Gamma for Medical Devices

FACTS

7,000,000,000
The global population as of 2011

164,000,000,000
The US$ value of the global medical device industry*

40%
The percentage of all single-use medical devices sterilized globally using Cobalt-60**

* – Source: Medical Devices Industry: Market Research Reports, Statistics and Analysis
** – Source: International Irradiation Association (iia)

Why Gamma?

According to the US Center for Disease Control, “Sterilization means the use of a physical or chemical procedure to destroy all microbial life, including highly resistant bacterial endospores*.” Cobalt-60 is an isotope that produces gamma irradiation. High-energy gamma rays disrupt living cells by damaging the DNA and other cellular structures. These changes at the molecular level cause death of organisms.
* – Source: Medical Device Industry Development and Investment CEO Summit 2012

Nordion’s Role

Our gamma expertise plays an important role in the health and well-being of the global population. Gamma is the technology of choice for sterilization by many of the world’s leading medical device manufacturers. Its proven process is safe, reliable, and highly effective.

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What are the Applications?

Combination Devices

A combination device is a medical device combined with a tissue, pharmaceutical or other component that falls within one or more regulatory standards. Sterilization can affect drug properties and material properties, so sterilization by gamma irradiation is applied to ensure that the combination device’s sterility and functionality are maintained.

Implantable Devices

Gamma is highly efficient for sterilization of implantable devices—orthopedics, stents, heart valves and more—in fact, the highest percentage of sterilization modalities for orthopedics is gamma. Additionally, many implantable devices are high value and therefore depend on a reliable process to ensure quality control and prevent the potential for lost product due to processing faults.

Examples

Sterilization of Single-use Medical Devices

Medical Devices

As the global health care field grows, the need for safe and sterile products is more paramount than ever. Gamma sterilization is a simple, proven process that’s safe, reliable, and highly effective at treating single-use medical devices. With the ability to penetrate products while sealed in their final packaging, gamma sterilization economizes the manufacturing and distribution process, while still ensuring full sterility of the product.

Cobalt-60 is an essential ingredient of medical device sterilization. Learn more at cleannuclearpowersafehospitals.com.

Sterilization of Tissue-based Devices

 Tissue-based Devices

Sterilization of tissue-based devices by gamma irradiation is conducted routinely and is gathering momentum in the healthcare industry. Tissue-based devices come from human donors. There are no living cells in the bone grafts, tendons, ligaments and various other tissues. While not currently required by regulatory standards, tissue banks are choosing to terminally sterilize tissue-based devices with gamma in order to increase patient safety.  This demonstrates the value added by gamma sterilization to this class of products.

Sterilization of Combination Devices

Combination Devices

A combination device is a medical device combined with a tissue or pharmaceutical or other component that falls within one or more regulatory standards, such as drug-eluting stents. Sterilization can affect drug properties and material properties, so sterilization by gamma irradiation is applied to ensure that the combination device’s sterility and functionality are maintained.

Sterilization of Implantable Devices

Implantable Devices

Implantable devices include orthopedics (e.g. knees), stents, heart valves and more. Metal and polymers present a challenge to some sterilization modalities. Ethylene Oxide (EO) gas, for example, is inefficient because of tight interfaces inherent in plastic to metal transitions in orthopedic devices; for example, E-Beam is ineffective because some implantable devices are high density or heterogeneous in nature. Gamma is highly efficient for sterilization of implantable devices; in fact, the highest percentage of sterilization modalities for orthopedics is gamma. Additionally, many implantable devices are high value and therefore depend on a reliable process to ensure quality control and prevent the potential for lost product due to processing faults.

Sterilization of Pharmaceuticals

Pharmaceuticals

Sterilization by gamma irradiation is advantageous for a wide range of pharmaceutical products. Due to the high demand for terminally sterilized products in the pharmaceutical industry, gamma has proven itself to be an effective method as indicated by its acceptance in the European Pharmacopeia and more recently drafted into the U.S. Pharmacopeial Convention. Some of the advantages of gamma over other modalities include high penetration power, isothermal character (small temperature rise) and no residues. It also provides a better assurance of product sterility than aseptic processing and lower validation demands.

Let’s Talk Medical

Here are some additional resources that you may find valuable.

Video at https://www.youtube.com/watch?v=n0o9hJXxtwc

Explore Gamma: Bridging the Gap Between Medical Device Design and Gamma Sterilization

Video at https://www.youtube.com/watch?v=MmFFq8DVDV4

Innovative Non-volatile Memory for Medical Devices Sterilized Using Gamma Irradiation 

Read Sterilization and Packaging: New Trends, New Limits, an article by Mark Crawford, Contributing Writer, in the June 2015 issue of Medical Product Outsourcing (MPO). Learn about more stringent regulatory requirements for sterilization and packaging, and increasing pressure on contract manufacturers from OEMs for data analysis, recording, reporting, review and validation.