Toxicity of Common Extractables and Leachables of Medical Devices

Nappier, Kandice M.; Smith, Sherrie

doi:10.1007/978-3-030-35241-7_12

Cited by 4 publications

(4 citation statements)

References 40 publications

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“…Medical devices/materials have different causes of carcinogenicity compared with drugs or chemicals. The carcinogenic mechanism of biomaterials implanted into the human body may be caused by many factors, not solely chemical factors [52,53], such as carcinogenic leachates (such as monomers of polymer materials, additives, process residues, degradation products, etc) generated in the body, but also the physical factor of the medical device, which is much more important for the carcinogenetic characteristic of implantation materials. In the absence of evidence to rule out the carcinogenicity risk of non-genotoxic implantation materials, while we could not collect information that can offer a long history of effective or adequate human application, carcinogenic tests for absorbable materials with an absorption time of more than 30 d and for materials that enter the human body for a sustained or cumulative exposure time of more than 30 d should be considered.…”

Section: Carcinogenic Test Of Implantation Materialsmentioning

confidence: 99%

Research progress of implantation materials and its biological evaluation

Wang,

Meng,

Zhao

et al. 2023

Biomed. Mater.

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With the development of modern material science, life science and medical science, implantation materials are wide employed in clinical fields. In recent years, these materials have also evolved from the inert supports or functional substitutes to the bioactive materials able to trigger or promote the regenerative potential of tissues. Reasonable biological evaluation of implantation materials is that the premise to make sure their safe application in clinical practice. With the continual development of implantation materials and therefore the emergence of new implantation materials, new challenges to biological evaluation have been presented. In this paper, the research progress of implantation materials, the progress of biological evaluation methods, and also the characteristics of biocompatibility evaluation for novel implantation materials, like animal-derived implantation materials, nerve contact implantation materials, nanomaterials and tissue engineered medical products were reviewed, that provided references for the rational biological evaluation of implantable materials.

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Section: Carcinogenic Test Of Implantation Materialsmentioning

confidence: 99%

Research progress of implantation materials and its biological evaluation

Wang,

Meng,

Zhao

et al. 2023

Biomed. Mater.

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“…Several 3D printing techniques such as extrusion-based direct-write (EDW) 3D printing, fused deposition modeling (FDM), inkjet printing (IP), and stereolithography (SLA) have been explored to design complex biological structures. − However, these techniques face similar limitations. − The most common materials used for 3D printing can be categorized into two groups: natural and synthetic polymers. Natural polymers often exhibit batch-to-batch variability, poor mechanical properties, and poor shape fidelity. − On the other hand, synthetic polymers offer improved mechanical properties and shape fidelity, making them suitable for applications such as tracheal splints, bone cancer metastasis studies, dental implants, ear implants, stents, , and orthopedic implants. , Unfortunately, synthetic polymers also come with their own drawbacks. , For instance, they can induce inflammation (poly(lactic- co -glycolic acid)), bone erosion after years of device implantation (poly(tetrafluoroethylene)), , systemic and local reactions due to acidic byproducts (poly(lactic acid) and poly(lactic- co -glycolic acid)), ,, poor cell adhesion due to hydrophobic characteristics (polycaprolactone), and poor mechanical properties due to low elasticity and flexibility (polyetheretherketone and poly(lactic acid)). , …”

Section: Introductionmentioning

confidence: 99%

Synergistic Effect of Physical and Chemical Cross-Linkers Enhances Shape Fidelity and Mechanical Properties of 3D Printable Low-Modulus Polyesters

Ortiz-Ortiz,

Mokarizadeh,

Segal

et al. 2023

Biomacromolecules

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Three-dimensional (3D) printing is becoming increasingly prevalent in tissue engineering, driving the demand for low-modulus, high-performance, biodegradable, and biocompatible polymers. Extrusion-based direct-write (EDW) 3D printing enables printing and customization of low-modulus materials, ranging from cell-free printing to cell-laden bioinks that closely resemble natural tissue. While EDW holds promise, the requirement for soft materials with excellent printability and shape fidelity postprinting remains unmet. The development of new synthetic materials for 3D printing applications has been relatively slow, and only a small polymer library is available for tissue engineering applications. Furthermore, most of these polymers require high temperature (FDM) or additives and solvents (DLP/SLA) to enable printability. In this study, we present low-modulus 3D printable polyester inks that enable low-temperature printing without the need for solvents or additives. To maintain shape fidelity, we incorporate physical and chemical cross-linkers. These 3D printable polyester inks contain pendant amide groups as the physical cross-linker and coumarin pendant groups as the photochemical cross-linker. Molecular dynamics simulations further confirm the presence of physical interactions between different pendants, including hydrogen bonding and hydrophobic interactions. The combination of the two types of cross-linkers enhances the zero-shear viscosity and hence provides good printability and shape fidelity.

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“…Medical devices in direct contact with blood and IV fluids have the potential to introduce chemicals that may prove toxic, and manufacturers must document contaminants introduced by their devices to ensure patient safety. 4 Recently, aluminum block-based fluid warmers were found to leach high levels of aluminum into the infusate, leading to the recall of several devices. 5 For example, the disposable cartridge for the enFlow™ IV/blood warmer (Vyaire Medical, Mettawa, IL, USA) was voluntarily withdrawn and replaced with a similar cartridge that included a thin coating of parylene over the aluminum heating blocks.…”

Section: Introductionmentioning

confidence: 99%

Levels of leachable elements from long-term use of enFlow fluid warmer

et al. 2022

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Objective: In the delivery of intravenous fluids, in-line warming devices frequently transfer heat using a metal heating plate, which if uncoated can risk elution. This bench study examined extractable elements detected following long-term use of the parylene-coated enFlow® Disposable IV/Blood Warmer. Methods: We tested 16 clinically relevant challenge fluids typical of the surgical setting, including commercially available single donor blood and blood products as well as intravenous saline and electrolyte solutions. After 72 h of warming at 40°C (104°F) via the enFlow, analytical chemistry identified and quantified the most clinically significant extractable elements (arsenic, barium, cadmium, copper, and lead) to estimate chemical exposure. We also measured the extracted concentrations of these five elements following simulated use of the device with three solutions (Sterofundin ISO, Plasma-Lyte 148, and whole blood) that were pumped through the warmed device at two different flow rates (0.2 and 5.5 mL min−1). Results: Across all scenarios of acute and long-term exposures for different populations, the enFlow demonstrated low toxicological risks as measured by the calculation of tolerable exposure for extracted arsenic, barium, cadmium, copper, and lead. Conclusion: The results suggest biological safety for the use of parylene-coated enFlow with a variety of intravenous solutions and in different therapeutic scenarios.

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Toxicity of Common Extractables and Leachables of Medical Devices

Cited by 4 publications

References 40 publications

Research progress of implantation materials and its biological evaluation

Research progress of implantation materials and its biological evaluation

Synergistic Effect of Physical and Chemical Cross-Linkers Enhances Shape Fidelity and Mechanical Properties of 3D Printable Low-Modulus Polyesters

Levels of leachable elements from long-term use of enFlow fluid warmer

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