What Plastics are Used in Medical Devices?

Class 1 Medical Devices

Medical plastic products have become more advanced as the global market for high-quality medical devices continues to expand. Such devices have become a necessary and vital component in the modern healthcare system. Medical plastic products are available in a wide assortment of devices. From test equipment like vials and beakers to surgical instruments, catheters, and implants, plastics are used more and more for their high performance, lightweight, and lower costs.

Creating Safe and Effective Medical Devices

Diverse medical applications, product durability, and biocompatibility are all important factors that original equipment manufacturers (OEMs) of medical plastic products must consider to meet market demands. Just as important, medical grade plastic materials must meet regulatory requirements throughout the globe. To ensure that the plastic material is safe and effective for medical products, polymers for medical devices are generally made of thermoplastic materials.

  • Thermoplastic is a type of synthetic polymer. All plastics are made from specific types of synthetic polymers, and the terms ‘polymer’ and ‘plastic’ are generally used synonymously. That said, thermoplastics are distinguished from other synthetic polymers because they can be reheated and remolded time and again without irreversible degradation. The changes are physical, not chemical, which means thermoplastics can be reused and recycled. When heated, thermoplastics liquefy, and the material becomes easily moldable, then solidifies into a durable finished product when cooled. This makes thermoplastics ideal for custom plastic injection molding and injection blow molding services.
  • The choice of thermoplastic materials must be of medical grade polymers. The properties of medical grade plastics or polymers share common characteristics, meaning they must be manufactured under a physician’s license to pass verification and validation requirements of the regulatory agencies. For specific applications regarding patient safety, they must offer biocompatibility. Further, the finished product must be temperature, impact, and corrosion resistance to withstand the high wear and repeated sterilization cycles medical plastic products are subject to. Common thermoplastic materials used in the manufacturing of medical plastic products include polycarbonate, polypropylene, polyethylene or the formulation of custom polymers to meet specific medical device applications.
  • Polycarbonates are used in a variety of materials, but are most well-known for their impact resistance properties and withstanding high-temperature ranges. Applications for polycarbonate polymers include plastic lenses in eyewear, automotive components, protective gear, and medical devices. Because polycarbonates have good heat resistant properties, they are very pliable and can be formed at room temperature without cracking or breaking. Such properties make polycarbonate very useful in prototyping applications, such as with medical devices.
  • Polypropylene is a cost-effective medical grade plastic material and is used where steam-sterilized medical devices are necessary. In addition to resistance to steam sterilization, mechanical performance properties of polypropylene include durability for the number of cycles it can be reused. Its recyclability also makes it an attractive medical grade plastic.
  • Polyethylene is a versatile, durable thermoplastic with a wide range of applications. Its high impact resistance and resistance to chemicals, along with low moisture absorption make it a choice medical grade plastic. It doesn’t fade nor retain dangerous bacteria and can withstand harsh cleaning agents. It is often one of the materials used in medical implants because it is a porous synthetic polymer that is biologically inert and does not degrade in the body.

Medical Plastic Products That Meet Market Demands

Medical plastic products are revolutionizing the healthcare industry. The growth of polymers in medical devices has transformed the marketplace, with plastic medical devices steadily replacing other material such as glass, ceramics, and metals, wherever applicable. Medical grade polymers can vary, but have certain characteristics and properties in common, along with meeting regulatory standards and requirements.