Table of Contents

What Are Medical-Grade Plastics?

medical plastics

Description

Medical grade plastics refer to materials designed and intended for making medical products. Manufacturers use it for in vitro diagnostics, primary packaging for pharmaceuticals, and medical devices. Among other things, these plastic materials preserve and contain medicines, avoiding possible contaminations. Our IV sets are made of plastics such as medical PVC, PE, PP, ABS, etc which are some of the most important factors that influence the IV set price.

Most common medical grade plastics

Name of Medical PlasticsOutstanding PropertiesApplications and Uses
Polyvinyl chloride (PVC)Flexible and with reliable strength and durability, chemical resistance and stabilityBlood and dialysis bags, IV bags and IV tubing, blood transfusion set, blister packaging, oxygen masks, oxygen tubing, surgical gloves and gowns, and catheters
Polyethylene (PE)Resists impacts and corrosion and retains structural integrity even with repeated sterilizations.Implants, PPE equipment, catheters 
Polypropylene (PP)High chemical resistance, resists stress, cracking, impact, fatigueDisposable syringes, membranes for membrane oxygenators, connectors, non-absorbable sutures, finger-joint prostheses, reusable plastic containers, prescription bottles, surgical trays, implant caddies 
Polystyrene (PS)It does not conduct electricity, is tasteless and odorless, excellent gamma radiation resistance, excellent insulating propertiesCulture trays, test tubes, Petri dishes, diagnostic components, housings for test kits and devices, implants
Polyethylene terephthalate (PE)Resists attack by micro-organisms, high uniformity, resistance to chemicals and abrasion, good mechanical strength, and biostabilityExtrusion of sutures, implantable textiles, and tubing for angioplasty balloons, sewing cuff of heart valves, vascular prostheses
Acrylonitrile butadiene styrene (ABS)Rigid and rigidity, durable, resists chemicals and impacts, good dimensional stability, and insulating properties.Medical masks, valves for ventilators, non-absorbable sutures, tendon prostheses, drug-delivery systems, and, some parts of IV set (Luer lock connector of IV set, flow regulator), tracheal tubes. 
Polycarbonate (PC)Lightweight for easy handling, solid and tough to prevent breakage, transparent, resistant to sterilizationsHemodialyzers, infusion systems, anesthesia containers, blood oxygenators, blood reservoirs, arterial filters, intravenous connectors, surgical instruments, and endoscopic appliances
AcetalExcellent creep resistance, low water absorption, high wear characteristics, good electrical properties, resistance to hydrocarbons, chemicals, and solventsHandheld diagnostic wands, sterilization trays, dental instruments, imaging equipment 
Polysulfone (PSU)Withstands repeated sterilizations, high-impact strength, good mechanical strength, chemical resistance.The transparent portion of anesthesia masks, heart valve sizers, dialysis filtration cartridges, the outer shell of implantable catheter ports, surgical instrument cases and trays, dental instruments
Polyurethane (PUR)Flexible, strong, durable, resistant to abrasions and chemicals, not absorbed by the body, non-allergenicImplant devices, feeding tubes, dialysis devices, intra-aortic balloon pumps, surgical drains, pacemakers, artificial hearts, hospital beds, surgical tables

Standardization and regulation

Production of medical grade plastics needs to pass the requirements of the following medical certifications:

  • ISO 10993
  • ISO 13485:2016
  • FDA registration

Testing protocols

Approving plastic for medical use requires that it hurdles some biocompatibility tests. The required tests vary from one product to another. In our company, the products undergo the following tests: hemolysis test, in-vitro cytotoxicity test, acute systemic toxicity test, irritation test, pyrogenicity test, and intradermal reaction test. A discussion of these biocompatibility tests follows hereunder.  

Hemolysis test

The test involves the exposure of the test material or material extract to a blood cell suspension. After the exposure for some time, medical examiners determine the amount of hemoglobin released. The test uses citrated human blood.

Pyrogenicity test

The test involves the measurement of the rise in temperature of the experimental animal after intravenous administration of test article extract.  

In-vitro cytotoxicity testing 

Cytotoxicity testing determines if the material under examination can potentially damage the cell. The test involves exposing a cell culture to a sample of the material in question, followed by incubating both. After some specified time, medical examiners look at the cells and determine if lysis or malformations have occurred. The presence of changes in the cell structures means a cytotoxic effect.

Sensitization testing (intradermal reaction test)

Sensitization testing determines if the medical grade plastics provoke an immunological or allergic reaction from the subject. This test applies extracts from the material under investigation to the test recipient. Then possible responses and reactions will be monitored and followed up. Responses, such as the formation of rashes and itchiness, may indicate sensitization to the material under examination.

Irritation testing

Irritation testing finds out the irritant potential of the material under examination. Medical examiners look at the reactions from the skin or the mucosal membranes of the subject. To test the effect of implantable materials, investigators deposit material extracts in the subject’s skin (intracutaneous injection) and look for possible reactions, such as redness or swelling in the skin. The presence of positive reactions indicates that the material could irritate the subject. 

Acute systemic toxicity testing

Acute systemic toxicity testing determines the effects of the material extracts on the systems of the subject—immediately and after extended exposure. In the previous tests, investigators apply the material extracts locally. In this test, the medical examiners inject the material extracts into the subject. Immediately, they look for some adverse reactions. They repeat checking possible responses several times before the test concludes. Vital signs of the test recipients, such as the blood pressure and respiratory rates, will be monitored to ensure the presence or absence of reactions.

Genotoxicity testing 

Genotoxicity testing finds out the damaging effect of the material extracts on the genes. It determines if the material incurs permanent genetic damage to the subject. In this test, medical investigators use salmonella bacteria because they are sensitive to mutagens. After exposure to the materials, only the mutated salmonella will survive. Researchers could determine the prevalence of mutations among the bacteria based on this.

Implantation testing 

Implantation testing determines the reactions of the tissue to the implantable device or material. Hence, investigators implant the material or part of it into a particular tissue of an animal subject. After some time, the medical examiners remove some tissue samples around the implant and examine them microscopically for signs of disease.

Advantages of using medical grade plastics

Medical devices have medical plastic components for the following reasons:        

One-time use stops the spread of possible infections

Suppose a medical device has plastic components, such as IV tubing which is composed of a drip chamber, roller clamp, injection port, PVC tubing, and hypodermic needle. Medical practitioners can throw them away after one use. This action prevents the spread of possible infections. Check how we produce an IV tubing

A practical choice for manufacturing

The flexibility of plastics provides medical device manufacturers with an excellent alternative to metals. Plastics can very well offer metal-like robustness and strength and yet flexibility.

Lightweight hand ergonomics

Medical surgeons experience hand fatigue when performing long surgery. Hence, they prefer surgical tools with plastic components. The use of plastics in surgical tools lightens the weight of the medical device. Reducing the weight of hand-held medical devices increases mobility in using the instrument.

Economical

Manufacturing with plastic resins entails lesser costs compared to using metals. This consequence holds at high or low volume production. Using plastics also entails cheaper storage and shipping fees because of their lightweight. With lesser production costs, manufacturers can cite affordability as one of the benefits of using their product.

Compatibility

Medical grade plastics offer superior compatibility with imaging and X-ray machines compared to metals. Metals prevent the normal functioning of the MRI’s magnetism and create interference with equipment featuring WiFi and Bluetooth. Medical devices using plastic materials produce more accurate images.

Recyclability

Some plastic medical applications allow recyclabilities, such as polypropylene sterilization wraps, irrigation bottles, basins, pitchers, and trays. Recycling lowers production expenditures and carbon footprints.

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