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 […]
U.S. exempts more Chinese medtech products from tariffs
The U.S. has exempted another 18 medical devices or device components from the 25% tariffs imposed on Chinese goods by the Trump administration. The new list includes ultrasound, X-ray, MRI and infusion equipment. The Office of the U.S. Trade Representative (USTR) said the new exclusions are retroactive to August 23, 2018, when additional tariffs went […]
Ethylene oxide plant reopening won’t halt FDA plans to seek alternatives
The FDA will continue its efforts to find alternative medical device sterilization methods to ethylene oxide (EO), even though a major EO plant is slated to reopen. Yesterday, medtech sterilization company Sterigenics and the state of Illinois announced they had reached a proposed consent agreement to reopen a plant in Willowbrook, Ill., which the state shut down in […]
Sterigenics moves to upgrade shuttered device sterilization plant
Sterigenics said today that it has applied for permits to upgrade emissions controls at its Willowbrook, Ill. medical device sterilization plant, which had sterilized thousands of devices daily until its Feb.15 shutdown. The Illinois Environmental Protection Agency (EPA) closed the Willowbrook plant, citing excessive emissions of the sterilant ethylene oxide (EO), based on a federal […]
Tariffs on Mexico could hit medtech hard
The medical device industry is bracing for a potential multi-million-dollar fallout from a proposed tariff on all products coming into the United States from Mexico. The StarTribune of Minneapolis reports that the cost of these devices could skyrocket and that the effects would be widespread within the industry, costing tens of millions of dollars a […]
AdvaMed head Whitaker lauds FDA, ignores recent device issues in NYT Op-ed response
AdvaMed prez & CEO Scott Whitaker shot back at a New York Times op-ed published earlier this month pushing for tighter FDA regulations, calling the federal watchdog “the gold standard the world over” while avoiding commenting on any of the issues raised in the original piece. Last week, the Times cited a number controversial devices […]
Sterilization plant closures: Here’s why you need to care
The recent shutdown of a Sterigenics medical device sterilization plant in Willowbrook, Ill. has affected medtech giants such as Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), according to an FDA list of devices processed at the sterilization plant. Medium-sized and smaller firms, including Teleflex (NYSE:TFX), Arthrex and ArthroCare also had devices processed there. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, […]
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