In April of this year, the Food and Drug Administration (FDA) released a safety communication alerting healthcare facilities to stop the use of Other-Sonic Generic Ultrasound Gel manufactured during the months of June through December of 2011. The gel was found to be contaminated with the bacteria Pseudomonas aeruginosa and Klebsiella oxytoca, which were transmitted to patients and caused serious complications.
In addition to this alert regarding the Other-Sonic Generic Ultrasound Gel, the FDA issued further guidance regarding the use of all ultrasound gels, both sterile and non-sterile.
The Joint Commission standard IC.01.05.01 EP 1 requires accredited organizations to use evidence-based national guidelines or, in their absence, expert consensus when developing infection and prevention control activities.
Hospitals should review their current policies and practices for the management of ultrasound gel in light of the FDA communication and consider the following:
- Use sterile ultrasound gel for any procedure with mucosal contact regardless of whether a biopsy is planned.
- Use open containers of ultrasound gel promptly. Consider implementing a process that requires the disposal of unused gel at a specified timeframe after opening.
- If possible, use an existing timeframe that has been defined by the hospital for other items to avoid confusion by staff members.
- Remember that TJC now requires the expiration date to be marked, not the date opened, unless required by the manufacturer, in which case both dates should be marked.
- Eliminate the practice of refilling or “topping off” containers. Discard the original container after use or expiration.
- Incorporate the monitoring of compliance with the change in practice into current monitoring practices.
Prevention of hospital-acquired infections requires continuous vigilance. Hospitals should include the review of evidence-based guidelines in their pursuit to provide excellent care.
For more information please contact Donna Giles, RN, MS at email@example.com or 1-800-241-0142
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