Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers

FDA – October 28, 2022 Update

On October 27 2022, the FDA cleared changes to Fresenius Medical’s 2008T hemodialysis machines that include use of modified silicone tubing in the hydraulics of the machine, specifically platinum catalyst silicone tubing. Based on information provided by the manufacturer, non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) were not detected in machines with the modified silicone tubing. 2008T hemodialysis machines with modified silicone tubing will be shipped after October 27 2022, and should be used according to their instructions for use. The recommendations in the May 6, 2022, letter below do not apply to these machines with the modified silicone tubing.

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Sleep apnea device recall drags on, stoking frustration

AP News – October 25, 2022 – By MATTHEW PERRONE

WASHINGTON (AP) — A massive recall of millions of sleep apnea machines has stoked anger and frustration among patients, and U.S. officials are weighing unprecedented legal action to speed a replacement effort that is set to drag into next year.

Sound-dampening foam in the pressurized breathing machines can break down over time, leading users to potentially inhale tiny black particles or hazardous chemicals while they sleep, manufacturer Philips warned in June 2021.

Philips initially estimated it could repair or replace the units within a year. But with the recall expanding to more than 5 million devices worldwide, the Dutch company now says the effort will stretch into 2023.

That’s left many patients to choose between using a potentially harmful device or trying risky remedies, including removing the foam themselves, buying second-hand machines online or simply going without the therapy.

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How Medtronic’s billion-dollar HeartWare device went bust

StarTribune – July 9, 2022 – By Burl Gilyard

The company spent five years developing updates that were never completed, derailed by FDA recalls and life-threatening manufacturing defects.

Five years after Medtronic’s billion-dollar purchase of HeartWare International, the company discontinued the device at the center of acquisition — a miniaturized, implantable heart pump — with no clear plans for ever selling it again.

Despite pulling it from the market one year ago, Medtronic is still dealing with the fallout from the device’s shortcomings, including lawsuits, ongoing regulatory recalls and media investigations.

The HeartWare Ventricular Assist Device (HVAD) was designed for patients battling severe heart failure. Once the market leader, HVAD is now associated with a number of life-threatening manufacturing defects that resulted in serious adverse patient events, including at least 14 deaths.

Several medical technology experts said it was surprising HeartWare remained on the market as long as it did.

“I think the question [at the time] was, ‘Why hasn’t it been pulled from the market yet?'” said Madris Kinard, CEO of Pennsylvania-Based Device Events. “When it happened we were thinking, ‘Of course. This needed to happen.'”

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Signals Newsletter – July 2022 – Ventilators (CPAP & BiPAP)

DEVICE DETAILS
PRODUCT CODES – DESCRIPTION                                                   
BZD                         Ventilator, Non-Continuous (Respirator)
MNS                        Ventilator, Continuous, Non-Life-Supporting

REPORTS RECEIVED BY THE FDA                                                   

View Signals Newsletter – July 2022 – Ventilators (CPAP & BiPAP)

FDA can’t explain drop in device recalls, but experts point to COVID disruptions

Medical Design & Outsourcing – July 6, 2022 – By Danielle Kirsh 

The FDA acknowledged interruptions with notifications from recalling firms during the pandemic, while regulatory experts point to fewer inspections and fewer procedures.

FDA medical device product recalls dropped last year to their lowest level since 2013, according to a Medical Design & Outsourcing analysis of recall data from the regulatory agency.

Medtech regulatory experts said the COVID-19 pandemic showed room for improvement in FDA oversight and postmarket surveillance of medical devices.

Device products recalled in fiscal year 2021 (ended Sept. 30, 2021) totaled 2,607, a 14.3% decrease from the 3,042 recalls reported in fiscal 2020.

Making the difficult call

Some devices may have stayed on the market longer than they should have due to a fear of shortages in healthcare facilities during the pandemic, said Madris Kinard, the founder and CEO of Device Events and a former unique device identification (UDI) external program manager and adverse events SME for medical devices at the FDA.

“The companies are making these decisions, and then the FDA might review them, but isn’t necessarily taking an active enough approach,” Kinard said.

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‘Where’s the patient?’: Experts question FDA’s final recall guidance

MEDTECHDIVE – April 6, 2022 – By Ricky Zipp

While the guidance encouraged the use of electronic communications in recalls, a change experts have advocated for, some questioned why the agency did not address more problems with the system.

Medical device recalls and product safety issues have gained public attention over the last several years.

Patients, in particular, have questioned the recall process and criticized the FDA and industry after high-profile events highlighted inefficiencies in the system that put patient safety at risk.

Madris Kinard, CEO of Device Events, a company that compiles and interprets FDA medical device reports and recalls, also thought the inclusion of electronic communications was needed but added that the agency still did not go far enough to address the issue.  “I felt [the guidance] was not written strongly enough,” Kinard said, “because there are serious deficiencies with the recall processes, and moving to all electronic notifications is critical and long, long past due, and that wasn’t mandated or even encouraged as strongly as it needed to be.”

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Millions reported problems with dental implants

YouTube Video – November 9, 2021 – azfamily powered by 3TV & CBS5AZ 

Arizona’s Family Investigates looked into the costly procedure of getting dental implants and why millions of reported problems went unnoticed.

Madris Kinard, CEO and Founder of Device Events, is interviewed at 2:32 of the video.  The Device Events software was used to search the FDA’s MAUDE database and to provide metrics on medical device adverse event reports for this investigation.

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FDA says Philips knew about toxic foam for years before massive recall

Medical Design & Outsourcing – November 16, 2021 – By Jim Hammerand 

The FDA said it observed potential violations of federal medical device safety rules when inspecting a Philips Respironics manufacturing facility connected to the Class I recall of more than 15 million respiratory devices.

The FDA recently requested additional safety testing on replacement materials and issued a Form 483. The form details how Philips and its foam supplier were aware for years that polyester-based polyurethane (PE-PUR) sound abatement foam could break down and potentially enter a device’s air pathway, causing health problems for users.

In the Form 483, FDA alerted management at the Royal Philips (NYSE:PHG) subsidiary of conditions that the inspector considered possible violations of the U.S. Food, Drug and Cosmetic Act or related regulations. The post-inspection report is not a determination of wrongdoing and will be considered by the FDA along with any evidence or documents collected from the facility and responses offered by Philips.

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Signals Newsletter – October 2021 – Staples & Staplers

DEVICE SPOTLIGHT

PRODUCT CODES – DESCRIPTION                                                   
GAG                           Stapler, Surgical
GDW                          Staple, Implantable

REPORTS* RECEIVED BY THE FDA                                                    


 

 

 

 

 

* Includes both Medical Device Reports (MDRs) and Alternative Summary Reports (ASRs)

View Signals Newsletter – August 2021 – Staples & Staplers