Because of the penetrating properties of ionizing radiation and their ability to kill microorganisms, ionizing radiation is used to sterilize or reduce the microbial load of many different types of products such as medical devices, packaging, cosmetics, foods, and agricultural products. Ethylene oxide is a colorless, odorless, volatile, and toxic gas. Scientific theory and principles of radiation sterilization. If you have any questions, please email education@aami.org. Radiation is a safe and cost-effective method for sterilizing single-use medical devices such as syringes and surgical gloves. Gerry O'Dell is owner and president of Gerry O'Dell Consulting, a consulting firm based in the United States with medical device and pharmaceutical clients around the world. Gerry is lead instructor for the AAMI industrial ethylene oxide sterilization course, Terms of Use, Governmental, legal and regulatory framework, Security of nuclear and other radioactive material, Radioactive waste and spent fuel management, Zoonotic Disease Integrated Action (ZODIAC), Programme of Action for Cancer Therapy (PACT), IAEA Water Availability Enhancement Project (IWAVE), International Project on Innovative Nuclear Reactors and Fuel Cycles (INPRO), Catalogue of review missions and advisory services, Peer review and advisory services calendar, Global Nuclear Safety and Security Network (GNSSN), International Nuclear Information System (INIS), Advanced Reactors Information System (ARIS), Integrated Nuclear Fuel Cycle Information System (iNFCIS), Spent Fuel and Radioactive Waste Information System (SRIS), Offices Reporting to the Director General. More than 40 per cent of all single-use medical devices produced worldwide are sterilized with gamma irradiation. More than 160 gamma irradiation plants around the world are operating to sterilize medical devices. Radiation sterilisation utilises ionising radiation to sterilise medical devices. Introduced as a sterilization method to the medical industry in the 1960’s, radiation gamma sterilization using Cobalt 60 or electron beam irradiation (“E-beam”), kills microorganisms and operates in a very tightly controlled parameter: 25 kGy, radiation does not cause a significant rise in temperature. This includes design and process engineers, manufacturing and operations managers, and members of research and development or new product development teams. Gamma rays are attractive for use in commercial sterilization of materials of considerable thickness or volume, eg., packaged food or medical devices. 6 November 2019. ISO11137-3 MDIC Sterilization of health care products — Radiation … Radiation Sterilization Several AAMI/ISO methods are available for validation of the radiation dose used to sterilize a medical device. Some of the topics covered are: FDA expectations regarding successful submissions, inspections, recalls, problem solving, and risk avoidance. products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. New CRP: Radiation Effects on Polymer Materials Commonly Used in Medical Devices (F23035), Radiation Effective in Sterilizing Personal Protective Equipment Except For Respiratory Masks – IAEA, Vienna International Centre, PO Box 100 Dates: January 19-22, 2021 Location: Virtual Description. Selecting the best sterilization for a medical device depends on many factors. There are various methods of sterilization available, which include autoclaving, radiation, ethylene oxide (ETO) sterilization, chlorine dioxide sterilization, hydrogen peroxide sterilization… Note: gamma, e-beam and x-ray radiation sterilization are in scope. AAMI uses Zoom for virtual classes. Medical Devices Sterilization by Ethylene Oxide : Product examples . With a wealth of experience providing sterilization for medical devices, STERIS AST has been providing a first class sterilization service for … © 2020 Association for the Advancement of Medical Instrumentation. Therefore, the presence of microorganisms on the individual item can be expressed in terms of probability. The course includes electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, and additional references. Those users elect gamma ray sterilization, in which items are exposed to a strong gamma radiation source to kill contaminants, or electron beam sterilization… Radiation sterilization deactivates microorganisms such as bacteria, fungi, viruses, and spores by relying on ionizing radiation, primarily gamma, X-ray or electron radiation. is an instructor for the industrial radiation course and has presented several webinars through ComplianceOnline related to environmental monitoring excursion, testing failures, PCD development and reusable device cleaning validations. Sterilization by ionizing radiation, primarily by cobalt 60 gamma rays or electron accelerators, is a low-temperature sterilization method that has been used for a number of medical products (e.g., tissue for transplantation, pharmaceuticals, medical devices). with requirements during design, development, and manufacturing to assure that single-use products are sterile and that reusable medical devices can be processed effectively. For participants to gain the maximum benefit from this course, it is recommended they have a working knowledge of general sterilization principles. Processing with gamma irradiation yields quick turnaround time, easily penetrating packaging and product, and is ideal for many types of materials. Steam Heat Sterilization. She holds both a bachelor's degree and a master's degree in microbiology from the University of South Florida and has over thirty years of experience in the medical device industry. Times: 8:00AM-5:00PM ET (Days 1-3)8:00AM-12:00PM ET (Day 4). All of the methods use product bioburden enumeration and a bioburden organism resistance sterility test which is referred to as the verification dose resistance experiment. For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). She is also a member of the American Society for Microbiology (ASM), American Society for Testing & The 11137 series of radiation sterilization standards. Medical Device Sterilization. There are several physical sterilization methods, the most efficient of which combines heat with humidity and pressure in a device called an autoclave. The presence of moisture significantly speeds up heat penetration (steam sterilization). This 3.5-day program covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices. FDA expectations regarding successful submissions, inspections, recalls, problem solving, and risk avoidance, Scientific theory and principles of radiation sterilization, The 11137 series of radiation sterilization standards. Commercial radiation sterilization has existed since the late 1950s and has grown tremendously in popularity over the last 60 years. Ionizing radiation utilizes Gamma or X-rays, whereas non-ionizing uses longer wavelengths and lower energy. A wide variety of sterilization methods are used in the medical industry, including electron beam (e-beam) irradiation, gamma irradiation, ethylene oxide (EtO), autoclave, and low-temperature hydrogen peroxide gas plasma. It is emitted by a radioisotope , usually cobalt-60 ( 60 Co) or caesium-137 ( 137 Cs), which have photon energies of up to 1.3 and 0.66 MeV , respectively. One technique is to use a device called an autoclave, essentially a large and highly concentrated chamber, which exposes whatever is inside to extreme temperature and/or chemical reactions. Gamma irradiation facility (Image source: MDS Nordion, Canada). Cathode Rays (Electron-Beam Radiation) Cathode rays or electron-beams can sterilize materials at room temperature with brief exposure. Gerry O'Dell Consulting works to assist companies of all sizes to comply She is currently co-chair of the AAMI Industrial Ethylene Oxide Sterilization Working Group and a member of the U.S. Sub-TAG for Over the years, radiation sterilization has increasing favorability among users of medical devices and equipment. This course is for professionals currently working in or with sterilization processes, particularly related to radiation sterilization. Some of the topics covered are: Participants will learn integration of industry standards with the U.S. Quality System Regulation, auditing processes for contract laboratories and sterilizers, and radiation sterilization processing, including safety precautions, characteristics, constraints, and impact of radiation operations. Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. Autoclave for Sterilizing Medical Equipment. Gerry Radiation kills germs that can cause disease  and neutralizes other harmful organisms. Johnson & Johnson as a manager of laboratory & sterilization services; the department charged with oversight of the sterilization program for J&J Medical in addition to providing laboratory testing services to several J&J companies. This 3.5-day program covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices. Sterilization is defined as validated process used to render a product free from viable microorganisms and is described by an exponential function. This course is designed to be highly interactive between faculty and participants and will include relevant real-life examples and “hands-on” exercises from a broad spectrum of medical device products. Prior to starting Gerry O'Dell Consulting in 1998, she worked for Sterilization with ionizing radiation inactivates microorganisms very efficiently and, when used for product wrapping, ensures that healthcare products are safe and can be relied upon. "Severe damage" to DNA is … Medical Device Sterilization Validation Steam Sterilization Dry-Heat Sterilization Gas Sterilization Sterilization by Ionizing Radiation Sterilization by Filtration It is also important to formally assess the potential effects of the sterilization process on product and packaging materials. Download : Download Materials (ASTM), and PDA. Industrial Sterilization for Medical Devices is a comprehensive 4-day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more. Currently, 40–50% of disposable medical products Its usage has grown in recent decades as more facilities have been built, radiation resistant materials developed and dosage levels more tightly defined. You can test your connectivity and ability to use Zoom at zoom.us/test. She is also a member of the most of the sterilization related working groups and several of the groups related the processing of reusable medical devices. Radiation Sterilization. During this period, the market for disposable medical products has undergone enormous growth, and with it the use of ionizing radiation as a method of sterilization. Radiation sterilization relies on Around 50 per cent of all single-use polymer-based medical devices manufactured worldwide are sterilized using ionizing radiation from two main sources – the cobalt-60 radioisotope (gamma irradiation), or an electron accelerator, using either e-beams or, less commonly, X-rays. So, in order to reuse such medical devices after surgery, effective sterilization is necessary. is a registered microbiologist with the National Registry of Microbiologists in the area of consumer products & quality assurance. In this particular case it is used for steam sterilization. and tissues. (Credit: Sterigenics) Single-use medical devices, pharmaceuticals, components, and packaging that need to be sterile must be treated with an appropriate and validated technique. The autoclave, invented in 1879, combines heat and moisture with elevated pressure. STERIS Applied Sterilization Technologies (AST) offers the medical device industry’s most comprehensive array of contract sterilization options using gamma irradiation, electron beam irradiation, X-ray irradiation and ethylene oxide sterilization. FDA Medical Device Advisory Meeting. There are no FDA-cleared ionizing radiation sterilization processes for use in healthcare facilities. If you would like to learn more about the IAEA’s work, sign up for our weekly updates containing our most important news, multimedia and more. However, since 1950, there has been an increase in medical devices and instruments made of materials (e.g., plastics) that require low-temperature sterilization. Most medical and surgical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat, primarily steam, sterilization. Used for applications such as Medical Device sterilization. The IAEA helps its Member States set up radiation facilities and provides guidelines for the use of sterilization applications that use radiation. A packaged medical device comprising a medical device; a gas-permeable sterile bag containing the medical device therein; a wrapping member made of oxygen-impermeable material and wherein said medical device-containing bag, previously subjected to radiation-sterilization, is sealed; and a deoxidizing agent contained in the wrapping member together with the medical device-containing bag. Sterilizing medical products Radiation is a safe and cost-effective method for sterilizing single-use medical devices such as syringes and surgical gloves. A variety of life-saving equipment is sterilized with radiation. Electron and X-ray Sterilization of Medical Devices ... are given sterilization- level radiation doses from e- beam or X -ray A variety of life-saving equipment is sterilized with radiation. All Rights Reserved. • … Gerry O’Dell is a member of AAMI and actively participates in the sterilization standards committee activities. Gamma radiation is very penetrating, and is commonly used for sterilization of disposable medical equipment, such as syringes, needles, cannulas and IV sets, and food. ISO/TC 198/WG 1. The gamma sterilization process uses Cobalt 60 radiation to kill microorganisms on a variety of different products. A-1400 Vienna, Austria Heat sterilization of medical instruments is known to have been used in ancient Rome. If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. One of its key advantages is that it allows already-packaged products to be sterilized. The introduction of electron beam sterilisation has also expanded the use of radiation for sterilisation. Commercial radiation sterilization has now been used for more than 50 years. 4. • iiA 2017 Publication • A Comparison of Gamma, E-beam, X-ray and Ethylene Oxide Technologies for the Sterilization of Medical Devices and other Products. Around 12 million m3 of medical devices are sterilized by radiation annually. Radiation sterilization for medical devices (syringes, dressings etc.) The series has the general title of Sterilization of healthcare products – Radiation and the four parts now consist of: BS EN ISO 11137‑1:2006 +A2:2019 Requirements for development, validation and routine control of a sterilization process for medical devices; BS EN ISO 11137-2: 2015 Establishing the sterilization dose; One of its key advantages is that it allows already-packaged products to be sterilized. 27 Sterilization : Comparison Radiation & Ethylene Oxide Parameter Gamma E-Beam EO Process Individual product, box, tote, pallet Boxes Pallets Material compatibility Not compatible with some type of … Gamma Sterilization: An ionizing sterilization technique that involves exposing materials to gamma rays, most commonly Cobalt-60. Device Sterilization Validations – Radiation, Steam and ETO For medical devices and health care products that must be sterilized before use, the appropriate sterilization cycle parameters must be determined through a sterilization validation process. Rhodotron® TT200/300: IBA’s high energy E-beam accelerator reaching energies up to 10MeV and up to 560 kW of beam power. Sterilization of medical devices using radiation does not leave behind any trace radioactivity, therefore, irradiating medical devices using gamma or electron beam (E-beam) radiation is a clean way to sterilize. Telephone: +43 (1) 2600-0, Facsimile +43 (1) 2600-7, © 1998–2020 IAEA, All rights reserved. Radiation sterilization is well known to those of ordinary skill in the art. Like ethylene oxide sterilization, radiation can penetrate product packaging. 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