MEDICAL DEVICE STERILIZATION SEMINAR & FACILITY TOUR OFFERED BY STERIS ISOMEDIX SERVICES

June 13, 2012 By MassDevice

Join STERIS Isomedix Services for a TechTeam seminar on topics critical to success in medical device sterilization. The event, being held September 11-12 in Mahwah, New Jersey, will provide attendees the opportunity to gain an in-depth understanding of the relationship between sterilization and medical device design, validation, manufacturing and packaging.

In addition to the TechTeam experts from STERIS Isomedix Services, the seminar will feature thought leaders from around the industry. Seminar topics include:
Fundamentals of Radiation Processing
Overview of radiation and how gamma radiation is used, comparison of technologies, product validation and materials selection, dosimetry, and process validation

Ethylene Oxide (EO) Sterilization Overview
Introduction to ethylene oxide sterilization, standards and guidelines, process challenge devices, parametric release, and process validation

Materials Compatibility and Selection
Materials selection criteria, effects of radiation, the chemistry of plastics, materials issues, and qualification testing / shelf life testing

Laboratory Services and Techniques
Testing techniques, laboratory procedures, and laboratory services

Packaging for Sterilization
Effects of irradiation and EO sterilization processes on packaging materials and packages

Cleaning Programs for Medical Device Cleanrooms
Types of bacteria found in cleanrooms, differences in cleaning chemistries and their appropriate application

Polymer Design and Testing
Design considerations, plastics classifications and polymer testing
This two-day seminar includes an optional tour of the STERIS Isomedix gamma irradiation facility in Chester, New York. Participants can visit the facility to learn what happens when their product is received at a gamma processing facility.

Visit the STERIS Isomedix Services website to learn more about the Medical Device Sterilization Seminar and register today!

About STERIS Isomedix Services

STERIS Isomedix Services is a provider of contract sterilization services with 18 facilities located throughout the U.S.A., Canada and Puerto Rico. Utilizing gamma and ethylene oxide (EO) sterilization technologies, Isomedix Services has been meeting the sterilization needs of the medical device, pharmaceutical and biotechnology community for over 35 years. For more information about STERIS Isomedix Services please call (877) 783-7479 or visit the STERIS Isomedix Services website.

Isomedix Services is a division of STERIS Corporation, a worldwide leader in infection prevention, decontamination and health science technologies, products and services. STERIS is traded on the NYSE under the STE symbol.

Contact:
Sarah Crowl, Sr. Product Manager
isomedix_seminars@steris.com
877.783.7479
www.isomedix.com

CVRx CEO details the path from being engineer to medtech executive
Nadim Yared, CEO of CVRx[/caption] This week, CVRX reported positive six-month trial results for its Barostim Neo, an FDA-approved treatment for heart failure. The results follow years of close work between the agency and CVRx, one of the more ambitious startups in medtech. CVRx is targeting a huge clinical need with novel neuromodulation technology. In… […]
What’s next for nitinol tubing?
Nitinol’s unique properties have made it the darling of the medical device industry. A novel technique for mechanically joining nitinol to other metal tubing could reduce cost and mitigate risk. Mark Broadley, Viant Nitinol has revolutionized the medical device industry. With its flexible superelasticity, shape memory and biocompatibility, nitinol has become a go-to material for… […]
Report: Haemonetics’ blood-collection devices could leave particles in donors
A consortium of news outlets is questioning the safety of Haemonetics (NYSE:HAE) blood-collection devices, claiming that particles have been detected in donors whose plasma was extracted by the machines. According to a report in the Miami Herald, whistleblower documents indicate that more than 150 Haemonetics customer reports have been made regarding the presence of particles by plasma collection centers and heathcare… […]
Spinal Elements’ cervical fixation system wins FDA nod
Spine surgery technology developer Spinal Elements announced today that it received FDA clearance for its Sapphire X product for anterior cervical fixation. Sapphire X is comprised of integrated instrumentation and high-angulation screws designed to help surgeons perform a procedure while preserving the patient’s skeletal and muscle tissue. The instrumentation is designed to reduce procedural steps… […]
How COVID-19 impacts FDA interactions with medical device manufacturers
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration may revise performance goals and timelines set under the Medical Device User Fee Amendments IV (MDUFA IV) as emergency efforts targeting the coronavirus pandemic take up more of the agency’s time. Get the full story here at the Emergo Group’s blog. The opinions expressed… […]
Switchback Medical adds ‘sandbox approach’ to device testing
Contract manufacturer Switchback Medical (Maple Grove, Minn.) today announced that it has added a new division. Switchback BioSim Innovations offers functional dynamic biosimulator model development, cell culture services and physician training, according to the company. Biosimulator models use animal and human tissue to create functional models, such as a pumping heart with working valves to… […]
Smith College team wins ventilator design challenge
A team of Smith College engineering alumnae, staff and faculty has won the CoVent-19 Challenge to design a rapidly deployable ventilator to address shortages caused by the COVID-19 pandemic, particularly in developing countries. A dozen anesthesiology resident physicians from Massachusetts General Hospital kicked off the public challenge April 1, attracting 200 entries. The 30-person team… […]
FDA gives certain device makers more time to add UDIs
The FDA said today that it will grant manufacturers of Class 1 and unclassified medical devices and certain others more time to add unique device identifiers (UDIs) to their products. These companies will now have until Sept. 24, 2022 to comply with the agency’s UDI rule, including standard date formatting, labeling and Global Unique Device… […]
Eurofins launches 10-minute COVID-19 exposure testing device
Eurofins (Paris:ERF.PA) announced today that it launched its rapid point-of-care testing devices to identify past exposure to COVID-19. The serology-based, finger-prick tests detect antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, with results coming in just 10 minutes, according to a news release. Get the full story at our sister site,… […]
How is RF technology shaping the future of medtech?
RF technology, including microwaves, isn’t just about wireless communications or military radar these days. Times Microwave Systems experts point out that it is increasingly important when it comes to medtech. Many medical electronics systems such as magnetic resonance imaging (MRI) systems for cancer detection rely on RF/microwave technology. Times Microwave Systems (Wallingford, Conn.) is hosting… […]
Medical device litigation and COVID-19: What you need to know
The COVID-19 pandemic is creating a new set of medical device litigation challenges — but also a chance for an industry reset. One of Greenberg Traurig’s top medtech litigation lawyers shares her insights. Sara Thompson doesn’t take any guff when she tells people that she defends medical device and pharmaceutical companies from lawsuits. “I say,… […]