The Importance of Establishing Safe and Efficient Sterilization Processes of Medical Devices

November 5, 2024
Packing line with surgery equipment sets prepared for sterilization

In the medical-device industry, sterilization refers to the process of eliminating forms of bacteria, viruses, fungi, as well as spores from medical devices and instruments. This step helps in ensuring that devices that come in contact with a patient’s body, during surgery or even during routine care, are free from microorganisms that may cause infections. Without sterilization, these medical devices and instruments carry the risk of infections, which may lead to even life-threatening complications.

Aside from performing this crucial step for regulatory compliance, sterilization is very crucial for patient safety and for improving overall health outcomes. With how crucial sterilization is, it is important for medical-device manufacturers and healthcare professionals to learn about the regulations, methods, as well as the latest innovations and developments in sterilization technologies to ensure patient safety and regulatory compliance.

A brief look at sterilization methods and processes

A common sterilization method is the use of Ethylene Oxide (EtO). This method is typically used for heat and moisture-sensitive medical devices, such as catheters, dressings, as well as electronic components. This method works by exposing said devices to ethylene oxide at low temperatures, eliminating microorganism. One advantage of this method is its ability to sterilize devices with minimal risk of damage. On the other hand, one disadvantage is that EtO requires aeration afterward to eliminate any potentially toxic residue, which may become time consuming and must be managed to avoid exposure to both patients and healthcare professionals.

Electron beams, gamma rays, and x-rays are radiation sterilization methods used mainly for such single-use disposable medical devices as gloves, syringes, and implants. Gamma rays are able to penetrate into packaging, which makes it useful when sterilizing packed items and large medical devices. On the other hand, electron beam sterilization is typically faster but with a shallower depth of penetration, which makes it useful for thinner and smaller medical devices. X-ray sterilization can offer both benefits and is now being utilized for its efficiency in sterilizing a wide range of medical devices.

For medical devices that can handle steam, steam sterilization is one of the most common methods. This usually involves exposing medical devices and instruments to pressurized steam, aiming to eliminate microorganisms. Steam sterilization is very efficient and is utilized for surgical instruments, implantable devices, as well as hospital linens. This method is often favored for its efficiency, cost-effectiveness, as well as reliability, for as long as the medical devices and products can handle steam or moisture.

Regulatory requirements and ISO standards involving the sterilization of medical devices

Under the Medical Device Regulation (MDR), which replaced the previous Medical Device Directive (MDD), medical device manufacturers are required to show that their sterilization processes are validated, effective, consistent, and in line with certain requirements. This means that medical devices that require sterilization must be designed in a way that they can be manufactured, packaged, and shipped while ensuring that the devices are sterile until use. Furthermore, MDR also involves post-market surveillance that aims to monitor the safety of the devices after they have been introduced to the market.

In addition to the MDR, here are some of the ISO standards that are focused on sterilization practices:

  • ISO 14937:2009 – outlines the general requirements for developing and validating sterilization processes
  • ISO 11138 series (Part 1-8) – provides the specific requirements for biological indicators, used in validation and routine monitoring of sterilization processes.
  • ISO 11135 – provides requirements for development, validation, and routine control ethylene oxide sterilization
  • ISO 17665 – requirements for the development, validation, and routine control of sterilization, using moist heat
  • ISO 11137 series (part 1-3) – outlines the requirements for radiation sterilization

Medical device manufacturers, under the MDR, are also required to have their processes reviewed and assessed by notified bodies. The notified bodies typically conduct audits, review sterilization validation documentation, while also performing on-site inspections. While it may seem stringent, these are all implemented to ensure that patient safety is prioritized.

Common challenges faced in medical device sterilization, and the importance of staying up to date with the regulations

While medical device companies may have minimal issues and challenges involving products and instruments that are already commonly used, sterilizing complex and potentially sensitive devices can still be difficult, especially with today’s advancements and innovations, with products becoming increasingly smaller. Some complex and sensitive medical devices, such as heart valves and devices for valve repair contain a mix of delicate materials, making some sterilization methods and processes unusable.

The environmental impact of the use of ethylene oxide is also being brought to light, as it is also associated with emissions that are potentially harmful, encouraging medical manufacturers to explore more sustainable options. While this is a step in the right direction, some companies may find it difficult to move away from traditional sterilization processes. On the other hand, with the advancements in sterilization processes, medical device manufacturers now have access to more viable options for heat-sensitive devices. This includes low-temperature sterilization methods, such as vaporized hydrogen peroxide (VHP) and nitrogen dioxide (NO₂). Moreover, bioburden reduction techniques, which reduce the microbial load before sterilization, also improve the overall efficiency of the process. Efficiency in sterilization is crucial to medical device manufacturers, as well for patient safety, as inefficient sterilization processes can lead to delays in medical procedures, increased costs, and a higher risk of healthcare-associated infections.

Given the complexity of the whole sterilization process, the development of more complex medical devices, and with the industry moving toward more sustainable solutions, medical device manufacturers also stand to gain from expert guidance on sterilization.

Learn more about sterilization through GBA Key2Compliance’s courses!

Maintaining up-to-date knowledge on medical device sterilization is crucial for manufacturers, healthcare professionals, and regulatory bodies. If you are responsible for auditing, assessing, or setting up sterilization processes for medical devices, ensuring that your methods are compliant and effective is crucial.

At GBA Key2Compliance, our aim is to help you meet your goals with the help of the expertise of our team of industry experts. Our sterilization course will guide you and provide you with the knowledge and tools for selecting and implementing the sterilization method that best suits you and your products.

Throughout the course, you will learn about sterilization cycles, including product bioburden-based and bioburden/overkill methods, helping you to make informed decisions for your medical devices.

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