News

May 29, 2023

The Effect of Climate Change on Medical Device Manufacturing

Katie Hobbins | May 31, 2023 Climate change remains a key concern as the earth

Katie Hobbins | May 31, 2023

Climate change remains a key concern as the earth warms and environmental conditions become more extreme. Specifically, climate change can have indirect effects on the medical device industry and manufacturing, from an increase in climate related illness and supply chain disruptions to device lifespan shortages and impact on sterilization processes.

Increased demand for climate-related medical devices

The United States Environmental Protection Agency (EPA) reported that climate change affects health by changing the seriousness or frequency of health problems that people already face, and the creation of new or unanticipated health problems in people or places they have not been before.

"Climate change poses many threats to the health and well-being of all Americans," according to the EPA. "Climate change affects the food we eat, the air we breathe, the water we drink, and the places that provide us with shelter. Climate change can also impact people's health and well-being by altering the frequency or intensity of extreme weather events and spread of certain pests and diseases."

Additionally, a person's vulnerability to the health impact of climate change depends on how a person is exposed, their sensitivity to climate hazards, and their adaptive capacity to it. For instance, people who spend more time outdoors may be more exposed to extreme heat. Age and health condition can make a person much more sensitive to climate impacts than others — people with asthma have an increased sensitivity to air pollutants and wildfire smoke. Adaptability to adjust to, take advantage of, or respond to climate change hazards also depend on income, age, living situation, access to healthcare, among other factors.

Specific health effects of climate change include "respiratory and heart diseases, pest-related diseases like Lyme disease and West Nile Virus, water- and food-related illnesses, and injuries and deaths." From a behavioral standpoint, the Centers for Disease Control and Prevention (CDC) also noted that climate change has been linked to increases in violent crime and overall poor mental health.

"Some patients with mental illness are especially susceptible to heat," according to the CDC. "Suicide rates vary with weather, rising with high temperatures, suggesting potential impacts from climate change on depression and other mental illnesses. Dementia is a risk factor for hospitalization and death during heat waves. Patients with severe mental illness, such as schizophrenia, are at risk during hot weather because their medications may interfere with temperature regulation or even directly cause hyperthermia. Additional potential mental health impacts, less well understood, include the possible distress associated with environmental degradation and displacement and the anxiety and despair that knowledge of climate change might elicit in some people."

As these health effects continue to expand, there is also a higher demand for medical devices to detect or treat these conditions. For example, since the beginning of the COVID-19 pandemic in 2020, devices like ventilators, respiratory support systems, and diagnostic tools exploded in demand across not only the United States, but around the world. In turn, shortages for these devices became a major problem due to supply chain issues across the board.

Supply chain disruptions

The COVID-19 pandemic saw businesses alerted to the fragility of global supply chains. Struggling through heightened demand for personal protection equipment (PPE), ventilators, COVID-19 diagnostics and home tests, as well as trade restrictions, factory closures, rising freight rates, and a reliance on "just-in-time" inventory systems resulted in major global shortages and inflation which had a catastrophic impact on health institutions inundated with highly contagious COVID-19 patients.

Outside of the pandemic, extreme weather events like hurricanes, floods, wildfires, and overall rising sea levels can result in issues such as delays in manufacturing, shortages, and increased prices.

"The pandemic is ‘a temporary problem,’ while climate change is ‘long-term dire,’" said Austin Becker, a maritime infrastructure resilience scholar at the University of Rhode Island, in an article for YaleEnvironment360 – published through the Yale School of the Environment. "Climate change is a slow-moving crisis that is going to last a very, very long time, and it's going to require some fundamental changes. Every coastal community, every coastal transportation network is going to face some risks from this, and we’re not going to have nearly enough resources to make all the investments that are required."

In the last few years, major weather events disrupted the production of devices and components vital in device construction. For example, the February 2021 Texas freeze caused the worst involuntary energy blackout in US history. The blackout caused the closure of three major semiconductor plants, exacerbating an already critical shortage for the chips many medical devices use. Additionally, the outages closed railroad closures, severing important links between Texas and the Pacific Northwest.

Hurricane Ida, which is now categorized as the fifth-costliest hurricane in US history, also damaged vital manufacturing spaces that generate plastics and pharmaceuticals, along with an array of other products. The damage forced the diversion of trucks, which were already in short supply, for use in hurricane relief.

Rising sea levels are threatening ports, rail lines, highways, and other transportation and supply infrastructure at an estimated two to six feet, or more, by 2100. Ports are most at risk, with around 90% of the worlds freight moving by ship, and coastal port wharves generally lying just a few feet to 15 feet above current sea levels.

A Maritime Policy and Management paper, published in 2020, even reported that if current climate science is correct, "global supply chains will be massively disrupted, beyond what can be adapted to while maintaining current systems."

Medical device lifespan shortage

High temperatures and humidity are known to accelerate the degradation of certain medical devices, especially those with sensitive components and materials. Climate change and the increase of global warming could contribute to shorter device lifespans due to rising heat levels and humidity, especially in environments already known as very warm and humid.

Unusually high levels of heat and humidity may cause instruments to operate unexpectedly, reduce shelf-lives or totally destroy products, and cause laboratory reagents to lose potency, according to FDA. Specifically for polymers, humidity can cause a chemical degradation reaction known as hydrolysis, which can cause irreversible loss of mechanical properties over time. Ambient humility levels — the absence of humidity — during elevated temperature accelerated aging can cause polymers to dry out to levels beyond those that occur under ambient storage conditions. Low humidity at elevated temperatures can significantly alter mechanical properties, including stiffening and embrittlement of polyamides such as nylon, MD+DI previously reported.

"Even with knowledge of material properties, unforeseen degradation from humidity can occur that might not have done so for the bulk materials alone (e.g., polymers in contact with additives like radiopacifiers or colorants), which could catalyze bulk degradation (e.g., hydrolysis)," MD+DI reported. "Failure to consider humidity in accelerated aging protocols can ultimately result in inadequately predicting real-time aging behavior, whether that would be missing failures that occur in the field or artificially inducing failures during accelerated aging that do not occur in the field, both of which can have significant consequences."

Impact on sterilization processes

Ethylene Oxide (EtO) is a chemical gas used to sterilize about half of all medical equipment, but its potential impact on the environment and human health continue to make headlines. Communities that live close to manufacturers of EtO are colloquially known as "cancer alleys" and prolonged exposure to the chemical is associated with the development of non-Hodgkin lymphoma, myeloma, breast cancer, and lymphocytic leukemia. EtO is also mutagenic, meaning it can change a cell's DNA and is especially harmful for children.

While the chemical is harmful when emitted into the environment and absorbed by humans, its use in medical sterilization continues to be vital. "According to FDA, ‘For many medical devices, sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process,’" the American Chemistry Council wrote.

While EtO continues to be controversial for its potential health hazards and EPA implications, there has been increasingly louder murmurs about the use of supercritical carbon dioxide (scCO2) as an ecological alternative for medical device sterilization.

"scCO2 is a fluid in which carbon dioxide has liquid (density) and gas (diffusivity) like properties," said Tony Eisenhut, CEO and co-founder of NovaSterilis, in a Q&A for MD+DI. "The supercritical state is achieved when the temperature and pressure are above its critical points (~31C and 1,070 psi or 73 atm). scCO2 has been broadly used in the medtech space for decades. Emerging areas in the medtech space (regenerative medicine applications) is the use in decellularization of human and animal tissues without the use of harsh chemicals such as TritonX (use has been reduced and/or eliminated in some countries). Additionally, scCO2 is used for manufacturing of products whether it be via impregnation of bioactives into scaffolds or the creation of scaffolds themselves as aerogels. The uses of scCO2 are growing rapidly in the medical device, regenerative medicine, and therapeutics industries."

NovaSterilis was selected in 2019 as part of FDAs innovation challenge to identify and support alternatives to EtO. In 2022, FDA announced multiple clearances in that "used scCO2 as a cleaning and/or terminal sterilization process in the manufactured devices," Eisenhut told MD+DI. "The cleared applications range from terminal sterilization of therapeutics to additive manufactured products to tissue derived products."

Much like a medical device's lifespan, changes in temperature, humidity, and air quality may affect the efficiency and effectiveness of sterilization processes used in device manufacturing. The CDC reported that too great an increase in temperature causes a "disinfectant to degrade and weakens its germicidal activity and thus might produce a potential health hazard."

And relative humidity, according to CDC, "is the single most important factor influencing the activity of gaseous disinfectants/sterilants, such as EtO, chlorine dioxide, and formaldehyde."

More information about text formats