One of the important materials used in manufacturing medical components are medical-grade plastics. These plastics offer varying and amazing features and benefits that make them useful in the medical industry.
This guide explains all you need to know about medical grade plastics, including the types and uses, properties, and regulatory requirements, and lots more.
What are Medical Grade Plastics?
Medical-grade plastics are plastic materials used in the manufacturing of several medical components or devices.
These plastics offer unique features like resistance to heat, chemicals, and corrosion, machinability, etc, which makes them suitable for use in the medical industry.
From surgical tools to implants and prosthetics, medical-grade plastics are highly biocompatible and, as such, don’t have any adverse effect when used on patients.
They are also capable of withstanding sterilisation procedures without deforming or losing their functionality. Due to these properties and more, medical-grade plastics are used in medical device production to ensure regulatory standards are met.
Essential Properties of Medical Plastic Polymers
Medical plastics possess some important properties that make them valuable in the health care industry. Here are some of them
Biocompatibility
Biocompatibility explains the ability of the medical plastics to come in contact with the body system without causing any risk or danger to the body.
As such, the plastic material must not release toxic materials, cause injury or allergy, or have any adverse effect on the immune system.
Medical grade plastics are therefore able to maintain these properties due to their chemical and biological inertness, which makes them unreactive when used in the body.
Sterilization Resistance
Medical-grade components are consistently sterilised when used in a medical setting to prevent the spread of disease and infection.
As such, these plastic parts must be able to withstand sterilisation processes done with steam, heat, chemicals, etc, over time. They must not lose their physical appearance and functionality even after undergoing several sterilisations.
Non-Permeability
Medical grade plastics must also not be permeable, meaning they must not allow the free flow or diffusion of substances through them.
These substances can be liquid, gaseous, or chemical materials. This is to keep the functionality and properties of the medical component intact.
Light Weightness
Medical plastic polymers must also be lightweight to allow for easy handling and carriage. This is particularly important to medical professionals as it decreases fatigue and enhances ergonomics.
For the patient, it helps eliminate the burden of using heavyweight medical aids. For example, plastic-made braces and prosthetics.
Durability
Durability is another essential property of medical-grade plastic polymers. These materials must be durable enough to withstand consistent use.
They must therefore not damage or underperform even when being used, cleaned, and sterilised for an expected period of time.
Common Types of Medical Grade Plastics
Here are some medical-grade plastics you should know:
Polycarbonate (PC)
PC is widely known for its impact and heat resistance. It also offers great features like high durability, toughness, and dimensional stability. It can be easily worked on to form several shapes without deforming.
Because of its intense temperature resistance, it doesn’t crack or damage when exposed to high heat. Due to these essential features, it is used in manufacturing medical panels, surgical tools, dialysers, etc.
Polypropylene (PP)
PP is mostly used when high temperature resistance is required. The material can undergo intense heat sterilisation while also maintaining its durability feature.
It is recyclable, economical, and has a low density. Beyond that, it offers high tensile strength, chemical resistance, and the ability to be molded into shapes.
PP is a popular plastic and is used in producing connectors, clear bags, test tubes, syringes, etc.
Polyethylene (PE)
PE offers great features like impact and chemical resistance. It is durable and tough, and can be easily processed.
This plastic has low moisture absorption ability. It is biologically and chemically inert and doesn’t retain hazardous substances, making it suitable for medical use.
PE can go through several sterilization processes without losing its functionality. It is essential in making catheters, syringes, surgical trays, etc.
Polyvinylchloride (PVC)
PVC exists in several forms, but the widely used one in medicine is thermoplastic. This offers resistance to heat and corrosion and durability.
It is mostly used in manufacturing feeding tubes, dialysis equipment, oxygen masks, etc.
Acrylonitrile Butadiene Styrene (ABS)
ABS is usually used as a metal alternative due to its features. It’s durable, rigid, dimensionally stable, chemically resistant, and can be easily worked on to form many medical parts.
It is aesthetically appealing and can undergo many sterilization processes without damage. ABS is used in manufacturing tracheal tubes, medical housing, non-absorbable sutures, etc.
Polystyrene (PS)
PS offers good optical clarity, resistance to chemicals, and the ability to withstand sterilization. It is used in manufacturing petri dishes, test tubes, diagnostic equipment, tissue culture trays, vials, etc.
High-impact PS offers intense durability and toughness, and therefore is used for making emesis basins, surgical equipment trays, and so on.
Polyethylene Terephthalate Glycol (PETG)
TPETG offers features like durability, transparency, ability to be easily processed, and so on.
It can withstand sterilization procedures without losing its physical properties. It is used in making food containers for hospitals, sterilization trays, etc.
Polymethyl Methacrylate (PMMA)
This is also known as acrylic and it possesses some qualities similar to glass. It offers features like UV resistance, transparency, and the ability to transmit a beam of light.
It is therefore applicable for making orthopaedic implants, transparent lenses, incubators, dentures, etc.
Polymethylpentene (PMP)
This is one plastic that offers extreme sterilization resistance. It is transparent and has high tensile strength. It is used in producing autoclavable medical trays, orthopaedic implants, etc.
Polyetheretherketone (PEEK)
PEEK is a lightweight and durable plastic material. It offers features like dimensional stability, chemical and temperature resistance.
This material is highly biocompatible and can withstand the sterilization process. It is vital in manufacturing catheter bushings, spinal fusion cages, etc.
Benefits of Medical Plastic Parts in Healthcare
Here are some vital benefits of medical plastic components you should know:
Easier Sterilization
Many plastic-made medical components can easily be disposed of after being used once. This eliminates the spread of disease and infection.
For medical plastic components that can be used repeatedly, they are usually designed to withstand heat and other sterilization processes, and this can be done consistently without damaging the device.
Versatility
Plastic materials are now widely used in the medical industry. Earlier on, they were used in producing disposable medical components.
However, they are now being used to manufacture other important devices like implants, catheters, prosthetics, and lots more.
Increased Safety Features
The non-permeability feature of medical plastics allows for easy, safe transfer of medical waste without infecting the environment with harmful microorganisms.
This way, they prevent the passage or movement of these hazardous organisms through them.
Improved Quality of Life
Medical plastic devices make life much easier for many patients. Since these materials offer lightweight and durability, they are mostly used in manufacturing prosthetics.
This, in turn, eliminates the heavy weight burden on patients while allowing for easy movement and independence.
Environmental Friendliness
Medical grade plastic also offers environmental friendliness since it can easily be disposed of, reprocessed, and recycled. This makes them essentially useful in medical settings.
Different Applications of Plastic in Medical Products
Medical plastics go through the necessary scrutiny and regulatory procedure to ensure they are safe to use in manufacturing medical parts. Here are some medical devices and tools made with medical-grade plastics.
- Dental instruments like dam clamps, suction tips
- Surgical instruments, catheters, and gauges
- Implants and prosthetics
- Syringes
- IV bags
- Packaging instruments
- Bandages
- Sterilization trays
- Orthodontics
- Tubings and Connectors
- Imaging equipment
Regulatory Standards Imposed on Medical-Grade Plastics
Certain regulatory compliance requirements must be followed while producing and using medical-grade plastic. These standards and laws are there to ensure the safety of medical plastics professionals and patients, and also ensure the effectiveness of the device. Below are some standards.
FDA Device Classifications
The FDA classifies medical devices into three groups based on the chance and level of risk associated with using them.
For example, class I devices are identified as low risk and, as such, require minimal regulatory control. Devices here are bandages, dental floss, etc.
Class II devices are identified as moderate risk devices and, therefore, need more compliance standards to ensure patient safety and device effectiveness. Examples are diagnostic tools, infusion pumps, etc.
Class III devices pose a high risk and therefore go through intense scrutiny and compliance. Examples are defibrillators, breast implants, etc
ISO Standards
The International Organisation for Standardization provides guidelines to ensure that medical plastics are biocompatible. They also provide measures to ascertain that medical devices are safe and effective for use.
USP Class VI Passing
This regulatory standard is also imposed to ensure that medical devices are biocompatible. This is specifically required for medical devices that need to remain in contact with the human body for more than 24 hours.
Examples of this device include implants, and as such, the plastic used in manufacturing this device must go through extensive USP Class VI testing.
Get Medical Grade Plastic Parts at DEK
DEK specialises in manufacturing medical-grade plastic components using plastic materials that are biocompatible, durable, sterilization-resistant, and so on. With our many years of experience, skilled professionals, and advanced technological machines and tools, we manufacture several medical parts based on the client’s needs.
Our manufacturing processes follow FDA and ISO standards, so you can be sure your medical device is regulatory compliant. Send us a message now to get started.
Conclusion
The importance of medical-grade plastics in today’s healthcare system cannot be overemphasized. From PC, PP, PE, to PVC and ABS, there are a lot of plastic materials to choose from in your production process.
However, following the necessary regulatory standards and using a reputable medical parts manufacturing company is important to getting the best results.
