Chapter Summary
Healthcare-associated infections (HAIs) and outbreaks can be caused by use of contaminated medical products. These medical products include devices (also known as instruments or equipment) and drugs (also known as medications), as well as biological products, nutrition products, and patient care items.
The general principles outlined in the CORHA Principles and Practices can be employed when responding to events related to medical product contamination. These investigations often involve infection control assessments and require the active coordination of investigation partners across multiple jurisdictions.
In Supplement A, Medical Product Investigations, we address some unique challenges associated with identifying and responding to outbreaks related to contamination events.
This supplement contains information on:
- Intrinsic contamination, which occurs before a medical product arrives at its point of use in a healthcare facility
- Extrinsic contamination, which results from errors made during a medical product’s storage, preparation, and use in a healthcare facility
- Advice on recognizing and evaluating possible causes of product-related transmission relative to clinical illness and other factors
- Investigation procedures for outbreaks that potentially involve drugs and devices, with an emphasis on intrinsic product contamination
- Additional “Keys to Success” related to medical product investigations
Change Log
As advances occur in outbreak protocols, this guidance document will be updated. Previous changes can be tracked below:
- 2nd Edition – Published June 2024
- 1st Edition – Published March 2024
- URLs in this document are valid as of May 31, 2024.
Chapter References
Medical Product Investigations – Key Resources
1. Dolan SA, Arias KM, Felizardo G et.al. APIC position paper: Safe injection, infusion, and
medication vial practices in health care. Am J Infect Control. 2016 Jul 1;44(7):750-7.
2. FDA. MedWatch. Accessed at: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm.
3. FDA. Sharing Non-Public Information. Available at:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Pharmacy
Compounding/UCM446165.pdf.
Contaminated Medical Products – Selected Examples
Endoscopes
1. Botana-Rial M, Leiro-Fernández V, Núñez-Delgado M, Álvarez-Fernández M, Otero-Fernández S,
et. al. A Pseudo-Outbreak of Pseudomonas putida and Stenotrophomonas maltophilia in a
Bronchoscopy Unit. 2016;92(4):274-278.
2. FDA. Infections Associated with Reprocessed Duodenoscopes. Available at:
https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infectionsassociated-reprocessed-duodenoscopes
3. Guy M, Vanhems P, Dananché C, Perraud M, Regard A, et. al. Outbreak of pulmonary
Pseudomonas aeruginosa and Stenotrophomonas maltophilia infections related to
contaminated bronchoscope suction valves, Lyon, France, 2014. Euro Surveill. 2016 Jul
14;21(28).
4. Humphries RM, Yang S, Kim S, Muthusamy VR, Russell D, et. al. Duodenoscope-Related
Outbreak of a Carbapenem-Resistant Klebsiella pneumoniae Identified Using Advanced
Molecular Diagnostics. Clin Infect Dis. 2017 Oct 1;65(7):1159-1166.
5. Kumarage J, Khonyongwa K, Khan A, Desai N, Hoffman P, Taori SK. Transmission of multi-drug
resistant Pseudomonas aeruginosa between two flexible ureteroscopes and an outbreak of
urinary tract infection: the fragility of endoscope decontamination. J Hosp Infect. 2019
May;102(1):89-94.
6. Rahman MR, Perisetti A, Coman R, Bansal P, Chhabra R, Goyal H. Duodenoscope-Associated
Infections: Update on an Emerging Problem. Dig Dis Sci. 2019 Jun;64(6):1409-1418.
Heater-Cooler Devices
1. CDC. Contaminated Heater-Cooler Devices: Health Alert. Available at:
https://www.cdc.gov/hai/outbreaks/heater-cooler.html
2. Lyman MM, Grigg C, Kinsey CB, et. al. Invasive Nontuberculous Mycobacterial Infections among
Cardiothoracic Surgical Patients Exposed to Heater–Cooler Devices. Emerg Infect Dis. 2017
May; 23(5): 796–805.
3. Perkins KM, Lawsin A, Hasan NA, et al. Notes from the Field. Mycobacterium chimaera
Contamination of Heater-Cooler Devices Used in Cardiac Surgery — United States. MMWR
Morb Mortal Wkly Rep 2016;65:1117–1118.
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.
Medication/Product
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.
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.
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.
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.
5. CDC. Outbreak of Extensively Drug-resistant Psuedomonas aeruginosa Associated with Artificial Tears. Available at: https://www.cdc.gov/hai/outbreaks/crpa-artificial-tears.html
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.
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.