HSI Surface Materials & Products Certification Program
The Healthcare Surfaces Institute is developing the first certification program for healthcare surface and medical device manufacturers.The HSI certification program is our answer to this critical question:
How should surfaces be tested to ensure they can be efficiently and effectively cleaned and disinfected – using EPA-registered hospital-grade disinfectants – without damage that creates microbial reservoirs that support the growth and spread of microbes?
Currently, there are no scientific-based standard testing requirements for validation that surface materials or products can be effectively cleaned and disinfected following existing infection prevention protocols, processes, and products. We are going to change that.
Launching in 2023
HSI will soon launch its patent-pending certification program to provide surface disinfection compatibility testing as a minimum standard for surface materials and assembled products.
How it Works
Program Objectives
Development of consistent test methods that include compatibility testing of all categories of EPA-registered disinfectants and no-touch disinfection, such as UV and hydrogen peroxide vapor.
Evaluation of surfaces at a micro-level. Damage is often unseen, creating microbial reservoirs that support the growth and proliferation of microbes.
The identification of the top four microbes for all testing with the option for additional microbial testing. The goal is to have consistent, measurable data and information.
Testing of products as assemblies. Many products are made using multiple types of surface materials and or textiles. When combined on one product, the ability to disinfect all materials efficiently and effectively can be compromised, causing the degradation of surface materials.
Evaluation of IFUs to ensure they provide guidance and recommendations pertinent to active healthcare environments and that support infection prevention processes and protocols.
Our Certification Teams
Four teams of scientists have been working closely with healthcare professionals to develop a comprehensive science-based surface certification program. Along with our board of directors and scientific advisory board, our initiative groups are formed by volunteers highly experienced in many areas of science, healthcare, and industry. We would not be able to reach our goals without the commitment of these volunteers, who have given HSI their time and expertise to help create the guidelines, standards, and test methods for our comprehensive, science-based certification program. We thank all of you!
Rigid Plastics Initiative Team
Dr. Pooja Baja
Product Development manager, Medical devices, Röhm America LLC (Currently @ Honeywell)
Dr. Pooja Baja
Product Development manager, Medical devices, Röhm America LLC (Currently @ Honeywell)
Dr. Pooja Bajaj is formerly with Röhm America LLC working in molding compounds and leading product development of acrylic copolymers for medical applications. She is currently the Senior Manager of Global R&D Engineering at Honeywell. In 2010, she graduated with a Ph.D. in Chemistry from the University of Texas at Dallas. She worked at SABIC from 2010-2018, driving innovation and technology for thermo-engineering polymers and blends. Pooja has several granted patents, authored publications in trade journals, and has given presentations at several conferences.
“Collaborating beyond boundaries to bring rigor to testing standards for plastics in healthcare through a unified industry-wide approach.”
Dr. Kay Bernhard
Dr. Kay Bernhard
Director of Global Technical Competency Center, Röhm America LLC
Dr. Kay Bernhard is the Director of Global Technical Competency Center for Cyrolite® at the Wallingford site of Röhm America LLC (formerly Evonik Cyro LLC) since 2017. He received his diploma and doctoral degree in Chemistry from the University of Stuttgart in 2000 and 2005, respectively, and a diploma in business economics from the University of Hagen in 2003. He began his career as a Product Development Manager for fibers in 2005 and joined Evonik as the Head of R&D Performance Foams in 2008.
“Safe healthcare needs safe devices. I’m proud being part of the team that defines and sets the standards for testing to make healthcare safer.”
James Hicks
James Hicks
Technical Service Engineer, Solvay Advanced Polymers
James Hicks is an Application Development Engineer and has worked in the plastics industry for 33 years. He has experience in mechanical testing labs, including QC and R&D development testing, R&D product development, material testing, and now focuses on customer technical support and application development. James provides Solvay’s Healthcare customers design reviews, processing support, material recommendations and failure analysis material offerings.
“Collaboration with outside groups and organizations, such as ASTM, BPSA and now HSI, has been a growing part of my activities.”
Mark Lamont
Mark Lamont
Director of Mechanical Engineering, Enterprise Mobile Computing Division, Zebra Technologies
Mark leads the mobile computing mechanical teams in the design of an assortment of mobile devices and accessories addressing multiple uses cases across several industries, including healthcare specific device solutions. Mark got involved in the healthcare industry after creating Zebra’s engineering customer response team, working with hospitals, ambulatory, and ancillary healthcare customers to understand their product needs and assist in resolving issues they have experienced. He is excited to work with HSI in the development of new standards for the betterment of the overall healthcare industry.
Dr. Yubiao Liu
Dr. Yubiao Liu
Global Technical Lead, Medical Applications, Eastman Chemical
Yubiao Liu is the global technical platform lead in specialty plastics medical device segment at Eastman Chemical Company. Liu supports medical customers globally with a greater focus on developing new products to address previously unmet needs for medical device and housing applications. He earned a doctorate degree from the University of Akron in 2003. With 15 years of experience in the medical industry, he has 15 peer reviewed publications and holds 5 US patents.
“Customers, colleagues and competitors has become a necessary part of our work. Over a year ago, I first met some of the HSI’s team members at a tradeshow and have found the collaboration very rewarding.”
Mike Zettel
Mike Zettel
Materials Scientist and Consultant
Mike Zettel is a materials scientist with work experience ranging from nanoparticle synthesis to resin formulation development for wind blade applications to composite material development and qualification for oil and gas. He joined the medical device community in 2018, evaluating the effects of disinfectants on materials commonly found in healthcare environments. Mr. Zettel completed his undergraduate education at Texas A&M University and graduate work at Cornell University.
“Working with the medical device plastic certification committee has been a wonderful experience. The collaboration has been positive, engaging, and fruitful; with each member continually contributing to the overall objective of creating a data driven certification. I believe this is a testament to both the individuals and the culture of their respective organizations.”
Microbiology Initiative Team
Dr. Syed A. Sattar
Dr. Syed A. Sattar
Chief Scientific Advisor, CREM Co Labs
Dr. Syed A. Sattar, BSc, MSc, Dip Bact, MS, Ph.D., RM (CCM), FAAM, FRSPH is Professor Emeritus of Microbiology. He has been studying the environmental fate of microbes harmful to humans for over five decades, as well as evaluating and promoting safer and better means of preventing the environmental spread of such microbes. Microbicide test methods developed by Dr. Sattar now form the basis for several national and international standards. He has published well over 200 peer-reviewed papers and chapters in conference proceedings and books and has delivered some 375 invited lectures worldwide.
“HSI represents a unique blending of experts from a variety of fields to understand and address the role of healthcare-associated surfaces in the spread of infections. I am glad to be a part of this concerted effort to tackle a neglected issue.”
Barbara Strain
Barbara Strain
Barbara Strain Consulting LLC
Barbara Strain, MA, SM(ASCP), CVAHP is an independent healthcare value consultant specializing in new, emerging, and disruptive technology and established medical modalities. She spent more than 20 years as the Director of Value Management at the University of Virginia Health System. Earlier in her 40-year career, she focused on clinical laboratory operations, microbiology, disinfection, sterilization and infection control in provider hospital organizations. She is a founding member and past president of the Association of Healthcare Value Analysis Professionals (AHVAP) and serves its Board Strategic Liaison.
“My experience in coordinating hospital device introduction and assuring they are safe for patient care motivates continued participation in assuring industry is responding to identified needs.”
Dr. Curtis White
CEO and CTO, Nano Safe Coatings
Dr. Curtis White
Chief Technology Consultant and President, White IEQ Consulting
CEO and CTO, Nano Safe Coatings
Dr. Curtis White has been involved in the research, development, registration, and commercialization of antimicrobial agents since 1962 as a teacher and working at Dow Chemical, F. Jos Lamb, Dow Corning, and Aegis. He was the founder, CEO, and Director of R&D for AEGIS Environmental Management, a global supplier of solutions to microbial problems in buildings, enclosed transportation units and consumer and medical textiles including wound care products and construction materials.
“Helping deal with infectious organisms in healthcare environments will only be successful with the expertise of scientists, engineers, and practitioners from all key disciplines. HSI has the team and the vision that supports this holistic approach, and I am excited to be part of the efforts.”
Instructions For Use (IFU) Initiative Team
Jeanette Harris
Jeanette Harris
Infection Preventionist, Evergreen Healthcare
Jeanette Harris, MS, MSM has over 48 years of hands-on experience in providing high-quality patient care, both as a clinical microbiologist and as an infection prevention professional. She has worked for over 22 years in Infection Prevention with over 16 years specializing in Infection Prevention in the Peri-Operative and Procedural areas. She is certified in Infection Prevention, named Fellow by Association for Infection Prevention and Control (FAPIC) in 2016.
Joanna Mills
Joanna Mills
Director of Infection Prevention, John Muir Health, East Bay Area SF
Joanna Mills, RN, MSN, CNS, CIC is the Director of Infection Prevention for John Muir Health, East Bay Area SF. She is a Clinical Nurse Specialist and Clinical Infectious/Communicable Disease Prevention and Control Practitioner with extensive experience in epidemiology, program management, education, performance improvement, risk management, public health, case management, employee health, and emergency/critical care.
Barbara Strain
Barbara Strain
Barbara Strain Consulting LLC
Barbara Strain, MA, SM(ASCP), CVAHP is an independent healthcare value consultant specializing in new, emerging, and disruptive technology and established medical modalities. She spent more than 20 years as the Director of Value Management at the University of Virginia Health System. Earlier in her 40-year career, she focused on clinical laboratory operations, microbiology, disinfection, sterilization and infection control in provider hospital organizations. She is a founding member and past president of the Association of Healthcare Value Analysis Professionals (AHVAP) and serves its Board Strategic Liaison.
“My experience in coordinating hospital device introduction and assuring they are safe for patient care motivates continued participation in assuring industry is responding to identified needs.”
Jesiska Tandy
Jesiska Tandy
Lead Materials Science Engineer, Metrex Research
Jesiska Tandy currently leads the materials compatibility program. Her team focuses on chemical compatibility of materials commonly found in healthcare settings, and works closely with universities, polymer companies, medical device companies, and end-users to identify the gaps and develop robust solutions. They are dedicated to tackling compatibility issues and strive to deepen understanding in this area.
“I’m very excited to be working on this important and complex subject alongside experts of different backgrounds. Bringing all the stakeholders together will enhance our understanding of one another’s point of view and produce a solution to improve patient care.”
Sharon Ward-Fore
Sharon Ward-Fore
Infection Prevention Advisor, Metrex
Sharon Ward-Fore, MS, MT(ASCP), CIC, FAPIC, serves as Metrex’s Infection Prevention Advisor. Sharon’s team relies on her clinical expertise for infection prevention guidance and support when developing new surface disinfectant solutions. Her areas of expertise include special pathogens training, personal protective equipment selection and training, emergency preparedness, surgical services, disinfectants and cleaners, and environmental services. She also focuses on medical device material compatibility with surface disinfectants.
ElectroStatic Sprayer Initiative Team
Dr. Curtis White
President, White IEQ Consulting CEO
and CTO, Nano Safe Coatings
Dr. Curtis White
Chief Technology Consultant and President, White IEQ Consulting
CEO and CTO, Nano Safe Coatings
Dr. Curtis White has been involved in the research, development, registration, and commercialization of antimicrobial agents since 1962 as a teacher and working at Dow Chemical, F. Jos Lamb, Dow Corning, and Aegis. He was the founder, CEO, and Director of R&D for AEGIS Environmental Management, a global supplier of solutions to microbial problems in buildings, enclosed transportation units and consumer and medical textiles including wound care products and construction materials.
“Helping deal with infectious organisms in healthcare environments will only be successful with the expertise of scientists, engineers, and practitioners from all key disciplines. HSI has the team and the vision that supports this holistic approach, and I am excited to be part of the efforts.”
Dr. Graham Matthews
Consultant, Imperial Consultants
Dr. Graham Matthews
Emeritus Professor, Imperial College
Consultant, Imperial Consultants
Dr. Matthews has worked in the development of spray application technologies since 1958, including ground and aerial sprayers for cotton pest research, ultra-low volume sprayers (ULV), and electrostatic and UVL lightweight electrostatic sprayers. His work has taken him around the world and includes projects with the WHO and U.S. military. More recently, he has worked on projects use electrostatic sprayers in aircraft pre-embarkation to control mosquito vectors of disease.
Dr. Sanjay Wahal
Dr. Sanjay Wahal
VP, Technology, Product Development, Innovation & Quality, GPMI Company
Dr. Sanjay Wahal, Ph.D., MBA was most recently with GPMI Company as VP, Technology, Product Development & Innovation where he led a team to meet growing demands for disinfecting and cleaning wipes resulting from the SARS-CoV-2 pandemic. Prior to this, he was with Diversey as Director of Global R&D/Innovation in the Infection Prevention division, where he developed several novel disinfectant chemistries and no-touch disinfection technologies, including electrostatic spraying. He is inventor/co-inventor on 21 patents (awarded or pending).
Dr. Andrew Hewitt
Dr. Andrew Hewitt
Senior Research Fellow, School of Agriculture and Food Sciences, University of Queensland
Dr. Andrew Hewitt’s research is focused on application optimization and the management and modeling of chemical exposure to humans and the environment from agrichemical use. He recently returned to UQ and The University of Nebraska to conduct research and modeling into spray drift management, including developing new drift reduction technology schemes. His ongoing research in this area is supporting the risk assessment and management needs of both government and industry in several countries.
J. Hudson Garrett Jr.
J. Hudson Garrett Jr.
President and CEO, Community Health Associates, LLC
Dr. John Hudson Garrett Jr. is the President and CEO of Community Health Associates, LLC and has a faculty appointment as an Adjunct Assistant Professor of Medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. He holds a Graduate Certificate in Infection Prevention and Infection Control from the University of South Florida and has completed the Johns Hopkins Fellows Program in Hospital Epidemiology and Infection Control. He holds graduate certificates in healthcare leadership from both Cornell and the University of Notre Dame.
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