiological methods led to control of the outbreak without the institution of wide-scale culture of specimens from personnel and the environment or other expensive and labor-intensive measures.
Article
Pseudomonas aeruginosa was isolated from nine patients (16.2 isolations/1,000 patient-days) in a surgical intensive care unit during an outbreak in November 1990; this rate of isolation was three times higher than that noted previously on this unit. Three patients were infected with the same strain, as defined by identical serotypes, pyocin types, and contour-clamped homogeneous electric field (CHEF) electrophoresis patterns of digested genomic DNA. The hands of 80 health care workers were cultured, and a strain of P. aeruginosa identical to that infecting the three patients was isolated from the hands of a nurse providing care to all three. Environmental surfaces, medical devices, and ward stock supplies were cultured; none of these cultures yielded this strain. No clusters of infection with this strain or other strains of P. aeruginosa were observed after compliance with hand-washing and universal precautions was reemphasized. Thus this outbreak was linked to the carriage of P. aeruginosa on the hands of a health care worker. It could not be determined definitively whether this carriage was the source of the cluster or a consequence of it. However, the geographic and temporal clustering of carriage with an outbreak due to a strain of an apparently identical molecular type underlines the importance of routine hand washing between contacts with different patients.
Article
Handwashing practices are persistently suboptimal among healthcare professionals and are also stubbornly resistant to change. The purpose of this quasi-experimental intervention trial was to assess the impact of an intervention to change organizational culture on frequency of staff handwashing (as measured by counting devices inserted into soap dispensers on four critical care units) and nosocomial infections associated with methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE). All staff in one of two hospitals in the mid-Atlantic region received an intervention with multiple components designed to change organizational culture; the second hospital served as a comparison. Over a period of 8 months, 860,567 soap dispensings were recorded, with significant improvements in the study hospital after 6 months of follow-up. Rates of MRSA were not significantly different between the two hospitals, but rates of VRE were significantly reduced in the intervention hospital during implementation.
Article
Hand hygiene prevents cross infection in hospitals, but compliance with recommended instructions is commonly poor. We attempted to promote hand hygiene by implementing a hospital-wide programme, with special emphasis on bedside, alcohol-based hand disinfection. We measured nosocomial infections in parallel. We monitored the overall compliance with hand hygiene during routine patient care in a teaching hospital in Geneva, Switzerland, before and during implementation of a hand-hygiene campaign. Seven hospital-wide observational surveys were done twice yearly from December, 1994, to December, 1997. Secondary outcome measures were nosocomial infection rates, attack rates of methicillin-resistant Staphylococcus aureus (MRSA), and consumption of handrub disinfectant. We observed more than 20,000 opportunities for hand hygiene. Compliance improved progressively from 48% in 1994, to 66% in 1997 (p<0.001). Although recourse to handwashing with soap and water remained stable, frequency of hand disinfection substantially increased during the study period (p<0.001). This result was unchanged after adjustment for known risk factors of poor adherence. Hand hygiene improved significantly among nurses and nursing assistants, but remained poor among doctors. During the same period, overall nosocomial infection decreased (prevalence of 16.9% in 1994 to 9.9% in 1998; p=0.04), MRSA transmission rates decreased (2.16 to 0.93 episodes per 10,000 patient-days; p<0.001), and the consumption of alcohol-based handrub solution increased from 3.5 to 15.4 L per 1000 patient-days between 1993 and 1998 (p<0.001). The campaign produced a sustained improvement in compliance with hand hygiene, coinciding with a reduction of nosocomial infections and MRSA transmission. The promotion of bedside, antiseptic handrubs largely contributed to the increase in compliance.
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