This includes design and process engineers, manufacturing and operations managers, and members of research and development or new product development teams. There are several physical sterilization methods, the most efficient of which combines heat with humidity and pressure in a device called an autoclave. 4. She is currently co-chair of the AAMI Industrial Ethylene Oxide Sterilization Working Group and a member of the U.S. Sub-TAG for Radiation sterilization relies on Materials (ASTM), and PDA. Sterilization is defined as validated process used to render a product free from viable microorganisms and is described by an exponential function. There are various methods of sterilization available, which include autoclaving, radiation, ethylene oxide (ETO) sterilization, chlorine dioxide sterilization, hydrogen peroxide sterilization… Electron and X-ray Sterilization of Medical Devices ... are given sterilization- level radiation doses from e- beam or X -ray The introduction of electron beam sterilisation has also expanded the use of radiation for sterilisation. 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. minimize radiation damage, develop new approaches, partner with the device manufacturer in an increasingly complicated regulatory environment. 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). Note: gamma, e-beam and x-ray radiation sterilization are in scope. 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. Selecting the best sterilization for a medical device depends on many factors. 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. Scientific theory and principles of radiation sterilization. Gamma irradiation facility (Image source: MDS Nordion, Canada). All Rights Reserved. © 2020 Association for the Advancement of Medical Instrumentation. Like ethylene oxide sterilization, radiation can penetrate product packaging. Gerry O’Dell is a member of AAMI and actively participates in the sterilization standards committee activities. Gerry O'Dell Consulting works to assist companies of all sizes to comply Download : Download More than 40 per cent of all single-use medical devices produced worldwide are sterilized with gamma irradiation. Its usage has grown in recent decades as more facilities have been built, radiation resistant materials developed and dosage levels more tightly defined. Some of the topics covered are: FDA expectations regarding successful submissions, inspections, recalls, problem solving, and risk avoidance. She is also a member of the American Society for Microbiology (ASM), American Society for Testing & Processing with gamma irradiation yields quick turnaround time, easily penetrating packaging and product, and is ideal for many types of materials. 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. AAMI uses Zoom for virtual classes. Radiation sterilization for medical devices (syringes, dressings etc.) The gamma sterilization process uses Cobalt 60 radiation to kill microorganisms on a variety of different products. 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. The autoclave, invented in 1879, combines heat and moisture with elevated pressure. Telephone: +43 (1) 2600-0, Facsimile +43 (1) 2600-7, © 1998–2020 IAEA, All rights reserved. One of its key advantages is that it allows already-packaged products to be sterilized. Steam Heat 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. 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. Radiation sterilisation utilises ionising radiation to sterilise medical devices. 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. • iiA 2017 Publication • A Comparison of Gamma, E-beam, X-ray and Ethylene Oxide Technologies for the Sterilization of Medical Devices and other Products. Gerry 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. There are no FDA-cleared ionizing radiation sterilization processes for use in healthcare facilities. 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 … 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. The IAEA helps its Member States set up radiation facilities and provides guidelines for the use of sterilization applications that use radiation. Commercial radiation sterilization has now been used for more than 50 years. 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. One of its key advantages is that it allows already-packaged products to be sterilized. Currently, 40–50% of disposable medical products Over the years, radiation sterilization has increasing favorability among users of medical devices and equipment. 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 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. Around 12 million m3 of medical devices are sterilized by radiation annually. 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. Autoclave for Sterilizing Medical Equipment. Prior to starting Gerry O'Dell Consulting in 1998, she worked for Medical Devices Sterilization by Ethylene Oxide : Product examples . Radiation sterilization deactivates microorganisms such as bacteria, fungi, viruses, and spores by relying on ionizing radiation, primarily gamma, X-ray or electron radiation. 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. More than 160 gamma irradiation plants around the world are operating to sterilize medical devices. This course is for professionals currently working in or with sterilization processes, particularly related to radiation sterilization. Ethylene oxide is a colorless, odorless, volatile, and toxic gas. 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