Chloe Zhang
Sterilization of medical equipment is crucial to ensuring the health and safety of patients, especially during the COVID-19 pandemic, as the virus can survive on plastic surfaces for up to five days. While there are various sterilization methods available, such as dry heat and steam sterilization, these techniques require high temperatures that can damage plastic equipment. Alternative methods, such as ethylene oxide sterilization and radiation sterilization, are more suitable for plastic medical devices. Ethylene oxide gas is effective in killing microorganisms but must be handled with caution due to its toxicity and flammability. Radiation sterilization, on the other hand, utilizes gamma or beta rays to induce DNA chain breakage in microorganisms, rendering them incapable of multiplying. These sterilization techniques play a vital role in maintaining the safety of plastic medical equipment and protecting patient health.
| Characteristics | Values |
|---|---|
| Sterilization Techniques | Radiation, Ethylene Oxide, Moist/Dry Heat, Steam Sterilization |
| Radiation Types | Gamma Rays, Beta Rays (E-Beam), High-Energy Electrons |
| Ethylene Oxide | Toxic, Flammable, Explosive |
| Steam Sterilization Temperature | 120 °C - 130 °C for 20 minutes |
| Dry Heat Sterilization Temperature | 160 °C for 2 hours |
| Plastic Types | Acrylic, Polycarbonate, PETG, KYDEX® Thermoplastics |
| Plastic Considerations | Melting, Degradation, Bioburden, Mechanical Properties |
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What You'll Learn
Ethylene oxide sterilization
Ethylene oxide, a colorless gas, has strong antimicrobial properties and can eliminate bacteria, viruses, fungi, and spores. It is capable of penetrating deeply into hard-to-reach areas, ensuring a high level of sterility and minimal risk of contamination. This is especially important for medical devices with multiple layers of packaging or intricate geometries, such as catheters and diagnostic tools.
The sterilization process involves exposing the medical equipment to ethylene oxide gas. This gas is toxic to humans and must be handled with caution. Federal regulations and international guidelines ensure the safe and responsible use of ethylene oxide, with device manufacturers and sterilizers employing the best available technologies to capture, remove, and destroy it. The EPA, OSHA, and other government agencies have established rigorous controls to protect patients, workers, and the environment during the sterilization process.
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Radiation sterilization
Gamma rays are the most popular form of radiation sterilization and are used when materials are sensitive to the high temperatures of autoclaving but compatible with ionizing radiation. Cobalt-60 is commonly used as a source of gamma rays. The packages are transported around an exposed cobalt-60 source for a defined period, with the most commonly validated dose being 25 kGy.
Beta rays, or E-beam, consist of highly accelerated electrons. This method has a high radiation dose and low penetration.
The use of radiation sterilization has grown in recent decades due to the development of radiation-resistant materials, the construction of more radiation facilities, and the improved definition of dosage levels. It is a common method for sterilizing disposable products in an industrial environment.
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Steam sterilization
The steam sterilization process involves using steam heated to 121–134 °C (250–273 °F) with a holding time of at least 15 minutes at 121 °C or 3 minutes at 134 °C. Liquids and surgical instruments packed in layers of cloth require longer holding times. The two basic types of steam sterilizers (autoclaves) are gravity displacement autoclaves and high-speed prevacuum sterilizers. Gravity displacement autoclaves are primarily used to process laboratory media, water, pharmaceutical products, regulated medical waste, and non-porous articles with direct steam contact.
To ensure the reliability of steam sterilization, proper temperature, time, and complete replacement of air with steam are critical. The steam cycle is monitored using mechanical, chemical, and biological monitors. Chemical indicators are typically affixed to the outside and incorporated into the pack to monitor temperature and time. The effectiveness of steam sterilization is determined using a biological indicator containing spores of Geobacillus stearothermophilus.
It is important to consider the number of sterilization cycles when using steam sterilization to prevent cumulative effects on the plastic. Most plastics can withstand 1–5 cycles of steam sterilization, while polymers like polycarbonate (PC) with high heat distortion temperatures can undergo 1–2 cycles only. Additionally, the packaging material and method must be carefully chosen for items sterilized before packaging.
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Dry heat sterilization
There are two types of dry-heat sterilizers: the natural or static-air type and the forced-air or mechanical convection type. The natural or static-air type of dry-heat sterilizer is much slower in heating and requires a longer time to reach sterilizing temperatures. It is also less uniform in temperature control throughout the chamber compared to the forced-air type. The forced-air or mechanical convection sterilizer, on the other hand, is equipped with a motor-driven blower that circulates heated air throughout the chamber at a high velocity, allowing for a more rapid transfer of energy from the air to the instruments.
While dry heat sterilization is an effective method for sterilizing medical equipment, it may not be suitable for equipment made primarily of plastic due to the high temperatures required. Extreme heat can damage plastic, and there are only a few types of plastic materials that can tolerate such high temperatures. Therefore, when considering dry heat sterilization for plastic medical equipment, it is important to ensure that the plastic material used can withstand the high temperatures required for effective sterilization.
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Choosing the right plastic and disinfectant
When choosing the right plastic for medical equipment, it is important to evaluate the level of contact the device will have with the human body. For single-use devices with direct or prolonged contact, such as delivery systems, opt for a biocompatible plastic resin to prevent adverse reactions and ensure patient safety. Even for short-term contact, materials that adhere to safety rules are necessary for overall patient well-being.
Some common plastic resins that are often approved by the FDA for medical devices include Polyethylene (PE), which is widely used for containers, tubing, and orthopedic implants; Polypropylene (PP), which is used for containers, closures, and flexible packaging; Polyvinyl Chloride (PVC), used for tubing, blood bags, and other medical devices; and Polycarbonate (PC), used for incubators and medical equipment housings.
When selecting a plastic resin, it is also crucial to consider the mechanical needs of the device. Biocompatible materials are designed to interact with biological systems without triggering an immune response or causing harm. If the plastic device is intended to remain inside the body for a prolonged period, special materials are required to avoid adverse reactions and potential harm to the patient. UL Prospector is a useful tool for determining the biocompatibility of different plastic resins.
In terms of disinfectants, there are various options available for sterilizing medical equipment. Ethylene Oxide gas (EtO) is commonly used for materials sensitive to heat or radiation sterilization, including many plastics. However, it requires careful handling due to its flammability and toxicity. Ionizing radiation sterilization, such as gamma rays or E-beam sterilization, is another option, but it can affect the physical and chemical properties of polymers.
Other disinfectants recommended by the CDC for surface disinfection and non-critical patient care equipment include EPA-registered disinfectants or a 1:100 dilution of household bleach and water. For high-level disinfection of semicritical items, such as endoscopes and cryosurgical instruments, the CDC suggests following guidelines that recommend the use of liquid chemical sterilants/high-level disinfectants, including ≥2.4% glutaraldehyde, 0.55% ortho-phthalaldehyde (OPA), and 7.35% hydrogen peroxide with 0.23% peracetic acid.
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Frequently asked questions
Common methods to sterilize plastic medical equipment include autoclaving (steam or dry heat), ethylene oxide, and radiation (gamma or e-beam).
Radiation sterilization uses gamma or beta rays (E-beam). Gamma radiation has high penetration and a low radiation dose, while E-beam has a high radiation dose and low penetration.
Steam sterilization requires high temperatures to kill bacteria, which can damage plastic. Therefore, it is unsuitable for medical equipment made primarily of plastic.
