EO Sterilization for Medical Devices

A panel at www.bio2devicegroup.org discussed Ethylene Oxide (EO) Sterilization of Bio/Medical Devices on Tuesday, March 1, 2022. The panel consisted of Denny Christensen, CEO of Sterilization Validation and Consulting, Michael Anderson, Site Director at Infinity Laboratories, and Sam Sohal, President of Test-O-Pac Industries and EO Sterilization.

EO sterilization was discovered in 1928 and used as an insecticide in hospital rooms. In the 1940s, EO began to be used to sterilize spices and food preservatives. However, in 1948 it was found that EO could potentially cause cancer and that rang some alarm bells. But it was eventually found that the risk was miniscule in the amount used.

Currently EO sterilization is used in 50 percent of medical devices. In fact, EO has become a dominant method for sterilization of all disposable medical devices. FDA has been investigating alternative gas methods for sterilization but we are not closer to finding anything that can replace EO in the short term.  

EO is a valuable compound and is very versatile. Over 17 million tonnes of EO is produced annually, worldwide. EO is used in antifreeze, heavy machinery, acrylics, plastics, glue, paper, fabrics, carpets, polyester, cosmetics and more. EO also plays a massive role in sterilization of medical devices. There are two primary factors that drive its usage for medical devices. First, EO is consistently compatible with the majority of other materials and second, it can be performed at low heat. Other vaporized gas materials are often not compatible with cellulose, paper etc. For many medical devices, sterilization with Ethylene oxide may be the only method to effectively sterilize a device without causing damage. Medical devices made from certain polymers (plastic or resin), metals or glass or those that have multiple layers of packaging or hard to reach places like catheters are likely to be sterilized with ethylene oxide. Additionally, other gas alternatives are challenging to scale up because they can’t be effectively packaged in cardboard and shipped to various locations, with ease.

EO is regulated and controlled by FDA and EPA and shutdowns sometimes lead to shortages. There is a need for public information and there is need to balance use of EO with public and environmental safety. EO is an effective sterilization method and we will continue to need EO sterilization since there are fewer other efficient alternatives. 

It is also important to understand how EO can be used more effectively in medical devices. Four active ingredients required to deliver a successful process are: heat, humidity or moisture, gas concentration and time. Achieving a high sterility level reduces the chance of microbes and resulting infections. Additionally, EO sterilization companies need to have open communication with the designers of medical devices. Earlier medical device companies start thinking about sterilization, the more they can take full advantage of optimum sterilization process that in the end saves time, resources and helps the public and environment by achieving optimum sterilization with less exposure.

In summary, it was mentioned that state of the art technology will continue to evolve and enable fine tuning of sterilization cycles. Additionally, better planning and early communication between device engineers and sterilizers and consideration of the sterilization process in the design phase will mean fewer sterilization challenges later. Also important is communicating to those handling the devices that thorough cleaning of these devices prior to sterilization is of immense importance in helping minimize risk of infection through unclean devices. 

Life Sciences Industry Outlook for 2018: Post BiotechShowcase & JPM

JPM 2018 and concurrent events just ended with what may be one of its biggest draws.  As many as 10,000 people from life science industry and its related sectors are likely to have descended upon the city, during last four days.  In addition to JPM event itself, everything health was under review and up for discussion at various conferences including at EBD Group & Demy Colten’s #BiotechShowcase #DigitalMedicine #BTS18 and #WuXiGlobalForum2018 . Networking and deal making continued late in the nights at various receptions held across the city. Receptions by legal firms like #WilsonSonsini #MoFoLLP #ReedSmithLLP attracted some of the biggest crowds.

Overall the tone for 2018, seemed highly optimistic.  BiotechShowcase held a media roundup and echoes of optimism were heard from almost all panelists @barbara_ryan12 @TriangleInsight @CarolineYLChen @adamfeuerstein @statnews @SFBIZronleuty @BrittanyMeiling @endpts @juliet_preston @medcitynews @ldtimmerman .

There is a general agreement that the pace of #innovation in biotech greatly accelerated in 2017 and is likely to continue. According to Luke Timmeerman, “sheer velocity of news in healthtech innovation is fascinating”. Transformative therapies across huge and diverse range of diseases are increasingly focusing on cures and going beyond the short term treatment focus. The surge of innovation has been led by focus on oncology although concern was also raised in one of the panels that we still continue to get stymied and realize how friggin smart the disease of cancer is and if we will truly crack the code on cancer in the immediate upcoming years. All signs are however, that next year we may see critical data from some clinical trials in immuno-oncology space that can cause market spikes.

Here are some areas of concern raised in some of the panels. In 2017, a slight dip was observed in the areas of orphan and rare diseases. Also there seemed to be a general consensus that we need smart policies that incentivize new anti microbial drugs and other treatments for infectious diseases. Due to increasing resistance of antibiotics, there is an ongoing and real fear for some of the infectious diseases to turn into pandemics. These are areas that bold entrepreneurs may focus on. Also medical devices continues to remain somewhat underfunded. Discussions around accelerating healthcare costs and drug pricing issues creeped over into many panels. Entrepreneurs with disruptive pricing innovation in product development as well as healthcare can easily have a tremendous leverage. It can’t be overstressed that finding effective pricing solutions holds key to continued and sustainable growth in healthcare sector.

Discussion in one of the panels focused for a few minutes around large investments in life sciences and if that indicated a healthtech bubble that may be due for a crash.  Indeed, some experts observed that pace of 2017 is unlikely to continue and there may well be a slight dip in 2018. But overall the consensus seemed to be, that a steep and deep pipeline of innovation in R&D is likely to prevent a crash, and the venture funding blizzard is likely to continue. Overall, the feeling among investors and healthcare experts was that among the industry, there is a strong focus on science and people are pursuing innovation with discipline that will ensure unprecedented mechanisms and novel medicines. All this activity is taking healthcare to a new level of cures and sustainability and stability from temporary treatment focus. Exciting indeed to be living in this era of amazing healthcare innovation.

 

 

Immunotherapy, Bioinformatics, Devices: EPPICon 2017 Preview

 

One of the latest most talked about buzzwords in cancer treatment is “immunotherapy” where body’s immune system is used to wage a war against the cancer cells. Cancer cells divide rapidly than ordinary cells and manage to evade the immune system. The focus of a range of immunotherapies is to put body’s immune system on high alert so it can easily locate and destroy cancer cells.

This year, EPPICon (annual flagship conference at eppicglobal at www.eppicon.org) will focus on Immunotherapy, Bioinformatics, and Devices. Another recent buzzword, “bioinformatics” focuses on harnessing technological advances for management and analysis of data, for cancer immunology and immunotherapy.  The hope is that more reliable and comprehensive picture can emerge of tumor genomics landscape and that can point a way towards more effective personalized medicine.

Immunotherapy often involves delivery of a cocktail of immune drugs to awaken the body’s immune system and put it in a “ready” mode to get rid of the cancer cells. Implantable devices can be used to provide regular dosages of medication for several days or everyday for a few weeks and can be used to make localized delivery.  This convergence of technologies makes it an interesting time for treatment of cancer and other diseases.  

EPPICon, EPPIC’s all day conference will be held on Saturday, March, 25th at Crowne Plaza, Burlingame, CA and has a fabulous lineup of keynotes, speakers, and panels.

Morning keynote, Ira Mellman is VP of Cancer Immunology at Genentech and has an illustrious career in solving most profound health problems with strong research, grounded in science.  He spent 20 years at Yale University School of Medicine, prior to joining Genentech in 2007.  After the keynote, the conference program will continue with excellent speakers and panels with a special speed pitch session thrown in, where startups looking for funding will have an opportunity to pitch to a panel of investors and receive critical feedback, in real time. At the end of the day, 2017 “EPPIC Eleven” awards will be given out to chosen startups, from around the globe.

To register for the conference, please go to www.eppicon.org .