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Contamination level of transvaginal ultrasound probes in standard setting: A meta-analysis.

INTRODUCTION

Ultrasound is a high-frequency sound waves imaging of body organs. Not only safe and effective, ultrasound can be done in bedside setting. [1] Many improvisation of ultrasound had been made, especially ultrasound in obstetrics and gynecology, transabdominally and transvaginally. Although women may prefer transabdominal to transvaginal ultrasound, doing transvaginal scan can bring more accurate results. [2]

Transvaginal ultrasound, nowadays, has become a common procedure in the gynecologic even obstetric field. [3] Differs from transabdominal ultrasound, inserting probe into genitalia will allow very close view of the pelvic organs, uterus, cervix, endometrium, fallopian tubes, ovaries, bladder, and pelvic cavity. [4] This procedure will allow probe to make contact with skin or mucous membranes. Bacterial contamination can adhere to the probe through blood or genital secretion which will be transmitted if the probe is being used in another patient. This can be aggravated if there were incidental perforation of probe cover which causes leakage of blood or mucous secretion. [5]

Gynecologist should be aware of this cross infection. [6] Many studies had reported various levels of vaginal ultrasound probes contamination by bacteria, viruses, and fungi. [7] In fact, the rate of contamination usually being underestimated. Many centers did not aware of the risk and fail to carry out proper disinfection of the probes. [8] However, until now, there is no standard guideline for probe disinfection. [7] Almost all centers recommend to cover the probes. Methods of disinfection and cover remained controversial. [9,10] This systematic review will review the risk of probe contamination after the standard procedure and review the methods of disinfection and type of cover probe that is being used in worldwide.

Objective

To review the pooled proportion of contamination and type of microbes contaminated after the standard procedure at transvaginal probe and characterize the methods of disinfection and type of cover probe used in transvaginal ultrasound.

MATERIALS AND METHODS

Study Design

This study provided systematic review that discusses contamination proportion of transvaginal ultrasound contamination. The study design followed the rules in the preferred reporting items for systematic reviews and meta-analyses guidelines. [11,12] The steps of the systematic review followed guidelines for systematic reviews, the Cochrane Handbook for Systematic Reviews of Interventions. [13]

Data Sources

Comprehensive literature search was done by the author on 10th November 2015. Relevant citations were obtained from Medline (1966-2015), SCOPUS (2004-2015), EMBASE, and Cochrane Central Register of Controlled Trials. The references of all retrieved study were reviewed to identify relevant additional studies. The search terms (available from the authors) were then applied (with small modifications) to all electronic databases. The author used search strategy with words (Transvaginal ultrasound [all fields] or transvaginal [all fields] and ultrasound [all fields], contamination [all fields] or infect [all fields] or transmission [all fields]; transvaginal probe [all fields] or transvaginal [all fields] and probe [all fields], contamination [all fields] or infect [all fields] or transmission [all fields]; transvaginal transducer [all fields] or transvaginal [all fields] and transducer [all fields], contamination [all fields] or infect [all fields] or transmission [all fields]; vaginal ultrasound [all fields] or vaginal [all fields] and ultrasound [all fields], contamination [all fields] or infect [all fields] or transmission [all fields]).

Studies Assessment

The author assessed the methodological quality of all included studies using Jadad score (Table 1).

Data Selection

Duplicates of journals were managed using endnote software. A systematic review of these papers was performed after removal of repeated articles from the study searches. Titles and abstracts of the search results were reviewed. Full-text was analyzed in the case of doubtful eligibility.

We considered all published studies that assessed. All articles were assessed using inclusion and exclusion criteria that determined by the author. The articles were included if they contained original data from a cohort, clinical trial, case series, of patients for whom contamination of transvaginal ultrasound were reported. Only English language journal was included in this study. Full-text journals are more preferred, but the abstract only journal is considered based on if the data are provided in the abstract.

Data Extraction

Selected journals were evaluated for eligibility. Data were extracted from included studies using a data extraction form. The scope of the data collection is regarding the study design, contamination rate, ultrasound disinfection technique, and probe cover.

Parameters of Review

The primary parameter of this study is calculating the pooled proportion of contamination. The secondary parameters of this study are type of microbes contaminated after the standard procedure at transvaginal probe, methods of disinfection, and type of cover probe used in transvaginal ultrasound.

Statistical Analysis

This review will calculate the pooled proportion of microbes contamination in the transvaginal ultrasound. We used Metaprop in Stata 12/SE software (StataCorp LP, Texas) with 95% confidence interval (CI). [13] This method incorporates, the Freeman-Tukey arcsine transformation to normalize the variances [14] and pooling the estimated proportion using DerSimonian and Laird method under random effects model. [15] Further systematic review was done in review manager 5.4 (The Nordic Cochrane Center, The Cochrane Collaboration, Copenhagen, Denmark) software.

RESULTS

The last electronic search was performed of MEDLINE on 10 November 2015. The literature search identified 110 potentially eligible studies (3 additional articles were added through the analysis of the found articles references). 27 duplicates articles were removed (Figure 1). After examined articles, on the basis of abstract and title, the articles were excluded because they did not meet eligibility criteria. In remaining 83 articles yielded, we excluded two nonEnglish-based articles, one systematic review, one letter to the editor, and four abstract only articles. Five abstracts only articles were included because there was statistical data information provided in the abstract (Table 2).

Pooled Proportion of Microbes Contamination in Transvaginal Ultrasound after Standard Procedure

About 10 studies [5-6,10,16-22] were analyzed to determine the pooled proportion of microbes contamination in transvaginal ultrasound after using both probe cover and disinfection procedure. Not all studies analyzed both bacteria and viruses contamination. [6,10,16-19,21-22] There were only two studies which analyzed both microbes. [5,20] In this study, the contamination will be analyzed regardless how many microbes that analyzed in each study. Separate analysis was performed.

There were several conditions that carried out. To determine the bacteria contamination, the author included both pathogenic and commensal bacteria, assumed that normal flora can also become pathogenic. In Buescher et al. (2015) [16] and Ngu et al. (2015) [17] studies, contamination rates were taken in the group that undergoing standard disinfection procedures.

The pooled proportion of bacterial and viral contaminations (Table 3) was 31% (95% CI: 1-56%, [I.sup.2]: 99.14%, P = 0.00, Figure 2a). Bacterial and virus contamination analysis performed on six [10,16-18,21-22] and two studies, [6,19] respectively, that specifically analyzed the bacteria or virus alone. The pooled proportion of bacterial contamination was 50% (95% CI: 14-86%, [I.sup.2]: 98.83%, P = 0.00, Figure 2b). The pooled proportion of virus contamination 4% (95% CI: 2-5%, [I.sup.2]; 0%, P = 0.00, Figure 2c).

Figure 2a Forest plot of the pooled proportion of microbes contamination in transvaginal ultrasound after standard disinfection procedure. The pooled proportion of bacterial and viral contaminations was 31% (95% CI: 1-56%, [I.sup.2]: 99.14%, P = 0.00); (b) forest plot of pooled proportion of bacterial contamination in transvaginal ultrasound after standard disinfection procedure. The pooled proportion of bacterial contamination was 50% (95% CI: 14-86%, [I.sup.2]: 98.83%, P = 0.00); (c) forest plot of pooled proportion of virus contamination in transvaginal ultrasound after standard disinfection procedure. The pooled proportion of virus contamination 4% (95% CI: 2-5%, [I.sup.2]: 0%, P = 0.00).

Type of Contaminated Bacteria and Virus

Five studies provided the data of bacteria types that contaminated on probes. [5,10,17-18,20] The author took only three most common infected bacteria from each study (Table 2). In cumulative data, it was shown eight most common bacteria that can contaminate the probe even after standard cleaning procedure (Figure 3).

Four studies identified type and number of virus contaminated (Table 4). [5-6,10,16] Only one study identified various viruses. [20] No herpes virus [10] and CMV [20] contamination were identified in studies.

Transvaginal Ultrasound Probe Cover Analysis

There were different probe covers being used in various centers. Five studies were tabulated to assess the pooled risk proportion of contamination using either condoms or specific covers, while two studies were analyzed to assess the difference between using condoms and covers. [20,22-25] Milki et al. (1988) showed 17 of 840 condoms were defective, but they mentioned only 65% were contaminated because only that 65% presented with leaking distance <10 cm to intravaginal. [24] Contamination of bacteria and viruses in Kac et al. (2015) study were summed up. [20]

The pooled contamination proportion using whether condoms or specific probe covers were almost the same, yielding 3% (95% CI: 1-7%, [I.sup.2]: 85.83%, P = 0.00, Figure 4a) and 3% (95% CI: 1-4%, [I.sup.2]: 0%, P = 0.00, Figure 4b), respectively. The risk difference between both covers also showed slightly low contamination using probe cover (Risk difference -0.04, -0.02 -0.07- 95% CI, [I.sup.2]: 0%, P = 0.001, Figure 4c). Thus, it was shown that using both condom and probe cover had the same risk of contamination. On the other hand, Jimmenez et al. (1998) showed that only one out of 128 samples using gloves were contamination. [23]

Figure 4a Forest plot of pooled proportion of microbes contamination using condoms, (b) forest plot of pooled proportion of microbes contamination using specific probe covers, and (c) forest plot of risk contamination difference using condoms versus probe covers.

New Methods of Disinfection

In recent years, researchers have developed a new tool for disinfection called ADHH. Pooling the data from Buescher et al. (2015) [16] and Ngu et al. (2015) [17] studies, risk difference between both methods was -0.22 using ADHH (95% CI: -0.29--0.15, [I.sup.2]: 99%, P < 0,00,001, Figure 5). This result could not be taken because both studies showed quite different results.

DISCUSSION

Ultrasound probe is classified as the semicritical items that should be free from all microorganisms, while small numbers of bacterial spores are permissible. [7] Mechanism of probe contamination is still unclear. If there was macroscopic broke of probe cover, contamination can be understood logically. [23] In fact, we should understand that there was possibility of microscopic damage of the covers, which brought the risk of contamination probes. [5] Therefore, the examiner should carried out proper disinfection of the probes. [8]

Until now, there transvaginal probe disinfections, either using low-level disinfection (quaternary ammonium compounds or phenolics or chlorhexidine) or high-level disinfection (immersion in glutaraldehyde, hydrogen peroxide or peracetic acid, and then rinsing and drying), were still controversial. [26] The US preferred using high-level disinfection while some countries, such as France, used low-level disinfection, as high-level disinfection can harm either the transducer and vaginal mucosa. [9,27]

In this study, author showed 31% of pooled proportion of microbes contamination (95% CI: 1-56%, [I.sup.2]: 99.14%, P = 0.00). Differences in disinfection methods and probe covers used in each study might play an important role in this study bias. For cases of HIV infection, this would result in approximately 60 patients infected a year. Mathematical computer simulation by Leroy et al. (2014) showed that the probability of infection from a contaminated probe ranged from 1% to 6%. [28]

The lowest contamination rates were found in M'Zali et al. (2014) and Amis et al. (2000) study (0.03% rates of contamination). In M'Zali et al.' study, flocked swabs were swabbed directly to universal transport medium that did not enable any contamination with another thing, while in Amis et al. (2000) study, low contamination rates might be due to the relatively small sample size (n = 72). [5,10]

The highest contamination rates were found in Bueshcer et al. (2015) and Ngu et al. (2015) studies. Buesher et al. (2015) used alcohol swab as the method of disinfection. However, Velvizhi et al. (2015) that only use non-sterile disinfectant showed lower contamination levels (72%). Interestingly, Ngu et al. (2015) showed high rates of contamination even they used glutaraldehyde, a high-level disinfectant. Further research is needed to assess this. [16,17]

None of the low-level disinfectant chemicals that were superior to others. Studies showed various results. Casalegno et al. (2012) and Ma et al. (2012), which both used quaternary ammonium compound, showed contamination levels of 79% and 3%. [6,19] Only M'Zali et al. (2014), which used a combination of three chemicals, showed lower contamination rates. [5] The used of high-level disinfectant as recommended the American Disinfection seemed promising. [29] Kac et al. (2010) found contamination zero after low level followed by UV-B disinfection. However, the result could not be considered as a generalization. [20]

The pooled proportion of bacterial contamination showed a fairly high rates as 50% (95% CI: 14-86%, [I.sup.2]: 98.83%, P = 0.00). The pooled proportion virus showed 4% (95% CI: 2-5%, I: 2.0%, P = 0.00), quite low because mostly study only examined HPV. [20]

HPV is a physically stable and resistant viruses with long durability, which increase of its chance to be transmitted even after a long time interval of the probes using. A recent in vitro study demonstrated that it can survive on a wet surface for at least 7 days and carries an infection ratio of 30%. [30] About 3% of HPV was high-risk types. Furthermore and apparently, the same HR-HPV on an endovaginal probe persisted even after three disinfection procedures. [6] M'Zali et al. (2014) showed that 3/14 samples collected from HPV colonized patients were contaminated by HPV DNA that emphasized the importance of HPV transmission through transvaginal ultrasound. [5]

A recent systematic review and meta-analysis estimated pooled prevalence of 12.9% (95% CI: 1.7-24.3%) for pathogenic bacteria remaining on the probe after cleaning and low level disinfection even when a disposable cover is used, and 1.0% (95% CI: 0-10%) for frequently occurring viruses (HPV, HSV, and CMV). [7]

In formal settings, the probes were used by covering it with covers and chemical disinfection immediately after each examination. [8,9] Kac et al. (2010) showed advantage of using probe, which reduced contamination from 8.2% to 0.9% (Absolute risk reduction = 7.3%). Analysis of the ultrasound cover showed that HPV was detected in 28 samples and only 5 patients were infected. [20]

Control Disease and Prevention [31] and the American Institute of Ultrasound in Medicine (9) recommend the use of condoms rather than specific cover probes because they are less prone to perforations (1-9% and up to 81% in one study). However, the protective efficacy of condoms in preventing contamination are still doubted. [24] Even Storment et al. (1997) stated that the latex condom did not adequate to prevent contamination of the probe. [25]

In this study, it was demonstrated that using both condoms and specific cover showed similar risks of contamination (pooled proportion of 3%, risk difference -0.04). On the other hand, Jimmenez et al. (1998) recommended using gloves that only 1/128 samples were contaminated. Gloves were best suited to be probe cover because it was longer and bigger which can cover the entire probe. Velvizhi et al. (2013) also showed a signification reduction of contamination risk using double instead of single paper wipe (P < 0.001). However, author could not take a conclusion based on the single study. [23]

In recent years, some researchers have developed a new disinfection tool. [16] The idea of finding this machine based on the high contamination regardless of using chemical disinfectant and the risk of reducing the utility of the probe. [10] However, the automated disinfection machine remains controversial because the studies showed various results. [16,17]

It is our belief that both disinfection procedure and probe covers remain a matter of debate. The methodological heterogeneity of the included studies can subject to potential bias. Differences in examined population and hygiene practice can contribute to difference of the study results. The confounding factors, such as ultrasound gel, can also contribute to contamination. [32] Abdullah (1998) found a 23.5% incidence of Staphylococcus epidermidis in the ultrasound gel. [33] It cannot be forgotten that ultrasound equipment comes into direct contact with patients and practitioners during scanning procedures, enabling it to be a potential vehicle for the spread of nosocomial infections. This could be explained by the high copied of human DNA detected on transvaginal probe, 63/216 (29.2%) and 39/198 (19.7%) samples, before and after the probe use. [6]

Strength of this study was that the author included all the studies associated with transvaginal probe contamination. This study also showed which type of bacteria dominated the contamination. Limitations of this study were some of the studies analyzed only based on their abstracts. This study was also included only English language articles.

CONCLUSION

In conclusion, contamination rate, especially bacteria contamination, is still high even after using the standard disinfection procedure. However, definitive results are precluded because methodological heterogeneity of the included studies can subject to potential bias. Further research is needed to find new disinfection procedures to reduce the contamination morbidity rates.

REFERENCES

[1.] Clement S, Candy B, Heath V, To M, Nicolaides KH. Transvaginal ultrasound in pregnancy: Its acceptability to women and maternal psychological morbidity. Ultrasound Obstet Gynecol. 2003;22(5):508-14.

[2.] Pelvic Ultrasound. Coombe Women & Infants University Hospital. Available from: http://www.coombe.ie/content/files/Pelvic_ultrasound.pdf. [Last accessed on 2016 Jan, 11].

[3.] National Capital Diagnostic Imaging. Transvaginal Ultrasound. Royal Australian and New Zealand College of Radiology. Available from: http://www.insideradiology.com.au/PDF/T72Rtransvaginalus-referrer.pdf. [Last accessed on 2016 Jan, 11].

[4.] NHS. Having a Transvaginal (Internal) Pelvic Ultrasound Patient Information. The Hillingdon Hospital. Available from: http://www.thh.nhs.uk/documents/_Patients/PatientLeaflets/radiology/PIID157-TV_Ultrasound_scan-Apr13.pdf.

[5.] M'Zali F, Bounizra C, Leroy S, Mekki Y, Quentin-Noury C, Kann M. Persistence of microbial contamination on transvaginal ultrasound probes despite low-level disinfection procedure. PLoS One. 2014;9(4):e93368.

[6.] Casalegno JS, Le Bail Carval K, Eibach D, Valdeyron ML, Lamblin G, Jacquemoud H, et al. High risk HPV contamination of endocavity vaginal ultrasound probes: An underestimated route of nosocomial infection? PLoS One. 2012;7(10):e48137.

[7.] Leroy S. Infectious risk of endovaginal and transrectal ultrasonography: Systematic review and meta-analysis. J Hosp Infect. 2013;83(2):99-106.

[8.] Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities; 2008. Available from: http://www.cdc.gov/hicpac/pdf/guidelines/disinfection_nov_2008.pdf. [Last accessed on 2016 Jan, 15].

[9.] American Institute of Ultrasound in Medicine. Guidelines for Cleaning and Preparing Endocavitary Ultrasound Transducers Between Patients. Ultrasound in Obstetrics & Gynecology. American Institute of Ultrasound Medicine; 2014;7:94-5. [Last Accessed on 2016 Feb 05].

[10.] Amis S, Ruddy M, Kibbler CC, Economides DL, MacLean AB. Assessment of condoms as probe covers for transvaginal sonography. J Clin Ultrasound. 2000;28(6):295-8.

[11.] Liberati A, Altman DG, Tetzlaff J, Mulrow C, G0tzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: Explanation and elaboration. BMJ. 2009;339:b2700.

[12.] The Cochrane Collaboration. Cochrane Handbook for Systematic Reviews of Interventions, 4.2.6. Available from: http://www.community.cochrane.org/sites/default/files/uploads/Handbook4.2.6Sep2006.pdf. [Last accessed 2016 Jan 17].

[13.] Nyaga VN, Arbyn M, Aerts M. Metaprop: A Stata command to perform meta-analysis of binomial data. Arch Public Health. 2014;72(1):39.

[14.] Freeman MF, Tukey JW. Transformations related to the angular and the square root. Ann Math Stat. 1950;21(4):607-11.

[15.] DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7(3):177-88. "

[16.] Buescher DL, Mollers M, Falkenberg MK, Amler S, Kipp F, Burdach J, et al. Disinfection of transvaginal ultrasound probes in a clinical setting Comparative performance of automated and manual reprocessing methods. Ultrasound Obstet Gynecol. 2015;44(1):1.

[17.] Ngu A, McNally G, Patel D, Gorgis V, Leroy S, Burdach J. Reducing transmission risk through high-level disinfection of transvaginal ultrasound transducer handles. Infect Control Hosp Epidemiol. 2015;36(5):581-4.

[18.] Velvizhi G, Sucilathangam G. An investigation of the microbiological contamination of ultrasound probes: Evaluation of cleaning. Int J Sci Res. 2013;2(8):419-20.

[19.] Ma ST, Yeung AC, Chan PK, Graham CA. Transvaginal ultrasound probe contamination by the human papillomavirus in the emergency department. Emerg Med J. 2013;30(6):472-5.

[20.] Kac G, Podglajen I, Si-Mohamed A, Rodi A, Grataloup C, Meyer G. Evaluation of ultraviolet C for disinfection of endocavitary ultrasound transducers persistently contaminated despite probe covers. Infect Control Hosp Epidemiol. 2010;31(2):165-70.

[21.] Sykes A, Appleby M, Perry J, Gould K. An investigation of the microbiological contamination of ultrasound equipment. Br J Infect Control. 2006;7(4):16-20.

[22.] Rooks VJ, Yancey MK, Elg SA, Brueske L. Comparison of probe sheaths for endovaginal sonography. Obstet Gynecol. 1996;87(1):27-9.

[23.] Jimenez R, Duff P. Sheathing of the endovaginal ultrasound probe: Is it adequate? Infect Dis Obstet Gynecol. 1993;1(1):37-9.

[24.] Milki AA, Fisch JD. Vaginal ultrasound probe cover leakage: Implications for patient care. Fertil Steril. 1998;69(3):409-11.

[25.] Storment JM, Monga M, Blanco JD. Ineffectiveness of latex condoms in preventing contamination of the transvaginal ultrasound transducer head. South Med J. 1997;90(2):206-8.

[26.] APIC. Cleaning, Disinfection, and Sterilization. Basics of Infection Prevention 2-day Mini Course. Available from: https://www.cdph.ca.gov/programs/hai/Documents/Slide-Set-13-Cleaning-Disinfection-Sterilization.pdf. [Last accessed 2016 Feb 5].

[27.] Haut Conseil de la Sante Publique. Gaines de Protection a Usage Unique Pour Dispositifs MEDICAUX Reutilisables: Recommandations D'utilization. Available from: http://www.cfef.org/archives/document/dhosdesinfect.pdf. [Last accessed 2016 Feb 12]

[28.] Leroy S, M'Zali F, Kann M, Weber DJ, Smith DD. Impact of vaginal-rectal ultrasound examinations with covered and low-level disinfected transducers on infectious transmissions in france. Infect Control Hosp Epidemiol. 2014;35(12):1497-504.

[29.] Bloc S, Mercadal L, Garnier T, Komly B, Leclerc P, Morel B, et al. Evaluation of a new disinfection method for ultrasound probes used for regional anesthesia: Ultraviolet C light. J Ultrasound Med. 2011;30(6):785-8.

[30.] Ding DC, Chang YC, Liu HW, Chu TY. Long-term persistence of human papillomavirus in environments. Gynecol Oncol. 2011;121(1):148-51.

[31.] Centers for Disease Control and Prevention (CDC). Pseudomonas aeruginosa infections associated with transrectal ultrasound-guided prostate biopsies--Georgia, 2005. MMWR Morb Mortal Wkly Rep. 2006;55(28):776-7.

[32.] Karadenz YM, Kili[rho] D, Kara Altan S, Altinok D, Guney S. Evaluation of the role of ultrasound machines as a source of nosocomial and cross-infection. Invest Radiol. 2001;36(9):554-8.

[33.] Abdullah BJ, Mohd Yusof MY, Khoo BH. Physical methods of reducing the transmission of nosocomial infections via ultrasound and probe. Clin Radiol. 1998;53(3):212-4.

How to cite this article: Aryanti C. Contamination level of transvaginal ultrasound probes in standard setting: A metaanalysis. Natl J Physiol Pharm Pharmacol 2017;7(1):1-12.

Citra Aryanti

Department of Obstetrics and Gynecology, University of Sumatera Utara, Medan, Indonesia

Correspondence to: Citra Aryanti, E-mail: citra.aryanti@hotmail.com

Received: March 21, 2016; Accepted: September 08, 2016

DOI: 10.5455/njppp.2017.7.0307808092016
Table 1: Jadad score of included studies

Jadad score     Buescher       Ngu            M'Zali
                et al. (2015)  et al. (2015)  et al. (2014)

Was the study   -              +              -
describe as
random?
Was the         -              -              -
randomization
scheme
describe and
appropiate?
Was the study   -              -              -
describe as
double-blind?
Was the         +              +              +
method
of double
binding
appropriate?
Was there a     +              +              +
description of
dropouts and
withdrawals?
Overall Jadad   1              2              1
score

Jadad score      Velvizhi        Casalegno,      Ma              Kac
                 et al. (2013)   et al. (2012)   et al. (2012)   et al.
                                                                 (2010)

Was the study    -               -               -               -
describe as
random?
Was the          -               -               -               -
randomization
scheme
describe and
appropiate?
Was the study    -               -               -               -
describe as
double-blind?
Was the          +               +               +               +
method
of double
binding
appropriate?
Was there a      +               +               +               +
description of
dropouts and
withdrawals?
Overall Jadad    1               1               1               1
score

Jadad score     Sykes          Amis           Storment       Rooks
                et al. (2006)  et al. (2000)  et al. (1997)  et al.
                                                             (1996)

Was the study   +              -              -              -
describe as
random?
Was the         -              -              -              -
randomization
scheme
describe and
appropiate?
Was the study   -              -              -              -
describe as
double-blind?
Was the         +              +              +              +
method
of double
binding
appropriate?
Was there a     +              +              +              +
description of
dropouts and
withdrawals?
Overall Jadad   2              1              1              1
score

Jadad score     Jimenez        MilkiAA.
                et al. (1993)  (1988)

Was the study   -              -
describe as
random?
Was the         -              -
randomization
scheme
describe and
appropiate?
Was the study   -              -
describe as
double-blind?
Was the         +              +
method
of double
binding
appropriate?
Was there a     +              +
description of
dropouts and
withdrawals?
Overall Jadad   1              1
score

Table 2: Studies included in this systematic review

Author, year,  Type of      Samples     Type of
country        study                    infection
                                        studied

Buescher       Cohort       120         Bacteria
et al. (2015)  prospective              (culture)
Ngu            Cohort       152         Bacteria
et al. (2015)  prospective              (culture)
M'Zali         Cohort       300         HPV, C.
et al. (2014)  prospective              trachomatis,
                                        mycoplasma
                                        (PCR), Bacteria
                                        (culture)
Velvizhi       Cohort       50 samples  Bacteria
et al. (2013)  prospective              (culture)
Casalegno,     Cohort       414         HPV (PCR)
et al. (2012)  prospective
Ma             Cross        120         HPV (PCR)
et al. (2012)  sectional
Kac            Cohort       440         All microbes
et al. (2010)  prospective              (Culture)
                                        Virus:
                                        EBV, HPV
                                        CMV (PCR)
Sykes          Cohort       62          Bacteria
et al. (2006)  prospective              (culture)
Amis           Cohort       217         Herpes virus
et al. (2000)  prospective              (culture)
                                        Bacteria (cultur
Storment       Cohort       173         -
et al. (1997)  prospective
Rooks          Cohort       180         -
et al. (1996)  prospective
Jimenez et al  Cohort       230         None
(1993)         prospective
Milki AA.      Cohort       840         -
(1988)         prospective

Author, year,   Study design          Results
country

Buescher        Analyze difference    93 of 113 (78.8%) by
et al. (2015)   of disinfection       manual disinfection and
                using manual          106 of 116 (91.4%) by
                (113 samples) and     automated machine
                automated             (P=0.009), mostly
                (116 samples)         S. aureus,
                disinfection          Enterobactericeae,
                                      Pseudomonas sp.
Ngu             Analysis difference   Contamination: 62 of
et al. (2015)   between 77 using      75 (80.5%) by GDHH,
                glutaraldehyde        mostly Micrococcacea (2),
                disinfection and 72   Acinetobacter (1), Bacillus
                using automated       sp. (1); 4 of 77 (5.3%) by
                disinfection          ADHH
                machine               (P<0.0001), mostly
                                      Staphylococci coagulase
                                      negative (30), S. aureus
                                      ('1), Micrococcaceae (6)
M'Zali          100 samples for       HPV in 13 of 100 (13%,
et al. (2014)   each HPV,             95% CI: 6-20%).
                C. Trachomatis/       C. trachomatis and
                Mycoplasma, and       Mycoplasma in 20 of
                Bacteria              100 (20%, 95% CI: 3-13)
                                      Commensal bacterial flora
                                      in 86 of 100 (86%, 95%
                                      CI: 79-93) at 10-3000
                                      CFU/probe); with the most
                                      common Staphylococci
                                      coagulase negative (73%),
                                      Micrococcus (20%), and
                                      S. Aureus (4%)
Velvizhi        Analysis probes       Bacteria contamination in
et al. (2013)   after disinfection    36 of 50 (72%), mostly
                without using         Gram-negative Bacillie
                probe cover           (K. pneumonia) (32),
                                      Gram-positive
                                      cocci (5)
                                      Risk is 6.71 for the probes
                                      cleaned by single paper
                                      wipe and 0.76 for the
                                      probes cleaned by
                                      double paper
                                      wipe (P<0.001)
Casalegno,      1st: 198 swab taken   1st: 7 of 198 (3.5%) were
et al. (2012)   after the probe was   HPV positive, with 1 is low
                disinfected           risk HPV and 7 are high
                2nd: 216 swab taken   risk HPV.
                before the next       2st (control): 6 of
                examination           216 (2.8%) were HPV
                                      positive, with 4 is low risk
                                      HPV and 2 are high risk
                                      HPV.
                                      No break of probe covers in
                                      all samples
Ma              1st: HPV detection    Contamination of HPV in
et al. (2012)   on probe used         9 of 120 (7.5%)
                by surveillance
                samples
                2nd: HPV detection
                on probe used
                by patients with
                early pregnancy
                complications
Kac             440 samples for       Contamination: Bacterial
et al. (2010)   bacterial analysis,   flora in 301 of 440 (68.4%)
                only 336 samples      with 1-1,000 CFU/
                for viral analysis    plate; pathogenic flora
                267 samples using     in 15 of 440 (3.4%) with
                condoms and 173       3-1,000 CFU/plate,
                using specific        mostly Enterobacter (8),
                cover                 Acinetobacter (3),
                                      Pseudominas (2). Virus
                                      in 5 0f 56 (8.9%; 95%
                                      CI: 3.5-19.7%), the most
                                      common virus are HPV (3),
                                      EBV (2). After chemical
                                      and UVC disinfection, no
                                      microbal found.
                                      Probe covers: Bacterial
                                      and virus contamination
                                      3 of 173 (1.7%) and 1 of
                                      68 (1.5%) with specific
                                      probe; 12 of 267 (4.5%)
                                      and 4 of 268 (1.5%) with
                                      condom (P=0.2).
Sykes           Analysis of           Bacterial contamination in
et al. (2006)   transvaginal          50 of 62 (83%) while 6.7%
                ultrasound probe      is potential pathogens
Amis            46 samples            Contamination:
et al. (2000)   for bacteria          Bacteria in 1 of 46 (2.2%),
                e) assessment,        Acinetobacter spp.; No
                26 samples for        herpes virus contamination.
                herpes virus          Probe covers: 3 of 217
                assessment            condoms broke, 2 of
                Condom defects        remaining 214 condoms
                were detected by      perforate, none of
                adding hydrogen       remaining 212 condoms
                peroxide and filling  leaked
                500 ml water
Storment        Condoms were          8 of 173 (5%) had a positive
et al. (1997)   filled with 10 ml of  [H.sub.2][O.sub.2] test for
                hydrogen peroxide,    contamination. In only 3 of
                bubbling are          8 gross contamination was
                considered positive   seen
Rooks           Remaining non         Perforation in 15 of
et al. (1996)   perforated sheaths    180 (8.3%) by specific
                filled with water to  cover and 3 of 180 (1.7%)
                determine potential   by condom (P<0.05)
                contamination         Contamination in 9 of 174 by
                                      specific cover and 1 of 178
                                      by condom (P<0.05)
Jimenez et al.  Comparing gloves      Gloves: contamination
(1993)          (2.5 x 8.5 cm) and    1 of 128 (0.78%, 95%
                condoms               CI: 0.1-1.6%), perforation
                (diameter 3.7,        4 of 128 (3.1%, 95%
                stretched to 5 cm     CI: 1.6-4.6%)
                stretched)            Condoms: Contamination
                Both were tested      8 of 102 (7.8%, 95%
                for perforation by    CI: 5.2-10.4%), perforation
                filling water.        7 of 102 (6.9%, 95%
                                      CI: 4.4-9.4%)
Milki AA.       Condoms were          17 of 840 (2%) condom
(1988)          filled with water     leaked, 65% of leaks
                to determine          were <=10 cm from the
                leakage               tipe, that potential for
                                      contamination

Author, year,         Disinfection            Probe cover
country

Buescher              Manual disindecti       Not clear
et al. (2015)         (Mikrozid) on or        (only
                      automated method        mentioned
                                              standard
                                              procedures)
Ngu                   Probe disinfected by    Not mentioned
et al. (2015)         detergent and water
                      then disinfected
                      whether with
                      paper towel+2.4%
                      glutaraldehyde or
                      20 min automated
                      disinfection system
M'Zali                Low level               Disposable
et al. (2014)         disinfectiwith          probe cover
                      alcohol, quartenary     (medical CE
                      ammonium, and           mark)
                      chlorhexidine
Velvizhi              Low level disinfection  No cover
et al. (2013)         using single or double
                      paper wipe
Casalegno,            Low level disinfection  Disposable
et al. (2012)         wipes                   probe cover
                      (quarternary            (93/42/EEC
                      ammonium compunds       CE mark)
                      (Sani-Cloth Active)
                      performed by nurse
Ma                    Low level disinfection  Condom
et al. (2012)         (quarternary
                      ammonia, T-spray)
Kac                   Low level disinfection  Condoms and
et al. (2010)         (quartenary             specificcover
                      ammonium, alcohol       (Microtec)
                      (Aniospray) followed
                      by High level
                      disinfection
                      (5-minute disinfectiin
                      UVC chamber)
Sykes                 Low level disinfection  Not mentioned
et al. (2006)         (alcohol,
                      chlorhexidine)
Amis                  Low level disinfection  Condom
et al. (2000)         with alcohol
Storment              Not mentioned           Condom
et al. (1997)
Rooks                 Not mentioned           Specific cover
et al. (1996)                                 and condom
Jimenez et al.        Not mentioned           Gloves
(1993)                                        (128 samples),
                                              condoms (102)
Milki AA.             Germicidal              Condom
(1988)                disposable cloth

S. aureus: Staphylococcus aureus, K. pneumonia: Klebsiella pneumonia,
C. trachomatis: Chlamydia trachomatis

Table 3: Manual and computerized calculated of pooled proprotion of
microbes contamination in transvaginal ultrasound after standard
procedure

Contamination   Number of         Number    Total
                studies analyzed  of cases  samples

Bacteria+virus      10              388      1820
Only bacteria        6              248       546
Only virus           2               21       534

Contamination   Manual calculated  Computerized metaprop
                proportion         calculated pooled proportion (%)

Bacteria+virus   21                  31 (95% CI:1-56)
Only bacteria    45                  50 (95% CI:14-86)
Only virus        4                    4 (95% CI:2-5)

*This table showed number of studies analyzed to obtain the pooled
proportion of microbes contamination, whether bacteria or virus or
combined. Manual calculated proportion was also shown compared to
pooled proportion that is calculated in STATA using metaprop

Table 4: Type and number of bacteria and viruses identified on
transvaginal probes

Study                              Bacteria identified      Virus i
                                                            dentified

M'Zali et al. (2014), France       73 Staphylococci         13 HPV
                                   coagulase negative
                                   20 Micrococcus
                                   20 C. trachomatis
                                   and Mycoplasma
Ngu et al. (2015), UK              30 Staphylococci
                                   coagulase negative
                                   6 Micrococcus
                                   1 S. aureus
Velvizhi et al. (2013), India      32 K. pneumonia
                                   5 Gram-negative cocci
Casalegno, et al. (2012), France                            12 HPV
Ma et al. (2012), Hong Kong                                  9 HPV
Kac et al. (2010), France          8 Enterobacter            3 HPV
                                   3 Acinetobacter           2 EBV
                                   2 Pseudomonas
Amis et al. (2000), UK             1 Acinetobacter

S. aureus: Staphylococcus aureus, K. pneumonia: Klebsiella pneumonia
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Title Annotation:REVIEW ARTICLE
Author:Aryanti, Citra
Publication:National Journal of Physiology, Pharmacy and Pharmacology
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Date:Jan 1, 2017
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