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Ever wondered how the right plastic is chosen for medical devices? Today, let's explore the medical-grade plastics in healthcare.
Different plastics play important roles, from PVC in catheters to PET for stress resistance. Polypropylene excels in steam sterilization, and PETg, PMMA, and ABS offer durability.
The best part? They're safe. Medical-grade plastics meet top standards, ensuring they're top-notch for biomedical use.
Read on to learn more about plastic for medical device!
How Does Plastic Work in Medical Devices?
Plastic is a key material in modern medical device production, as its durability, cost-effectiveness, and versatility make it an ideal choice.
Its strong barrier properties protect the patient from infection or exposure to hazardous materials during treatment.
With the knowledge of biocompatibility standards and careful selection of plastic types being used in manufacturing processes, medical-grade plastics are safe for use in many different applications.
Types of Plastics Used for Medical Devices
From thermoplastics to polypropylene, a wide range of materials can be used for medical applications. Each has benefits and qualities that make it suitable for medical devices and instruments.
Let's explore some of the most popular plastic types in today’s healthcare industry.
Thermoplastic
Thermoplastic polymers are ideally suited for medical device injection molding, with polyethylene being a common choice.
These thermoplastics are polymers that can be repeatedly melted, shaped, formed, and then cooled back into solids. This property makes them particularly suitable for designing and manufacturing medical devices.
One example is PVC, which has exceptional thermal stability and corrosion resistance features that make it great for medical applications such as communications cables and catheters.
For those applications requiring radiation-resistant materials, ABS plastics, PARA plastic resins, PEEKs (polyetheretherketone), PEIs (Polyetherimide), PESs (polyether sulfones), PSUs (polyphenylene sulfides)and PPSUs( Polyphenylene Sulphone) have all been developed to provide reliable performance in these settings.
The types of thermoplastics used in the development of medical apparatus include polyethylene terephthalate glycols (PETg), hi-impact polystyrenes (HIPS), acrylonitrile butadiene styrenes (ABS's), vinyl chlorides(PVCs), polymethyl methacrylates(PMMA's) and many others.
Polypropylene (PP)
Polypropylene, a thermoplastic material, is one of the most widely used plastics in medical devices today.
It provides cost-effective properties, high strength and stiffness, excellent chemical resistance, and superior delamination resistance.
Its durability makes it ideal for steam sterilization of medical equipment at a relatively low cost while preserving its aesthetic finish and mechanical properties over time.
It can be used to make various types of rigid plastic components - from catheter housings to syringe barrels - all with excellent barrier protection against microbiological particles or other contaminants.
Polypropylene's versatility also allows for food-safe applications when FDA-approved for human contact, as well as weight-bearing prosthetic materials that are resistant to fatigue.
This plastic option has been proven reliable in medical device manufacturing due to its safety assurance and lightweight compared to other synthetic products such as acrylics.
Polyethylene terephthalate (PET)
PET is a thermoplastic polymer resin commonly used in the healthcare sector for medical device applications due to its durability, cost-effectiveness, versatility, and barrier properties.
It has high mechanical properties, which makes it suitable for containers for liquids and fibers for clothing.
PET bottles and containers have better stress-cracking resistance than other plastics. This makes them highly withstanding when put under pressure or experiencing sudden impacts that would cause the breaking or shattering of most plastic materials.
The material also offers excellent aesthetic finishes compared to standard options like PVC (polyvinyl chloride), often leaving an unattractive impression on clients and patients using the device.
Hi-Impact Polystyrene (HIPS)
HIPS is a cost-effective and versatile thermoplastic polystyrene polymer. With its high tensile strength, excellent chemical resistance properties, and increased durability, it has been adopted in various medical device applications.
As an example of its usage, HIPS are often used for pharmaceutical packaging when the ultimate protection against temperature changes needs to be achieved.
Additionally, HIPS material can also be found in disposable syringe bodies that must remain stable enough to withstand multiple injections over sustained periods without losing functionality or breaking apart while being handled.
HIPS, being hydrophobic, offers more than cost savings in the medical field. Its nature creates a barrier between moisture and delicate drug compounds (like those in IV therapy or MRI contrasts), enhancing patient safety.
Moreover, it meets FDA standards for sterilization, like gamma radiation, reducing cross-contamination risks among equipment components.
Poly Vinyl Chloride (PVC)
PVC is a popular type of plastic that is widely used in the medical device industry.
It has been around for over 70 years and remains one of the most versatile plastics, offering high mechanical properties, barrier properties, and aesthetic finishes.
PVC offers excellent durability and can remain intact even when under higher stress levels, making it ideal for use in disposable medical products.
Additionally, due to its low cost relative to other materials, such as metal-based components, PVC is often chosen first by manufacturers looking at affordability options while retaining performance needs.
Finally, many manufacturers appreciate PVC's biocompatibility, which makes it suitable for contact with human tissue without fear of adverse effects or irritation.
Polyethylene terephthalate glycol (PETg)
PETg is a widely used plastic for medical device packaging. It is an amorphous thermoplastic with strong tensile properties and high ductility, making it suitable for applications where flexibility or impact resistance is required.
The material has excellent resistance to moisture and solvents like alcohols—making it very useful in the healthcare sector—and its thermal stability allows it to maintain structural integrity during sterilization.
The combination of features that PETg offers makes it particularly suitable for use in medical devices and equipment; this includes trays made from material that can be sterilized multiple times since they retain their shape and strength when heated or cooled.
Additionally, due to its low permeability, the film formed by PETg minimizes leachables in pharmaceutical components such as drug vials while being safe enough to store food products in medical settings because it complies with US Food & Drug Administration regulations.
Polymethyl methacrylate (PMMA)
PMMA is an ideal material for medical device applications. It is highly biocompatible and 100% recyclable, making it suitable for long-term medical implants and devices.
PMMA also offers several advantages over other materials because of its lightweight characteristics, shatter resistance, excellent casting properties, and various mechanical properties such as rigidity, toughness, and durability against UV light.
PMMA is most commonly used in ocular implants to improve vision fields in cataract surgery procedures due to its optical clarity.
Other medical devices manufactured from this material include intra-corneal ring segments and capsular tension rings for cataract surgeries that help provide increased stability to the eye lens after implantation.
The ability of PMMA to form tight-fitting components with varying degrees of strength makes it well-suited for these intricate designs, which require demanding performance criteria when implanted within the human body.
Acrylonitrile butadiene styrene (ABS)
ABS is an impact-resistant engineering thermoplastic comprising three monomers – acrylonitrile, butadiene, and styrene.
The acrylonitrile present in ABS provides chemical and thermal stability, while the butadiene adds strength and toughness to the plastic.
This makes ABS highly sought-after for lightweight yet rigid products such as pipes, automotive body parts, wheel covers, and more.
Moreover, its utilization is not restricted only to manufactured goods; through 3D printing prototype development as well as injection molded part production processes using ABS, it can quickly produce complex pieces at low cost.
Primary Benefits of Using Plastic for Medical Devices
Utilizing polymeric materials for medical device applications can present a range of advantages over alternative options.
This section highlights some of plastic's key benefits for medical devices.
Durability
Plastics endure sterilization processes without losing strength, making them ideal for repeated use in short and long-term medical devices, ensuring patient safety and reliability.
Catheters made with hard plastic shells protect against cross-contamination between patients, while internal seals provide tight compartments that remain germ-free until it's broken upon insertion into the patient’s body cavity.
Cost-effective
Lower production costs than alternatives make plastics an efficient choice for creating safe medical products, including implants and disposable items, contributing to faster delivery and economic efficiency.
Polypropylene (PP), polyethylene terephthalate (PET), and hi-impact polystyrene (HIPS) are all reliable and affordable plastics used to manufacture implants like stents, pacemakers, prosthetics, or other surgical instruments.
These options also offer lighter weights compared with more expensive metals, which can contribute to quicker transportation times, resulting in faster delivery of these products around the world.
All factors are given consideration when assessing economic efficiency from a medical device manufacturer's perspective.
Versatility
Plastic's adaptable, lightweight nature suits various medical device needs, from disposables to implants, providing sterile and energy-efficient solutions, especially for sensitive areas or systems in the body.
Another advantage this type of material offers is its energy efficiency; without needing additional steps like baking or drying processes, production can occur at temperatures much lower than other competing materials – reducing not only time but harmful emissions, too.
Barrier properties
Plastics used in medical packaging offer exceptional sealing and protection against external factors like air, humidity, and chemicals, with certain types providing superior barriers such as moisture and oxygen resistance.
Different types of plastics offer varying levels of barrier protection; however, polypropylene (PP) and Polyethylene terephthalate (PET) are widely used because they deliver superior moisture, oxygen, and aroma barriers with several secondary characteristics, such as transparency.
Aesthetic finishes
Medical grade plastics offer attractive appearances, easy cleanliness, and durability, meeting demand for visually appealing and hygienic medical products, including devices like blood analysis machines and prostheses.
Highly polished surfaces come with an enhanced look and feel, making these interfaces easier and more comfortable to use over time.
Another area where plastic can provide aesthetic advantages is when printing decorative text or symbols onto the surface, allowing logos’ color coding to be easily distinguishable.
High mechanical property
These plastics boast high impact resistance, stability, and performance, making them durable and suitable for various medical components, ensuring longevity and safety in harsh environments.
Polycarbonates have a unique combination of physical attributes, including high impact resistance, superior clarity, and raised temperature thresholds.
These make them suitable choices in many medical devices such as stethoscope housings, infusion pumps, and MRI machine parts where safety is paramount.
Is Medical Grade Plastic Safe?
Medical-grade plastics are designed to meet manufacturing quality standards for producing medical equipment.
They have passed strength, durability, and biocompatibility tests that guarantee their compatibility in healthcare settings without causing any injury or harm to patients.
Furthermore, these plastics must adhere to sterilization protocols such as autoclaving and ethylene oxide treatment — which involve high temperatures and toxic gases –to ensure fatal pathogens like HIV, hepatitis B, etc., are eliminated from the plastic material before use.
In addition to this, regulatory organizations also test medical-grade plastic materials regularly against strict legislation standards developed by bodies like the United States Pharmacopeia (USP) or the Food & Drug Administration(FDA).
These regulations set limits for substances deemed potentially hazardous when used in biomedical applications, including heavy metals, migratable compounds, and residual monomers, which may all be present in various types of plastic materials depending on their composition.
The safety certification process allows for the ready classification of different plastics according to their suitability within a range of health settings – allowing engineers involved with developing medical devices to make informed decisions about the most suitable materials for certain applications.
Conclusion
Medical-grade plastics are an essential part of the modern healthcare industry. They offer a variety of benefits for use in medical devices, such as durability, low cost, and versatility.
By utilizing advanced polymer materials with biocompatibility and sterile packaging, these plastic components can create safer environments for patients while often providing superior performance compared to non-plastic alternatives.
When selecting materials for medical device applications, it is important to consider factors such as safety, effectiveness, and compatibility between the material and application method.
Through careful research and experience, manufacturers can ensure that their selection meets the requirements to execute their desired product design successfully.
If you are looking for a manufacturer of plastic medical parts, DEK has a wealth of machining experience and would be the ideal partner for you, contact us now to start our journey together!