Production of cardiac devices slowed by raw materials shortage

From personal protective equipment like N-95 face masks to vitally important medical devices like ventilators, product shortages were a common occurrence throughout the pandemic. While supply chain issues for some essentials have since been resolved, other shortages remain problematic for hospitals and physicians, as well as patients throughout the country. The devices that remain rare to this day include external defibrillators, chest drains, suction canisters and a number of dialysis products.

It appears that yet another medical device is quite scarce and it may be due to a deficiency of certain raw materials that are used in the manufacturing process.

The Food and Drug Administration maintains a regularly updated list of medical devices that are in limited quantity. Its latest entry concerns intra-aortic balloon pump devices, otherwise known as IABP. Made by the manufacturer Getinge, a long-standing medical technology company headquartered in Sweden, IABP devices are primarily used by cardiologists to help patients deal with health effects impacting the normal function of their hearts by providing temporary support to the ventricles. The ventricles serve as a muscular chamber and help pump blood from the heart out into the rest of the body’s cells.

As with most medical devices, the IABP requires a variety of supplementary materials to be assembled and made ready for use. That’s why in November, Getinge informed healthcare providers of how broader supply chain challenges were compromising its ability to produce items and meet orders.

“You should know that ongoing supply chain issues have significantly impacted our ability to build intra-aortic balloon pumps (IABPs), intra-aortic balloon catheters (IABs) and spare parts due to raw material shortages,” wrote Jennifer Paradise, a Getinge product representative, in a letter obtained by Medtech Dive.

Supply chain issues are affecting the availability of heart-related medical devices. Supply chain issues are affecting the availability of heart-related medical devices.

Combination of factors plaguing production
While the letter does not state which specific raw material is compromising the manufacturer’s ability to produce at a higher volume, it does cite other factors contributing to the issue. These include higher-than-normal demand for the device and the limited availability of a “component, part or accessory of the device.”

The missive also did not predict when Getinge would be able to ramp up production but did point out that it continues to fabricate the IABPs, just not at the pace it would like to in order to meet the growth in demand. The FDA, meanwhile, says that the shortage will persist into next year.

As for potential workarounds, Paradise noted that it would provide guidance for proper maintenance to ensure that IABPs will operate properly and avoid the potential of malfunction. The FDA made mention of what it’s doing to improve the situation on its website, adding that it will continue to monitor the latest development and will report any updates on an as-needed basis.

This isn’t the first time Getinge’s proprietary device has made headlines. Last year, the FDA issued a recall for intra-aortic balloon pumps after being advised by the Swedish manufacturer that the battery could fail, compromising the safety and welfare of patients. At the time, the recall affected over 4,300 devices in the US that were manufactured sometime between early March and late October 2021.

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