Sam Brusco, Associate Editor07.20.23
Traditionally, the concept of sustainable design focuses on the coexistence of natural and built environments. One typically imagines scenarios to “save the Earth”: planting trees, renewable energy, and collecting pollution from the environment.
Over the past few decades, the idea of sustainability has entered the design community with rating systems, standards, and professional credentialing. Usually, three pillars are considered for sustainability development in a corporation:
In healthcare, holistic, sustainable design is critical and has complex challenges. Medical device manufacturing has no “one-size-fits-all” solution to improve sustainability because each company’s goals and scope widely differ. However, areas exist to implement sustainable practices that run the gamut of the medical supply chain: device design, manufacturing process, packaging, distribution, disposal, and materials selection.
For example, polyvinyl chloride (PVC) is the most widely used plastic for medical devices, with a share of about 25%, according to Plastics Today.¹ Its formulations span soft, flexible rubber to rigid engineering thermoplastics. PVC is used to make tubing, oxygen masks, IV and dialysis fluid containers, IV sets, nasal cannulas, overshoes, exam and surgical gloves, blood vessels for artificial kidneys, blister packaging, mattress covers, training manikins, and many other products.
But like all materials, PVC has its limitations.
“We use an open-minded approach to sustainability—seeking information from our customers to discern what sustainability means to them, then incorporating those parameters into their selected materials from inception,” said Meg Henke, global head of product marketing at TekniPlex Healthcare, a Wayne, Pa.-based provider of medical device components and material science solutions. “Essentially, we approach sustainability as an integral part of DfE (Design for Environment) considerations. In doing so, we utilize both PVC and PVC-alternative material science expertise, as well as intricate knowledge of the broader healthcare landscape, to help meet our customers’ sustainability goals.”
The controversy over PVC doesn’t come from lack of functionality or patient safety. The concerns relate, in part, to PVC’s chlorine content and plasticizers needed to soften the material. The conversation about the benefits and risks of phthalates—DEHP, namely—in medtech is ongoing, and conclusions are varying.
“We’re actively exploring a broad range of polymer material chemistries,” said Henke. “Generally, what distinguishes various materials as more sustainable relies heavily on fully understanding the PVC concerns of medtech companies, including what they define as sustainable and the key product criteria of end applications. On the PVC-alternative side, material exploration is spread across a range of polyolefin and thermoplastic elastomer material families. We carefully select polymer chemistries—mixing them together if required—to deliver innovative material science solutions that address medtech companies’ sustainability needs.”
TekniPlex’s Cellene is a range of thermoplastic elastomer (TPE) compounds combining the benefits of vulcanized rubber with thermoplastic processing capabilities. Suitable for a wide variety of medical device and packaging applications, Cellene TPE compounds are formulated to be silicone, latex, phthalate, and halogen-free using FDA-compliant raw materials to meet USP Class VI and ISO 10993 standards.
“Our Cellene thermoplastic elastomer product platform is designed to complement our PVC product platforms,” said Henke. “We optimize the Cellene product platform technology according to our medtech partners’ specific needs, matching dimensional requirements, mechanical characteristics and assembly requirements to ensure a seamless ‘drop-in’ solution for their manufacturing processes. One recent example is our development of a PVC-alternative material that is solvent bondable—a longstanding challenge for design engineers.”
PVC’s chlorine content has raised concerns about the possible emission of waste substances from its incineration. Most PVC medical devices are short-term, single-use products and non-recyclable medical PVC waste is usually incinerated. Production of waste substances depends on incineration conditions—modern incinerators appropriately manage the substances based on strict procedures and standards under national regulations.
For waste management options of plastics in the circular economy, the trend is the classic axiom “reduce, reuse, recycle.” Incineration emits CO2 and landfills waste the resources, which are the least preferable options. Medical-grade PVC can be recyclable, however. This may not be well known—it began at a hospital in Australia over 10 years ago and has now spread to nine countries around the world.
“The hurdles to replace PVC are substantial, as currently no available alternative PVC material can achieve its functionality and cost-performance ratio,” said Henke. “In particular, PVC has the ability to bond to other materials with ease using solvents, and resists kinking when extruded into tubing. Hence, we have been proactively exploring a broad range of more sustainable materials across both PVC and PVC-alternative technologies. In the process, we’ve developed solutions to bridge the PVC-alternative ease-of-bonding technology gap.”
Henke went on to explain further efforts the company is taking to boost sustainability efforts.
“We’re active in storyboarding our products from gate to gate or cradle to grave, mapping all constituent ingredients and their logistics,” said Henke. “As part of our production, we articulate each process step, with particular attention given to minimizing water and energy usage. Our extrusion process uses a ‘closed-loop’ water management process, which reduces overall water use and guarantees lower bioburden levels. From a broader perspective, we also work collaboratively with customers on Life Cycle Analysis (LCAs) of materials utilized for their latest medical devices.”
LCAs—sometimes referred to as life cycle assessments—measure environmental impacts related to a life cycle of a product, process, or service. Extraction of materials from the environment, production of the product, the use phase, and what happens to the product after it’s no longer used can impact the environment. Undergoing an LCA can evaluate environmental impacts of a product or service from the initial stage to the final, or any stage in between.
“We also leverage our global manufacturing footprint, as we are located proximate to major medtech hubs in North America, Europe, and China,” said Henke. “This provides a more secure supply chain and reduces our customers’ carbon footprints. When companies choose us as a partner, this optimized global manufacturing footprint enables reduction in transportation costs, lead times, and emissions. We also seek to provide alternative materials that use less energy-intensive processing, and can be recycled in areas where relevant recycling infrastructure exists.”
Manchester, N.H.-based Pristine Surgical has the mission to simplify endoscopy. The company pairs single-use endoscopes with cloud-based software to render minimally invasive visualization more efficient, consistent, and safe. The company offers a subscription business model with transparent pricing and automated inventory management, aiming to improve workflow and reduce costs in the endoscopy suite.
This past January, Pristine Surgical earned FDA 510(k) clearance for Summit, a first-of-its kind 4K, single-use arthroscope with accompanying cloud-based software. Summit is simple to set up and completely sterile. The company developed it to address challenges with conventional surgical visualization and reusable arthroscopes that are difficult and costly to maintain. Reusable scopes can be prone to wear, damage, and potential infection, bringing inefficiency and variability into the operating room.
“When evaluating the best options around a product’s sustainability, it's important to consider the entire ecosystem of its use, cleaning, and care,” said Bryan Lord, president and CEO of Pristine Surgical. “In the case of endoscopy, there have been substantial studies conducted examining the amount of resources used for cleaning and sterilizing routine reusable equipment. When you consider the amount of cleaning materials, water, energy, caustic cleaning chemicals, wraps, and PPE involved with cleaning reusable endoscopic programs, single-use alternatives become a viable sustainability option. Companies like Pristine Surgical also offer recycling partnership platforms to give healthcare facilities the ability to further their sustainability objectives.”
According to Pristine, reusable visualization systems net a $100,000+ capital expense for new equipment. They also require three times the lifetime additional expense for service and sterilization, with a 35-step, time-consuming sterilization process. According to the company, 71% of endoscopes contain bacterial growth after reprocessing. Pristine Surgical is also developing a portfolio of rigid and flexible single-use endoscopes, including those used for laparoscopy and flexible endoscopy.
“We believe we’re in the early stages in this effort within medtech,” said Lord. “For the sustainability movement to reach its full potential, the industry must find ways to identify sustainability practices that are economically advantageous while improving patient care and workflow. These are the main drivers of any product or program’s success in medtech. Downrange, companies are now just starting to consider sourcing their product and packing materials from sustainable ingredients, including recycled packaging and bioplastics. As prices for these come down, they will continue to gain well-deserved traction.”
On the other side of the debate, the Association of Medical Device Reprocessors (AMDR) is a global trade association of the single-use device reprocessing and remanufacturing industry. AMDR believes by reprocessing medical devices, hospitals can lower costs, waste, and greenhouse emissions, while strengthening the supply chain. The association represents commercial reprocessing and promotes it as a critical healthcare strategy to help hospitals and healthcare providers boost quality, reduce costs, and improve patient care. AMDR also protects the interest of the industry in regulation, legislation, and setting standards worldwide.
TekniPlex touched on the importance of LCAs, and AMDR has invested heavily in evaluating the LCA strategy.
“Dating to the 1980s, environmental researchers devised LCAs to review a comprehensive range of environmental impact that comes from purchasing decisions,”2 said Daniel Vukelich, Esq., CAE, president and CEO of AMDR. “LCAs look ‘cradle to grave’ at the environmental impacts of purchasing decisions on the land, air, and water from the time the raw materials are mined to the time the product is disposed. Early examples of LCAs examined whether plastic or paper bags at the grocery store were better for the environment, from the time the raw materials were resourced to the time the products were disposed.”
“Without LCAs, we could be making purchasing decisions that improve environmental impact in one area—for example, using fewer raw materials—while generating a huge amount of toxic waste that impacts groundwater during manufacturing,” Vukelich went on. “Without LCAs, manufacturers may tout the environmental benefits of their products in one area, while turning a blind eye toward the harm the products create in another area. That may make some feel better about purchasing decisions but it’s not necessarily better for the environment overall.”
The single-use vs. reusable device debate continues to rage on in the medical device industry. Medical device manufacturers and suppliers must be extremely familiar with the benefits of virgin single-use, disposable, and reusable medical devices to provide customers with the optimal tools for their practice.
“AMDR is highly interested in comprehensive LCA research that looks at all impacts of the decision to use reprocessed versions of single-use devices,” said Vukelich. “The first, most comprehensive LCA in our field, published in the journal Sustainability, compared 16 major environmental impacts from the use of virgin electrophysiology catheters to the identical reprocessed device.3 The study was conducted by researchers from Germany’s prestigious Fraunhofer Institute.”
“Key findings from the study found that use of the reprocessed EP catheter had significant environmental benefits, including strong advantages when it comes to minimizing cancer-causing human health problems, climate changing CO2, ozone-depleting CFCs, and formation of photochemical ozone,” Vukelich continued. “Use of the reprocessed devices is superior in 13 of the 16 categories. We anticipate several additional LCAs publishing in 2023 that will show comparable, significant environmental benefits for reprocessed over virgin single-use devices.”
The cost of sustainable practices can vary depending on a program’s size and scope. Setting up and maintaining corporate sustainability practices can be costly, but many benefits arise from the initiatives. Initiatives can take different forms, from improving the recycling process to building a sustainable production line.
“We are conditioned to believe sustainable practices cost more,” said Vukelich. “Sometimes that’s the case; sometimes it’s not. In the case of reprocessing, over 10,500 hospitals in 19 countries used 33.4 million reprocessed single-use devices in 2021. We estimate that saved over $468 million. But it also sustained thousands of green American jobs. Significantly, use of these devices lowered our dependence on the global supply chain because once the devices are in the circular economy, they stay domestic.”
The costs can be generally broken down into three categories. Setup costs are usually the most expensive and depend on the organization’s goal and scope. Ongoing maintenance costs differ according to goals and objectives and can include dedicated staff and regular material costs. Sunk costs are investments that can’t be recovered once made, like merchandise for an event that has to be trashed because the event was canceled.
“Best practices should be those, like reprocessing, that are well regulated, proven to reduce greenhouse gas emissions in well-designed LCAs, and save money simultaneously,” Vukelich concluded. “Although reprocessed devices are widely used, we estimate only a small percent of the over 300 types of devices that could be reprocessed are actually being put into bins for collection and reprocessing. Education is the greatest barrier: we thank MPO for helping inform more thought leaders in the healthcare supply chain.”
References
Over the past few decades, the idea of sustainability has entered the design community with rating systems, standards, and professional credentialing. Usually, three pillars are considered for sustainability development in a corporation:
- Economic: The ability to contribute to economic development and growth by limiting risks posed by production (recycling, renewable energy, the ISO 50001 energy efficiency standard)
- Social: Values that promote equality and respect for individual rights (combatting discrimination, promoting solidarity, contributing to stakeholder well-being)
- Environmental: Commitment to protecting the environment by reducing risks and measuring environmental impacts (saving/preserving natural energy and resources, assessing carbon footprint and reducing emissions, reducing overall waste)
In healthcare, holistic, sustainable design is critical and has complex challenges. Medical device manufacturing has no “one-size-fits-all” solution to improve sustainability because each company’s goals and scope widely differ. However, areas exist to implement sustainable practices that run the gamut of the medical supply chain: device design, manufacturing process, packaging, distribution, disposal, and materials selection.
For example, polyvinyl chloride (PVC) is the most widely used plastic for medical devices, with a share of about 25%, according to Plastics Today.¹ Its formulations span soft, flexible rubber to rigid engineering thermoplastics. PVC is used to make tubing, oxygen masks, IV and dialysis fluid containers, IV sets, nasal cannulas, overshoes, exam and surgical gloves, blood vessels for artificial kidneys, blister packaging, mattress covers, training manikins, and many other products.
But like all materials, PVC has its limitations.
“We use an open-minded approach to sustainability—seeking information from our customers to discern what sustainability means to them, then incorporating those parameters into their selected materials from inception,” said Meg Henke, global head of product marketing at TekniPlex Healthcare, a Wayne, Pa.-based provider of medical device components and material science solutions. “Essentially, we approach sustainability as an integral part of DfE (Design for Environment) considerations. In doing so, we utilize both PVC and PVC-alternative material science expertise, as well as intricate knowledge of the broader healthcare landscape, to help meet our customers’ sustainability goals.”
The controversy over PVC doesn’t come from lack of functionality or patient safety. The concerns relate, in part, to PVC’s chlorine content and plasticizers needed to soften the material. The conversation about the benefits and risks of phthalates—DEHP, namely—in medtech is ongoing, and conclusions are varying.
“We’re actively exploring a broad range of polymer material chemistries,” said Henke. “Generally, what distinguishes various materials as more sustainable relies heavily on fully understanding the PVC concerns of medtech companies, including what they define as sustainable and the key product criteria of end applications. On the PVC-alternative side, material exploration is spread across a range of polyolefin and thermoplastic elastomer material families. We carefully select polymer chemistries—mixing them together if required—to deliver innovative material science solutions that address medtech companies’ sustainability needs.”
TekniPlex’s Cellene is a range of thermoplastic elastomer (TPE) compounds combining the benefits of vulcanized rubber with thermoplastic processing capabilities. Suitable for a wide variety of medical device and packaging applications, Cellene TPE compounds are formulated to be silicone, latex, phthalate, and halogen-free using FDA-compliant raw materials to meet USP Class VI and ISO 10993 standards.
“Our Cellene thermoplastic elastomer product platform is designed to complement our PVC product platforms,” said Henke. “We optimize the Cellene product platform technology according to our medtech partners’ specific needs, matching dimensional requirements, mechanical characteristics and assembly requirements to ensure a seamless ‘drop-in’ solution for their manufacturing processes. One recent example is our development of a PVC-alternative material that is solvent bondable—a longstanding challenge for design engineers.”
PVC’s chlorine content has raised concerns about the possible emission of waste substances from its incineration. Most PVC medical devices are short-term, single-use products and non-recyclable medical PVC waste is usually incinerated. Production of waste substances depends on incineration conditions—modern incinerators appropriately manage the substances based on strict procedures and standards under national regulations.
For waste management options of plastics in the circular economy, the trend is the classic axiom “reduce, reuse, recycle.” Incineration emits CO2 and landfills waste the resources, which are the least preferable options. Medical-grade PVC can be recyclable, however. This may not be well known—it began at a hospital in Australia over 10 years ago and has now spread to nine countries around the world.
“The hurdles to replace PVC are substantial, as currently no available alternative PVC material can achieve its functionality and cost-performance ratio,” said Henke. “In particular, PVC has the ability to bond to other materials with ease using solvents, and resists kinking when extruded into tubing. Hence, we have been proactively exploring a broad range of more sustainable materials across both PVC and PVC-alternative technologies. In the process, we’ve developed solutions to bridge the PVC-alternative ease-of-bonding technology gap.”
Henke went on to explain further efforts the company is taking to boost sustainability efforts.
“We’re active in storyboarding our products from gate to gate or cradle to grave, mapping all constituent ingredients and their logistics,” said Henke. “As part of our production, we articulate each process step, with particular attention given to minimizing water and energy usage. Our extrusion process uses a ‘closed-loop’ water management process, which reduces overall water use and guarantees lower bioburden levels. From a broader perspective, we also work collaboratively with customers on Life Cycle Analysis (LCAs) of materials utilized for their latest medical devices.”
LCAs—sometimes referred to as life cycle assessments—measure environmental impacts related to a life cycle of a product, process, or service. Extraction of materials from the environment, production of the product, the use phase, and what happens to the product after it’s no longer used can impact the environment. Undergoing an LCA can evaluate environmental impacts of a product or service from the initial stage to the final, or any stage in between.
“We also leverage our global manufacturing footprint, as we are located proximate to major medtech hubs in North America, Europe, and China,” said Henke. “This provides a more secure supply chain and reduces our customers’ carbon footprints. When companies choose us as a partner, this optimized global manufacturing footprint enables reduction in transportation costs, lead times, and emissions. We also seek to provide alternative materials that use less energy-intensive processing, and can be recycled in areas where relevant recycling infrastructure exists.”
Manchester, N.H.-based Pristine Surgical has the mission to simplify endoscopy. The company pairs single-use endoscopes with cloud-based software to render minimally invasive visualization more efficient, consistent, and safe. The company offers a subscription business model with transparent pricing and automated inventory management, aiming to improve workflow and reduce costs in the endoscopy suite.
This past January, Pristine Surgical earned FDA 510(k) clearance for Summit, a first-of-its kind 4K, single-use arthroscope with accompanying cloud-based software. Summit is simple to set up and completely sterile. The company developed it to address challenges with conventional surgical visualization and reusable arthroscopes that are difficult and costly to maintain. Reusable scopes can be prone to wear, damage, and potential infection, bringing inefficiency and variability into the operating room.
“When evaluating the best options around a product’s sustainability, it's important to consider the entire ecosystem of its use, cleaning, and care,” said Bryan Lord, president and CEO of Pristine Surgical. “In the case of endoscopy, there have been substantial studies conducted examining the amount of resources used for cleaning and sterilizing routine reusable equipment. When you consider the amount of cleaning materials, water, energy, caustic cleaning chemicals, wraps, and PPE involved with cleaning reusable endoscopic programs, single-use alternatives become a viable sustainability option. Companies like Pristine Surgical also offer recycling partnership platforms to give healthcare facilities the ability to further their sustainability objectives.”
According to Pristine, reusable visualization systems net a $100,000+ capital expense for new equipment. They also require three times the lifetime additional expense for service and sterilization, with a 35-step, time-consuming sterilization process. According to the company, 71% of endoscopes contain bacterial growth after reprocessing. Pristine Surgical is also developing a portfolio of rigid and flexible single-use endoscopes, including those used for laparoscopy and flexible endoscopy.
“We believe we’re in the early stages in this effort within medtech,” said Lord. “For the sustainability movement to reach its full potential, the industry must find ways to identify sustainability practices that are economically advantageous while improving patient care and workflow. These are the main drivers of any product or program’s success in medtech. Downrange, companies are now just starting to consider sourcing their product and packing materials from sustainable ingredients, including recycled packaging and bioplastics. As prices for these come down, they will continue to gain well-deserved traction.”
On the other side of the debate, the Association of Medical Device Reprocessors (AMDR) is a global trade association of the single-use device reprocessing and remanufacturing industry. AMDR believes by reprocessing medical devices, hospitals can lower costs, waste, and greenhouse emissions, while strengthening the supply chain. The association represents commercial reprocessing and promotes it as a critical healthcare strategy to help hospitals and healthcare providers boost quality, reduce costs, and improve patient care. AMDR also protects the interest of the industry in regulation, legislation, and setting standards worldwide.
TekniPlex touched on the importance of LCAs, and AMDR has invested heavily in evaluating the LCA strategy.
“Dating to the 1980s, environmental researchers devised LCAs to review a comprehensive range of environmental impact that comes from purchasing decisions,”2 said Daniel Vukelich, Esq., CAE, president and CEO of AMDR. “LCAs look ‘cradle to grave’ at the environmental impacts of purchasing decisions on the land, air, and water from the time the raw materials are mined to the time the product is disposed. Early examples of LCAs examined whether plastic or paper bags at the grocery store were better for the environment, from the time the raw materials were resourced to the time the products were disposed.”
“Without LCAs, we could be making purchasing decisions that improve environmental impact in one area—for example, using fewer raw materials—while generating a huge amount of toxic waste that impacts groundwater during manufacturing,” Vukelich went on. “Without LCAs, manufacturers may tout the environmental benefits of their products in one area, while turning a blind eye toward the harm the products create in another area. That may make some feel better about purchasing decisions but it’s not necessarily better for the environment overall.”
The single-use vs. reusable device debate continues to rage on in the medical device industry. Medical device manufacturers and suppliers must be extremely familiar with the benefits of virgin single-use, disposable, and reusable medical devices to provide customers with the optimal tools for their practice.
“AMDR is highly interested in comprehensive LCA research that looks at all impacts of the decision to use reprocessed versions of single-use devices,” said Vukelich. “The first, most comprehensive LCA in our field, published in the journal Sustainability, compared 16 major environmental impacts from the use of virgin electrophysiology catheters to the identical reprocessed device.3 The study was conducted by researchers from Germany’s prestigious Fraunhofer Institute.”
“Key findings from the study found that use of the reprocessed EP catheter had significant environmental benefits, including strong advantages when it comes to minimizing cancer-causing human health problems, climate changing CO2, ozone-depleting CFCs, and formation of photochemical ozone,” Vukelich continued. “Use of the reprocessed devices is superior in 13 of the 16 categories. We anticipate several additional LCAs publishing in 2023 that will show comparable, significant environmental benefits for reprocessed over virgin single-use devices.”
The cost of sustainable practices can vary depending on a program’s size and scope. Setting up and maintaining corporate sustainability practices can be costly, but many benefits arise from the initiatives. Initiatives can take different forms, from improving the recycling process to building a sustainable production line.
“We are conditioned to believe sustainable practices cost more,” said Vukelich. “Sometimes that’s the case; sometimes it’s not. In the case of reprocessing, over 10,500 hospitals in 19 countries used 33.4 million reprocessed single-use devices in 2021. We estimate that saved over $468 million. But it also sustained thousands of green American jobs. Significantly, use of these devices lowered our dependence on the global supply chain because once the devices are in the circular economy, they stay domestic.”
The costs can be generally broken down into three categories. Setup costs are usually the most expensive and depend on the organization’s goal and scope. Ongoing maintenance costs differ according to goals and objectives and can include dedicated staff and regular material costs. Sunk costs are investments that can’t be recovered once made, like merchandise for an event that has to be trashed because the event was canceled.
“Best practices should be those, like reprocessing, that are well regulated, proven to reduce greenhouse gas emissions in well-designed LCAs, and save money simultaneously,” Vukelich concluded. “Although reprocessed devices are widely used, we estimate only a small percent of the over 300 types of devices that could be reprocessed are actually being put into bins for collection and reprocessing. Education is the greatest barrier: we thank MPO for helping inform more thought leaders in the healthcare supply chain.”
References
