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FDA Warns of Rare But Serious Allergic Reactions to CHG
WASH CAREFULLY Ask patients about CHG allergies before prescribing pre-op showers.

Skin-prepping products containing chlorhexidine gluconate (CHG) can cause potentially serious allergic reactions, including breathing difficulty, swelling of the face, hives, severe rash or life-threatening shock, says the FDA in a drug safety communication.

"Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years," says the FDA.

The FDA is asking manufacturers of solutions, sponges and swabs containing chlorhexidine gluconate to add a warning about this risk to the drug facts labels.

The FDA says 24 of the 43 worldwide reactions to CHG products reported between January 1969 and June 2015 were reported after 2010: 26 reported the outcome as life-threatening, 12 required hospitalization and 2 deaths were attributed to an anaphylactic reaction. Hypotension in association with either skin, respiratory or gastrointestinal allergy symptoms was reported in 39 of the 43 cases, says the FDA.

The FDA suspects more cases have likely gone unreported. It wants healthcare providers to report all CHG-related adverse events to the FDA MedWatch program by using an online form, a downloadable form or by calling (800) 332-1088.

The FDA lists several steps you can take:

  • Ask patients if they've ever had an allergic reaction to products that contain CHG. If they have, consider an alternative skin prep, such as povidone-iodine, alcohols, benzalkonium chloride, benzethonium chloride or parachlorometaxylenol (PCMX).
  • Instruct patients to seek immediate medical attention if they experience any allergic reaction while cleaning their skin with a CHG product at home.
  • If you're caring for a patient who experiences a suspected allergic reaction to CHG, immediately stop using the CHG product, monitor the situation closely, and provide respiratory or cardiovascular support as needed.

Daniel Cook

Damaged Colonoscopes Difficult to Disinfect
COMPROMISED Sixty percent of the reprocessed endoscopes studied tested positive for microbial growth.

Inadequate reprocessing is usually to blame for endoscopy-associated outbreaks, but infections can also occur when you adhere to reprocessing guidelines, a new study in the American Journal of Infection Control has found.

Despite rigorous reprocessing, researchers found visible irregularities — residual fluid, discoloration and channel debris — in all 20 endoscopes they studied over a 7-month period. Twelve of the 20 scopes tested positive for microbial growth.

Endoscopes with physical damage or defects were particularly susceptible to pathogens. Researchers observed visual signs of compromised external surfaces, including scratched lenses, dents and scaly deposits. Eighty-five percent of endoscopes — 17 out of 20 — required repair in light of the researchers' findings.

Researchers from Ofstead & Associates examined 2 groups of endoscopes from one ambulatory surgical center: those reprocessed using customary practices; and those subjected to more rigorous reprocessing, meaning they were cleaned at least twice prior to high-level disinfection. All 20 endoscopes were fairly new, subjected to low procedure volumes and reprocessed according to current recommended guidelines or more thorough measures.

Researchers say their findings bolster the need for routine visual inspection and cleaning verification tests recommended in new reprocessing guidelines.

Bill Donahue

Mesh Associated with Fewer Repairs, But More Complications in Hernia Repair
MIXED MESSAGE Mesh patients were about 50% less likely to need repairs.

Using mesh in incisional hernia repairs tends to provide significant benefit in the short run, but may be substantially less beneficial over time, according to a study.

Researchers in Denmark found that patients who had non-mesh surgeries were much more likely to need subsequent repairs than patients who had either open or laparoscopic mesh repairs, but that after 5 years, a much higher percentage of the mesh patients had serious complications.

The study covered roughly 3,200 patients who had hernias repaired from 2007 to 2010. Of the 366 (11%) who had non-mesh repairs, 17.1% eventually required repairs. Only 12.3% of those who had open mesh procedures and only 10.6% of those who had laparoscopic mesh procedures needed repairs.

But the 5-year complication rates were 5.6% (open mesh) and 3.7% (laparoscopic mesh), compared with 0.8% for non-mesh. Between 1% and 2% of the mesh-related complications were life-threatening. They included bowel perforation, enterocutaneous fistulas, chronic surgical site infections, hematomas, seromas and bowel obstruction.

The authors note, however, that the non-mesh patients generally had smaller hernia defects than their mesh counterparts. They add that they would expect mesh-related complications to continue to develop over time, but that they still recommend using it.

Jim Burger

InstaPoll: How Do You Keep Propofol Secure?

Securing propofol has been shown to dramatically reduce abuse and deaths. Do you double-lock propofol? Or do you count it at the beginning and end of your day? Tell us in this week's InstaPoll.

In a near-unanimous response, 95% of last week's 277 respondents say it's a challenge to find and keep good reprocessing techs. The results:

How difficult is it to find and retain qualified central sterile techs?

  • very difficult 61%
  • somewhat difficult 34%
  • somewhat easy 5%
  • very easy 0%

Dan O'Connor

News & Notes
  • Stored scopes stay safe longer than expected As long as they're properly cleaned and disinfected, GI endoscopes can be stored safely for longer than typically recommended, a recent study suggests. Researchers examined reprocessed scopes at 1-, 2-, 4-, 6- and 8-week intervals and found that none had clinically relevant contamination.
  • Are clotting risks overblown? The use of anticoagulants to prevent post-op venous thromboembolism (VTE) is unnecessary in up to 75% of the cases in which the agents are administered, according to a study published in the Annals of Surgery. The study's authors say basing VTE prophylaxis on the clotting risk scores of individual patients would ensure the therapy is used only in appropriate circumstances and might also minimize bleeding complications after surgery.
  • A tool for reducing re-excision surgery in breast-cancer patients A device called MarginProbe from Dune Medical Devices can be used to reduce the number of procedures needed to remove lingering cancer cells after breast-cancer surgery. When surgeons use MarginProbe to explore the margins of cancerous tissue they've removed, the handheld device detects any remaining malignant tissue and prompts doctors to remove it. "You need to be able to say to the patient, 'One outpatient surgery and you are done,'" Freya R. Schnabel, MD, director of breast surgery at NYU Langone's Perlmutter Cancer Center, tells the Wall Street Journal. In a randomized trial involving nearly 600 patients in America and Israel, Dr. Schnabel found that MarginProbe reduced the number of patients requiring re-excision surgery by 26%.