{"c9374286-f051-4a4a-a20b-da25d3c319ff": "<p><strong>Medical Product Investigations – Key Resources</strong></p><p>1. Dolan SA, Arias KM, Felizardo G et.al. APIC position paper: Safe injection, infusion, and<br />medication vial practices in health care. Am J Infect Control. 2016 Jul 1;44(7):750-7.</p><p>2. FDA. MedWatch. Accessed at: <a href=\"https://www.accessdata.fda.gov/scripts/medwatch/index.cfm.\">https://www.accessdata.fda.gov/scripts/medwatch/index.cfm.</a></p><p>3. FDA. Sharing Non-Public Information. Available at:<br /><a href=\"https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Pharmacy%20Compounding/UCM446165.pdf\">https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Pharmacy</a><br /><a href=\"https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Pharmacy%20Compounding/UCM446165.pdf\">Compounding/UCM446165.pdf</a>.</p><p><strong>Contaminated Medical Products – Selected Examples</strong></p><p><i>Endoscopes</i></p><p>1. Botana-Rial M, Leiro-Fernández V, Núñez-Delgado M, Álvarez-Fernández M, Otero-Fernández S,<br />et. al. A Pseudo-Outbreak of Pseudomonas putida and Stenotrophomonas maltophilia in a<br />Bronchoscopy Unit. 2016;92(4):274-278.</p><p>2. FDA. Infections Associated with Reprocessed Duodenoscopes. Available at:<br /><a href=\"https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infectionsassociated-reprocessed-duodenoscopes\">https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infectionsassociated-reprocessed-duodenoscopes</a> </p><p>3. Guy M, Vanhems P, Dananché C, Perraud M, Regard A, et. al. Outbreak of pulmonary<br />Pseudomonas aeruginosa and Stenotrophomonas maltophilia infections related to<br />contaminated bronchoscope suction valves, Lyon, France, 2014. Euro Surveill. 2016 Jul<br />14;21(28).</p><p>4. Humphries RM, Yang S, Kim S, Muthusamy VR, Russell D, et. al. Duodenoscope-Related<br />Outbreak of a Carbapenem-Resistant Klebsiella pneumoniae Identified Using Advanced<br />Molecular Diagnostics. Clin Infect Dis. 2017 Oct 1;65(7):1159-1166.</p><p>5. Kumarage J, Khonyongwa K, Khan A, Desai N, Hoffman P, Taori SK. Transmission of multi-drug<br />resistant Pseudomonas aeruginosa between two flexible ureteroscopes and an outbreak of<br />urinary tract infection: the fragility of endoscope decontamination. J Hosp Infect. 2019<br />May;102(1):89-94.</p><p>6. Rahman MR, Perisetti A, Coman R, Bansal P, Chhabra R, Goyal H. Duodenoscope-Associated<br />Infections: Update on an Emerging Problem. Dig Dis Sci. 2019 Jun;64(6):1409-1418.</p><p><i>Heater-Cooler Devices</i></p><p>1. CDC. Contaminated Heater-Cooler Devices: Health Alert. Available at:<br /><a href=\"https://www.cdc.gov/hai/outbreaks/heater-cooler.html\">https://www.cdc.gov/hai/outbreaks/heater-cooler.html</a> <br /> </p><p>2. Lyman MM, Grigg C, Kinsey CB, et. al. Invasive Nontuberculous Mycobacterial Infections among<br />Cardiothoracic Surgical Patients Exposed to Heater–Cooler Devices. Emerg Infect Dis. 2017<br />May; 23(5): 796–805.</p><p>3. Perkins KM, Lawsin A, Hasan NA, et al. Notes from the Field. Mycobacterium chimaera<br />Contamination of Heater-Cooler Devices Used in Cardiac Surgery — United States. MMWR<br />Morb Mortal Wkly Rep 2016;65:1117–1118. </p><p>4. van Ingen J, Kohl TA, Kranzer K, Hasse B, Keller PM, et. al. Global outbreak of severe Mycobacterium chimaera disease after cardiac surgery: a molecular epidemiological study. Lancet Infect Dis. 2017 Oct;17(10):1033-1041. </p><p><i>Medication/Product </i></p><p>1. Dolan SA, Littlehorn C, Glodé MP, Dowell E, Xavier K, et. al. Association of Bacillus cereus infection with contaminated alcohol prep pads. Infect Control Hosp Epidemiol. 2012 Jul;33(7):666-71. </p><p>2. Kainer MA, Reagan DR, Nguyen DB, et. al. Fungal Infections Associated with Contaminated Methylprednisolone in Tennessee. N Engl J Med. 2012 Dec 6; 367(23): 2194–2203. </p><p>3. West K, Janelle S, Schutz K, Hamilton S, Mayo K, et. al. Outbreak of Serratia marcescens bacteremia in pediatric patients epidemiologically linked to pre-filled heparin flushes. Infect Control Hosp Epidemiol. 2019 Jul 25:1-2. </p><p>4. Hudson MJ, Park SC, Mathers A, Parikh H, Glowicz J, Dar D, Nabili M, LiPuma JJ, Bumford A, Pettengill MA, Sterner Jr MR. Outbreak of Burkholderia stabilis infections associated with contaminated nonsterile, multiuse ultrasound gel—10 states, May–September 2021. Morbidity and Mortality Weekly Report. 2022 Dec 12;71(48):1517. </p><p>5. CDC. Outbreak of Extensively Drug-resistant Psuedomonas aeruginosa Associated with Artificial Tears. Available at: <a href=\"https://www.cdc.gov/hai/outbreaks/crpa-artificial-tears.html\">https://www.cdc.gov/hai/outbreaks/crpa-artificial-tears.html</a>  </p><p>6. Schwartz NG, Hernandez-Romieu AC, Annambhotla P, Filardo TD, Althomsons SP, Free RJ, Li R, Wilson WW, Deutsch-Feldman M, Drees M, Hanlin E. Nationwide tuberculosis outbreak in the USA linked to a bone graft product: an outbreak report. The Lancet Infectious Diseases. 2022 Nov 1;22(11):1617-25. </p><p>7. Hartnett KP, Powell KM, Rankin D, Gable P, Kim JJ, Spoto S, Breaker E, Hunter R, Dotson N, McAllister G, Stevens V. Investigation of Bacterial Infections Among Patients Treated With Umbilical Cord Blood–Derived Products Marketed as Stem Cell Therapies. JAMA Network Open. 2021 Oct 1;4(10):e2128615.</p>", "f394434c-cdd6-422c-857c-73fdb47ec55d": "Chapter References"}