News Scan for Mar 13, 2015

Melioidosis-linked lab lapses
More Saudi MERS cases
Hospital Listeria outbreak
Cleaning medical devices
New campus meningitis case

CDC notes safety lapses at melioidosis-linked Tulane lab

Federal officials noted several biosafety lapses at a Tulane University animal lab after animals were infected with Burkholderia pseudomallei, the bacterium that causes melioidosis, or Whitmore's disease, the Centers for Disease Control and Prevention (CDC) announced today.

Officials from the CDC and the US Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) did not pinpoint an exact "transmission event," but they identified lapses in personal protective equipment (PPE) use that may have allowed transport of B pseudomallei on researchers' clothing.

The investigation was initiated when two non-human primates at the Tulane National Primate Research Center (TNPRC) were diagnosed as having melioidosis. A CDC lab analysis in mid-January determined that the strain of bacteria that sickened the primates was identical to the one being used in research at the TNPRC.

Improper PPE use "could have led to the bacteria clinging to inner garments and getting carried out of the select agent lab where research was being conducted with the bacteria on mice," the CDC said in a statement. "The bacteria could have been transferred this way to the breeding colony where the non-human primates resided and/or to the clinic where routine examinations and treatments were administered."

Also, the CDC and APHIS inspectors determined that TNPRC staff often entered the select-agent lab without appropriate PPE, "which would increase the risk of bringing the bacteria out of the lab or becoming infected themselves."

Federal officials have suspended all select-agent research at the lab until Tulane officials demonstrate that specific steps have been taken, including establishing procedures for managing exposed animals, ensuring compliance with PPE procedures, conducting PPE training, and improving entry and exit steps.

The CDC said the incident poses little threat to the public.
Mar 13 CDC statement


MERS strikes two young men in Riyadh, one fatally

MERS has struck two young male expatriates in Riyadh, Saudi Arabia, killing one of them, the Saudi Ministry of Health (MOH) reported today, as the city continued to be a hot spot for the virus.

The man who died was a 31-year-old who had a preexisting illness and no contact with other MERS-CoV (Middle East respiratory syndrome coronavirus) cases. Authorities are looking into whether he had any contact with animals, the MOH said.

The other patient is a 21-year-old with a preexisting disease who is in critical condition. He has no history of exposure to risk factors and, like the older man, is not a healthcare worker, the MOH said.

The ministry also reported the recovery of two other patients, both men: a 61-year-old Saudi and a 57-year-old foreigner, both in Riyadh.

The two new cases increase the country's MERS count for March to 32 cases and the cumulative total to 952 cases, with 413 deaths, 514 recoveries, and 25 patients still under treatment or observation.
Mar 13 MOH statement


Listeria-tainted ice cream sickens 5 hospital patients, 3 fatally

Kansas, Texas, and federal health officials are investigating a cluster of Listeria infections in five patients hospitalized at the same facility for unrelated conditions, three of whom died. The outbreak appears to be linked to ice cream made by Blue Bell Creameries.

The patients were sickened between January 2014 and January 2015, according to a statement today from the Kansas Department of Health and Environment (KDHE). The outbreak was detected recently after tests revealed that two of the patients were sickened by the same strain of Listeria monocytogenes. Further investigation found three more infected patients.

The US Food and Drug Administration (FDA) said the patients in Kansas have one of four rare Listeria strains, three of which are very similar and have been found in products made at the Blue Bell facility in Brenham, Tex.

In February, routine sampling by South Carolina officials turned up three of the four rare strains, plus four other rare Listeria strains, in two types of Blue Bell products, both individual serving items made at the Brenham plant. Testing by Texas officials of products made at the plant found the Listeria in the same two products, plus a third one.

The FDA said hospital records available for four of the patients show that they were all served Blue Bell prepackaged single-serving ice cream, as well as milkshakes made from the ice cream. The agency added that the hospital gets products made by Blue Bell, but it hasn't confirmed if all of the products it receives are made at the Brenham plant.

Blue Bell has removed 10 products from the market and has shut down the affected production line.
Mar 13 KDHE statement
Mar 13 FDA statement


FDA issues guidance on cleaning reusable medical devices, sets meeting

The FDA yesterday announced the release of final guidance for industry on the reprocessing of reusable medical devices, such as the duodenoscopes that were recently linked to drug-resistant infections in several hospitals.

At the same time, the FDA said it would hold a public meeting May 14 and 15 to discuss the epidemiologic investigations of infections associated with duodenoscopes and gather experts' opinions on reprocessing of the devices.

The FDA said the guidance document, titled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," focuses on recommendations to ensure that the instructions for cleaning and disinfecting reusable devices are appropriate and understandable. The guidance lists six criteria that the instructions for all devices should meet.

The agency said it issued draft guidance on the topic in 2011 and considered almost 500 comments before issuing the final guidance. The guidance provides more clarity about testing protocols and what data should be submitted to the agency for a premarket evaluation.

Plans for the May 14 and 15 meeting concerning duodenoscopes were detailed today in the Federal Register. The sessions will be held on the FDA's White Oak Campus in Silver Spring, Md., and run from 8 am to 6 pm.

At the meeting, the Gastroenterology and Urology Devices Panel of the FDA's Medical Devices Advisory Committee will seek expert opinion on the reprocessing of duodenoscopes and other endoscopes, as well as automated endoscope reprocessors.
Mar 12 FDA press release
Mar 13
Federal Register notice
Related Mar 5
CIDRAP News item


University of Oregon has 5th meningitis case

A University of Oregon sophomore has contracted the college's fifth case of meningitis this year, the first one since a female freshman member of the acrobatics and tumbling team died of the disease on Feb 17.

The sophomore, a 19-year-old man, lives in an off-campus student apartment complex in downtown Eugene with three roommates, the Eugene Register-Guard reported today. He is hospitalized but "doing very well," a university spokeswoman said.

The student's roommates will receive antibiotics, and the university set up an open house in the apartment complex this afternoon and evening to administer vaccine.

The outbreak began in mid-January, and the other three infected students, all freshmen, have recovered, the story said. The university conducted a 4-day vaccination campaign starting on Mar 2 that targeted all undergraduates, graduate students living on campus, and students with certain high-risk medical conditions.

The university would not say whether the infected student received the first dose of the vaccine, citing federal health privacy laws, according to the Register-Guard.
Mar 13 Regiser-Guard story

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