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  1. CDRH Research Programs

Microbiology and Infection Control

Contact information

CDR Kenneth Scott Phillips, Ph.D. - Kenneth.Phillips@fda.hhs.gov
Jon Weeks, PhD - jon.weeks@fda.hhs.gov
Poulomi Nandy, PhD - Poulomi.nandy@fda.hhs.gov

Spice Simulation

Potential infection sources of a percutaneous intravascular device. Medical devices introduce a vulnerable biointerface into normally well-protected organs and vasculature. Contamination can come from (1) infusate (2) from nonsterile catheter materials, (3) the skin, or (4) from distant hematogenous infections.


dynamic biofilm life cycle on a medical device

Dynamic biofilm life cycle on a medical device: (1) transport and initial attachment of microbes, (2) irreversible adhesion or attachment, (3) microcolony formation, (4) maturation of the biofilm, and (5) detachment and dispersion of the cells.


Figures from Vertes et al., Analytical challenges of microbial biofilms on medical devices. Analytical Chem, 2012.

Summary

With the increased use of medical devices and their promise to improve quality of life, preventing device-associated infection is a top public health priority. Every medical device may become limited by microbial colonization and biofilm formation, resulting inevitably in device failure and patient harm. In addition, the association of colonized devices with development of drug resistant organisms is a serious and under-investigated area of importance. The Medical Device Biofouling and Biofilms Research Program seeks to address medical-device failure and patient harm caused by the combined effects of biofouling, colonization, and biofilms. Rather than study these phenomena as individual events, the research uses sophisticated high-throughput microfluidic approaches to assess how variables such as biofouling, cleaning and material properties affect bacterial adhesion and biofilm progression. The group uses optical and electron microscopy, surface plasmon resonance (SPR), and other biosensing and surface analysis methods to study biomolecular interactions at the interface of device, host and microorganism. Some of the current research areas addressed include:

  • Bacterial interactions with soft medical device materials (contact lenses, dermal fillers, ophthalmic surgical devices
  • Development of better test methods and endpoint measurements for antimicrobial device technologies (wound dressings, catheters)
  • Biofilm specific diagnostics. (optical coherence tomography, biomarkers)
  • Detection of biofouling and biofilm on reprocessed devices. (endoscopes, surgical tools, heater cooler units)
  • Influence of material, device design, roughness, and presence of soil on cleanability
  • Performance Testing of One-Way Valves Intended to Prevent Cross-Contamination and Infections in Patients
  • Ability of Personal Protective Equipment to protect against infectious Viruses 
  • Reprocessing flexible endoscopes 
  • Chemically defined clinically relevant test soils for cleaning validation of reusable medical devices 
  • Evaluation of next generation sequencing for use in the identification of pathogens
  • Rapid, multiplexed assay for pathogenic virus identification
     

Current funding sources:

Biomedical Advanced Research and Development Authority (BARDA)
Defense Advanced Research Projects Agency (DARPA)
FDA Critical Path Initiative
FDA Medical Countermeasures Initiative (MCMi)
FDA Office of Women's Health (OWH)
National Institute of Allergy and Infectious Diseases (NIAID)
Burroughs Wellcome
National Science Foundation

FDA collaborators

Kathleen Clouse
Tzanko Stantchev
Julie Kase
Charles Clavet
Donna Clevenger
Matthew Silverman
Steven Turtil,
Kris Roth,
Brandon Kitchel,
Shani Haugen,
Jim Weaver,
Leonard Sacks
 

External collaborators:

Catholic University, Mechanical Engineering Department
Department of Defense, Uniformed Services University of the Health Sciences (USUHS)
Marquette University
University of Michigan, School of Public Health
Montana State University, Center for Biofilm Engineering
National Institute of Occupational Safety and Health (NIOSH)
Novaflux Technologies
Syracuse University, Biomaterials Institute
The George Washington University, Department of Bioengineering
Veterans Hospital, Baltimore, MD
UCLA Medical School
Washington Adventist Hospital
 

Personnel:

FTE:
David Kaplan, PhD – david.kaplan@fda.hhs.gov
Anne D Lucas, Ph.D. – Anne.Lucas@fda.hhs.gov
CDR Kenneth Scott Phillips, Ph.D. – Kenneth.Phillips@fda.hhs.gov
Jon Weeks, PhD – jon.weeks@fda.hhs.gov
Poulomi Nandy, PhD – poulomi.nandy@fda.hhs.gov 
Steven C Wood, Ph.D. – Steven.Wood@fda.hhs.gov
 

ORISE:
Sojan Abraham, PhD
Keaton Nahan, PhD
Yi Wang, PhD
David Wolloscheck, PhD
Banu Saritas-Yildirim, PhD
 

Resource facilities:

bioBUBBLE Containment Facility
Biofilms Research Facility
FDA White Oak Animal facility
Molecular Analysis and Mass Spectrometry Facility
MCMI Flow Cytometry facility: BD Canto
Fortessa and Aria
FDA White Oak animal facility
Luminex xMAP technology
AID Elispot reader
Roche Lightcycler real time PCR and Ion Torrent Next Generation Sequencing machines
Leica SP8 Confocal Microscope
Reichert Surface Plasmon Resonance Spectrometer
Tecan Microplate Spectrometer;
Pharmacologically relevant simulation setup for evaluating emergence of drug resistance
Ex situ pigskin test setup for skin preparation testing
“Flow system for measuring bacterial adhesion rate with insert for ultrasoft materials
 

Relevant Standards & Guidances

Guidance documents:

  1. FDA Guidance for Industry and FDA Staff: Endotoxin testing recommendations for single-use intraocular ophthalmic devices.
  2. FDA Guidance for Industry: Pyrogen and endotoxins testing: Questions and Answers, June 2012
  3. Support revision of CDRH Guidance Document: Premarket notification of 510(k) for contact lens care products, 1997
  4. Guidance document: Processing medical devices in health care settings: validation methods and labeling (March 2015).
     

National and International Standards:

  1. AAMI/ST/WG11, General Criteria for Sterilization Processes
  2. AAMI TIR17:2017, Compatibility of materials subject to sterilization
  3. ANSI/AAMI PB70, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
  4. ISO 14729 Ophthalmic Optics-Contact lens care products-Microbiological requirements and test methods for products and regimens for hygienic management of contact lens.
  5. ANSI Z80.18-2003: Contact lens care products-Vocabulary, performance specifications and test methodology.
  6. ISO/TS 15883-5:2005: Washer-disinfectors -- Part 5: Test soils and methods for demonstrating cleaning efficacy. International Organization for Standardization ISO Central Secretariat 1, ch. de la Voie-Creuse CP 56 - CH-1211 Geneva 20 Switzerland; 2005.
  7. AAMI Technical Information Report (TIR) 30: 2011. A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
  8. AAMI TIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.
  9. ISO 17664: Sterilization of medical devices-Information to be provided by the device manufacturer for processing medical devices
  10. ISO/TS 15883-5 Washer disinfectors; Part 5: Test soils and methods for demonstrating cleaning efficacy of washer-disinfectors.
  11. ISO 10993 -7, Biological evaluation of medical devices, Part 7: Ethylene oxide residuals
  12. ASTM 5712 D5712-05e1 Standard test method for analysis of aqueous extractable protein in natural rubber and its products using the modified Lowry method
  13. ASTM F04.15 Material Test Methods
  14. WK 31799: Guide to device design and cleaning
  15. WK 33429: Test soils for cleaning validation
  16. WK 33660: Guide to cleaning validation
  17. ASTM F04.16: Biological response to particle debris; Recovery of foreign particles in tissue
  18. ASTM D11: Consumer Rubber Products/General Hospital/General Plastic Surgery (latex chemical sensitivity; latex protein assays)
  19. ASTM F0388-14, Standard Test method for Use of a Centrifugation method to Quantify/Study Cell-Material Adhesive Interactions (F04.43)
     

Selected peer-review publications: (required)

  1. Arcidiacono J, et al. “FDA and NIST Collaboration on Standards Development Activities Supporting Innovation and Translation of Regenerative Medicine Products”. Cytotherapy, 20(6):779-784, 2018.
  2. Wang Y, et al. “Effect of skin preparation and dermal filler injection techniques on transfer of biofilm bacterial burden”. Nature Scientific Reports. 2017, 7:45070.
  3. Nandy P, et al. “Evaluation of one-way valves used in medical devices for prevention of cross-contamination”. American Journal of Infection Control, 2017, 45(7):793-798.
  4. Gonzalez EA, et al. “Designing for cleanability: The effects of material, surface roughness, and the presence of blood test soil and bacteria on devices”. American Journal of Infection Control, 2017, 45:194-19 25.
  5. Yi Wang, et al, “Injections through skin colonized with Staphylococcus aureus biofilm introduce contamination despite standard antimicrobial preparation procedures”, Scientific Report, 2017
  6. Yi Wang, et al, “Antimicrobial and Anti-biofilm Medical Devices - Public Health and Regulatory Science Challenges” in: Antimicrobial Coatings and Modifications on Medical Devices, Springer, 2017.
  7. Allan Guan, et al, “Medical devices on chips (MDoC)”, Nature Biomedical Engineering, 2017
  8. Hongli Li, et al "Direct Analysis of Endotoxin in Real Time by Mass Spectrometry" Anal Chim Acta. 2016 Nov 2; 943:98-105.
  9. Nandy P, et al. “Secondary Features of Cleaning/Disinfecting : Efficacy of commercially available wipes for disinfection of pulse oximeter sensors”. AJIC 2016;44(3):304-310.
  10. Wang, Y. et al. “Interactions of Staphylococcus aureus with Ultrasoft Hydrogel Biomaterialsdisclaimer icon”, Biomaterials 2016, 95, 74-85.
  11. Guan, A. et al. “A contact-lens-on-a-chip companion diagnostic tool for personalized medicinedisclaimer icon”, Lab-on-a-Chip 2016, 16, 1152-1156.