Surface Standards
The complexity and confusion in determining which surfaces should be used for the design of products or within the built environment have caused tremendous confusion. There are many discrepancies in test methods and caused by inconsistencies in standards across the board:
Currently, outside of the FDA testing for medical devices, there are no minimum standard testing requirements for cleaning and disinfection of products or surfaces, let alone testing for surface disinfection compatibility or cleanability.
The Institute reviewed 31 different organizations for their definition of “clean” and “disinfected.” While there were similarities, there were clear differences. These differences again were based on area of expertise (e.g., manufacturing versus environmental services, infection prevention versus surgical staff).
Recommendations and guidelines created by professional organizations can be skewed toward the industries they represent. Requirements by various regulatory agencies also have some conflicting guidance and none of them have guidelines for the selection of surfaces.
We believe a certification program will address many of the critical issues healthcare professionals face and reduce the high cost of testing for manufacturers as we set minimum testing requirements that put surface materials and products on a level field for evaluation. More than testing, it will also evaluate other aspects of the problem and provide both manufacturers and end-users with consistent data and information.
Certification Program
HSI is working to develop these guidelines and standards as part of our Healthcare Surfaces Certification Program. This program will:
Establish consistent testing requirements to validate cleanability and consistency in test methods used for validation. This includes all categories of EPA-registered disinfectants, as well as no-touch disinfection, such as UV and hydrogen peroxide vapor.
Ensure IFUs provide guidance and recommendations pertinent to active healthcare environments and that support infection prevention processes and protocols.
Reduce healthcare costs by providing a healthcare organization’s value analysis and supply chain access to standardized test methods and validation of manufacturing claims.
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