Analysis of the integrity of ultrasound probe covers used for transvaginal examinations.

ABSTRACT

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.