Disinfection of gloved hands for multiple activities with indicated glove use on the same patient

Accepted Manuscript Disinfection of gloved hands for multiple activities with indicated glove use on the same patient Günter Kampf, Sebastian Lemmen PII:

S0195-6701(17)30343-2

DOI:

10.1016/j.jhin.2017.06.021

Reference:

YJHIN 5144

To appear in:

Journal of Hospital Infection

Received Date: 30 January 2017 Accepted Date: 16 June 2017

Please cite this article as: Kampf G, Lemmen S, Disinfection of gloved hands for multiple activities with indicated glove use on the same patient, Journal of Hospital Infection (2017), doi: 10.1016/ j.jhin.2017.06.021. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

ACCEPTED MANUSCRIPT Disinfection of gloved hands for multiple activities with indicated glove use on the same patient

Günter Kampf1,2*, Sebastian Lemmen3

und Team GmbH, Infection Control Science, Kattrepelsbrücke 1, 20095 Hamburg, Germany;

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2Ernst-Moritz-Arndt

University, Institute for Hygiene and Environmental Medicine, WalterRathenau-Straße 49 A, 17475 Greifswald, Germany; email: [email protected] Hospital Aachen, Department of Infection Control and Infectious Diseases, Pauwelsstr. 30, 52074 Aachen, Germany

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ACCEPTED MANUSCRIPT Summary

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Most hand hygiene guidelines recommend that gloves should be changed during patient care when an indication for hand disinfection occurs. Observational studies indicate that the majority of healthcare workers (HCWs) do not disinfect their hands at all during continued glove wear. The aim of this narrative review is to assess the potential benefits and risks for disinfecting gloved hands during patient care for multiple activities with indicated glove use on the same patient. Continued glove wear for multiple activities on the same patient often results in performing procedures, including aseptic procedures with contaminated gloves, especially in a setting where there are many indications in a short time, e.g. anaesthetics or accident and emergency departments. Of further note is that hand hygiene compliance is often lower when gloves are worn. To date, three independent studies have shown that decontamination is at least as effective on gloved hands as on bare hands and that puncture rates are usually not higher after up to 10 disinfections. One study on a neonatal intensive care unit showed that promotion of disinfecting gloved hands during care on the same patient resulted in a significant reduction in the incidence of late-onset infections and of necrotizing enterocolitis. We conclude that disinfection of gloved hands by HCWs can substantially reduce the risk of transmission when gloves are indicated for the entire episode of patient care and when performed during multiple activities on the same patient.

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ACCEPTED MANUSCRIPT Introduction

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Disinfection of gloved hands was first proposed in 1899 by Kocher who advocated the wearing of sterile gloves for every operation, whether hands were washed beforehand or not. He proposed that during long operations the gloved hands should be immersed from time to time in a strong antiseptic solution in cases “when the surgeon wants to work particularly carefully” [1]. Today, the topic is no longer relevant for procedures such as surgery where sterile gloves are worn. However, for medical examination gloves, disinfection of gloved hands might contribute to patient safety more than most healthcare workers (HCWs) would anticipate.

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It is generally recommended that gloves should be used for activities that could involve exposure to blood or other body fluids; where patients are isolated with contact precautions; and in outbreak settings. [2-6]. Gloves should then be removed when they are damaged or nonintegrity is suspected [2, 3]; after contact with blood or other body fluids, non-intact skin or mucous membranes [2, 3, 5]; on leaving an isolation room, and as soon as an episode of patient contact or treatment has ended [2-5]. Individual guidelines also recommend removal of gloves where there is an indication for hand hygiene [2, 3] or after use for washing a patient [3].

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Inappropriate glove use refers to the wearing of gloves where there is no indication, and also to the continued wearing of gloves that should have been removed [7]. For example, in rehabilitation units an indication for glove use was found in 17.1% of all contacts, but gloves were worn for 41.4% of all contacts [8]. In another study 213 anaesthetists were asked whether they routinely change gloves between patients. The total response rate was 68.1% with only 14.5% “always” changing gloves between patients and 40% doing so “frequently” [9]. Although levels of inappropriate glove use differ from country to country, the practice appears to be common worldwide. For example, data from Malaysia show a high proportion of inappropriate glove use of 74.3% [10], whereas in the UK a rate of 57.5% was reported, resulting in a risk of cross-transmission in 36.8% of patient care episodes [7]. The main risks of inappropriate glove use are missing opportunities for hand hygiene and that gloves may be a vector for microbial transmission [2]. Indeed in long-term care facilities, unnecessary glove use was observed to have a clear negative effect on hand hygiene compliance [11]. Substituting glove use for hand hygiene can place both HCWs and patients at risk of colonization or infection with pathogenic microorganisms [12].

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Despite the emphasis on removal of gloves after single use and avoidance of inappropriate glove use [7], there are many clinical situations when HCWs (perhaps appropriately) routinely wear gloves during multiple activities on the same patient. For example, anaesthetists and their assistants may wear the same gloves during an entire surgical procedure [13-15], despite limited hands-on patient time. The routine use of gloves is recommended in this setting [16, 17]. However, whilst wearing gloves that may be contaminated with a patient’s microorganisms anaesthetists will repeatedly touch anaesthetic equipment and computer keyboards [18]. In accident and emergency departments and in ambulances staff continue to wear the same gloves when attending patients, despite the likelihood of their gloves becoming contaminated with patients’ microorganisms and having contact with the environment [19, 20]. Recently a survey among 417 paramedics in Australia revealed that all of them wear disposable gloves for every clinical case. The majority (57.8%) of them only changed gloves at the end of a case. The physical difficulty of changing gloves in some of the operational environments was a major barrier for hand hygiene compliance [21]. Another example is the insertion of central venous catheters (CVC). Kocent et al observed 20 CVC insertions and reported that immediately before CVC insertion the gloved fingertips of the operator was contaminated with microorganisms in 55% of cases; contamination was assumed to originate from touching the previously disinfected skin. 3

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However, use of alcoholic chlorhexidine successfully decontaminated gloved hands. The authors therefore proposed that gloved hands should be disinfected immediately before CVC insertion [22], especially if a no-touch technique was not performed. In the recent ebola virus disease (EVD) epidemic in West Africa decontamination of gloved hands became standard practice, following transmission of the disease to a nurse in Spain [23] and to two nurses in the USA [24]. A new key component of the WHO guidelines was the disinfection of gloved hands during patient care and during doffing of the personal protective equipment (PPE). Depending on the number of elements of PPE, the current guidelines recommend up to eight disinfections of gloved hands during doffing of PPE [25].

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The EVD guidance has reopened the debate about the pros and cons of disinfection of gloved hands. In this narrative review we explore the routine wearing of gloves during multiple activities on the same patient. We will assess (1) the risk of glove contamination and crosstransmission for subsequent activities; (2) the compliance with hand hygiene during continued glove use; (3) the efficacy of hand disinfection on gloved hands; (4) glove integrity after using hand rubs on gloved hands; and (5) the impact of disinfecting gloved hands on nosocomial infections.

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Method

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Results

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A systematic literature search was conducted via the National Library of Medicine (PubMed) on 10th January 2017 and via the Cochrane Library on 14th January 2017 using the following terms: medical glove (19 hits), examination glove (29 hits), compliance, adherence, glove use (371 hits) with compliance (74 hits) or adherence (41 hits), universal gloving (12 hits), gloving practice (89 hits), gloved hand (78 hits), contaminated glove (126 hits), disinfection of gloves (0 hits), disinfection of gloved hands (0 hits), glove integrity (19 hits) and glove puncture (44 hits). In addition, studies deemed suitable for this review were also included. Data were extracted from the publications by one author and reviewed by the other author. Studies were selected when they provided original data on glove use (medical or examination gloves) and hand hygiene compliance for multiple and/or single patients as well as for multiple and single patient care activities (15 studies), when they contained original data on glove integrity after washing or disinfecting gloved hands (9 studies), when they contained original data on the efficacy of hand hand disinfection on gloved hands (6 studies), and when they contained original data on the nosocomial infections when gloved hands are allowed or even promoted to be disinfected during patient care (1 study). Guidelines from the UK (epic3 and NICE), Germany (AWMF and RKI) and the WHO were also reviewed.

Risk of glove contamination and cross-transmission for subsequent activities The recommendations on glove use when HCWs perform multiple activities in a single patient are clearly defined by the WHO, who state that “when wearing gloves, change or remove gloves during patient care if moving from a contaminated body site to either another body site (including non-intact skin, mucous membrane or medical device) within the same patient or the environment” [5]. In the NICE guideline, it says “gloves must be changed between different care or treatment activities for the same patient” [4]. Furthermore, the epic3 guideline recommends that “gloves must be removed as soon as an episode is completed” and “changed between caring for different patients” [6]. We found three studies that addressed glove contamination. An observational study in a Swedish Department of Anaesthetics showed that patient care procedures with used gloves 4

ACCEPTED MANUSCRIPT (described as contaminated) occurred in 65.7% of 242 observed activities. Gloves are not always doffed even when afterwards an aseptic procedure is performed on the same patient [26]. In two convalescence and rehabilitation hospitals in Hong Kong, it was described that in 75% of cases gloves were not changed after a “dirty activity” when multiple activities were performed on the same patient [27]. On ICUs in the USA, only 72% of HCWs removed gloves after suctioning, whereas the remaining HCWs may have performed other clinical activities on the same patient, or even on other patients, with the same gloved hands [28].

Compliance with hand hygiene during continued glove use

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One approach that has been proposed to deal with this problem in anaesthetics is double gloving, where the outer pair of gloves is removed after completion of the induction before touching the anaesthesia cart or keyboard, thereby resulting in an immediate reduction of the workspace and stopcock contamination [29].

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When HCWs perform multiple activities on the same patient, different indications for a hand hygiene procedure might occur. What should be done in these situations? WHO [2, 5], RKI [30] and AWMF [3] all recommend that gloves should be taken off when there is an indication to perform hand hygiene.

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Moreover, a number of studies have looked at hand hygiene compliance rates in the context of wearing gloves. On a medical ICU, contact precautions were implemented for a total of 3 months (study period 1). During the next 3 months, HCWs were instructed to wear gloves before every patient contact without contact precautions (“universal gloving”; study period 2). In study period 1, HCWs wore gloves in 31.7% of all patient care activities. In study period 2, the rate rose dramatically to 87.0%. The compliance rates with hand hygiene before and after patient contact were significantly reduced for study period 2 at the same time from 18.7% to 11.4% and 57.7% to 52.5%, respectively. Of further interest is that in period 2, the incidence density of nosocomial bloodstream infections increased significantly from 6.2 to 14.1 cases per 1000 patient days, the incidence density of urinary tract infection increased from 4.4 to 7.4 cases per 1000 patient days, and the incidence density of ventilator-associated pneumonia increased from 0 to 2.3 cases per 1000 patient days [31].

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In addition, Girou et al found that the continued use of gloves without removal after patient contact resulted in 64.4% of all contacts being performed without adequate hand hygiene. Especially for patient contacts requiring strict aseptic precautions, 82.3% were performed with gloves that have not been removed after previous care. Poor compliance with glove changing during patient care was identified as an independent factor for hand hygiene non-compliance [32]. Another example of the effect of wearing gloves on hand hygiene compliance is the analysis of compliance data from HCWs caring for patients in contact precautions. Cusini et al observed that HCWs donned gloves before entering the room of an isolated patient and tended to remove them only after leaving the room without changing them and without performing adequate hand hygiene when indicated. To change this negative behaviour, they stopped mandatory glove use and implemented contact precautions. Hand hygiene compliance increased significantly from 51.9% to 85.4% [33]. Data from Malaysia indicated that HCWs often regarded wearing gloves as a substitute for hand hygiene (70.3%) [10]. Finally, a similar finding was reported from the UK, i.e. that hand hygiene compliance is significantly lower when gloves are worn [34]. Decontamination of gloved hands 5

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Efficacy of hand disinfection on gloved hands

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For HCWs wearing gloves to comply with international recommendations during multiple activities on the same patient they would frequently have to doff gloves, perform hand disinfection, and don a new pair of gloves, which is probably unrealistic [8]. Thus, decontamination of gloved hands may be an attractive alternative. In 1992, Best and Kennedy proposed that decontamination of gloved hands may be carried out under limited circumstances [35]. Indeed this approach is already endorsed by some national guidelines. In 2016, the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute, Berlin, Germany stated that when the workflow can only be assured without a glove change, gloves may be used for multiple activities on the same patient with a disinfection of gloved hands [30]. The Association of the Scientific Medical Societies (AWMF) in Germany adds that as an exception, gloved hands may be disinfected instead of changing gloves when the work flow can only be assured this way [3], for example when undertaking consecutive venepunctures on different patients, or moving from a clean to a dirty task on the same patient [3].

As early as 1933, the outer surface of surgical gloves was described as easier to disinfect than bare hands [36].

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Bactericidal efficacy

To date, three studies have addressed the bactericidal efficacy of alcohol-based hand rubs on gloved and artificially contaminated hands similar to the EN 1500 study protocol (Table I). these studies confirm that the mean efficacy of hand rubs is at least as good on gloved hands as on bare hands for the various combinations of medical gloves and types of hand rubs . Even hands wearing perforated gloves can be effectively disinfected on their outer surface with alcoholbased solutions as shown on gloves contaminated with E. coli or P. aeruginosa [37].

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Virucidal efficacy

Sporicidal efficacy

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Using poliovirus type 1, it was shown that the virucidal efficacy was similar on gloved and bare hands. Interestingly, the application of 5 ml of 80% ethanol on gloved hands for 30 s reduced the viral load by 0.42 log10-steps, whereas the effect of 5 ml of 70% ethanol for the same conditions was 1.26 log10-steps [38]. The authors went on to conclude that viral load from non-enveloped viruses is easier to be reduced on gloved hands [38].

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When gloved hands are contaminated with spores of C. difficile, it is also possible using. chlorinated lime or a “sporicidal alcohol” to achieve a 1.7 to 3.3 log10 reduction in contamination, depending on the type of hand rub and application method (rubbing in or wiping away) [39]. In summary, it can be concluded with reasonable certainty that decontamination of gloved hands is at least as effective as treating bare hands Glove material integrity after repeated application of hand rubs A prerequisite for the disinfection of gloved hands is the evidence of compatibility of the glove with the hand disinfectant [3]. Leakage rate Three studies have investigated whether treatment of gloved hands with alcohol-based hand rubs results in higher perforation rates using EN 455-1. In one study, 20 gloves from 5 different types of gloves were treated 10 times with an unknown volume of 60% iso-propanol for 60 s 6

ACCEPTED MANUSCRIPT [40]. In another, 48 to 50 gloves from 2 different types of powder-free latex gloves were treated 10 times with hand rubs or water [41]. A third study looked at perforation rates after treating 3 different types of gloves 5 times with 5 different types of hand rubs [42]. The results are summarized in Table II. Leakage rates of different types of gloves treated 10 times on hands with different types of hand rubs or water were in a similar range as usually found for untreated gloves [42-44] although specific glove-handrub combinations may show leakage rates up to 15% after 5 treatments [42].

Effect on tensile strength and ultimate elongation

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Overall, clinically relevant damage to the gloves was not detected. Clinically relevant damage is therefore probably more due to mechanical stress leading to perforations in gloves. Physical activity can indeed result in higher perforation rates as shown with nitrile gloves although the difference to unused gloves is still small (2.1% versus 1.5% perforation rate) [45].

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Permeability

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A new study revealed changes of tensile strength and ultimate elongation of 5 latex examination gloves (mean thickness: 0.176 mm) and 8 nitrile examination gloves (mean thickness: 0.093 mm). Up to six hand disinfections were performed every 2 minutes with 2.5 ml per application on gloved hands with commercially available products based on 70% ethanol or 63% isopropanol. The tensile strength of latex gloves was reduced on average by 4.3% and 18.1% after using the ethanol- and iso-propanol-based products, respectively. Notably, the tensile strength of nitrile gloves was reduced by 26% and 35.3% after using the ethanol- and the iso-propanolbased products, respectively. Ultimate elongation did not change much in latex gloves irrespective of the type of hand rub. In stark contrast, in some types of nitrile gloves, the ultimate elongation increased by 30.5%, whereas in other types of nitrile gloves, it was reduced by 17.3%. Overall, latex gloves treated with the ethanol-based product showed the smallest changes, whereas nitrile gloves treated with the iso-propanol-based product showed the largest changes – although all combinations were still within the normative acceptability limits [46]. Finally, the WHO guideline statement that cleansing plastic-gloved hands with an alcohol-based formulation leads to early dissolving of the plastic material was not generally confirmed by Gao et al. [46].

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One option to demonstrate compatibility of the glove with the hand disinfectant is to prevent permeation according to EN 374 [3]. First, alcohol itself may permeate through the glove. When gloves composed of different types of material were exposed to an ethanol-based hand rub, it was possible for the ethanol to permeate through the glove material after 10 min with any type of glove. Of note is that for some types of glove, ethanol permeated in only 2 min [47]. This finding does, however, not constitute a risk for the glove user in clinical practice because hand disinfection usually lasts approximately 30 s, and entails ethanol having direct contact with the skin. Importantly, it is currently not clear whether repeated exposure (e.g. 3 times for 30 s within 6 min) increases general permeability for other substances that (1) may be harmful to the skin and (2) may have contaminated the outer site of the glove during patient care. In another study, three types of latex gloves, two types of nitrile gloves and one type of neoprene gloves were exposed to 70% iso-propanol for 15 min (equivalent to 30 hand disinfections for 30 s each). After this exposure, the permeability of 17 cytotoxic drugs was measured. Only in latex gloves, did the permeability increase a little; however, this small increase was still under the threshold considered to be safe. All other types of gloves showed effectively no change in permeability [48]. 7

ACCEPTED MANUSCRIPT Impact of targeted disinfection of gloved hands on nosocomial infections in critical care patients In one study, the effect of two different hand hygiene procedures was evaluated over 6 years on very low birth weight infants with a maximum weight of 1500 g on a neonatal intensive care unit. During the first 3 years, hands were routinely washed with an antiseptic soap based on 4% chlorhexidine and the use of gloves was not mandatory. During the second 3 years, HCWs had to perform hand hygiene as described in Table III.

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The number of patients were similar in both study periods (161 in period 1 versus 176 in period 2), as was mean birth weight (1115 g versus 1163 g), mean days of ventilation (9 versus 8) and the mean number of hospital days (80 versus 76). The modified hand hygiene regime in period 2 resulted in a significant decrease in the rate of late-onset infections (4.8 per 1000 patient days in period 2 compared to 13.5 in period 1). There was a particularly dramatic reduction in the rate of necrotizing enterocolitis, to 0.8 per 1000 patient days in period 2 compared to 3.0 in period 1 [49]. Discussion

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There are some situations when HCWs should routinely wear gloves during patient care, and the number of these situations is likely to increase as multidrug-resistant Gram-negative bacteria become more prevalent. Most studies have shown that HCWs who wear gloves do not perform adequate hand hygiene (doffing gloves, hand disinfection, donning new pair of gloves) when an indication occurs. Disinfection of gloved hands requires less time and requires fewer resources than changing gloves. However, against that, there is also a psychological component in that wearing gloves seems to replace hand hygiene. Although HCWs are trained to perform hand disinfection whenever 1 of the 5 moments occurs, doffing gloves, followed by hand disinfection, and then donning a new pair of gloves is complex and time-consuming. The reality is that healthcare workers do not decontaminate their hands frequently in such settings. Disinfection of gloved hands is simpler, and allows HCWs to intuitively follow the 5 moments concept during clinical care.

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Medical examination gloves are recommended by manufacturers for single use and belong to class I medical devices [50]. In fact, a definition is provided in the medical devices directive and states that class I medical devices are “a device intended to be used once only for a single patient” (Directive 2007/47/EC). The WHO may advise against glove washing, decontamination or reprocessing [5] but reprocessing and reuse is common in some healthcare settings, especially in developing countries where glove supply may be limited. Manufacturers are not responsible for glove integrity when the single use principle is not respected [5]. Disinfection of gloves which are still on the hands of the same HCW during the care of the same patient is different to reprocessing, and we believe that currently no guideline specifically outlaws this practice. The practice is even gaining currency in developed countries; a proposal to allow disinfection of gloved hands was recently published by the “Aktion Saubere Hände” in Germany [51]. Indeed, disinfection of gloved hands for multiple activities on the same patient has become accepted procedure in some hospitals, including at the University Hospital Aachen. We propose that the Directive 2007/47/EC does not preclude decontamination of gloves on the hands of the same HCW between activities on the same patient. We also consider that it is very unlikely that disinfection of gloved hands during indicated glove use would result in an overall prolongation of glove wearing compared to changing gloves when an indication for hand hygiene occurs. Thus, we would not expect this practice to be associated with an increased risk 8

ACCEPTED MANUSCRIPT of contact dermatitis.

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To date, many studies on the efficacy of alcohol-based hand rubs have been performed according to EN 1500. The norm is usually applied to determine the efficacy of hand rubs on bare hands and to verify whether a product fulfils the European efficacy requirements. In two of the three studies, the fingertips were sampled in broth containing neutralizing agents as recommended to obtain valid data [40, 42]. However, in one study, this detail was not described [41], and thus, the efficacy of the hand rubs may have been overestimated. A hand rub that passes the efficacy requirements of EN 1500 may be recorded in a positive list for disinfectants (e.g. by the VAH) or approved as a biocidal product for hygienic hand disinfection. Of note is that quite a number of hand rubs have been described not to fulfil the EN 1500 efficacy requirements [52, 53]. Hand rubs that are already effective on bare hands and also have a sufficient efficacy on gloved hands should therefore be effective enough for the application on gloved hands.

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In our review we found no evidence to indicate that disinfection of gloved hands is not safe, from the point of view of either efficacy of hand disinfection or the integrity of gloves being affected by decontamination procedures. Despite the current lack of conclusive studies for some aspects (e.g. effect on compliance in hand hygiene, acceptance by healthcare workers, and effect on nosocomial infections), we still strongly recommend that targeted disinfection of gloved hands can be used in selected clinical settings.

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We recommend that implementation of such an approach should be preceded by a trial period to refine, and ensure acceptance of the new practice. If HCWs notice that the glove material does not tolerate the used hand rub (e.g. stickiness, perforations, etc.), it would be appropriate to review the selected type of glove and hand rub. Overall, nitrile gloves seem to show a better material compatibility compared to latex gloves and ethanol-based hand rubs seem to stress the glove material less than propanol-based ones. Nevertheless, it would be useful if glove manufacturers provided compatibility data for different hand rubs. Training of HCWs would also be vital, including: (1) indications for routine wearing and removal of gloves; (2) highlighting that gloves are only for the treatment of one single patient; (3) highlighting that 3 of the 5 moments for hand hygiene are now performed on gloved hands, namely “before aseptic tasks” (moment 2), “after body fluid exposure risk” (moment 3) and “after contact with patient surroundings” (moment 5); (4) the importance of changing gloves that are visibly soiled or perforated; (5) the need to remove gloves, and clean hands immediately after all patients activities are finished; (6) limiting the number of disinfections of gloved hands to a maximum of 10 times before the gloves need to be changed; and (7) use of gloves without powder (powdered gloves are likely to become sticky). For implementation, we also recommend that HCW must use the best fitting glove size, because creases in overlarge gloves will prevent effective decontamination. Our review has highlighted a lack of good quality evidence. In particular, we recommend further research is required to examine hand hygiene compliance rates with and without disinfection of gloved hands being permitted. Studies of user acceptability are also an important hgap in the existing literature. Conclusions When gloves are used for an appropriate purpose, and multiple activities are carried out on the same patient, compliance with hand disinfection is very low. In this setting, we suggest that there is sufficient evidence that up to ten disinfections of gloved hands for the moments 2, 3 and 5 is safe and effective. 9

ACCEPTED MANUSCRIPT Conflict of interest None. References

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Barr N, Holmes M, Roiko A, Dunn P, Lord B Self-reported behaviors and perceptions of Australian paramedics in relation to hand hygiene and gloving practices in paramedic-led health care. Am J Infect Control 2017; doi 10.1016/j.ajic.2017.02.020. Kocent H, Corke C, Alajeel A, Graves S Washing of gloved hands in antiseptic solution prior to central venous line insertion reduces contamination. Anaesthesia and intensive care 2002; 30: 338-40. Lopaz MA, Amela C, Ordobas M et al. First secondary case of Ebola outside Africa: epidemiological characteristics and contact monitoring, Spain, September to November 2014. Euro Surveill 2015; 20. McCarty CL, Basler C, Karwowski M et al. Response to importation of a case of Ebola virus disease--Ohio, October 2014. MMWR Morbidity and mortality weekly report 2014; 63: 108991. CDC. Guidance on Personal Protective Equipment To Be Used by Healthcare Workers During Management of Patients with Ebola Virus Disease in U.S. Hospitals, Including Procedures for Putting On (Donning) and Removing (Doffing). Centers for Disease Control and Prevention 2014. Megeus V, Nilsson K, Karlsson J, Eriksson BI, Andersson AE Hand hygiene and aseptic techniques during routine anesthetic care - observations in the operating room. Antimicrob Resist Infect Control 2015; 4: 5. Chau JP, Thompson DR, Twinn S, Lee DT, Pang SW An evaluation of hospital hand hygiene practice and glove use in Hong Kong. Journal of clinical nursing 2011; 20: 1319-28. Husni RN, Goldstein LS, Arroliga AC et al. Risk factors for an outbreak of multi-drug-resistant Acinetobacter nosocomial pneumonia among intubated patients. Chest 1999; 115: 1378-82. Loftus RW, Koff MD, Birnbach DJ The dynamics and implications of bacterial transmission events arising from the anesthesia work area. Anesthesia and analgesia 2015; 120: 853-60. KRINKO am Robert Koch Institut Händehygiene in Einrichtungen des Gesundheitswesens. Bundesgesundheitsbl 2016; 59: 1189-220. Bearman GM, Marra AR, Sessler CN et al. A controlled trial of universal gloving versus contact precautions for preventing the transmission of multidrug-resistant organisms. Am J Infect Control 2007; 35: 650-5. Girou E, Chai SH, Oppein F et al. Misuse of gloves: the foundation for poor compliance with hand hygiene and potential for microbial transmission? J Hosp Infect 2004; 57: 162-9. Cusini A, Nydegger D, Kaspar T, Schweiger A, Kuhn R, Marschall J Improved hand hygiene compliance after eliminating mandatory glove use from contact precautions-Is less more? Am J Infect Control 2015; 43: 922-7. Fuller C, Savage J, Besser S et al. "The dirty hand in the latex glove": a study of hand hygiene compliance when gloves are worn. Infect Control Hosp Epidemiol 2011; 32: 1194-9. Best M, Kennedy ME Effectiveness of handwashing agents in eliminating Staphylococcus aureus from gloved hands. Journal of Applied Bacteriology 1992; 73: 63-6. Gilliat W The preventive aspects of medicine: a series of lectures in progress during the winter session at King's College Hospital Medical School. The Lancet 1933; 222: 1051-6. Mehtar S, Tsakris A, Castro D, Mayet F The effect of disinfectants on perforated gloves. J Hosp Infect 1991; 18: 191-200. Davies JG, Babb JR, Bradley CR, Ayliffe GAJ Preliminary study of test methods to assess the virucidal activity of skin disinfectants using poliovirus and bacteriophages. Journal of Hospital Infection 1993; 25: 125-31. Tomas ME, Nerandzic MM, Cadnum JL et al. A Novel, Sporicidal Formulation of Ethanol for Glove Decontamination to Prevent Clostridium difficile Hand Contamination During Glove Removal. Infect Control Hosp Epidemiol 2016; 37: 337-9. Pitten FA, Muller P, Heeg P, Kramer A [The efficacy of repeated disinfection of disposable gloves during usage]. Zentralbl Hyg Umweltmed 1999; 201: 555-62.

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ACCEPTED MANUSCRIPT

[47]

[48]

[49]

[50]

[51]

[52] [53]

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[46]

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Pitten F-A, Kramer A Desinfizierbarkeit medizinischer Handschuhe. Hygiene + Medizin 2001; 26: 10-2. Scheithauer S, Hafner H, Seef R, Seef S, Hilgers RD, Lemmen S Disinfection of gloves: feasible, but pay attention to the disinfectant/glove combination. J Hosp Infect 2016; 94: 268-72. Calhoun AJ, Rodrick GE, Brown FH Integrity of powdered and powder-free latex examination gloves. Journal of public health dentistry 2002; 62: 170-2. Fiehn NE, Westergaard J Physical and microbiological quality of five different examination and surgical gloves before and after use in dental practice. Zentralbl Hyg Umweltmed 1993; 195: 27-36. Phalen RN, Wong WK Integrity of disposable nitrile exam gloves exposed to simulated movement. Journal of occupational and environmental hygiene 2011; 8: 289-99. Gao P, Horvatin M, Niezgoda G, Weible R, Shaffer R Effect of Multiple Alcohol-Based Hand Rub Applications on the Tensile Properties of Thirteen Brands of Medical Exam Nitrile and Latex Gloves. Journal of occupational and environmental hygiene 2016; 13: 905-14. Baumann MA, Rath B, Fischer JH, Iffland R The permeability of dental procedure and examination gloves by an alcohol based disinfectant. Dental materials : official publication of the Academy of Dental Materials 2000; 16: 139-44. Capron A, Destree J, Jacobs P, Wallemacq P Permeability of gloves to selected chemotherapeutic agents after treatment with alcohol or isopropyl alcohol. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists 2012; 69: 1665-70. Ng PC, Wong HL, Lyon DJ et al. Combined use of alcohol hand rub and gloves reduces the incidence of late onset infection in very low birthweight infants. Archives of disease in childhood Fetal and neonatal edition 2004; 89: F336-40. EUROPEAN COMMISSION DHAC, Directorate B, Unit B2 “Cosmetics and medical devices”, MEDICAL DEVICES: Guidance document - Classification of medical devices. GUIDELINES RELATING TO THE APPLICATION OF THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES. 2010: http://ec.europa.eu/consumers/sectors/medicaldevices/files/meddev/2_4_1_rev_9_classification_en.pdf. Wissenschaftlicher Beirat der Aktion Saubere Hände. Positionspapier „Desinfizierbarkeit von medizinischen Untersuchungshandschuhen" in Absprache mit der Abteilung Prävention der DGUV. 2015. Kramer A, Rudolph P, Kampf G, Pittet D Limited efficacy of alcohol-based hand gels. The Lancet 2002; 359: 1489-90. Kampf G, Ostermeyer C, Werner H-P, Suchomel M Efficacy of hand rubs with a low alcohol concentration listed as effective by a national hospital hygiene society in Europe. Antimicrobial Resistance and Infection Control 2013; 2: 19.

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ACCEPTED MANUSCRIPT Table I: Mean log10-reduction by treating artificially contaminated gloved and bare hands with various types of hand rubs; experiments based on EN 1500. Type of glove

Active ingredient(s) in Mean log10-reduction after hand rub and type of application application application application 1 5 10 4.3 4.9

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[41] [41]

3.6

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3.8 3.2

[41] [41]

3.8

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Sterillium, 3 ml for 30 s 7.0 4.8 Sterillium Virugard, 3 ml 4.0 4.9 for 30 s Amphisept E, 3 ml for 30 3.3 3.9 s Satin Plus Sterillium, 3 ml for 30 s 4.5 4.2 Sterillium Virugard, 3 ml 4.5 3.7 for 30 s Amphisept E, 3 ml for 30 4.6 4.9 s Biogel iso-propanol (60%) for 6.4 Diagnostic 60 s* Safeskin iso-propanol (60%) for 6.1 Satin Plus 60 s* Safeskin LPE iso-propanol (60%) for 5.1 60 s* Baxter Non- iso-propanol (60%) for 6.6 Sterile 60 s* Best Nitrile iso-propanol (60%) for 5.2 60 s* No glove iso-propanol (60%) for 4.1 (bare hand) 60 s* Vasco Braun Sterillium** 5.65 Sensiva** 5.55 Descoderm** 5.67 Desderman pure** 5.27 Promanum pure** 5.48 Nitrile Blue Sterillium** 5.81 Eco-Plus Sensiva** 6.06 Descoderm** 5.38 Desderman pure** 5.61 Promanum pure** 5.71 Latex Med Sterillium** 5.41 Comfort Sensiva** 5.61 Descoderm** 5.57 Desderman pure** 5.48 Promanum pure** 5.40 *volume not specified; ** volume and application time not specified

RI PT

Peha-soft Puderfrei

Reference

6.4

[40]

5.9

[40]

3.8

[40]

5.2

[40]

4.1

[40]

-

[40]

-

[42] [42] [42] [42] [42] [42] [42] [42] [42] [42] [42] [42] [42] [42] [42]

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ACCEPTED MANUSCRIPT Table II: Leakage rate of different types of gloves after different types of treatment on gloved hands. Treatment of gloved hand with

Gloves with leak Reference (n) Safeskin Satin plus 10 x iso-propanol (60%)* for 60 s 0 out of 20 [40] Biogel Diagnostic 10 x iso-propanol (60%)* for 60 s 0 out of 20 [40] Baxter Non-Sterile 10 x iso-propanol (60%)* for 60 s 0 out of 20 [40] Safeskin LPE 10 x iso-propanol (60%)* for 60 s 0 out of 20 [40] Best Nitrile 10 x iso-propanol (60%)* for 60 s 3 out of 20 [40] Peha-soft 10 x 3 ml water for 30 s each 1 out of 49 [41] 10 x 3 ml Amphisept E for 30 s each 0 out of 50 [41] 10 x 3 ml Sterillium for 30 s each 0 out of 50 [41] 10 x 3 ml Sterillium Virugard for 30 s 1 out of 50 [41] each Satin Plus 10 x 3 ml water for 30 s each 2 out of 48 [41] 10 x 3 ml Amphisept E for 30 s each 0 out of 50 [41] 10 x 3 ml Sterillium for 30 s each 2 out of 50 [41] 10 x 3 ml Sterillium Virugard for 30 s 0 out of 50 [41] each Vasco Braun 5 x Sterillium** 0 out of 20 [42] 5 x Sensiva** 0 out of 20 [42] 5 x Descoderm** 0 out of 20 [42] 5 x Desderman pure** 0 out of 20 [42] 5 x Promanum pure** 0 out of 20 [42] Nitril Blue Eco- 5 x Sterillium** 1 out of 20 [42] Plus 5 x Sensiva** 1 out of 20 [42] 5 x Descoderm** 0 out of 20 [42] 5 x Desderman pure** 0 out of 20 [42] 5 x Promanum pure** 0 out of 20 [42] Latex Med Comfort 5 x Sterillium** 3 out of 20 [42] 5 x Sensiva** 1 out of 20 [42] 5 x Descoderm** 1 out of 20 [42] 5 x Desderman pure** 2 out of 20 [42] 5 x Promanum pure** 0 out of 20 [42] *volume not specified; ** volume and application time not specified

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Type of glove

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ACCEPTED MANUSCRIPT Table III: Hand hygiene regimes in a neonatology intensive care unit as described by Ng et al [49] When

What

Before each patient contact in the incubator

Hand disinfection, followed by donning gloves, followed by disinfection of gloved hands

RI PT

More patient care activities at the same No visible contamination of hands: patient disinfection of gloved hands, e.g. after touching utensils such as the monitor, thermometer, pencils or patient charts. Visible contamination of hands: glove change. Doffing gloves followed by hand disinfection

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After finishing all activities at the same patient

15