Ultrasound Gel as a Source of Hospital Outbreaks: Indian Experience and Literature Review

Clinical Issues — August 2023

“…Surgical smoke evacuation devices are typically more efficient at capturing surgical smoke than medical-surgical suction systems because the latter have lower suction flow rates. 3,7 The surgical team should place the capture device accessory as close as possible to the surgical site where the surgical smoke is being generated without damaging tissue and should make adjustments as needed to maximize the capture of surgical smoke.…”

“…7 Some of these outbreaks may have been caused by health care personnel using extrinsically contaminated nonsterile ultrasound transmission gel in multidose containers. 7,8 However, there have been outbreaks of B cepacia complex bacterial infections caused by contaminated gel in both nonsterile multidose containers and sterile, single-use packages that were determined to have been intrinsically contaminated by the manufacturer. 4,6 In a multistate outbreak involving 119 patients who developed B stabilis infections, public health officials identified the source of the outbreak as nonsterile ultrasound transmission gel that was intrinsically contaminated by the manufacturer.…”

“…There have been many reports of outbreaks related to contaminated ultrasound transmission gel. Contaminated ultrasound transmission gels have caused Burkholderia cepacia complex infections and bacteremia, 6,7 Staphylococcus aureus pyoderma, Mycobacterium massiliense surgical site infections, and P aeruginosa pneumonia 7 . Some of these outbreaks may have been caused by health care personnel using extrinsically contaminated nonsterile ultrasound transmission gel in multidose containers 7,8 .…”

“…Contaminated ultrasound transmission gels have caused Burkholderia cepacia complex infections and bacteremia, 6,7 Staphylococcus aureus pyoderma, Mycobacterium massiliense surgical site infections, and P aeruginosa pneumonia 7 . Some of these outbreaks may have been caused by health care personnel using extrinsically contaminated nonsterile ultrasound transmission gel in multidose containers 7,8 . However, there have been outbreaks of B cepacia complex bacterial infections caused by contaminated gel in both nonsterile multidose containers and sterile, single‐use packages that were determined to have been intrinsically contaminated by the manufacturer 4,6 …”

“…However, ultrasound transmission gel is not a medication; rather, the US Food and Drug Administration considers it a medical device, so the regulatory processes are different than those for medications. Nonsterile gel also may not contain antimicrobial preservatives to inhibit the growth of microorganisms; if it does, the preservative may not be effective against certain pathogens, such as S aureus 12 or B cepacia complex 4,6,7 …”