Healthcare Hygiene magazine August 2020 | Page 26

There are no tests that exist which can definitively prove that a medical device will last 10 years unless you have waited 10 years to see the results, so screening materials early by exposing them to drugs, disinfectants, etc., will weed out some that have a lesser chance of surviving 10 years of service.” not vetted adequately before the material is manufactured into products for the healthcare setting; only after the products are in use is it discovered that they lack robustness and durability. “The lack of standardized testing is one of the biggest issues I see,” says UCSF’s Fechter. “Because testing procedures are not standardized, everyone does it their own way. When I conducted my own super-cheap compatibility testing, I got so-so results. I could identify incompatible combinations, but I couldn’t necessarily quantify any of it. There have been some attempts at devising better testing procedures, but, again, none of them are the standards we need. That said, Eastman Chemical Company is using one of the best processes I have seen, which is an impact test, which goes beyond merely testing for tensile strength. In real life what breaks equipment is impact, but I think either of these tests would give you a good idea of whether your materials are going to be compatible. My testing was non-quantitative, so all I had were observations. I would stress the samples, expose them to chemicals, and then look for cracks, so it was a visual inspection — it was a pass-fail kind of test. The only quantitative part of my testing was that the incompatible combinations would break faster. I would look at the samples every 24 hours each day, and once the materials and parts broke faster, I assumed they were less compatible than the ones that took longer to break.” “Test methods are lacking, despite so many standards bodies,” confirms Ellen Turner, global market development manager for specialty plastics in medical devices at Eastman Chemical Company. “As a result, you must ensure there are standard test methods in manufacturing that say to the healthcare end user, ‘If you claim this is cleanable, show me what test method(s) you used to prove it.’ The current testing methods don’t relate to the failure mechanisms involved. And because there is not a high-level entity calling for and monitoring standards and test methods, we are not seeing robust-enough products in healthcare.” “Facilities cannot accept this,” asserts Linda Lybert, founder and executive director of the Healthcare Surfaces Institute, which is addressing the compatibility issue head on through its education and research programs. “Plenty of organizations, including ASTM and ANSI, have created test methodologies that manufacturers follow, but they aren’t evaluated further. In a literature review conducted by the Healthcare Surfaces Institute, we found great inconsistency in test methods to validate a product, as well as a shocking lack of scientific data, and inconsistency in the type of microorganisms used in the testing. I believe that surface compatibility testing needs to be EPA-registered so hospitals can select products and materials based on their performance.” Lybert adds that their literature review revealed inconsistencies in the definitions of the processes of cleaning and disinfecting. “This means that when determining validation, manufacturers weren’t considering the same definitions and criteria that should have been standardized across the board and that they most likely validated these variable methods and passed them down to the end user. Many manufacturers use only a visual inspection to tell if a product works; this is a BIFMA (Business and Institutional Furniture Manufacturers Association) test method involving a 4-inch by 4-inch square piece of material that is looked at in order to validate disinfectant damage to a textile. This is flawed, because in the real world, the healthcare environment doesn’t function as a single textile in an area of 16 square inches, and the test only determines if the textile discolors, and that’s all. Instead, manufacturers must look at a product as an assembly, and the impact that the disinfectant has on the entire surface, device or textile. Microphotography needs to be conducted during the validation process, instead of looking at the material on a macro level.” Lybert says it would behoove industry to establish a standardized test for equipment and device manufacturers as well as disinfectant-makers who are united in the desire to improve disinfectant chemistries to maintain efficacy against pathogens while limiting damage to surfaces. The tension continues between OEMs’ profitability by continuing to sell products that may have not been validated robustly enough, and their inherent desire to not harm patients by producing good products. Less stringent rules protect profits, but at what cost, ultimately? “We are at a crucial crossroads,” Turner emphasizes. “Hospitals can no longer afford to accept the status quo.” As we have seen, currently, there is no standard that tells healthcare end users that a product’s materials have been screened before they are incorporated in materials before they enter the healthcare environment. That is, the materials should be determined to be cleanable and durable before they are even incorporated into a manufactured product. This would be beneficial for healthcare designers and architects, who often choose materials based on aesthetics instead of performance. “Not only is there significant discrepancy in test methodologies, but materials are not being tested as assemblies,” Lybert confirms. “Medical devices are tested as assemblies, as required by the FDA, but there is still lingering confusion as to what is required for surface materials. The issues of testing and validation causes confusion in healthcare facilities because there are no guidelines.” Turner concurs. “We need better material-screening studies and tests. Once materials are screened and selected, only then is it appropriate to move into final product design and testing. Currently, it’s a bit like the Wild West in manufacturing plants – there is no good definition between the screening studies to select the materials with which to design, then the final screening to see if a product should be introduced into the hospital environment.” She adds, “There are no tests that exist which can definitively prove that a medical device will last 10 years unless you have waited 10 years to see the results, so screening materials early by exposing them to drugs, disinfectants, etc., will weed out some that have a lesser chance of surviving 10 years of service. The assembled device must be tested as well, but if adequate screening has been done, the chances of passing full assembly testing is much higher. It will also reduce time to market if you choose the right materials up front and don’t have to rework the design later after a failure.” Order can be restored to this Wild West, and manufacturers can become agents for change. 26 august 2020 • www.healthcarehygienemagazine.com