Microplastics seemingly are everywhere, from the bottom of the ocean to the highest peaks, in products that we drink and eat, and in our bodies, including in brain tissue and testicles. One recent study investigated the presence of
microplastics in medical devices
, including implantables. Although there has been extensive reporting on the presence of microplastics, paradoxically little is known about their potential impact on human health. In this article, we will focus, in particular, on microplastics in medical devices and their possible toxicological impacts.
First, though, let’s define what we are talking about.
What we refer to as microplastics are plastic debris measuring less than 5 mm in length, which is roughly the size of a pencil eraser. They generally come from larger pieces of plastic that have eroded over time, often through natural processes.
They may also come from polyethylene microbeads, which are already minute when they are fabricated for use as exfoliants in a range of health and beauty products. To allay concerns related to their environmental impact, they have been outlawed in many parts of the world in certain applications. In 2015, President Obama signed into a law a bill that banned their use in cosmetics and personal care products, and the European Union followed suit in 2023 (although transitional compliance periods extend to 2035 in some cases). They are banned in many other countries, including Canada, the United Kingdom, and China.
Microplastics in single-use devices
Hundreds of studies have been conducted over the years focusing on the proliferation of microplastics. One such study published in
Environmental Research
claimed to find that single-use plastic medical devices, which are typically made from polypropylene (PP), polystyrene (PS), and PVC, release significant quantities of microplastics following high-temperature steam disinfection (HSD), which is generally required prior to disposal, according to the researchers.
While the researchers recognize that disposable devices — a broad category that includes syringes, infusion sets, blood collection systems, and plastic blood bags — offer numerous conveniences, they can be a “non-negligible source of secondary microplastics” as a result of the waste treatment process.
The research led by An Xu at the University of Science and Technology of China in Hefei used optical photothermal infrared spectroscopy to determine the release profiles of eight typical disposable medical devices under HSD. The scientists found that morphological changes were mainly associated with the material. In the online article preview, they note the following:
PP and PS exhibited high aging phenomena (e.g., bumps, depressions, bulges, and cracks), and HSD broke their oxygen-containing functional groups and carbon chains.
By contrast, only minor changes in the chemical and physical properties were observed in the PVC-based disposable medical devices under the same conditions.
Further physico-chemical characterization indicated that the amount of microplastics released from PP-prepared disposable medical devices was greater than that from PVC-prepared disposable medical devices.
The paper cites other studies that have explored the potential impact of microplastics on the reproductive, developmental, and neurological systems of worms. Those findings demonstrated, for example, that exposure to 10 and 100 mg/L low-density PE and polylactide (PLA) reduced the brood size of worms, and PS exposure affected their development by shortening body length and width.
Xu’s team stressed, however, that the “release profiles of microplastics during medical waste treatment and their potential risks to the environment and human health remain unclear.”
A more recent study investigated the
release of microplastics from disposable infusion tubes and blood needles
using laser direct infrared analysis. Published in
Analytica Chimera Acta
, the study found that PA, PVC, and polyethylene terephthalate (PET) were primarily released from infusion tubes, while blood collection needles mainly released polyurethane (PU) and PET.
The significance of the study, according to lead researcher Xuejiao Qie from Anhui Medical University in China, is the implication that microplastics can enter the bloodstream directly through infusion tubes and blood collection needles, “highlighting the need for greater attention to the risk of patient exposure.”
Other studies, primarily from researchers in China, have attempted to show increased exposure to microplastics through
plastic packaging of infusion products
and as a result of percutaneous coronary interventions (PCIs). The latter study noted that
PCI may be a new way for microplastics to enter the body
. “Many devices used during PCI and their packaging contain plastic materials, such as guidewires, catheters, balloons, and stents. As a result of friction and collisions during the PCI, [microplastics] may be produced and enter directly into the blood,” write the researchers, led by Ming Zhang of Capital Medical University in Beijing. Noting that no previous studies have tested for the release of microplastics during PCI, this research showed for the first time the possibility of a large quantity of microplastics entering the bloodstream through this procedure.
Regulatory remedies
There are currently no laws regulating microplastics in medical devices. The medical device industry is one of the most tightly regulated sectors, with FDA’s Center for Devices and Radiological Health and the European Union’s Medical Device Regulation responsible for ensuring the safety of devices in those two parts of the world. Other countries to a greater and lesser extent have similar regulatory oversight.
The only federal legislation regulating the use of microplastics in the United States is the
Microbead-Free Waters Act of 2015
. It prohibits the manufacturing, packaging, and distribution of rinse-off cosmetics containing plastic microbeads. In noting this legislation, US FDA added that the law is intended to prevent microbeads from ending up in lakes and oceans, where they may be mistaken for food by small fish and other wildlife. “The . . . law does not address consumer safety,” the agency goes on to say, “and we do not have evidence suggesting that plastic microbes, as used in cosmetics, pose a human health concern.”
More recently, Sen. Jeff Merkley (D-OR) introduced
S.2353 - Microplastics Safety Act
in July 2025. The act directs the Secretary of Health and Human Services to conduct a study on the human health impacts of exposure to microplastics in food and water and submit a report to Congress. Co-sponsored by Sen. Rick Scott (R-FL), the act was read twice and referred to the Committee on Health, Education, Labor, and Pensions at the time of writing.
The European Union has passed more restrictive legislation pertaining to microplastics. Commission Regulation (EU) 2023/2055, which is laid down in entry
78 of Annex XVII of the REACH regulation
, restricts the use of “synthetic polymer microparticles (SPMs) in certain applications but does not “entail a ban on the use of SPMs,” as explained in the document. “The ban on placing SPM on the market starts applying at different times for different uses depending on the transitional period assessed as necessary taking into account the socio-economic impacts,” notes the explanatory guide. “The restriction measures laid down in entry 78 differ depending on whether using the SPM or the product containing them inevitably leads to SPM releases into the environment, or whether the releases can be prevented or minimized.” The regulation, enacted in October 2023, is phased in over several years, with some product categories having until 2035 to reach compliance.
Microplastics legislation is proliferating worldwide, and a
Global Plastic Laws Database
tracks those initiatives across 115 countries. Access is free but registration is required.
Health risks
Although there have been countless articles in scientific journals as well as the mainstream press on the presence of microplastics in human tissues and organs, including in the brain, testicles, heart, stomach, lymph nodes, and placenta, as well as in urine, breastmilk, semen, and meconium, which is a newborn's first stool, research on the health impacts is only just beginning, notes an
article
from Stanford Medicine. “Scientists have estimated that adults ingest the equivalent of one credit card per week in microplastics,” writes Katia Savchuk. “Studies in animals and human cells suggest microplastics exposure could be linked to cancer, heart attacks, reproductive problems, and a host of other harms. Yet few studies have directly examined the impact of microplastics on human health, leaving us in the dark about how dangerous they really are.”
Savchuk cites one of the earliest papers to examine health risks in humans, published in the
New England Journal of Medicine
in March 2024, which studied patients undergoing surgery to remove plaque from their arteries. According to this study, “more than two years after the procedure, those who had microplastics in their plaque had a higher risk of heart attack, stroke, and death than those who didn’t,” writes Savchuk.
That paper inspired a researcher at Stanford Medicine to conduct pilot studies investigating the effects of micro- and nanoplastics on animals and human cells that line blood vessels. The research so far has shown that these plastic particles reportedly can get inside cells and lead to major changes in gene expression. "These findings suggest that the particles contribute to vascular disease progression, emphasizing the urgency of studying their impact," researcher Juyonong Brian Kim told Savchuk.
Microplastics in packaging
Addressing the specific issue of micro- and nanoplastics in food packaging, FDA has concluded that there is insufficient scientific evidence that the particles can migrate into foods and beverages. Moreover, “while many studies have reported the presence of microplastics in several foods, including salt, seafood, sugar, beer, bottled water, honey, milk, and tea, current scientific evidence does not demonstrate that the levels of microplastics or nanoplastics detected in foods pose a risk to human health,” writes the agency. “Additionally, because there are no standardized methods for how to detect, quantify, or characterize microplastics and nanoplastics, many of the scientific studies have used methods of variable, questionable, and/or limited accuracy and specificity.”
On that note,
Chris DeArmitt
, PhD, founder of the
Plastics Research Council
and author of
The Plastics Paradox
, has devoted considerable resources to investigating these claims. The first question to address is whether we need to be concerned about the health effects of particles in general, and the answer is yes, he writes.
“Fine particles under 10 microns and especially under 2.5 microns in size can cause health problems,” says DeArmitt. Plastics, he contends are safe, but people may be surprised to learn how unsafe some other particles are, as illustrated in the chart below.
Compiled by Chris DeArmitt based on data from "Comparison between in-vitro toxicity of polymer and mineral dusts and their fibrogenicity" by J. A. Styles & J. Wilson published in The Annals of Occupational Hygiene, 16 (3), pp. 241–250, November 1973, and IARC Monographs, Volume 100, "A Review of Human Carcinogens" from the World Health Organization, 2012.
“Quartz is one of the most common rocks. When we go to the beach, we merrily bathe in the sunlight, which can give us cancer while breathing in quartz dust, which can also give us cancer. Workers are exposed to dangerous levels of quartz, including those in factories sawing quartz countertops,” notes DeArmitt.
Doing the math
DeArmitt says that he has read more than 500 studies on the subject of microplastics, “a painful experience for me, but the good news is that scientists already have all the answers,” he writes. One example he cites is the widely reported claim that we eat a credit card’s worth of plastic per week.
The World Wildlife Fund (WWF) made that claim based on a study it paid for, according to DeArmitt. “Other non-profits and the media repeated the claim. When considering evidence, it is always best to check other sources of information, preferably impartial ones,” he writes.
“So, what does the best impartial scientific study have to say about microplastic ingestion by humans? The authors of that study specifically state that the WWF study is wrong. In fact, it is massively wrong: According to that study, humans ingest in the neighborhood of 184 nanograms per day, or 0.000000184 g.” To visualize that amount, consider that a grain of salt weighs 60,000 nanograms.
“Remember, the WWF says that we ingest 5 g per week, which is what a credit card weighs, when the actual amount is just 0.0000013 g per week. Meaning that it would actually take tens of thousands of years to ingest a credit card’s worth of plastic,” writes DeArmitt.
The science underpinning some of those studies are also routinely questioned by
PlasticsToday
columnist John Spevacek. He holds a PhD in chemical engineering from the University of Illinois (Urbana) and currently teaches at Wake Tech Community College in Raleigh, NC, where he is an assistant professor of engineering. Commenting on a recent study which found that
black plastic cooking utensils
made from recycled materials contained a chemical, BDE-209, that could leach out of the plastic when exposed to high temperatures, Spevacek noted that the researchers seemed to be mathematically challenged. They estimated that consumption levels of the chemical would reach 34,700 ng/day, dangerously close to the acceptable limit published by the Environmental Protection Agency of 42,000 ng/day. “Close scrutiny of the
report
, however, found that the initial conclusion was wrong due to a simple math error. The EPA limit is actually 10 times greater — 420,000 ng/day,” wrote Spevacek. To make matters worse, a
second
math error, this time with the formula used to calculate the amount of extracted BDE-209 was discovered. Instead of consuming 34,700 ng/day, people are actually more likely to be taking in 7,900 ng/day. “Wow,” wrote Spevacek. “That went from an initial report stating that human exposure was 83% of the EPA value to a new value that is 1.9% of the limit.”
Alternative materials
To get back to the specific place we began this article — microplastics originating from medical devices and implantables — the question becomes: What are the alternatives? The ever-growing use of plastics in medical technology is predicated on the material’s biocompatibility, safety, and superiority in terms of performance and cost. Single-use devices, to take one example, have been instrumental in reducing hospital-acquired infections through contaminated instruments. And demand shows no signs of slowing down.
The global market for disposable medical devices was valued at $109.49 billion in 2024 and is forecast to expand at a CAGR of 4.9% between 2025 and 2030, reaching $144.85 billion by 2030, according a recent
report
from MarketsandMarkets. Demand continues to grow for the following reasons, according to an
article
in the
Globe and Mail
summarizing the report.
Infection prevention and cross-contamination control are central to medical practices, and the focus has grown exponentially since the COVID epidemic. Disposable medical devices minimize microbial transmission risks and, by eliminating sterilization concerns, safeguard both patients and healthcare providers, especially in high-risk environments.
Conditions such as diabetes, cancer, and cardiovascular disorders require ongoing monitoring, frequent interventions, and long-term management. Disposable drug-delivery systems, diagnostic kits, and monitoring devices play an essential role in ensuring safe, convenient, and accurate care.
A rising elderly population is susceptible to chronic illnesses, more surgeries, and long-term care needs, all of which amplify the demand for ready-to-use, sterile medical devices.
In regions with improving healthcare infrastructure and rising disposable incomes, patients and providers increasingly favor the safety and convenience of disposables.
Given the irrefutable safety benefits of single-use medical devices for patients and practitioners alike, and the conclusion drawn by global health authorities that current data do not support claims that microplastics represent a risk to human health, it’s hard to imagine
what
should replace plastics in the medical space and, more importantly,
why
an alternative is needed.