Medical device sterilization is a critical process in the healthcare industry. Sterilization standards for medical devices and instruments ensure that they are clean and free of any pathogenic microorganisms that could cause infection or illness when used on patients. It’s important for hospitals, clinics, biotech and life sciences companies, and other medical facilities to have reliable methods of sterilization available to them in order to maintain a high standard of hygiene and care.

There are several different methods available for medical device sterilization, each with its own advantages and disadvantages. Autoclaving is one of the most common methods available, utilizing heat, pressure and vacuum to rapidly kill off bacteria and other microorganisms present on items. Ethylene oxide (EO) is another common choice as it can quickly penetrate hard-to-reach areas while keeping temperatures low enough to not damage materials being sterilized. Other popular methods include dry heat sterilization, gamma irradiation, E-beam, ultraviolet light sterilization, plasma sterilization, chlorine dioxide gas sterilization and hydrogen peroxide vapor sterilization (HPV).

No matter which method you choose for your medical device sterilization needs, it’s important to take into account the size, shape and material of the items being treated as well as the type of pathogen you’re trying to eliminate so that you can select the best method available. Taking these extra steps will help ensure that all materials used in your facility are cleaned properly so that your patients remain safe from harm during their time with you.

Pathway Medtech is a medical device design, quality assurance, development, and manufacturing company based in San Diego, California. Medical device sterilization and packaging is an extremely important part of our service offering for companies of all sizes.

The Eight Most Common Methods for Medical Device Sterilization

Pathway Medtech currently offers four of the sterilization methods offered below, but we wanted to first run through the industry standards before going over the methods we recommend for our clients. Read on to learn more.


Autoclaving is a popular method of sterilization for medical devices. It works by exposing items to high-pressure steam, which quickly kills off any microorganisms present on the surface. Autoclaving is an efficient way to ensure that all medical instruments and devices used in healthcare settings are properly sterilized and safe to use.

Autoclaving can be used on a variety of different materials such as metals, plastics, glass and rubber. This makes it ideal for use with items such as scalpels, syringes and other medical tools that may not be able to withstand other methods of sterilization like UV light or gamma irradiation. Additionally, autoclaving can reach hard-to-reach areas in order to adequately clean and disinfect them. This helps reduce the risk of infection when using these items on patients and keeps both health care workers and those being treated safe from harm.

Ethylene Oxide (EO)

This is a highly effective sterilization method that is commonly used for medical devices that cannot be autoclaved. It works by exposing the device to ethylene oxide gas at low temperatures, which can penetrate hard-to-reach places and quickly kills bacteria, spores and viruses.

Ethylene oxide (EO) is a commonly used method of sterilization for medical devices, particularly ones that are difficult to clean or reach due to their size or shape. The EO gas penetrates and kills any microorganisms present on the items being sterilized while not harming the material itself due to its low temperature level. Furthermore, it can quickly move through materials like plastics and rubber which helps ensure adequate sterilization of these items.

EO sterilization provides an effective way of eliminating bacteria and other pathogens present in medical devices while still allowing them to function as intended. This is important when it comes to items such as joint replacement implants and catheters which require perfect sterility in order to be safe for use on patients. Additionally, EO sterilization is capable of reaching hard-to-reach areas on instruments, ensuring that all surfaces have been properly treated and cleaned without having to take further manual steps for disinfection.

Dry Heat Sterilization

This process utilizes hot air to remove microorganisms from surfaces and items. It works best when applied in a contained environment over long periods of time as it requires sustained temperatures above 180°C.

Dry heat sterilization is a popular option for sterilizing medical devices, particularly those that are prone to wear and tear or would be damaged by using other methods of sterilization. It works in much the same way as an oven, with temperatures ranging between 160°C and 180°C being able to appropriately disinfect items. This makes it ideal for instruments like forceps, retractors and scissors which need proper cleaning but may not be able to withstand more intense forms of sterilization such as steam or EO gas.

Dry heat sterilization is also often used with items like glassware, powders, oils and some metals due to its ability to quickly kill off any microorganisms present on surfaces at relatively low temperatures – usually within 15-30 minutes. This helps reduce the risk of infection when healthcare workers are handling these items and keeps both them and their patients safe from harm. Additionally, dry heat sterilization does not require the use of additional chemicals or liquids which can make it a more cost-effective option in certain circumstances.

Gamma Irradiation

Gamma irradiation sterilization works by bombarding objects with gamma rays, which destroys any organic material on them such as bacteria or viruses. It’s often used for products that are known contamination risks or for those that cannot withstand other methods of sterilization like EO or steam. It is especially useful for items like implants, as well as instruments that are prone to corrosion or other damage if exposed to steam or ethylene oxide.

Gamma irradiation also has a relatively short turnaround time in comparison to other forms of sterilization, usually taking around an hour, so it can be beneficial when dealing with urgent orders where speed is a priority. 

Additionally, this form of sterilization does not require any additional chemicals or treatment methods during the process. This means it can potentially be more cost-effective than other options in certain circumstances. Finally, because applications of gamma radiation do not leave any residue on objects being treated, there is no risk of inhalation or ingestion. Thus, there is no potential danger for healthcare professionals using these products.

Ultraviolet (UV) Light Sterilization

This technique uses UV light energy to destroy any living organisms present on the surface of items or within enclosed areas such as operating rooms or clean rooms where medical tools are prepared for use in surgery or other procedures.

UV light sterilization is a popular method for medical devices due to its effectiveness in killing microorganisms and disinfecting surfaces. This is because UV light has higher energy levels than other forms of sterilization, which means it can more effectively penetrate the outer layer of bacteria and viruses and cause irreparable damage to their genetic material.

This form of sterilization is often used when there may be some uncertainty over what microorganisms are present or where there is a need for rapid results – it can be completed within minutes. It also works on non-porous materials such as plastics, glass and metal surfaces which makes it ideal for shorter items like forceps or scalpels. Additionally, UV light sterilizers do not use any additional chemicals or liquids during the process, so they are better for protecting the environment as well as being potentially more cost-effective in certain circumstances.

Plasma Sterilization

Also known as cold atmospheric plasma sterilization (CAPS), this method uses an energized gas mixture consisting primarily of oxygen, nitrogen and hydrogen to destroy microorganisms without damaging the equipment or materials being treated.

Plasma sterilization is a method of sterilizing medical devices with a combination of heat and pressure in order to destroy microorganisms and other harmful agents. This form of sterilization offers the added benefit of being able to reach into hard-to-reach areas, like crevices or narrow tubes, which other forms may not be able to clean effectively. Because this process uses a combination of heat and pressure it is also able to penetrate into materials, like plastic, more deeply than other forms of sterilization.

Furthermore, plasma sterilization does not require any additional chemicals or liquids during the process which means there is no risk of inhalation or ingestion by healthcare workers as well as potentially being more cost-effective in certain circumstances. 

This form of sterilization can be used on items that are sensitive to traditional methods such as steam or ethylene oxide because it is gentler on materials that may deteriorate with these methods. Plasmatic incineration has been proven to be extremely effective at decontamination with far less damage to the environment than some other methods.

Chlorine Dioxide Gas Sterilization

Chlorine dioxide gas sterilization is a method of sterilizing medical devices that uses gas composed of chlorine dioxide molecules. This form of sterilization has been proven to be effective in killing microorganisms as well as being able to provide deep penetration and reach into tight or difficult-to-access spaces. This form of sterilization is particularly useful for items such as flexible tubes and orthopedic implants that may otherwise be difficult to clean with traditional methods.

Chlorine dioxide gas has been found to be an effective way to kill off some bacterial spores quickly and reliably, making it a popular choice among manufacturers looking for an efficient form of sterilizing their products before packaging them up for sale.

Chlorine dioxide gas sterilization also offers the added benefit of being environmentally friendly due to the lack of additional liquids or chemicals required during the process. This form of sterilizing does not require any additional drying time which can make it more efficient when there are time constraints on sterilizing medical equipment. 

Due to its effectiveness at killing microorganisms without harming materials, it has also been found to be an ideal method for sterilizing delicate items like endoscopes, catheters and ultrasound probes which are often damaged by other forms of sterilization.

E-Beam Sterilization

E-beam sterilization is a form of radiation sterilization that uses high-energy electrons to kill any existing microorganisms on medical devices. This form of sterilization utilizes an electron accelerator to generate and direct the beam of electrons onto the medical device, effectively destroying any bacteria or microorganisms in their path. This process is often used for items that are sensitive to heat, have intricate designs, or require minimal residue on the surface such as implants and components with electronics.

E-beam sterilization also offers the additional benefits of being fast and reliable due to its accuracy and ability to penetrate deep within materials without damaging them. Additionally, it is also environmentally friendly because it does not use chemicals or liquids when sterilizing medical devices. Furthermore, this method also ensures compliance with standards such as ISO 11137 since it can easily be validated after the process is complete. Also, E-beam sterilization is an ideal solution for items that require precision when being sterilized. It offers more control than other forms of radiation sterilization such as gamma radiation.

Medical Device Sterilization Options with Pathway Medtech

Pathway Medtech contracts out for any and all sterilization needs on behalf of our clients. Our available sterilization methods include EO, gamma, e-beam, and steam. Pathway Medtech specializes in handling projects of all sizes. Whether your sterilization requirements are limited to a single, limited run, or a larger project, we can support you.

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