Thursday, March 28, 2019

The Sterigenics Brouhaha: A Teaching Moment

A Note: I have found the people at Sterigenics to be very forthcoming in my previous interactions with them. They are "singled" out here, only because they made the news for all the wrong reasons!

What happened: It appears that Sterigenics was putting out untenable amounts of EtO into the atmosphere surrounding its Willowbrook, IL facility, and after the breakdown of negotiations, the State EPA shut down the facility. Viant in Michigan took a more voluntarily approach once the state level environmental agency started eyeing them.

This has created a gaping hole for many medical device companies - something that could have been totally avoided. The FDA with its highly tenuous and underwhelming leadership, is restating clearly obvious solutions as some sort of a strategy: use other techniques or other facilities. Yes, you can say, "D'uh!".

Bad Precedents: 

1. False Expertise: Thinking all experience is equal, many companies hire the same "experts". This has led to what can be ironically described as "extreme pigeonholing". That is the notion that EtO is the most effective way, Sterigenics is the only vendor to go with, and stupidly enough (any expert who tries to convince you otherwise, is not one, by paradox), a very specific chamber, at a very specific location within that organization.

Of course, this has created all kinds of logistics gymnastics for medical device companies and quite the financial cash-cow for Sterigenics. Instead of basing project planning on device safety and effectiveness, many companies planned it on when they "could get in on the queue for the chamber"! And of course, to jump the queue, you had to pay a fee!

Some smart companies at least got more than one chamber validated for their sterilization needs, but that is where most of it ended!

I have seen contract manufacturers suggest this to start ups, and I saw them agree to this utter, inexcusable madness as SOP! This has been the norm for as long as I have worked in the industry, and I used to sit up and wonder when the chickens will come to roost...well!

2. "Single Source" usually means you have not tried hard enough: Among some insane arguments I have heard, a common one is, "the stuff we want is so complex, only this one shop wants to do it". Yes, that is true, but that just means you have not worked to reduce complexity! And guess what? Sterilizing product, while challenging for some extreme cases, is usually not so.

A lot of irresponsibility abounds in the medical device industry, where again, the same people are recycled across companies as experts, ignorance of the fundamental principles of Supply Chain Management is fairly common!

Single sourcing, the use of unnecessarily obscure materials and processes and the absence of long term risk-mitigation and elimination strategies is plainly flabbergasting!

Now granted, there are exceptions, but it cannot be the norm. Part of your ongoing efforts from the very start has to be the effort to multi-source everything. This will help you mitigate unnecessary risks for your patients, your investors and your organization.

Imagine, if you have a device that works, but you can't use it to treat a loved one, because you didn't do enough! 

What you can learn and do

1. No sterilization technique is perfect. As you can clearly see, neither is EtO. So, in sterilization, as with everything else, look for diversity of options - vendors, methods, all of it!

2. Treat single-sourcing as a critical business risk! Risk mitigation and/or elimination is important for critical business risks, and sterilization is no exception.

3. Rid yourself of false prophets. No, EtO is not the best. No, you don't HAVE to stick with one vendor, and one chamber. No one sane has to!

4. Talk to different vendors. Diversify!

5. If you are the vendor: Don't pollute and cause harm to humans and offer more options and sites to your customers. Yes, every chamber must be validated, but find scientific means to make this more generic. There will always be enough medical devices for you to make money off of sterilization.


1. Sterilizer Shutdown:

2. Image of basket filled with poultry eggs:

3. Image of blackboard:

4. Image of the number 1:

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