Assumptions Don’t Belong in Healthcare: Product Testing, Manufacturer Warnings and Instructions for Use (IFUs)

This is the first in a series of articles about the Seven Aspects of Surfaces© by Linda Lybert and focuses on one of the Seven Aspects.

Healthcare-acquired infections (HAIs) are a leading cause of death in the United States. Healthcare surfaces contribute to the acquisition and spread of HAIs. Therefore, this is a serious issue!

There are many different surface materials and textiles within the healthcare environment. Most people don’t realize that there are often numerous surface materials on a single product, as can be seen in the photos below with a patient bed and an endoscope. I have pointed out some of the different surfaces assembled together, but not all.  Most people look at the patient bed as just a bed – and not as an assembly of different surfaces that must be cleaned differently to properly disinfect and sterilize the whole product. Now, take a look at the patient wall and see the multitude of different surfaces.

Facts:

  • Pathogens transmits via surfaces, air and water.

  • Pathogens can survive on surfaces for weeks.

  • Typical room turn-over time between patients is 5 to 10 minutes

  • Disinfectants can cause damage to products.

  • Damaged products can harbor microbes out of reach of biocides.

Lack of collaboration and understanding

There are two problems here. First, surface manufacturers are not testing the materials with a clear understanding of how their materials will be used within the healthcare environment or when combined with other surface materials during product design. Second, they are not testing actual disinfection products in the way they would be used during cleaning and disinfection. Then, on the flip side, healthcare professionals are required to follow the manufacturer instructions for use (IFUs). Therefore, if manufacturers don’t understand infection prevention protocol and what products are being used, how can they validate the surfaces can be cleaned and disinfected?

In the first part of April, I attended a meeting of healthcare professionals which included physicians, infection preventionists, facilities managers, authorities having jurisdiction, facilities planners, etc. The subject of surfaces came up in multiple meetings as these professionals discussed the number of surface and product failures they continue to experience because of product incompatibility with commonly used disinfectants. For example, a healthcare professional may use a certain disinfectant that meets the facility’s disinfection protocol, but the chemicals contained in the disinfectant seriously damage the product to the point it can’t be cleaned and disinfected and is removed from service.

When asked if they had requested and reviewed the manufacturer warnings before the products were purchased, the answer was no. But, they did follow the IFUs. Unfortunately, warnings are often embedded in technical data, not even in bold or red font color. What happens when the surface manufacturer warning states not to use acids or chlorine bleach, and your facility uses products that contain these chemicals? The answer is voided warranties and equipment/surfaces failures.

Standards and Test Method Development

Manufacturers know how critical it is to test and validate their product because this is a critical step to successful acceptance and implementation of products into healthcare. Depending on the type of product there may also be regulatory test requirements. This is where the confusion begins. There are many standards and professional organizations that provide guidelines for test method development.  What test standards should be used?

In 2018 the Healthcare Surfaces Institute conducted a literature review, proving significant inconsistencies in test methods used, as well as an inconsistency of the microbes used for testing.

It is important to know that testing standards are developed by volunteer consensus, which means a variety of experts share their knowledge and expertise to establish standards that are then accepted by the group and used. Over the years, many of these standards have become outdated due to innovation and advances in technology.  In the end, manufacturers typically select a standard and then add to it to develop their test method for validation.

Instructions for Use (IFUs)

IFUs don’t always provide the level of guidance needed for healthcare professionals, nor do they reflect testing validation. However, regulatory agencies will hold healthcare professionals accountable for following them. An example would be that a flooring manufacturer requires that only their disinfectant be used to mop the floors. Or the vague IFUs that say please “clean with soap and water.” Manufacturers would benefit tremendously by learning about infection prevention protocol and what processes exist.

Effective Collaboration is Necessary

The fact is testing, and validation of surface materials and products, has very little to do with the way a product will be used or maintained in the healthcare setting. And, quite often the instructions for use (IFUs) are created without understanding infection prevention protocol and processes. As a result, testing is not thorough enough to ensure successful implementation in infection control processes.

It is critical that all professionals get together and discuss before design and/or end users begin requiring testing data and manufacturer warnings regarding the use of specific disinfectants to ensure cleanability.

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Learn more! New Webinar Series

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Healthcare Surface Consulting is launching an educational webinar series to help bring clarity to the confusion and to support collaboration between healthcare industry professionals and manufacturers to gain a clear understanding of the holistic and complex surfaces issue. This program will use the Seven Aspects of Surfaces© methodology to empower participants to create surface selection criteria and identify solutions that provides sustainable reductions in healthcare infections. Throughout the series, participants will receive contact hours, written guidelines, checklists, and engage in open discussion around each topic.

The webinar series begins in May 2019. Learn more and register here!