Guest Insight: Materials Matter: How material choice impacts IV pump failures
By Ellen Turner, Global Market Development Manager for Medical Devices, Eastman
Ninety percent of patients who are admitted to a hospital receive an infusion during their stay. These infusions require an infusion pump, a critical medical device that delivers essential fluids or drugs in a measured way. They are also the No. 1 medical device plagued with significant safety issues related to failures that continue to get the U.S. Food & Drug Administration’s attention. Infusion pump failures, such as broken components, corrosion of electric pins or even cracks, no matter the size, can compromise the safe use of pumps and lead to catastrophic conditions.
In examining why devices fail, it’s important to look at what happens when they are exposed to disinfectants, and other harsh chemicals during cleaning. Constant exposure to many of these chemicals can damage a device’s structure — causing cracks, crazing, discoloration, and stickiness — and lead to compromised device performance, longevity, and ultimately, safety.
Material choice plays a big role in whether a device is successful or fails. The reality is that many materials commonly used in medical devices today have a low level of compatibility with current disinfectants and cleaning protocols. Devices also endure a lot of impact. They are constantly handled by multiple people, moved across many environments, and can get dropped or bumped on hard surfaces. Low chemical resistance combined with a high-stress environment often lead to device failures.
In today’s new reality where the concern for preventing transmission of COVID-19 is a top priority, healthcare workers are more vigilant than ever in their efforts to properly disinfect equipment. As noted in Infection Control Today, “While the level of surface contamination with COVID-19 is not known, studies with other epidemiologically important pathogens have shown that disinfection leads to decreased transmission. Further, studies of coronaviruses have demonstrated that they may survive on surfaces for hours to days depending on temperature and humidity.” While rigorous disinfection practices are critical to preventing the spread of disease, if the material in the device has low chemical compatibility, we can expect to see the problem of IV pump failures continue to grow.
Richard Fechter, a biomedical engineer at University of California San Francisco Medical Center, has been investigating pump failures for years. According to Fechter, “It’s an under-recognized problem in general. People don’t connect the cleaning products to the breakage.”
In examining broken and damaged devices, Fechter found certain combinations of cleaners and plastic formulations were not compatible and broke down in very short periods of time. “Some of the plastics are so susceptible to certain cleaners that you could clean it one time and it would be completely destroyed in less than 24 hours,” said Fechter.
Pump failures don’t just mean broken equipment — they can have catastrophic results for patients. In fact, Fetcher reported that “there are certain points on those pumps that if they fail your patient is at risk of death.”
Understanding how chemical resistance affects device failures can be complex because observations are often dependent on the nature of the chemical contact and the level and type of stress found in the part. Because of this, it’s crucial to test actual parts under realistic conditions. However, not all testing is created equal. Testing devices for durability after disinfection is an important step in predicting how they will perform in the real world.
Eastman collaborated with Ivenix to select the latest medical housing polymer for its debut product – an innovative infusion pump. The polymers used to make the Ivenix pump provides excellent chemical resistance and durability to the aggressive disinfectants for cleaning devices exposed to COVID-19. As a result, Eastman’s medical polymers enable Ivenix to deliver an infusion pump that is more disinfectant-ready for today’s COVID-19 era and years to come without sacrificing strength or durability.
Have your cleaning practices changed to ensure proper performance of your pump fleet? Have you experienced discoloration, cracks, or stickiness of a device that have led to failure?
Over the next few months, we’ll continue to explore why material choice is a critical component to device performance, longevity, and ultimately, patient safety…
About Eastman: Founded in 1920, Eastman is a global specialty materials company that produces a broad range of products found in items people use every day. With the purpose of enhancing the quality of life in a material way, Eastman works with customers to deliver innovative products and solutions while maintaining a commitment to safety and sustainability. The company’s innovation-driven growth model takes advantage of world-class technology platforms, deep customer engagement, and differentiated application development to grow its leading positions in attractive end markets such as transportation, building and construction, and consumables. As a globally inclusive and diverse company, Eastman employs approximately 14,500 people around the world and serves customers in more than 100 countries. The company had 2019 revenues of approximately $9.3 billion and is headquartered in Kingsport, Tennessee, USA. Learn more at www.eastman.com