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From: TSS (216-119-144-38.ipset24.wt.net)
Subject: Brief Report: Vancomycin-Resistant Staphylococcus aureus—New York, 2004
Date: August 10, 2004 at 1:54 pm PST

Vol. 292 No. 6, August 11, 2004
Brief Report: Vancomycin-Resistant Staphylococcus aureus—New York, 2004

JAMA. 2004;292:679-680.

MMWR. 2004;53:322-323

Staphylococcus aureus is a common cause of hospital- and community-acquired infections.1,2 The development of vancomycin-resistant enterococci in 1988 led the way to the emergence of vancomycin-resistant S. aureus (VRSA) (minimum inhibitory concentration [MIC] ≥32 µg/mL3), first recognized in 2002.4-7 This report describes the third documented clinical isolate of VRSA from a patient in the United States and provides evidence of failure to detect this VRSA by commonly used automated antimicrobial susceptibility testing.

On March 17, a urine culture obtained from a resident of a long-term–care facility yielded S. aureus. The isolate was tested for antimicrobial susceptibility by using Microscan® overnight panels (Dade Behring, Deerfield, Illinois); vancomycin MIC was 4 µg/mL. Further testing by Etest® (AB Biodisk North America, Inc., Piscataway, New Jersey) indicated that the isolate was resistant to vancomycin (MIC >256 µg/mL). After notification and subsequent analysis by the New York State Department of Health (NYSDOH), the isolate was forwarded to CDC, where it was confirmed to be VRSA (vancomycin MIC = 64 µg/mL, using the National Committee for Clinical Laboratory Standards broth microdilution reference method). The isolate contained both the mecA and vanA genes mediating oxacillin and vancomycin resistance, respectively. The isolate was susceptible to chloramphenicol, linezolid, minocycline, quinupristin-dalfopristin, rifampin, and trimethoprim-sulfamethoxazole.

The patient remains in a long-term–care facility, and NYSDOH is investigating the case. The goals of the investigation include assessment of infection-control practices and whether transmission to other patients, health-care providers, family, and other contacts has occurred. Previous investigations of VRSA demonstrated no transmission among contacts.5,6

This VRSA isolate appears to be unrelated epidemiologically to the VRSA isolate identified previously in Michigan and Pennsylvania.5,6 Although the New York isolate contained the vanA resistance gene, the vancomycin MIC of the isolate appeared low when tested initially by an automated method. Additional testing at CDC indicated that Microscan® and Vitek® (bioMerieux, Hazelwood, Missouri) testing panels and cards available in the United States did not detect vancomycin resistance in this VRSA isolate. Consequently, additional VRSA infections might have occurred but were undetected by laboratories using automated methods. Potential VRSA isolates should be saved for confirmatory testing, and clinical microbiology laboratories must ensure that they are using susceptibility testing methods that will detect VRSA. The most accurate form of vancomycin susceptibility testing for staphylococci is a nonautomated MIC method (e.g., broth microdilution, agar dilution, or agar-gradient diffusion) in which the organisms are incubated for a full 24 hours before reading results. Therefore, when performing automated susceptibility testing of S. aureus strains, particularly methicillin-resistant S. aureus, laboratories should include a vancomycin-agar screening plate containing 6 µg/mL of vancomycin and examine the plate for growth after 24-hour incubation.

The public health response to identification of this VRSA infection is ongoing. Use of proper infection-control practices and appropriate antimicrobial agent management can help limit the emergence and spread of antimicrobial-resistant microorganisms, including VRSA. CDC recommends contact precautions when caring for patients with these infections, including (1) placing the patient in a private room; (2) wearing gloves and a gown during patient contact; (3) washing hands after contact with the patient, infectious body tissues, or fluids; and (4) limiting the use of patient-care items to individual patients. In addition, the number of persons caring for a patient with VRSA or vancomycin-intermediate S. aureus should be minimized (e.g., by assigning dedicated staff to care for the patient).* Isolation of S. aureus with confirmed or presumptive vancomycin resistance should be reported immediately through state and local health departments to the Division of Healthcare Quality Promotion, National Center for Infectious Diseases, CDC, telephone 800-893-0485.


Reported by:

M Kacica, MD, New York State Dept of Health. LC McDonald, MD, Div of Healthcare Quality Promotion, National Center for Infectious Diseases, CDC.


Acknowledgments

This report is based in part on contributions by C Scott, DJ Bopp, MS, NB Dumas, G Johnson, DJ Kohlerschmidt, P Kurpiel, RJ Limberger, PhD, KA Musser, PhD, B Wallace, MD, P Smith, MD, New York State Dept of Health.

References: 7 available.

*Additional CDC guidelines for preventing spread of VRSA are available at http://www.cdc.gov/ncidod/hip/vanco/vanco.htm.
http://jama.ama-assn.org/cgi/content/full/292/6/679?etoc

Public Health Service
Food and Drug Administration

Cincinnati District Office
Central Region
6751 Steger Drive Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771

VIA FEDERAL EXPRESS

July 29, 2004

Edward A. Stoll, President/Owner
Todd E. Stall, Vice-President/Owner
Stoll Farms, Inc.
6818 Coal Bank Road
Marshallville, OH 44645-9729

WARNING LETTER CIN-04-21892

Dear Mr. Stoll:

An inspection of your dairy farm located in Marshallville, OH by Food and Drug Administration (FDA) Investigator Mishelle L. Harriger from 4/27/2004 - 4/29/2004 confirmed that you offered animals for sale as human food in violation of the Federal Food, Drug, and Cosmetic Act (the Act). The animals (bob veal calves) were adulterated food within the meaning of sections 402(a)(2)(C)(ii) and 402(a)(4) of the Act.

The United States Department of Agriculture (USDA)/Food Safety Inspection Service (FSIS) analyses of tissues collected from the animal disclosed the presence of the following drugs:
Animal ID Drug Tissue Level Tolerance
Back Tag 8674 Neomycin

Neomycin
kidney

Muscle
8.01 ppm

detected
None Established

None Established
Back Tag 8676 Neomycin Kidney 11.65 ppm None Established

Back Tag 8741


Neomycin Kidney 13.04 ppm None Established

Tolerance levels for residues of new animal drugs are found in Title 21, Code of Federal Regulations, Part 556. There is no established tolerance for Neomycin in bob veal calves. As such, the presence of this drugs in the edible tissues of these animals causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act.

The investigation also found that you hold animals under conditions that could allow medicated animals, bearing potentially harmful drug residues, to enter the food supply. For example:

*

There is no inventory list of drugs or medicated feeds used.
*

You do not maintain any records regarding the use of medicated milk replacer in the herd.

Food from animals held under such conditions is adulterated within the meaning of Section 402(a)(4) of the Act.

We also note that your employee signed a certificate (or guarantee ) from your firm stating that the animals you sell do not contain any illegal drug residues. If you continue to medicate animals without maintaining the records and procedures listed above, you may be giving a false guarantee. Giving a false guarantee is prohibited by section 301(h) of the Act.

You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to correct the violations may result in regulatory action without further notice. Such action includes seizure and/or injunction.

The violations listed above are not intended to be an all-inclusive list. It is your responsibility to assure that your operations are in compliance with the law.

You should be aware that it is not necessary for you to have personally shipped an animal in interstate commerce. The fact that you caused the adulteration of an animal that was subsequently offered for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.

You should notify this office in writing within 15 working days of the steps you have taken to bring your firm into compliance with the law. Your response should include each step being taken or that will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your reply should be addressed to Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237-3097, Attention: Stephen J. Rabe, Compliance Officer.

Sincerely

/s/

Deborah Grelle for Carol A. Heppe

District Director

Cincinnati District Office

http://www.fda.gov/foi/warning_letters/g4881d.htm

MORE ANTIBIOTIC WARNING LETTERS FOR THIS WEEK;

http://www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm

TSS




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