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Heart Surgeon, Small Medtech Company Leader Urges “Sensible” Sterilization Regulations, Cites Dire Consequences for Patients

WASHINGTON, D.C. – In testimony today before the U.S. House of Representatives Committee on Small Business, Dr. Lishan Aklog urged Congress and the executive branch to consider the dire consequences for patients and medtech innovation if proposals further regulating the most prevalent method of sterilizing medical technology go forward without significant changes.

“They could stifle development of new innovative products and adversely impact, in a dramatic way, the supply chain of existing life-saving products, putting millions of patients at risk of delayed care and even death,” Aklog told the committee. “This may sound like hyperbole, but I can assure you that it is not.”

Aklog testified as a heart surgeon, medical technology innovator, entrepreneur, and small public company chief executive. He described support for updating proposals on ethylene oxide (EtO), which sterilizes 20 billion, or half, of all medical technology in the United States each year, and urged policymakers to consider refining the pending Environmental Protection Agency proposals as written to minimize patient impact.

Because EtO sterilization is at capacity, medtech innovators face difficulty finding a sterilization facility. The EPA proposals could reduce capacity by 30 percent to 50 percent and as much as 70 percent in some cases.

Aklog described a cardiovascular device he helped develop that has saved many thousands of lives. The device is now the standard of care to treat a deadly type of heart valve infection without the need for highly invasive open surgery. Its parts are sterilized with ethylene oxide. “Any disruptions in access to ethylene oxide sterilization would immediately impact the often gravely ill patients who depend on” the device, he said.

The process of verifying and validating a sterilization method is labor- and capital-intensive, especially for the small companies who make up 80 percent of medtech companies and originate many new products. Innovation could suffer if this already difficult process becomes even more challenging, Aklog testified.

“Surgeons are known for their bluntness, so let me be blunt. The EPA regulations on device sterilization require the surgical precision of a scalpel. There are a variety of sensible, targeted, and scalable reforms to ethylene oxide sterilization regulation which would not risk patient access or medical device sterilization capacity. We can keep communities safe and lifesaving medical equipment available for patients,” Aklog said. 

“I implore this Committee, and Congress more broadly, to urgently work with the executive branch and ensure we get this rule right. We all share the same goal—of ensuring patients have access to the critical and lifesaving technologies they need.”

Testifying before a key House subcommittee last October, Scott Whitaker, president and CEO of AdvaMed, the medtech association, described communicating with the EPA on how to make the proposals more workable to protect patient care. He said, “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.”

In comments submitted on the EPA proposals, the U.S. Small Business Administration wrote, “Advocacy is concerned that these actions would lead to a significant number of small entities leaving the market for commercial sterilization, harming small medical device manufacturers, causing significant supply chain disruptions, and hurting patients needing sterilized medical devices.”

The EPA is expected to release the final version of its air emissions regulation on or near March 1. 

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