U.S. Rep. Suzan DelBene (D-Wash) reintroduced a bill today to improve Medicare patient access to breakthrough medical devices. The Ensuring Patient Access to Critical Breakthrough Products Act of 2019 (H.R. 5333) would require Medicare to temporarily cover all devices approved through the FDA’s breakthrough pathway for three years, during which the Centers for Medicare and […]
Medical device tax will cost 20,000 jobs, report says
The medical device excise tax could result in a loss of 21,390 full-time jobs and a GDP reduction of $1.7 billion, according to a report from the Tax Foundation, a nonpartisan, business-friendly think tank. According to the report, the tax is projected to raise about $25 billion over the next 10 years. Other research from […]
Federal agencies will control the fate of medtech’s most-used sterilization method
The fate of the medical device industry’s most widely used sterilization process lies in the hands of the Environmental Protection Agency. The EPA gave the medtech industry mixed signals in November about the gas used to sterilize billions of devices annually. The agency said it might seek to cut industrial emissions of ethylene oxide (EtO) […]
Insights from Cathy Burzik’s 40 years in the healthcare industry
From the early days of software development to personalized cell and gene therapies, Cathy Burzik has witnessed a lot of technological evolution over the course of her 40-year career in the healthcare industry. She sat down with DeviceTalks’ former program manager Sarah Faulkner for an interview at AdvaMed’s The MedTech Conference this year, where she […]
EPA proposes drastic cuts to EtO emissions nationwide
The EPA has announced plans to greatly reduce industrial emissions of ethylene oxide (EtO), the carcinogenic gas used to sterilize billions of medical devices annually. The agency proposed cutting EtO emissions from industrial facilities by 93% as part of amendments to the Miscellaneous Organic Chemical Manufacturing National Emission Standards for Hazardous Air Pollutants (NESHAP) to reduce hazardous […]
Battles over sterilization plants intensify as industry warnings about shortages grow
The fight over plants that use ethylene oxide (EO) to sterilize medical devices is escalating across the country. New proposed legislation in Illinois would ban the use of the carcinogenic gas by sterilizers by 2021 and by hospitals by 2022, according to reports by the Chicago Tribune. A legislative hearing on the bill is scheduled for […]
Georgia mayor wants BD sterilization plant shuttered for now
The mayor of Covington, Ga. has asked Becton Dickinson (NYSE:BDX) to temporarily shut down a plant there following a weeklong leak of the gas it uses to sterilize medical devices. A letter from Mayor Ronnie Johnston says that independent air quality tests performed for the city from Sept. 17 to Sept. 24 revealed “particularly high levels of […]
AdvaMed launches digital health center
AdvaMed said this week that it launched a Center for Digital Health advocacy platform for advancing digital health and highlighting the contributions of the medtech industry to data-driven health care. The association established its Digital Health Sector in 2016 to serve the needs of companies in the space, and it said the new center is […]
BD Georgia sterilization plant leaked 54 lbs. of ethylene oxide in September
A weeklong valve leak at a Becton Dickinson (NYSE:BDX) medtech sterilization plant in Covington, Ga., released 54 lbs. of ethylene oxide into the air, according to a City of Covington incident report obtained by a local TV station. The plant began experiencing intermittent elevated levels of EO indoors Sept. 15, but inspections and systems checks failed to locate the […]
A ‘rolling effect’ on medtech sterilization plants?
The types of regulatory hurdles that contributed to the permanent closure this week of the Sterigenics medtech sterilization plant in Willowbrook, Ill., have created a “rolling effect” on ethylene oxide (EO) plants around the country, according to an industry official. The state of Illinois temporarily shut down the Willowbrook plant in February over emissions of EO, a […]
Medtech trade lobbies unite for anti-tax push
A group of medical device industry trade associations are joining together to push the U.S. Congress toward repealing the medical device tax that’s been in abeyance since 2015. MDMA, AdvaMed, MITA and a group of medical innovators, physician inventors, patient groups and more today sent a letter urging congressional leadership to permanently repeal the medical […]
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