Whitaker: If the rules are “finalized as written, the U.S. could face a 30-50% reduction in the medical devices available to patients”

WASHINGTON, D.C. – In testimony today before a key congressional subcommittee hearing, AdvaMed, the Medtech Association, called for a balance in the proposed regulations of the method used to sterilize 20 billion, or half, of all medical devices in the United States each year. The Environmental Protection Agency (EPA) is proposing restrictions of ethylene oxide (EtO) that if finalized as written, would cause severe interruptions in patient care and access to sterile medical technology. An industry analysis predicts a 30 percent to 50 percent reduction in sterilization capacity for life-saving devices and as much as 70 percent in some cases. 

“The EPA’s mandate to protect the public is critical. Which is why we have approached the EPA as partners, not adversaries,” AdvaMed President and CEO Scott Whitaker told the Committee on Energy and Commerce Committee’s subcommittee on the Environment, Manufacturing, & Critical Materials. “For the rules to be updated in a way that continues to protect surrounding communities and ensures medical device availability, we are seeking a series of changes we have outlined in our public comments to the EPA. We remain hopeful the EPA will take them to heart.”  

Whitaker continued: If “the EPA’s proposed rules are finalized as written, the U.S. could face a 30 to 50 percent reduction in the medical devices available to patients. This would have a disastrous effect on patient care. Because 95 percent of all surgical instruments are sterilized with EtO, virtually every patient awaiting surgeries could be impacted: C-sections. Heart-valve repairs. Open-heart surgeries. Hip replacements. Knee replacements. Brain surgeries. Cancer biopsies … all could be disrupted. The FDA has been very clear, and we agree with the FDA: We simply cannot risk this.”   

AdvaMed’s proposed changes the EPA must address to preserve patient access to the medtech necessary for timely care include the capacity reduction concern, which the FDA shares; the lack of uniformity of sterilization facilities, requiring flexibility to meet mandates; the extensive time and effort required to revalidate the safety, effectiveness, and sterility of millions of products if sterilization methods change; conflicting elements of the two provisions; and too-short implementation timelines.  

The text of Whitaker’s testimony, as prepared, follows. Video of his testimony is here. More on AdvaMed’s comments on the EPA regulations is here. 

Oral Testimony Before the House of Representatives  

Committee on Energy and Commerce Committee    

Environment, Manufacturing, & Critical Materials Subcommittee Hearing:   

“Exposing EPA Efforts to Limit Chemicals Needed for Life-Saving Medical Devices and Other Essential Products”   

Wednesday, October 18, 2023   

Chair McMorris Rodgers, Ranking Member Pallone, Chair Johnson, Ranking Member Tonko, thank you for the opportunity to testify at this important hearing.     

I am Scott Whitaker, president and CEO of AdvaMed, the Medtech Association. We represent more than 450 medical technology companies, from the smallest startups to midsize organizations to the largest companies. All of which serve patients in every health setting with lifesaving, life-enhancing medical technology.   

Half of all medical devices produced every year in the U.S. are sterilized with ethylene oxide. That’s approximately 20 billion.  

And we accomplish this with only one half of one percent of all the ethylene oxide used commercially in the U.S.  

The list of critical, everyday medical equipment that relies solely on this sterilization method is long:   

Surgical kits with instruments such as scopes, clamps, scalpels, tubing, staplers, drills. All the tools necessary for surgery.    

Heart valves, pacemakers, respirators, IV sets, endoscopes, kidney dialysis instruments, continuous glucose monitors, and insulin infusion kits.    

All of these and more are sterilized with ethylene oxide and regulated by the FDA.  

And the FDA has been clear that it is concerned about the availability of these 20 billion medical devices if the EPA’s proposed rules aren’t done right.    

On March 15^th, the FDA wrote: “Without EtO, there would be a significant sterilization shortfall with no commensurate sterilization alternative available,” saying shortfalls “of a variety of critical medical devices would likely be imminent.” These disruptions, “stemming from a lack of EtO, would have significant impacts on patient health and access to critical medical devices and patient care.”

Safe ethylene oxide usage by commercial sterilizers has been regulated by EPA for decades. We follow all federal and state requirements.   

We have made it clear that we welcome updated regulations.   

After all, our industry’s commitment to saving and improving lives does not end where the sterilization process begins.    

It bears repeating: We welcome updated rules.    

But it is absolutely critical that the regulations be done right.  

Sterilization is currently at capacity.   

And no new EtO sterilization facilities are currently under construction in the United States.  

Our industry is and has been working to develop new sterilization methods.   

However, they do not currently exist at the scale and effectiveness of ethylene oxide.  

The reality is, according to a gap analysis of our industry, if EPA’s proposed rules are finalized as written, the U.S. could face a 30 to 50 percent reduction in the medical devices available to patients.   

This would have a disastrous effect on patient care.   

Because 95 percent of all surgical instruments are sterilized with EtO, virtually every patient awaiting surgeries could be impacted:    

C-sections. Heart-valve repairs. Open-heart surgeries. Hip replacements. Knee replacements. Brain surgeries. Cancer biopsies … all could be disrupted.  

The FDA has been very clear. And we agree with the FDA: We simply cannot risk this.   

The EPA’s mandate to protect the public is critical. Which is why we have approached the EPA as partners, not adversaries.   

For the rules to be updated in a way that continues to protect surrounding communities and ensures medical device availability, we are seeking a series of changes we have outlined in our public comments to the EPA.  

We remain hopeful the EPA will take them to heart.  

In closing, let me say a quick word about PFAS, as it is related and will be discussed today.   

It is hard to imagine the medical industry without the many important products that contain fluoropolymers.   

C-PAP machines, prosthetics, IV bags, surgical instruments, and many other medical technologies contain PFAS.  

These medical devices are critical to the treatment and health of Americans.   

Much like the regulations on EtO, it’s essential that any regulation on PFAS takes into account the manufacturing and availability of essential medical devices.  

When it comes to the regulatory process, congressional oversight is vital. Hearings like this are an important part of making sure regulations meet their intent and do not harm the patients and innovators impacted by them.   

So, with that, let me thank you again for inviting me to testify on this critical public health issue.   

   

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