FDA removes dialysis-related products from device shortage list

The FDA has removed two dialysis-related product codes from its device shortage list.

The products — kidney perfusion system (product code KDN) and disposable kidney perfusion set (product code KDL) — had been on the FDA’s shortage list since January 2022.

The agency attributed the shortages to a “shortage or discontinuance of a component, part or accessory of the device” and shipping delays.

As of the May 2023 expiration of the COVID-19 public health emergency, the FDA no longer requires medical device manufacturers to report product shortages, though the agency encourages voluntary reporting of device production interruptions or permanent discontinuations.

The medical device shortages list now only includes five product codes, including automated external defibrillators (AEDs) and two types of oxygenator devices intended for extracorporeal circulation:

BYS: Oxygenators for long-term support (greater than 6 hours), added to…
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Medtronic cuts suppliers and manufacturing sites, CEO says in supply chain and operations update

Medtronic CEO and Chair Geoff Martha [Photo courtesy of Medtronic]

Medtronic is closing at least five manufacturing sites, consolidating distribution centers and stopped doing business with approximately 200 suppliers as part of a push to improve its operations and supply chain.

That’s according to a presentation by Medtronic Chair and CEO Geoff Martha at the J.P. Morgan Healthcare Conference today emphasizing the focus on profitability at the world’s largest medical device manufacturer.

“One of the biggest opportunities for us to leverage our scale and drive leveraged earnings over time is with our global operations and supply chain,” Martha said. “We spent nearly $11 billion on cost of goods sold last year. That’s a lot. And over half of the company’s employees are involved in global operations and supply chain.”

Medtronic is “also beginning to wor…

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FDA expects longer AED shortage, reports plans for Abbott HeartMate II discontinuation

The FDA now expects shortages of automated external defibrillators (AEDs) to persist longer than previously estimated, but removed four other product types from its list of medical device shortages.

The agency also added to its list of discontinued devices, including plans by Abbott to stop manufacturing its HeartMate II Left Ventricular Assist System (LVAS) in 2026.

AED shortage update

The FDA said shortages of wearable and non-wearable AEDs (product codes MVK and MKJ, respectively) will likely last through summer 2024. The federal agency updated its forecast last month after saying as recently as October that the shortage would last through 2023.

The FDA said the shortages are due to an increase in demand for the devices as well as a shortage or discontinuance of a component, part or accessory. Those devices have been on the shortage list since July 2022 as the agency required manufacturers to file for premarket approval (PMA) for previously cleared ac…

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Medtech vet Sean Gilligan’s tips and red flags for vetting suppliers

AVS Chief Operating Officer Sean Gilligan [Photo courtesy of AVS]

After a career spanning almost three decades at Boston Scientific, Sean Gilligan’s new role at a startup has him working more closely with contract manufacturers and suppliers.

Gilligan is the chief operating officer at Amplitude Vascular Systems (AVS), which is developing a new intravascular lithotripsy system for treating severely calcified arterial disease.

He joined the Boston-based startup in March 2023 after a 29-year career at Boston Scientific. He started in 1994 as an engineer in Ireland and moved his way up to VP of program management and R&D, leading the portfolio for a large part of the interventional cardiovascular business.

“I had my fingers on a lot of different areas. I wasn’t in the weeds dealing with too many suppliers — we had a whole supplier engineering group [of] experts who had expert rel…

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Stryker CEO Kevin Lobo offers supply chain update after ‘wild year’

Kevin Lobo is CEO and chair of Stryker. [Photo courtesy of Stryker]

The medtech industry as a whole suffered over the past year or so as supply chain issues — namely semiconductors — came to a head.

Midway through last year, Medtronic CEO Geoff Martha labeled it as a problem for everyone as medtech’s biggest names navigated serious shortages of chips and other key supplies.

An industry survey from Deloitte showed that some medtech manufacturers slowed down or halted manufacturing operations after depleting their semiconductor inventories. Nearly 80% of survey respondents reported extended lead times, with some stretching more than a year.

At AdvaMed’s The MedTech Conference on Monday in Anaheim, Stryker Chair and CEO Kevin Lobo explained the low point that his company and the industry hit last year.

“In this industry, we never had to worry about [chip supply] before,” Lobo…

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FDA removes more products from medical device shortages list

The FDA removed more products from its medical device shortages list as supply chain issues from the COVID-19 pandemic continue to improve.

The federal safety agency recently removed devices spanning 17 different product codes, including ventilator products

The products removed from the FDA medical device shortages lists in the latest update were:

Ventilation-related products

The FDA removed three ventilation-related devices from the list: non-continuous ventilators (product code: BZD), non-life-supporting continuous ventilators (product code: MNS) and continuous ventilators with minimal ventilatory support for facility use (product code: MNT).

All had been in short supply due to the global semiconductor shortage and good manufacturing practices requirement compliance. Increase in demand was another factor specific to non-continuous ventilators, which had been in short supply since at least August 2020. The shortage of the two continuous ventilato…

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How Medtronic’s conflict minerals program investigates red flag suppliers

Gold is one of the most commonly used conflict minerals. [Illustration by Yuliia via Adobe Stock]

Materials like gold, tin and tungsten can save lives when used in medical devices, but global manufacturers like Medtronic must take steps to avoid inadvertently funding violence and human rights abuses with these “conflict minerals.”

Medtronic is the largest medical device company in the world, so its conflict minerals program is a good example of how medtech manufacturers look deep into their supply chain to comply with federal disclosure requirements.

“At Medtronic, we’re committed to maintaining good citizenship as a company, which includes obtaining the minerals necessary to manufacture our products only from socially responsible sources,” the company said in a statement to Medical Design & Outsourcing.

What are conflict minerals?

Conflict minerals include cassiterite,…

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FDA removes products from medical device shortage list, reports AED discontinuation

The FDA removed several products from its medical device shortages list and expects the shortage of prefilled saline flush syringes to end soon.

The agency also said Stryker is discontinuing certain automatic external defibrillators (AEDs), a product category for which manufacturers have faced heightened regulatory scrutiny in recent years.

Previously: FDA’s mandatory medical device shortage reporting ends

Relief in sight for prefilled saline flush syringe shortage

Prefilled 0.9% sodium chloride intravenous lock/flush syringes have been in short supply since at least March 2022 due to increased demand. At the same time, supply chain challenges and manufacturing discontinuances have reduced product availability.

These single-use syringes help to prevent blockage of vascular access systems and remove residual medication from the catheter site.

The FDA estimates the prefilled saline flush syringe shortage will end in October 2023. Until then, …

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Medtronic CEO Geoff Martha offers updates on supply chain, labor, R&D, Hugo and more

Medtronic CEO and Chair Geoff Martha [Photo courtesy of Medtronic]

Medtronic CEO and Chair Geoff Martha spoke today at the Goldman Sachs Annual Global Healthcare Conference, sharing insights on a range of important issues for medtech developers.

Martha — who leads the world’s largest medical device company — offered his latest observations on labor, supply chain issues and international markets. He also discussed plans to increase R&D spending and the latest on Medtronic’s surgical robotics system, Hugo.

The 35-minute interview is already available for replay. The following excerpts have been lightly edited for space and clarity:

Labor issues are abating, allowing for increased procedure volumes

“The labor markets have gotten a little better. Some of the procedures that were lagging were really dependent on labor like TAVR (transcatheter aortic valve replacement) and things l…

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FDA’s mandatory medical device shortage reporting ends

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

Reporting of medical device shortages to the FDA is no longer mandatory with last week’s expiration of the COVID-19 public health emergency.

Manufacturers can still voluntarily report device production interruptions or permanent discontinuations to the FDA. Patients, healthcare providers, healthcare systems and other stakeholders can also notify the FDA of any supply chain disruptions they’re experiencing by emailing patients, healthcare providers, healthcare systems, distributors, group purchasing organizations) experiencing supply chain disruptions may also notify the FDA by emailing [email protected].

“The FDA encourages device…

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FDA updates medical device shortage list due to shipping delays and semiconductors

Medical device shortages persist due to shipping delays and semiconductor availability, the FDA said last week in an update to its medical device shortage list.

The updated medtech products in short supply include radiological devices, general plastic surgery devices, cardiac diagnostic and monitoring products, general ICU/ hospital products, specimen collection supplies and ventilators.

Philips Invivo MRI breast biopsy grid plates

Philips product shipping delays caused a shortage of magnetic resonance imaging (MRI) breast biopsy grid plates used with breast biopsy/localization trays, surgical guide needles and specialty magnetic resonance coils.

Those Philips Invivo MRI breast biopsy grid plates have been on the shortage list since October 2022 after imaging facilities notified the FDA of the shortage in July. The FDA said it does not know how long the shortage will last, but said it “is still compiling and evaluating data on manufacturing and pro…

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ResMed’s new factory brings it closer to meeting CPAP demand after Philips recall

The AirSense 11 CPAP system [Image courtesy of ResMed]

The opening of a new plant — billed as the biggest of its kind on Earth — brings ResMed closer to catching up with skyrocketing CPAP demand.

That was one of the big takeaways from ResMed CEO Mick Farrell’s talk at the annual J.P Morgan Healthcare Conference in San Francisco yesterday. The San Diego–based company has found supply chain challenges hindering its ability to meet the demand that surged after a serious recall forced competitor Philips out of the market.

“Every month and every quarter we get closer to meeting that demand,” Farrell said.

ResMed held a grand opening for the 270,000-square-foot Singapore plant in November. Farrell yesterday described it as the biggest respiratory devices manufacturing facility on the planet.

“We have the capability in that plant to take the whole of the market’s need…

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