Manufacturing
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EPA wants more data from ethylene oxide sterilizers, strikes device-friendly tone
Administrator Andrew Wheeler said "medical device sterilization is vital to protecting public health" on release of a notice ahead of rulemaking that could impact sterilizers reliant on the carcinogenic gas.
By David Lim • Dec. 06, 2019 -
Q&A5 insights into Dexcom's year ahead from CEO Kevin Sayer
The diabetes tech giant has "not turned on the faucet full blast" in marketing to new customers. Sayer told MedTech Dive he plans to change that as Dexcom quadruples its sensor production capacity for its continuous glucose monitors.
By Maria Rachal • Nov. 25, 2019 -
FDA launches pilot to speed new ethylene oxide sterilization methods
Device makers should also reduce paper in packaging "as soon as possible" to trim the amount of the gas required for effective sterilization. The agency also named its innovation challenge winners.
By David Lim • Nov. 25, 2019 -
AdvaMed lobbied EPA chief Wheeler on cancer report amid delay in ethylene oxide regs
A bipartisan congressional task force is pushing EPA to issue ethylene oxide regulations that rely on EPA's 2016 report on the toxicity of the gas.
By David Lim • Nov. 22, 2019 -
FDA clears Pentax duodenoscope with disposable part in bid to cut infection risk
Center for Devices and Radiological Health Director Jeff Shuren called the clearance "another major step toward lowering the risk of infection among patients," and said duodenoscope safety is a top priority for the agency.
By David Lim • Nov. 18, 2019 -
Edwards recalls Pascal valve guide sheath in Europe amid potential for embolizations
A manufacturing problem resulting in damage to the inner lining of the sheath in fewer than 1% of devices prompted the recall. No adverse events were linked to the issue.
By Susan Kelly • Nov. 18, 2019 -
FDA advisers: Metal implants need beefed up ingredient labels
Industry representative Whitney Christian, a toxicologist at Medtronic, told the panel that medical device manufacturers support patients' and doctors' "right to know" what's in implants and are willing to work with FDA on the issue.
By Maria Rachal • Nov. 15, 2019 -
Duodenoscope reprocessors' poor work conditions exacerbate infection problem, FDA panel says
The advisory meeting followed FDA disclosing reports of three deaths, 45 patient infections and 159 cases of device contamination related to inadequate device reprocessing between October 2018 and March 2019.
By David Lim • Nov. 08, 2019 -
SponsoredStreamlining your portfolio can actually improve profitability. Here's how.
Retiring products is not an easy decision, but taking this step can have a real and positive impact on the P&L, customer, cross-functional teams and the ability to drive innovation.
By Matt Singer • Oct. 08, 2019 -
Sterigenics abandons effort to reopen Willowbrook ethylene oxide sterilization facilities
The company behind the major medical device sterilization plant said it is "actively taking steps to ensure customer and patient needs continue to be met by our other facilities."
By David Lim • Sept. 30, 2019 -
EPA delays ethylene oxide sterilizer rule timeline amid industry pushback
Separately, it is unclear how long it will be until a second proposed rule that aims to address air pollution emissions from the ethylene production process is published.
By David Lim • Sept. 25, 2019 -
FDA warns closure of Atlanta Sterigenics facility could impact medical device supply
Sterigenics said it aims to complete construction of technology upgrades at the plant, designed to reduce ethylene oxide emissions, by early October.
By David Lim • Sept. 16, 2019 -
FDA sets November ethylene oxide sterilization, duodenoscope safety advisory panel
The dual-topic expert panel will be tasked with developing recommendations for FDA on two of the largest challenges currently facing the Center for Devices and Radiological Health.
By David Lim • Sept. 03, 2019 -
Medline, Vantage ethylene oxide emissions caused cancer, lawsuits claim
Commercial sterilizer Sterigenics, which was forced to shut down a Willowbrook medical device sterilizing plant in February, is defending itself against at least 32 lawsuits in the same state court over similar claims.
By David Lim • Aug. 29, 2019 -
Sterigenics strikes deal to reopen Willowbrook sterilization plant
The closure of the Illinois facility caused millions of dollars of losses for major medical device firms like Medtronic, Boston Scientific and Smiths Medical.
By David Lim • UPDATED: Sept. 9, 2019 at 10:41 a.m. -
FDA launches innovation challenge to boost ethylene oxide sterilization alternatives
The agency also plans to hold an advisory committee meeting Nov. 6-7 to discuss how to further encourage innovations in medical device sterilization.
By David Lim • July 16, 2019 -
Baxter to expand home dialysis on heels of Trump kidney initiative
Amid a push to move away from costly dialysis centers, Baxter said it expects to add and bolster facilities for making and distributing peritoneal dialysis solutions, devices and cassettes.
By Maria Rachal • July 11, 2019 -
FDA hits Clinicon with warning letter over sterility failings
Inspectors found fault with the validation and calibration of processes and equipment involved in ensuring sterility of laser devices.
By Nick Paul Taylor • July 11, 2019 -
Amazon's momentum in medical supply chain slowing, poll finds
A UBS survey of hospital purchasing managers found providers are allocating purchases of surgical tools, orthopaedic and cardiology implants, and other medical supplies to Amazon at a lower rate this year compared to 2018.
By Rebecca Pifer • July 10, 2019 -
Deep DiveLooming EPA ethylene oxide rules hang over device supply chain
The medical device industry is lobbying Capitol Hill and statehouses, warning limited access to the sterilant could pose deadly disruptions.
By David Lim • June 25, 2019 -
B. Braun invests $1B in IV fluid manufacturing to alleviate shortages
FDA's task force on drug shortages is expected to submit a report to Congress by year's end outlining potential solutions to address root causes of scarcities.
By David Lim • May 15, 2019 -
Haemonetics sells plant, gains expanded indication for blood analyzer systems
After reporting a 6.7% jump in quarterly revenue, the blood technologies maker has offloaded a manufacturing site to CSL Plasma and received clearance for use of its hemostasis analyzer system in adult trauma settings.
By Susan Kelly • May 15, 2019 -
Medical equipment hit by escalation of US-China trade war
Between tariffs already enacted and an additional $300 billion in products on the table, imaging equipment, diagnostic reagents, surgical gloves and contact lenses stand to be among the medical devices affected.
By Nick Paul Taylor • May 15, 2019 -
FDA floats 5-day notice for device inspections in draft guide
The agency is filling an obligation under the FDA Reauthorization Act of 2017 to adopt uniform standards around not-for-cause inspections.
By David Lim • March 29, 2019 -
Accenture to buy Irish manufacturing services firm ESP
ESP will join Accenture's digitally-focused unit and bring along its clients, which include Stryker and Boston Scientific.
By Kristin Jensen • March 07, 2019
