Comparison of probe sheaths for endovaginal sonography

doi:10.1016/0029-7844(95)00336-3

Obstetrics & Gynecology

Volume 87, Issue 1, January 1996, Pages 27-29

https://doi.org/10.1016/0029-7844(95)00336-3 Get rights and content

Objective

To compare the effectiveness of commercially available probe covers with less expensive condoms.

Methods

During a 10-month period, sonographers performed endovaginal ultrasound examinations on patients by randomly testing either commercially available probe covers or condoms on the vaginal probe. After use, the sheaths were tested for damage by filling them with water to observe for leakage and thereby determine the breakage rate.

Results

Perforations were noted in 15 of 180 probe covers and three of 180 condoms (8.3 versus 1.7%, P < .05; relative risk [RR] 5.4, 95% confidence interval [CI] 1.4–18.5). Potential contamination of the endovaginal probe occurred during nine of 174 examinations and one of 178 examinations in which probe covers and condoms, respectively, were used (P < .05; RR 9.7, 95% CI 1.2–67.7).

Conclusion

Condoms are less expensive and superior to commercially available probe covers for covering the ultrasound probe during endovaginal examinations.

References (8)

WelchJ et al.
Hepatitis B infections after gynaecological surgery
Lancet
(1989)
ChapmanS et al.
Frequency of glove perforations and subsequent blood contact in association with selected obstetric surgical procedures
Am J Obstet Gynecol
(1993)
Recommendations for preventing transmission of human immunodeficiency virus and hepatitis B virus to patients during exposureprone invasive procedures
MMWR
(1991)
Possible transmission of human immunodeficiency virus to a patient during an invasive dental procedure
MMWR
(1990)

There are more references available in the full text version of this article.

Cited by (49)

Reprocessing semicritical items: An overview and an update on the shift from HLD to sterilization for endoscopes
2023, American Journal of Infection Control
Semicritical medical devices are defined as items that come into contact with mucous membranes or nonintact skin (e.g., gastrointestinal endoscopes, endocavitary probes). Such medical devices require minimally high-level disinfection.
Analyze the methods used to reprocess semicritical medical devices and identify methods and new technologies to reduce the risk of infection.
The reprocessing methods for semicritical medical devices is described as well as a shift from high-level disinfection to sterilization for lumened endoscopes.
Strict adherence to current guidelines and transition to sterilization for endoscopes is required as more outbreaks have been linked to inadequately disinfected endoscopes and other semicritical items than any other reusable medical devices.
Dynamics of papillomavirus in vivo disease formation & susceptibility to high-level disinfection—Implications for transmission in clinical settings
2021, EBioMedicine
High-level disinfection protects tens-of-millions of patients from the transmission of viruses on reusable medical devices. The efficacy of high-level disinfectants for preventing human papillomavirus (HPV) transmission has been called into question by recent publications, which if true, would have significant public health implications.
Evaluation of the clinical relevance of these published findings required the development of novel methods to quantify and compare: (i) Infectious titres of lab-produced, clinically-sourced, and animal-derived papillomaviruses, (ii) The papillomavirus dose responses in the newly developed in vitro and in vivo models, and the kinetics of in vivo disease formation, and (iii) The efficacy of high-level disinfectants in inactivating papillomaviruses in these systems.
Clinical virus titres obtained from cervical lesions were comparable to those obtained from tissue (raft-culture) and in vivo models. A mouse tail infection model showed a clear dose-response for disease formation, that papillomaviruses remain stable and infective on fomite surfaces for at least 8 weeks without squames and up to a year with squames, and that there is a 10-fold drop in virus titre with transfer from a fomite surface to a new infection site. Disinfectants such as ortho-phthalaldehyde and hydrogen peroxide, but not ethanol, were highly effective at inactivating multiple HPV types in vitro and in vivo.
Together with comparable results presented in a companion manuscript from an independent laboratory, this work demonstrates that high-level disinfectants inactivate HPV and highlights the need for standardized and well-controlled methods to assess HPV transmission and disinfection.
Advanced Sterilization Products, UK-MRC (MR/S024409/1 and MC-PC-13050) and Addenbrookes Charitable Trust
Society for Maternal-Fetal Medicine Special Statement: Reducing the risk of transmitting infection by transvaginal ultrasound examination
2020, American Journal of Obstetrics and Gynecology
Citation Excerpt :
The AQL is 0.25% for condoms, 1.5% for surgical gloves, and 2.5% for standard examination gloves.1,22,23 Leakage rates of 1% to 2% have been reported when condoms are used to cover endovaginal ultrasound probes.20,24 In a study of 500 commercially produced probe covers of 10 brands, leakage rates ranged from 0% to 5%.25
Recent surveys have shown widespread lapses in the procedures used to reduce the risk of transmitting infection via medical devices. Transvaginal ultrasound examination has the potential to transmit vaginal infections, including human papillomavirus. Areas of particular concern are the use of probe covers with high rates of leakage, disinfectants that are not effective against human papillomavirus, and coupling gel from multiple-use containers. We reviewed these issues, and we recommend 4 steps to reduce the risk of transmitting infection. First, during every transvaginal ultrasound exam, the probe should be covered with a sterile, single-use “viral barrier” cover or a condom. Second, sterile, single-use ultrasound gel packets should be used. Third, after every examination, the probe should be cleaned to remove any visible gel or debris. Finally, after cleaning, the probe should undergo high-level disinfection using an agent with proven efficacy against the human papillomavirus, including hydrogen peroxide, hypochlorite, or peracetic acid. Glutaraldehyde, orthophthalaldehyde, phenols, and isopropyl alcohol have virtually no efficacy against the human papillomavirus.
Effect of a Condom Cover on Vaginal Photoplethysmographic Responses
2020, Journal of Sexual Medicine
Citation Excerpt :
2 film clips were from the study by Chivers et al5 and 2 were from that of Fairweather et al54; the latter were abbreviated from 120 s to 60 s. Female nude exercise was selected as an appropriate low-intensity sexual stimulus category because it elicits higher self-reported sexual arousal and genital responses relative to neutral (nonsexual) stimuli, whereas the response discrimination between male exercise and neutral categories is less distinct.5 More explicit sexual film clips were not used as low-intensity stimuli in light of recent research showing that in some samples, films depicting manual stimulation or masturbation elicit comparable responses to depictions of sexual intercourse.52,55 The high-intensity sexual stimuli were 60 s excerpts from the four 300 s sexual films clips used in the study by Dawson et al.8 The clips from the study by Dawson et al were originally sourced from female-oriented commercially available films.
The vaginal photoplethysmograph (VPP) is a reusable intravaginal device often employed in sexual psychophysiology studies to assess changes in vaginal blood flow, an indicator of sexual arousal.
To test whether placing a disposable cover on the VPP probe impacts the acquired data. A condom cover would reduce risk of disease transmission and likely increase participant comfort but may negatively impact the VPP signal.
The genital responses of 25 cisgender women (mean age = 21.3 years, standard deviation = 2.6) were assessed with VPP in a within-subjects design with 2 conditions—with and without a polyisoprene condom cover. Sexual responses were elicited by audiovisual film clips that varied in erotic intensity: nonsexual (nonsexual male-female interaction), low-intensity sexual (nude exercise), and high-intensity sexual (male-female intercourse). Women continuously rated their sexual arousal during stimulus presentations.
Change in vaginal pulse amplitude and also self-reported sexual arousal.
The magnitude of sexual response to each stimulus category and the overall pattern of results were found to be highly similar in the cover-off and cover-on conditions. The high-intensity sexual stimulus category elicited a greater sexual response than all other categories. The low-intensity sexual category elicited a (small) genital response in only the cover-on condition, although we suspect this is a spurious finding. There was no difference in the average number of edited movement artifacts across conditions.
Potential benefits of encasing the VPP probe with a protective cover include enhanced participant safety and comfort, especially if assessing genital responses of high-risk or immunocompromised samples. The use of a cover complies with current guidelines for reprocessing semi-critical medical devices (eg, vaginal ultrasound probes) in many regions.
Although the idea of a VPP probe cover had been discussed among sexual psychophysiology researchers, this is the first study to empirically test whether a cover could jeopardize VPP data. Potential limitations include the use of a 10-Hz VPP sampling rate and a cover that was not tailored to the size of the VPP probe.
Placing a protective cover on the VPP probe did not appear to meaningfully impact sexual arousal or the VPP data. Based on these results and the potential advantages of a protective cover, researchers may wish to integrate the use a condom cover in their experiment protocols and clinical applications.
Sawatsky ML, Lalumière ML. Effect of a Condom Cover on Vaginal Photoplethysmographic Responses. J Sex Med 2020; 17:702–715.
Analysis of the integrity of ultrasound probe covers used for transvaginal examinations
2020, Infection, Disease and Health
Citation Excerpt :
Strengths of the study included the sample size of covers tested (total of 500 of each cover), numerous brands assessed (5 commercial and 5 condoms), the variability of covers (latex and latex free), the multiple sites involved and different users to limit any user bias. Previous studies examining breakage rates of ultrasound probe covers are outdated with many covers no longer in circulation [16] and limited with a small variety of brands tested [12,15]. This is the first comprehensive study that thoroughly evaluated and assessed the integrity of commercial covers and condoms in a clinical setting, and it is the first to conclude that non-latex commercial covers have a lower failure rate than condoms for transvaginal ultrasound examination.
Ultrasound probe covers should be used for any ultrasound procedure where there is contact with body fluids or mucous membranes. The type and quality of probe covers used in clinical practice differ widely and studies in the early 1990s showed that condoms were more superior for use with transvaginal examinations than commercial probe covers. Since then, although products have changed, there have been no further studies to assess the breakage rate of different probe covers. The objectives of this study were to assess the integrity of the most commonly used probe covers for transvaginal ultrasound examinations under clinical conditions and report the breakage rate.
The study was conducted in public and private hospitals and private practices. A total of 500 covers for each of 10 brands of commercial covers and condoms (latex and latex free) were distributed to ultrasound practitioners. The transvaginal ultrasound examination practice was unchanged except that all covers were placed in a container for assessment instead of discarding post ultrasound examination. All covers were collected and subjected to a water leak test. Covers that broke upon deployment onto the ultrasound probe prior to the ultrasound examination were recorded. All covers that were broken or had microtears or leaks were recorded as well as photographed. Statistical analysis was performed along with Chi-squared analysis of the data and significance considered at P < 0.05.
None of the commercial covers broke upon deployment onto the ultrasound probe prior to ultrasound examination. A total of 5000 probe covers were examined post-transvaginal ultrasound examinations. The breakage rate for condoms ranged from 0.4% to 13% and for commercial covers 0–5%. Statistical analysis of the data by comparison of p-values revealed that the best performing group were the commercial non-latex probe covers and worst performing group were the non-latex condoms.
The breakage rates for commercial covers were not as high as previously reported and do not break upon deployment onto the ultrasound probe. This is the first comprehensive study that thoroughly evaluated the integrity of commercial covers and condoms used for transvaginal ultrasound examination in a clinical setting, with regards to brand, numbers and types of covers assessed.
Reprocessing semicritical items: Outbreaks and current issues
2019, American Journal of Infection Control
Semicritical medical devices are defined as items that come into contact with mucous membranes or nonintact skin (eg, gastrointestinal endoscopes, endocavitary probes). Such medical devices require minimally high-level disinfection. As many of these items are temperature sensitive, low-temperature chemical methods must be used rather than steam sterilization. Strict adherence to current guidelines is required as more outbreaks have been linked to inadequately cleaned or disinfected endoscopes and other semicritical items than any other reusable medical devices.

View all citing articles on Scopus

^*: The opinions and assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Army or the Department of Defense.

View full text

Comparison of probe sheaths for endovaginal sonography*

Objective

Methods

Results

Conclusion

Lancet

Am J Obstet Gynecol

Recommendations for preventing transmission of human immunodeficiency virus and hepatitis B virus to patients during exposureprone invasive procedures

MMWR

Possible transmission of human immunodeficiency virus to a patient during an invasive dental procedure

MMWR