Missouri Department of Health & Senior Services Health Alert: Health Alert October 21, 2011 TT ooppiicc FROM: MARGARET T. DONNELLY DIRECTOR PPllaakk--VVaacc OOrraall CCaarree SUBJECT: Potential Contamination of Plak-Vac Oral Care System SSyyssttee mm AAddvviissoorryy The Department of Health and Senior Services advises health care facilities to temporarily suspend the use of Plak-Vac Oral Care System. The product has been used by health care facilities for oral hygiene of patients on ventilators. One lot of this product was analyzed and found to be contaminated with Burkholderia cepacia. In addition to patients on October 21, 2011 ventilators, this organism is hazardous to those with chronic respiratory disease, cystic fibrosis or are otherwise immune compromised. The department is working with the Food This document will be updated as new and Drug Administration on the investigation and further details will be provided as they information becomes available. The become available. current version can always be viewed at http://www.health.mo.gov The product label is pictured below. The Missouri Department of Health & Senior Services (DHSS) is now using 4 types of documents to provide important information to medical and public health professionals, and to other interested persons: Health Alerts convey information of the highest level of importance which warrants immediate action or attention from Missouri health Plak-Vac- providers, emergency responders, public health agencies, and/or the public. Health Advisories provide important information for a specific incident or situation, including that impacting neighboring states; may not require immediate action. 08:00 Swab Health Guidances contain Or I Care Pr-oo-edbure _-_ comprehensive information pertaining to a particular disease or condition, ~ # -.8.r...A..f.tl.,M...,C 1' agnudid ienlicnlueds,e e rtecc. oemndmoersnedda tbioy nDs,H SS. , C:~>nlcd4 g'Iu m ..s ~ntfhs -"• p o"'1e ·-.- c__......., li12ll11ilid --- Health Updates provide new or , Apply rnouUl fflOG1u,1Ze<10 ·lll5--!!s-!II• 1'1)9endmouflumg updated information on an incident or MJl)blor situation; can also provide informa- NfitOOfllOD l!l2!1l.l!!lu tion to update a previously sent Health Alert, Health Advisory, or Health Guidance; unlikely to require immediate action. __________________________________ Office of the Director 912 Wildwood P.O. Box 570 Jefferson City, MO 65102 Telephone: (800) 392-0272 Fax: (573) 751-6041 Web site: http://www.health.mo.gov Missouri Department of Health & Senior Services Health Alert: Health Alert FROM: MARGARET T. DONNELLY October 26, 2011 DIRECTOR SShh iiggaa ttooxxiinn-- SUBJECT: Increase in reported Shiga toxin-producing Escherichia coli pprroodduucciinngg (STEC) Illnesses in St. Louis Area EEsscchheerriicchhiiaa ccoollii Situational Update The St. Louis County Health Department has reported a marked increase in cases of Shiga toxin-producing Escherichia coli (STEC). The cases are being investigated by the St. Louis County Health Department and the Missouri Department of Health and Senior Services (DHSS). At this time the cause of the illnesses is unknown. CDC has recommended that any person who has signs or symptoms of STEC infection should seek medical care and let the October 26, 2011 medical provider know about the increase of STEC infections in St. Louis region and the importance of being tested for STEC infection. This document will be updated as new Symptoms of STEC infection include severe stomach cramps, diarrhea (which is often bloody) and vomiting. If there is fever, information becomes available. The it usually is not very high. Most people get better within 5–7 days, but some patients go on to develop HUS (hemolytic current version can always be viewed uremic syndrome), usually about a week after the diarrhea starts. The classic triad of findings in HUS is acute renal damage, at http://www.health.mo.gov microangiopathic hemolytic anemia (evidence of schistocytes and helmet cells on peripheral blood smear), and thrombocytopenia. The Missouri Department of Health & Senior Services (DHSS) is now using It is not recommended to give antibiotics to patients with suspected STEC infections until complete diagnostic testing can be 4 types of documents to provide performed and STEC infection is ruled out. Some studies have shown that administering antibiotics in patients with STEC important information to medical and infections might increase their risk of developing HUS. However, clinical decision making must be tailored to each individual public health professionals, and to patient. There may be indications for antibiotics in patients with severe intestinal inflammation if perforation is of concern. other interested persons: Guidelines to ensure as complete as possible detection and characterization of STEC infections include the following: Health Alerts convey information • All stools submitted for testing from patients with acute community-acquired diarrhea should be cultured for of the highest level of importance STEC O157:H7. These stools should be simultaneously assayed for non-O157 STEC with a test that detects the which warrants immediate action or Shiga toxins or the genes encoding these toxins. attention from Missouri health • Clinical laboratories should report and send E. coli O157:H7 isolates and Shiga toxin-positive samples to the state providers, emergency responders, public health laboratory as soon as possible for additional characterization. public health agencies, and/or the • Specimens or enrichment broths in which Shiga toxin or STEC are detected, but from which O157:H7 STEC public. isolates are not recovered should be forwarded as soon as possible to the state public health laboratory so that non- O157:H7 STEC can be isolated. Health Advisories provide • It is often difficult to isolate STEC in stool by the time a patient presents with HUS. Immunomagnetic separation important information for a specific (IMS) has been shown to increase recovery of STEC from HUS patients. For any patient with HUS without a incident or situation, including that culture-confirmed STEC infection, stool can be sent to the CDC (through the state public health laboratory). In impacting neighboring states; may not addition, serum can be sent to CDC (through the state public health laboratory) for serologic testing of common require immediate action. STEC serogroups. Health Guidances contain The benefits of adhering to the recommended testing strategy include early diagnosis, improved patient outcome, and comprehensive information pertaining detection of all STEC serotypes. to a particular disease or condition, E. coli is a Category I reportable disease. All patients with Shiga toxin-positive diarrheal illness or HUS either known or and include recommendations, suspected cases should be reported to your local public health agency, or to the Missouri Department of Health and Senior guidelines, etc. endorsed by DHSS. Services (DHSS) at 800/392-0272 (24/7). Health Updates provide new or Laboratory consultation is available from the Missouri State Public Health Laboratory (MSPHL) by calling 573/751-3334, or updated information on an incident or 800/392-0272 (24/7). situation; can also provide informa- tion to update a previously sent Questions should be directed to DHSS’ Bureau of Communicable Disease Control and Prevention at 573/751-6113 or Health Alert, Health Advisory, or 800/392-0272 (24/7). Health Guidance; unlikely to require immediate action. Office of the Director 912 Wildwood P.O. Box 570 Jefferson City, MO 65102 Telephone: (800) 392-0272 Fax: (573) 751-6041 Web site: http://www.health.mo.gov Missouri Department of Health & Senior Services Health Alert: Health Alert October 28, 2011 FROM: MARGARET T. DONNELLY DIRECTOR SShhiiggaa ttooxxiinn-- SUBJECT: Increase in reported Shiga toxin-producing Escherichia coli pprroodduucciinngg (STEC) Illnesses in St. Louis Area EEsscchh eerriicchhiiaa ccoollii Situational Update 10/28/11 All stools submitted to clinical laboratories for testing from patients with suspected E coli infection should be cultured for O157 STEC on selective and differential agar. These stools should be simultaneously assayed for non-O157 STEC with a test that detects the Shiga toxins or the genes encoding these toxins. Specimens or enrichment broths in which Shiga toxin or STEC are detected but from which O157 STEC are not recovered October 28, 2011 should be forwarded as soon as possible to the Missouri State Public Health Laboratory. This document will be updated as new information becomes available. The Situational Update 10/26/11 current version can always be viewed at http://www.health.mo.gov The St. Louis County Health Department has reported a marked increase in cases of Shiga toxin-producing Escherichia coli (STEC). The cases are being investigated by the St. Louis County Health Department and the The Missouri Department of Health & Missouri Department of Health and Senior Services (DHSS). At this time the cause of the illnesses is unknown. Senior Services (DHSS) is now using 4 types of documents to provide CDC has recommended that any person who has signs or symptoms of STEC infection should seek medical important information to medical and care and let the medical provider know about the increase of STEC infections in St. Louis region and the public health professionals, and to importance of being tested for STEC infection. other interested persons: Symptoms of STEC infection include severe stomach cramps, diarrhea (which is often bloody) and vomiting. If Health Alerts convey information there is fever, it usually is not very high. Most people get better within 5–7 days, but some patients go on to of the highest level of importance develop HUS (hemolytic uremic syndrome), usually about a week after the diarrhea starts. The classic triad of which warrants immediate action or findings in HUS is acute renal damage, microangiopathic hemolytic anemia (evidence of schistocytes and attention from Missouri health helmet cells on peripheral blood smear), and thrombocytopenia. providers, emergency responders, public health agencies, and/or the It is not recommended to give antibiotics to patients with suspected STEC infections until complete diagnostic public. testing can be performed and STEC infection is ruled out. Some studies have shown that administering Health Advisories provide antibiotics in patients with STEC infections might increase their risk of developing HUS. However, clinical decision making must be tailored to each individual patient. There may be indications for antibiotics in patients important information for a specific with severe intestinal inflammation if perforation is of concern. incident or situation, including that impacting neighboring states; may not Guidelines to ensure as complete as possible detection and characterization of STEC infections include the require immediate action. following: Health Guidances contain comprehensive information pertaining • All stools submitted for testing from patients with acute community-acquired diarrhea should be to a particular disease or condition, cultured for STEC O157:H7. These stools should be simultaneously assayed for non-O157 STEC and include recommendations, with a test that detects the Shiga toxins or the genes encoding these toxins. guidelines, etc. endorsed by DHSS. • Clinical laboratories should report and send E. coli O157:H7 isolates and Shiga toxin-positive samples to the state public health laboratory as soon as possible for additional characterization. Health Updates provide new or • Specimens or enrichment broths in which Shiga toxin or STEC are detected, but from which O157:H7 updated information on an incident or STEC isolates are not recovered should be forwarded as soon as possible to the state public health situation; can also provide informa- laboratory so that non-O157:H7 STEC can be isolated. tion to update a previously sent • It is often difficult to isolate STEC in stool by the time a patient presents with HUS. Immunomagnetic Health Alert, Health Advisory, or separation (IMS) has been shown to increase recovery of STEC from HUS patients. For any patient Health Guidance; unlikely to require with HUS without a culture-confirmed STEC infection, stool can be sent to the CDC (through the immediate action. state public health laboratory). In addition, serum can be sent to CDC (through the state public health __________________________________ laboratory) for serologic testing of common STEC serogroups. Office of the Director The benefits of adhering to the recommended testing strategy include early diagnosis, improved patient 912 Wildwood outcome, and detection of all STEC serotypes. P.O. Box 570 Jefferson City, MO 65102 E. coli is a Category I reportable disease. All patients with Shiga toxin-positive diarrheal illness or HUS either Telephone: (800) 392-0272 known or suspected cases should be reported to your local public health agency, or to the Missouri Department Fax: (573) 751-6041 of Health and Senior Services (DHSS) at 800/392-0272 (24/7). Web site: http://www.health.mo.gov Laboratory consultation is available from the Missouri State Public Health Laboratory (MSPHL) by calling 573/751-3334, or 800/392-0272 (24/7). Questions should be directed to DHSS’ Bureau of Communicable Disease Control and Prevention at 573/751- 6113 or 800/392-0272 (24/7). Missouri Department of Health & Senior Services Healt h Health Alert October 31, 2011 Alert: FROM: MARGARET T. DONNELLY SShhiiggaa TTooxxiinn-- DIRECTOR pprroodduucciinngg SUBJECT: Outbreak of Shiga Toxin-producing E. coli Infection in St. Louis EEsscchheerriicchhiiaa ccoollii Metropolitan Area The Missouri Department of Health and Senior Services (MODHSS) together with the local public health agencies and the Centers for Disease Control and Prevention (CDC) is investigating an outbreak of Shiga toxin-producing Escherichia coli infection in St Louis metropolitan area. As of October 31, 2011 October 31, 2011, 35 specimens have been submitted to the State Public Health Lab. Thus far, 28 of those specimens are positive for E. coli O157:H7, representing 26 cases (more than one specimen This document will be updated as new was submitted for some cases). In total, there are 32 suspected, probable and confirmed cases of information becomes available. The Shiga Toxin-producing E. coli (STEC) infection. Cases of infection have been detected in St Louis current version can always be viewed County, St Louis City, and St Charles, Jefferson, and Franklin counties in Missouri. Preliminary at http://www.health.mo.gov findings from case interviews indicate that food from the salad bar at a local supermarket chain The Missouri Department of Health & could be a source. Additional investigation and testing of food items is in progress. Senior Services (DHSS) is now using The MODHSS asks providers to consider E. coli O157:H7 infection when evaluating patients with 4 types of documents to provide diarrhea, particularly bloody diarrhea. Testing for E. coli O157:H7 should be specifically requested important information to medical and on stools collected from suspect cases. Laboratories should attempt to isolate E. coli O157:H7 on public health professionals, and to sorbitol-MacConkey (SMAC) agar in addition to standard testing for detection of Shiga-toxin other interested persons: producing bacteria. Suspect or confirmed cases should be reported promptly to the local health Health Alerts convey information department. of the highest level of importance which warrants immediate action or Disease due to E. coli O157:H7 attention from Missouri health E. coli O157:H7, or STEC O157:H7, which is a Shiga toxin-producing E. coli is an important cause providers, emergency responders, of bloody diarrhea and hemolytic uremic syndrome (HUS). Infection commonly occurs through public health agencies, and/or the ingestion of the bacteria, usually through contaminated food products of bovine origin such as public. undercooked ground beef. Outbreaks have also been associated with consumption of such foods as Health Advisories provide lettuce, alfalfa sprouts, unpasteurized juices, and fresh spinach. Any food that can be contaminated important information for a specific by beef, cow manure, contaminated water, or an infected food handler may be a potential source of incident or situation, including that infection. The infectious dose is low, and person-to-person transmission can be quite common. impacting neighboring states; may not When disease develops, the fever is not usually high, or could be absent. Infection can be entirely require immediate action. asymptomatic or can present with a wide range of clinical features, including watery diarrhea, Health Guidances contain bloody diarrhea, HUS or thrombocytopenic purpura (TTP). The classic triad of findings in HUS is comprehensive information pertaining acute renal damage, microangiopathic hemolytic anemia, and thrombocytopenia. Illness typically to a particular disease or condition, begins 3-4 days (ranges from 1-9 days) after exposure. Patients usually and include recommendations, develop watery diarrhea; in most patients, the diarrhea resolves without progression and the guidelines, etc. endorsed by DHSS. illness is mild. In those with progressive illness, bloody diarrhea usually begins on the second or Health Updates provide new or third day, with stool content ranging from blood streaks to all blood. Most people get better within updated information on an incident or 5–7 days, but some patients go on to develop HUS, usually about a week after the diarrhea starts. situation; can also provide informa- Physicians evaluating patients presenting with gastrointestinal illness, particular bloody diarrhea, tion to update a previously sent should include E. coli O157:H7 in their differential diagnosis. Health Alert, Health Advisory, or Health Guidance; unlikely to require immediate action. TESTING __________________________________ It is required that physician specifically request testing stool for E. coli O157:H7 when infection is suspected, especially for patients with bloody diarrhea or HUS. E. coli O157:H7 is not detected by Office of the Director standard methods; the recommended medium for isolation is sorbitol-MacConkey (SMAC) agar. 912 Wildwood Any isolates positive for E. coli O157:H7 should be forwarded to the MODHSS for further analysis. P.O. Box 570 If a patient specimen tests negative for E. coli O157:H7 but the submitting provider has a high Jefferson City, MO 65102 clinical suspicion for E. coli O157:H7 disease, the original stool specimens could be forwarded to Telephone: (800) 392-0272 the State Public Health Laboratory (SPHL) for organism isolation. Laboratories that perform a Shiga Fax: (573) 751-6041 toxin detecting assay should forward the enrichment broth from the original stool specimens to the Web site: http://www.health.mo.gov SPHL for organism isolation. Specimen broths positive for Shiga toxin should be subcultured to SMAC for E. coli O157:H7 isolation or forwarded to the SPHL. It is often difficult to isolate STEC in stool by the time a patient presents with HUS. Immunomagnetic separation (IMS) has been shown to increase recovery of STEC from HUS patients. For any patient with HUS without a culture- confirmed STEC infection, stool can be sent to a public health laboratory that performs IMS or to 2 SMAC for E. coli O157:H7 isolation or forwarded to the SPHL. It is often difficult to isolate STEC in stool by the time a patient presents with HUS. Immunomagnetic separation (IMS) has been shown to increase recovery of STEC from HUS patients. For any patient with HUS without a culture-confirmed STEC infection, stool can be sent to a public health laboratory that performs IMS or to the CDC (through the SPHL). In addition, serum can be sent to CDC (through the SPHL) for serologic testing of common STEC serogroups. TREATMENT Treatment for E. coli O157:H7 diarrhea includes standard rehydration. Patients should be advised to not use over-the-counter antidiarrheal medications, and should not be prescribed antibiotics. Both treatments have been reported to worsen symptoms and may lead to adverse outcomes. Patients who are showing signs of anemia or kidney dysfunction should be referred for care immediately. It is not recommended to give antibiotics to patients with suspected STEC infections until complete diagnostic testing can be performed and STEC infection is ruled out. Some studies have shown that administering antibiotics in patients with STEC infections might increase their risk of developing HUS. However, clinical decision making must be tailored to each individual patient. INFECTION CONTROL RECOMMENDATIONS • Always wash hands after using the toilet, changing diapers, or coming in contact with fecal matter • Persons involved in patient care, food service, or day care, and experiencing gastrointestinal illness should notify their employer and be excluded until symptoms resolve, unless the cause of illness is determined to be non-infectious. Those positive for E. coli O157 may not return until two successive stool samples collected 24 hours apart and obtained no sooner than 48 hours after the last dose of antibiotics (if given) have tested negative. • Children with diarrhea in day care centers must be sent home and advised to seek medical attention. Children who have been diagnosed with E. coli O157 must be excluded until two successive stool samples collected 24 hours apart and obtained no sooner than 48 hours after the last dose of antibiotics (if given) have tested negative. Laboratory consultation is available from the Missouri State Public Health Laboratory (SPHL) by calling 573/751-3334, or 800/392-0272 (24/7).] In Missouri, report all known or suspected cases to your local public health agency, or to the Missouri Department of Health and Senior Services (DHSS) at 800/392-0272 (24/7). FURTHER INFORMATION Further information is available at the following websites: MODHSS website – http://health.mo.gov/living/healthcondiseases/communicable/communicabledisease/cdmanual/pdf/stec.pdf CDC website – http://www.cdc.gov/ecoli ___________________________________________________________________________ Missouri Department of Health & Senior Services Health A lert: Health Alert December 19, 2011 TTwwoo ccaasseess ooff FROM: MARGARET T. DONNELLY iinnvvaassiivvee DIRECTOR EEnntteerroobbaacctteerr ssaakkaazzaakkiiii iinnffeeccttiioonn SUBJECT: Two cases of invasive Enterobacter sakazakii infection in infants treated in Missouri hospitals iinn iinnffaannttss ttrreeaatteedd iinn MMiissssoouurrii hhoossppiittaallss The Missouri Department of Health and Senior Services (DHSS) has been notified of two cases of invasive Enterobacter sakazakii infection in newborns treated in Missouri December 19, 2011 hospitals within the last month. The most recent case notification occurred yesterday. Of these two cases, one was an out-of-state resident who recovered, and the most recent This document will be updated as new case was a Missouri resident who has died. Both infants were fed powdered infant information becomes available. The formula. Clusters of E. sakazakii infections have previously been reported around the current version can always be viewed world among infants fed milk-based powdered formula from various manufacturers. at http://www.health.mo.gov Testing of all baby formulas involved, as well as all other products given to the babies The Missouri Department of Health & reported in Missouri is on-going. Senior Services (DHSS) is now using 4 types of documents to provide important information to medical and Enterobacter sakazakii is a gram-negative rod-shaped bacterium within the family public health professionals, and to Enterobacteriaceae. Recently, E. sakazakii has been reclassified as a Cronobacter other interested persons: sakazakii; the genus Cronobacter is synonymous with Enterobacter sakazakii. The Health Alerts convey information natural habitat of E. sakazakii is not well understood. The bacterium can be detected in of the highest level of importance the gut of healthy humans, most probably as an intermittent guest. It can also be found which warrants immediate action or attention from Missouri health in the gut of animals, as well as in the environment. providers, emergency responders, public health agencies, and/or the The majority of cases of E. sakazakii infection reported in the literature have been public. described in newborns with sepsis, meningitis, or necrotizing enterocolitis as a Health Advisories provide consequence of the infection, and the case-fatality rate among infected neonates has important information for a specific been reported to be as high as 33% - 80%. The pathogen is also a rare cause of incident or situation, including that impacting neighboring states; may not bacteremia and osteomyelitis in adults, but the outcomes related to adult disease seem require immediate action. to be significantly milder. Health Guidances contain comprehensive information pertaining The scientific literature suggests that premature infants and those with underlying to a particular disease or condition, medical conditions are at highest risk for developing E. sakazakii infection. Several and include recommendations, outbreaks have occurred in neonatal intensive care units worldwide. However, an guidelines, etc. endorsed by DHSS. apparently healthy full-term newborn infant who suffered permanent neurological Health Updates provide new or sequelae has also been previously reported. updated information on an incident or situation; can also provide informa- tion to update a previously sent Although the reservoir of the organism is unknown, a growing number of outbreaks of Health Alert, Health Advisory, or infection among newborns has provided compelling evidence that milk-based Health Guidance; unlikely to require powdered infant formulas have served as the source of infection. One study tested immediate action. __________________________________ milk-based powdered infant formula products obtained from a number of different countries and found that E. sakazakii could be recovered from 14% of samples. The Office of the Director results of another investigation suggest that even low levels of E. sakazakii in milk- 912 Wildwood based powdered infant formula can lead to development of infection. E. sakazakii has P.O. Box 570 been detected in other types of food, but only powdered infant formula has been linked Jefferson City, MO 65102 to outbreaks of disease. No exclusively breastfed infants have been reported to have E. Telephone: (800) 392-0272 Fax: (573) 751-6041 sakazakii infections. Web site: http://www.health.mo.gov 2 There are at least three routes by which E. sakazakii can enter infant formula: a) through the raw material used for producing the formula; b) through contamination of the formula or other dry ingredients after pasteurization; and c) through contamination of the formula as it is being reconstituted by the caregiver just prior to feeding. It is important to remember that powdered infant formulas are not commercially sterile products. Powdered milk-based infant formulas are heat-treated during processing, but unlike liquid formula products they are not subjected to high temperatures for sufficient time to make the final packaged product commercially sterile. FDA has noted that infant formulas nutritionally designed for consumption by premature or low birth weight infants are available only in commercially sterile liquid form. However, so-called "transition" infant formulas that are generally used for premature or low birth weight infants after hospital discharge are available in both non-commercially available sterile powder form and commercially sterile liquid form. Some other specialty infant formulas are only available in non-sterile powder form. Recommendations In light of the epidemiological findings and the fact that powdered infant formulas are not commercially sterile products, FDA recommends that powdered infant formulas not be used in neonatal intensive care settings unless there is no alternative available. If the only option available to address the nutritional needs of a particular infant is a powdered formula, risks of infection in healthy and sick newborn babies can be reduced by: Preparing only a small amount of reconstituted formula for each feeding to reduce the quantity and time that formula is held at room temperature for consumption. Do not hold reconstituted formula for longer than two hours without refrigeration. Recognizing differences in infant formula preparation among hospitals, individual facilities should identify and follow procedures appropriate for that institution to minimize microbial growth in infant formulas; Minimizing the holding time, while under refrigeration, before a reconstituted formula is fed; and Minimizing the "hang-time" (i.e., the amount of time a formula is at room temperature in the feeding bag and accompanying lines during enteral tube feeding), with no "hang-time" exceeding 4 hours. Longer times should be avoided because of the potential for significant microbial growth in reconstituted infant formula. The World Health Organization guidelines on safe preparation of powdered infant formula are available at: http://www.fao.org/ag/agn/agns/files/pif_guidelines.pdf. DHSS urges health care providers to report cases of E. sakazakii infections in infants to your local public health agency, or to DHSS at 800/392-0272 (24/7).