The U.S. FDA is holding a series of town halls on the use of sterilization methods as alternatives to ethylene oxide (EtO) in response to other federal agency rulemaking, and some of these changes in sterilization methods will not require a new regulatory filing.
The U.S. Environmental Protection Agency (EPA) has issued its long-awaited final rule governing emissions of ethylene oxide (EtO), a rule announced by the agency with the concurrence of Xavier Becerra, the Secretary of Health and Human Services. However, the final rule provoked an immediate response from Sen. Bill Cassidy (R-La.), who said the final rule will “put American lives in danger.”
The ongoing saga of the Environmental Protection Agency’s (EPA) pending rule on ethylene oxide (EtO) made its way to a Feb. 14 hearing in the U.S. House of Representatives, which included the testimony of Lishan Aklog of Pavmed Inc., who warned that a significant curtailment of EtO as a sterilant for medical devices could hamper patient access to medical devices.
The U.S. Medicare program for coverage of U.S. FDA-designated breakthrough devices has gone through some significant alterations over the past few years, but there is legislation on Capitol Hill that would codify this program at the Centers for Medicare & Medicaid Services. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), told BioWorld that one of the sources of drag on this kind of legislation is how the Congressional Budget Office (CBO) scores the legislation, a problem that might not be resolved until CBO works through other legislation.
The ongoing controversy over the use of ethylene oxide (EtO) as a medical device sterilant has yielded a certification by the U.S. FDA for hydrogen peroxide as an alternative category A sterilant. The news is a welcome bit of relief for industry and for patients as the Environmental Protection Agency still seems bent on imposing what some in industry see as draconian controls on EtO, which is still employed to sterilize half of all medical devices used in the U.S. each year.
The U.S. Environmental Protection Agency (EPA) has struggled to devise a final rule regarding regulation of ethylene oxide (EtO) after several years, a regulatory activity that has device makers concerned about domestic capacity for sterilization.
The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was a long time in coming, much longer than any legislative proposals to overhaul the agency’s regulatory mechanisms for these tests. Nonetheless, Scott Whitaker, president and CEO of the Advanced Medical Technology Association (Advamed), believes that the FDA draft rule is likely to prompt Congress to pass the Verifying Accurate, Leading-edge IVCT development (VALID) Act, a development that would truncate an FDA final rule that would almost certainly face litigation.
The U.S. FDA recognized several new standards for sterilization of medical devices as part of an effort to reduce the use of ethylene oxide (EtO) for this purpose. While the recognition may stimulate adoption of alternative methods, Congress is applying yet more pressure on the EPA to act more decisively in regulating EtO, thus amplifying pressure on a system that device makers believe is already under stress.
Sotera Health Holdings LLC has finalized a $408 million settlement for litigation over the company’s use of ethylene oxide (EtO) at a Sterigenics facility in Willowbrook, Ill., although litigation is still pending in connection with sites in other U.S. states. The news comes as med-tech trade associations register their disappointment with an EPA proposed rule for EtO that both the Medical Device Manufacturers Association (MDMA) and the Advanced Medical Technology Association (Advamed) argue would crimp availability of sterilization capacity, which would in turn create shortages of medical devices and supplies that are desperately needed by patients.
The U.S. Environmental Protection Agency (EPA) has proposed a more stringent set of requirements for the use of ethylene oxide for sterilization of a variety of products, including medical devices, a proposal that is expected to increase the cost of operating these facilities.