Michael Barbella, Managing Editor02.03.21
The medical technology industry can help fight global warming by boosting the use of reprocessed devices.
A Life Cycle Analysis (LCA) study conducted by the Fraunhofer Institute for Environmental, Safety, and Energy Technology UMSICHT, a division the world’s leading applied research organization Fraunhofer-Gesellschaft, evaluated the use of a reprocessed electrophysiology catheter compared with the use of original catheters for 16 different environmental impact categories and found that the use of reprocessed devices was superior in 13 categories. Published in Sustainability, the study is the first comprehensive LCA exploring the environmental impact of a reprocessed “single-use” medical device compared to the “take-make-dispose” use of “single-use” original devices.
“By avoiding the use of virgin materials, reprocessing can reduce the environmental impacts of resource consumption and emissions, such as reducing abiotic resource use and the global warming impact (GWI),” said Anna Schulte, M.S.c., Fraunhofer Institute for Environmental, Safety, and Energy Technology UMSICHT and lead study author. “Hospitals that want to reduce harmful environmental impact should strongly consider using remanufactured 'single-use' medical devices like the EP catheters we studied.”
Researchers concluded that hospitals could cut emissions associated with some medical device use in half by opting instead for regulated, reprocessed “single-use” medical devices.
“This comprehensive LCA confirms what we’ve thought to be true - that reprocessed medical devices are significantly environmentally superior to the original device,” said Daniel J. Vukelich, president and CEO, Association of Medical Device Reprocessors. “These definitive environmental benefits, combined with the well documented financial and supply chain resiliency benefits of reprocessed devices, make clear what EU Member States gain by ‘opting in’ to the EU MDR, and that hospitals already using remanufactured devices should double-down and expand their reprocessing programs.”
Last December, the journal Health Affairs concluded that the health sector is “responsible for 4.6 percent of global greenhouse gas emissions” and that the “vast majority of health care global greenhouse gas emissions originate in the supply chain.” Hospitals’ over-reliance on “disposable” or “single-use” medical devices and equipment over the last 30 years has been further exacerbated by the challenges associated with COVID. And supply chain vulnerabilities have demonstrated that reliance on a disposable culture may not always provide healthcare workers with the supplies they need.
LCA Finds Reprocessing Superior in 13 of 16 Environmental Impact Categories
The authors researched 16 “Impact Categories” and found reprocessed catheters superior to original catheters in 13, including:
Ozone Depletion. Reprocessed devices reduced ozone depletion by nearly 90 percent (89.7).
Climate Change. Reprocessed catheters cut CO2-equivalent emissions in half (50.4 percent).
Photochemical Ozone Formation. Reprocessed devices reduced human health-impacted photochemical ozone formation by 72.8 percent.
Respiratory Inorganics. Reprocessed devices reduced disease incidents from respiratory inorganics by 66.8 percent.
Cancer Human Health Effects. Reprocessed catheters reduced cancer causing human health effects by 60.9 percent.
Disinfectants and cleaning agents used for reprocessed catheters were found to elevate two environmental impacts for remanufactured devices compared to original catheters: land use for agriculture associated with citric acid cleaning agents (15.2 percent) and eutrophication freshwater use (25.1 percent). The authors note, however, that certain environmental inputs for original catheter production are unknown and thus not entered in their calculations.
The environmental analysis confirms that reprocessing leads to a significant reduction in global warming, when studying the “cradle to grave” impact of water, sterilization gasses, detergents and disinfectants, packaging materials, and electricity (excluding the electricity used in original plastic production which is unknown by the authors).
Global Warming Impact of Plastic Manufacturing for Original “Single-Use” Medical Devices
The Fraunhofer researchers found that the global warming impact of plastic manufacturing for original EP catheters, which is avoided when using their reprocessed counterparts, accounts for more CO2 than the entire remanufacturing process, including the impact of cleaning the devices.
Global Use and Impact of Reprocessed SUDs
Reprocessing “single-use” medical devices, which requires regulated, commercial companies to collect, clean, sterilize, test and return devices for use again at hospitals, is already in place at over 7,600 hospitals in the United States, Canada, Germany, England, Israel and Japan, yet only a small percent of the devices that can legally be remanufactured are. In the European Union and the United States, over 300 devices labelled for “single-use” are CE marked and cleared by the U.S. Food and Drug Admnistration respectively for reprocessing.
Sustaining value after the end of life for SUDs helps hospitals to lower costs, as reprocessed devices cost significantly less than their original counterparts. Use of the reprocessed devices helps hospitals redirect money to pressing needs, such as toward fighting COVID-19.
A Life Cycle Analysis (LCA) study conducted by the Fraunhofer Institute for Environmental, Safety, and Energy Technology UMSICHT, a division the world’s leading applied research organization Fraunhofer-Gesellschaft, evaluated the use of a reprocessed electrophysiology catheter compared with the use of original catheters for 16 different environmental impact categories and found that the use of reprocessed devices was superior in 13 categories. Published in Sustainability, the study is the first comprehensive LCA exploring the environmental impact of a reprocessed “single-use” medical device compared to the “take-make-dispose” use of “single-use” original devices.
“By avoiding the use of virgin materials, reprocessing can reduce the environmental impacts of resource consumption and emissions, such as reducing abiotic resource use and the global warming impact (GWI),” said Anna Schulte, M.S.c., Fraunhofer Institute for Environmental, Safety, and Energy Technology UMSICHT and lead study author. “Hospitals that want to reduce harmful environmental impact should strongly consider using remanufactured 'single-use' medical devices like the EP catheters we studied.”
Researchers concluded that hospitals could cut emissions associated with some medical device use in half by opting instead for regulated, reprocessed “single-use” medical devices.
“This comprehensive LCA confirms what we’ve thought to be true - that reprocessed medical devices are significantly environmentally superior to the original device,” said Daniel J. Vukelich, president and CEO, Association of Medical Device Reprocessors. “These definitive environmental benefits, combined with the well documented financial and supply chain resiliency benefits of reprocessed devices, make clear what EU Member States gain by ‘opting in’ to the EU MDR, and that hospitals already using remanufactured devices should double-down and expand their reprocessing programs.”
Last December, the journal Health Affairs concluded that the health sector is “responsible for 4.6 percent of global greenhouse gas emissions” and that the “vast majority of health care global greenhouse gas emissions originate in the supply chain.” Hospitals’ over-reliance on “disposable” or “single-use” medical devices and equipment over the last 30 years has been further exacerbated by the challenges associated with COVID. And supply chain vulnerabilities have demonstrated that reliance on a disposable culture may not always provide healthcare workers with the supplies they need.
LCA Finds Reprocessing Superior in 13 of 16 Environmental Impact Categories
The authors researched 16 “Impact Categories” and found reprocessed catheters superior to original catheters in 13, including:
Ozone Depletion. Reprocessed devices reduced ozone depletion by nearly 90 percent (89.7).
Climate Change. Reprocessed catheters cut CO2-equivalent emissions in half (50.4 percent).
Photochemical Ozone Formation. Reprocessed devices reduced human health-impacted photochemical ozone formation by 72.8 percent.
Respiratory Inorganics. Reprocessed devices reduced disease incidents from respiratory inorganics by 66.8 percent.
Cancer Human Health Effects. Reprocessed catheters reduced cancer causing human health effects by 60.9 percent.
Disinfectants and cleaning agents used for reprocessed catheters were found to elevate two environmental impacts for remanufactured devices compared to original catheters: land use for agriculture associated with citric acid cleaning agents (15.2 percent) and eutrophication freshwater use (25.1 percent). The authors note, however, that certain environmental inputs for original catheter production are unknown and thus not entered in their calculations.
The environmental analysis confirms that reprocessing leads to a significant reduction in global warming, when studying the “cradle to grave” impact of water, sterilization gasses, detergents and disinfectants, packaging materials, and electricity (excluding the electricity used in original plastic production which is unknown by the authors).
Global Warming Impact of Plastic Manufacturing for Original “Single-Use” Medical Devices
The Fraunhofer researchers found that the global warming impact of plastic manufacturing for original EP catheters, which is avoided when using their reprocessed counterparts, accounts for more CO2 than the entire remanufacturing process, including the impact of cleaning the devices.
Global Use and Impact of Reprocessed SUDs
Reprocessing “single-use” medical devices, which requires regulated, commercial companies to collect, clean, sterilize, test and return devices for use again at hospitals, is already in place at over 7,600 hospitals in the United States, Canada, Germany, England, Israel and Japan, yet only a small percent of the devices that can legally be remanufactured are. In the European Union and the United States, over 300 devices labelled for “single-use” are CE marked and cleared by the U.S. Food and Drug Admnistration respectively for reprocessing.
Sustaining value after the end of life for SUDs helps hospitals to lower costs, as reprocessed devices cost significantly less than their original counterparts. Use of the reprocessed devices helps hospitals redirect money to pressing needs, such as toward fighting COVID-19.
