Excellence in Sterilizing Medical Devices

April, 22-23, 2020 | Chicago, IL, USA

 For registration details and multiple attendee discounts, please contact:

Jeremy Wise
jeremywi@marcusevansch.com

Interested? Do you feel you will benefit?

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LOCATION

CHICAGO, IL

ABOUT THE INTERVIEW

You will be presenting on “Anticipating the Potential Ban of EO Entirely to Reduce the Overall Impact of Sterilized Devices to the Industry,” what are some key takeaways the attendees can expect from your session?

This question is one that has been in our industry for decades. I remember hearing at the beginning of my career from our EO forefathers how this was mentioned back in the 70’s and 80’s. What attendees can expect is a look at the use of EO sterilization, not only in the US or worldwide, but for industries outside of medical device. This is the first time that sterilization has been involved with social media and having regulations implemented that are not built on science but on pressures from public opinion. So it’s not something we can analyze and extrapolate based on studies or literature. It’s an ever evolving storm that changes at any moment. So we are going to discuss the latest science behind the perceived risk so that everyone is informed to educate those within their organization. We are also going to look at what options exist outside of EO and how/if it’s possible to change to those.

Why is it important to explore other means to sterilize medical devices in replacement of Ethylene Oxide (EO)?

Everyone should always have a “Plan B”.  Some contingency plan to ensure business continuity and ultimately our ability to do our jobs.  Putting all your eggs into one basket is never a wise decision for any mid to large size company.  The struggle will be for small companies but honestly, in my experience, most start ups will start with radiation technology due to it’s minimal validation costs.  It’s when you have large quantities or multiple product sku’s and variations that EO really pays back the benefits and so it’s often times the companies with healthy product offerings that turn to this modality.  So it’s those companies that typically use EO and should always have a contingency plan in place for sterilization.

Which other processes can be contemplated to better suit the environmental impact?

Honestly there is not really one out there.  I know there are people wanting to argue that statement right now, but consider this.  The very nature of what we do is to “kill organisms”, which means it has to be lethal and will always carry a risk.  Radiation technologies either utilize radioactive isotopes or substantial amounts of electricity.  For those that utilize the electricity route, often times around 80% of the energy is lost to heat.  Electricity is not void of environmental impact for the amount needed in these processes and so we say it’s cleaner for ebeam or x-ray, but we are not accounting for the fossil fuels utilized to generate the electricity for those processes.  The other gas technologies are less impactful to the environment, but really struggle with penetration and are really more surface sterilant and currently are not robust enough for those devices and configurations that utilize EO.

How difficult is it to switch from EO to another sterilization method? What are the regulatory steps that would need to take place?

It’s all time and money.  The sterilization validation is just one part and is often what most sterilization providers focus on when speaking of time and cost to change, but in reality, there are stability studies, packaging studies, biocompatibility evaluations, and when all that is done, regulatory updates and submissions.  It can take up to 2 years to change modalities and receive approval to sale a high risk device and the cost for this can easily run into the hundreds of thousands of dollars.  The hard truth is that if you did not include the new modality in your design and verification process, all of that will need to be assessed and verified to be equivalent and honestly, often times it’s not.  There are many devices out there that just can’t be sterilized by radiation without complete material redesign.

What key drivers motivated you to participate at this particular conference? What is the one factor you hope to gain from this forum?

I am dealing daily with the US EO propaganda and working to ensure proper steps are taking to mitigate these shifts for not only my organization, but for the industry I have dedicated my career to.  The news articles that most are seeing are not typically accurate and are spreading fear and misconceptions.  Most countries understand EO and have adequate safety requirements in place to mitigate risk to people and the environment.  EO is not perceived as a cause to every adverse health case around, but a necessary tool to bring sterile devices to patients.  To save and improve lives.  The EU has done a good job establishing limits and requirements while allowing this technology to continue to save lives.  We just need all suppliers to ensure strict compliance and monitoring and for all the experts and users in the US to speak up to ensure we can continue to have this technology so that we can provide safe and sterile products to those in need.

Prior to the Excellence in Sterilizing Medical Devices Conference, we spoke to Beau Rollins, the Director of Quality Services at ConvaTec. Beau obtained his BS in Microbiology from Weber State University and for the past 15 years, has worked at a contract laboratory (Nelson Laboratories), contract manufacture (QTS) and medical device manufacture (ConvaTec & Arthrex).  Beau is currently an ISO Delegate for 10993, active AAMI US representative for 11135 and 11737, member of the Society of Toxicology, and has received his RM(NRM).  In his current role at ConvaTec, he oversees Biocompatibility, Sterilization, and Auditing on a global scale and has recently been part of the in-vitro irritation development and validation for ISO.

Beau Rollins will be one of our expert speakers!

Anticipating the Potential Ban of EO Entirely to Reduce the Overall Impact of Sterilized Devices to the Industry  

- Exploring other means to sterilize medical devices to replace gas sterilization

- Contemplating using radiation or steam to process certain medical devices for environmental reasoning

- Acknowledging the regulatory steps that will take place in order to switch from EO to another process

- Requiring a full regulatory filing for MDR in order to move forward in switching methods and predicting what the timeline capacity would be