Although recently gaining a spot in the limelight by playing a key role throughout the pandemic, plastics have always been a vital part of the medical device industry. Medical devices such as single-use syringes, catheters, and ventilators comprised of mostly plastic saw a rise in demand. Plastics have many attributes that make them ideal for applications in the healthcare market:
- Temperature resistance
- Chemical and corrosion resistance
- Biocompatibility
- Hemocompatibility
- Ability to be sterilized via multiple different methods
- Gamma & E-beam radiation
- Ethylene oxide (EtO)
- Autoclave/steam sterilization
Plastics for the healthcare market, depending on the device being made, will have to meet specific criteria for use. The most critical criterion for plastics is biocompatibility. Biocompatibility means having properties that make a material or a device compatible with the human body. Some examples of biocompatibility:
- A catheter that does not trigger blood clot formation or trigger other reactions as a result of its contact with the bloodstream
- Suture materials that support tissue healing without triggering an inflammatory response and are constructed in a way that does not interfere with the body’s normal function
- Polymers suited for effective storage of blood cells since the blood will be re-introduced into a patient and the blood cannot be adversely affected by the storage container materials
Medical device manufacturers are responsible for providing test data to the Food and Drug Administration (FDA) that proves their device is biocompatible in its final form to gain approval to market and sell their devices within the United States. Plastic manufacturers can support that by giving confidence that the plastic used in the final medical device assembly is biocompatible by itself. Plastic materials for medical use are typically subjected to United States Pharmacopeia (USP) testing. USP VI (class 6) is regarded as a minimum requirement for plastics being used in medical devices. USP classes I-V (1-5) also exist but are not as stringent as class VI (6).
- USP VI testing includes systemic injection, intracutaneous, and implantation testing of the plastic prepared in extracts with saline, alcohol saline, polyethylene glycol (PEG), and vegetable oil in mice and rabbits along with blanks to gauge reaction to the extracts
- USP VI cannot be used in place of providing overall medical device testing per ISO 10993 standards, but it does provide a level of confidence and is seen as a minimum requirement for plastic to be used in a healthcare application
ISO 10993 standard for biological evaluation provides testing framework for medical devices. However, some plastic manufacturers will also subject their materials to some of the tests within ISO 10993 to again show a level of confidence to the device manufacturers that their materials will be well-suited for use in the medical device. Some of the common ISO 10993 section tests that might be available for plastic materials:
- ISO 10993-3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity
- ISO 10993-4: Selection of Tests for Interactions with Blood
- ISO 10993-5: Tests for Cytotoxicity—In Vitro Methods
- ISO 10993-10: Tests for Irritation and Sensitization
- ISO 10993-11: Tests for Systemic Toxicity
The healthcare market for medical devices is complex, and much testing and data are required to get a device approved for production and sale within the United States. The Engineering Team here at Chase Plastics are technically equipped to walk you through any analysis needed to offer healthcare application material recommendations. Give us a call at 844-411-2427 or send an email to engineering@chaseplastics.com to get support on any of your technical questions today!
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