FDA Warns of Another Compounding Pharmacy Recall

A New Jersey compounding pharmacy has issued a voluntary nationwide recall of a variety of antibiotics and anesthetic/analgesic solutions due to mold contamination, according to an FDA alert.

Medprep Consulting, Inc., of Tinton Falls, N.J., initiated the recall over the weekend after being notified by a Connecticut hospital of visible particulate contaminants in 50ml bags of magnesium sulfate 2 grams in dextrose 5% for injection IV solution that was later confirmed to be mold. The recall has been upgraded to include 84 products compounded at the firm, including bupivacaine, cefazolin, clindamycin, fentanyl citrate, gentamicin, heparin, midazolam, ropivacaine and succinylcholine.

The news comes as the CDC issued new guidance on infections associated with the contaminated steroid injections recalled from the New England Compounding Center in October. New reports of fungal meningitis infections among patients who received the contaminated methylprednisolone acetate continue to occur, says the agency, with most recent cases involving localized spinal infections. The CDC recommends that clinicians "remain vigilant for fungal infections, especially in patients with mild or even baseline symptoms."

Stephanie Wasek

May 7th E-WEEKLY

Are We Falling Behind on C. Diff?

Ramped-up efforts against Clostridium difficile have reaped only mixed results in prevention, according to a survey by the Association for Professionals in Infection Control and Epidemiology. What's more, staffing and monitoring are not seen as keeping pace with the intestinal superbug's looming threat.

For the survey, conducted in January and presented at APIC's conference on the infection in Baltimore last week, the association asked 1,087 members nationwide about practices at their facilities. While 70% of respondents said their facilities have initiated specific interventions against C. diff since March 2010, 42% have seen a decline in C. diff incident rates and 43% have not. Only 21% of facilities surveyed have added to their infection prevention staffs.

"We're encouraged that many institutions have adopted stronger measures to prevent C. diff infection, but as our survey indicates, more needs to be done to reduce the spread of this infection," says APIC President-Elect Jennie Mayfield, BSN, MPH, CIC, a clinical epidemiologist at Barnes-Jewish Hospital in St. Louis, Mo. "We're concerned that staffing levels are not adequate to address the scope of the problem."

Cleaning and follow-up measures are another concern, as the bacteria can survive in clinical environments for months. Ninety-two percent of respondents said they've boosted their surface disinfection and equipment decontamination practices. But 64% said they gauge their results through observation as opposed to using monitoring technologies, which APIC notes is more accurate and reliable. Another 14% said they don't monitor environmental cleaning at all.

"Environmental services must take the lead in developing aggressive programs to monitor cleaning practices and then ensure that the results are shared with frontline staff," says Ms. Mayfield. "Without that buy-in, practices are unlikely to improve."

David Bernard

Surgery in the State Capitol?

Imagine a Pennsylvania lawmaker's surprise as she walks through the state capitol's rotunda and comes across … a surgery in progress?

Members of the Pennsylvania Association of Surgical Technologists descended on Harrisburg to stage the attention-grabbing mock laparoscopic procedure — complete with fully gowned surgical team, instrument sets, supplies and imaging equipment — to emphasize its desire to mandate a minimum level of education and oversight for the state's 3,600 techs.

According to a report in the Patriot News, regulations for surgical techs vary at hospitals across the state, from requiring certification to hiring without certification but mandating it within a year's time to recommending certification but not requiring it.

Mary Grogan, CST, CSFA, president of PAST, wants certification required and standardized. "We're currently the only person in the operating room who's not registered or licensed," she told a local news station. "Because we're the last line of defense with respect to preventing surgical site infections or injuries to patients, it's a priority that we become certified."

Her organization backs efforts by the state's House Republican Majority Leader Mike Turzai to set education requirements and certification standards for all techs working in the state.

A spokesman for the Association of Surgical Technologists says only Idaho, Indiana, Massachusetts, New Jersey, South Carolina, Tennessee and Texas currently have state laws that require individuals to be graduates of accredited surgical technology programs and hold the CST credential before working as surgical technologists. Surgical techs practicing in Colorado or Washington must be registered with the states, according to the spokesman.

Daniel Cook

InstaPoll: How Do You Mark the Surgical Site?

Smiley faces. Bull's-eyes. Asterisks. Surgeon's initials. There's no shortage of ways to mark the surgical site. Tell us in this week's InstaPoll which method you use most often in your ORs.

You're in good company if you pre-warm patients before surgery. Last week's poll of 268 readers showed that most (82%) begin warming patients in the pre-operative phase. The results:

Do you pre-warm patients at risk of unplanned hypothermia before induction of anesthesia?

  • Yes, always 47%
  • Yes, sometimes 26%
  • Yes, but only rarely 9%
  • Never 18%

Dan O'Connor

News & Notes

  • Reversal drug's review delayed The FDA's review of sugammadex, a drug that reverses the muscle-relaxing effects of rocuronium and vecuronium for quicker anesthesia emergence, will not be completed until the latter half of 2013, according to drugmaker Merck & Co. The first in a new class of medications, sugammadex was accepted for review in January, with approval anticipated before July. While the FDA rejected the drug in 2008 due to side effect concerns, it did not cite safety issues as the reason for the present delay.
  • Steroids don't solve back pain Patients who don't receive epidural spinal steroid injections have better clinical outcomes and a lower rate of crossover to surgery than patients who do receive injections, according to a study appearing in a recent issue of the journal Spine. Researchers from the Rothman Institute at Thomas Jefferson University in Philadelphia say injection patients had longer operative times (26 minutes) and hospital stays (0.9 days); less improvement in health and functioning over 4 years; less improvement using non-surgical treatments; and increased crossover to surgical treatment.
  • Anesthesia awareness rare Sedated patients are highly unlikely to regain consciousness before or during procedures, according to a study published in the British journal Anaesthesia. A 2011 survey of anesthetists in England showed anesthesia awareness occurred in 1 in 15,000 surgeries, a lower rate than the previously reported 1 in 1,000 cases. Nearly half of the 153 incidences of awareness occurred at or after induction of anesthesia, notes the study, while 30% occurred during surgery. Awareness during procedures appeared to lead more frequently to pain or distress than awareness at induction and emergence, say the researchers. Depth of anesthesia monitors were readily available to providers, but used by only 1.8% of the more than 7,000 who responded to the survey.