From personal protective equipment like N-95 face masks to critically important medical equipment like ventilators, product shortages were common during the pandemic. Supply chain problems for some essentials have since been resolved, but other shortages remain a problem for hospitals, doctors and patients across the country. Devices rarely used to date include external defibrillators, chest drains, suction canisters, and numerous dialysis products.
Yet another medical device appears to be in great shortage, possibly due to the lack of certain raw materials used in the manufacturing process.
Food and Drug Administration Maintain a regularly updated list This is a limited medical device.this is Latest entry It concerns an intra-aortic balloon pump device, also known as an IABP. Manufactured by Getinge, a long-established medical technology company headquartered in Sweden, IABP devices are primarily used by cardiologists to provide temporary support to the ventricles of the heart, thereby affecting its normal functioning. Help patients cope with the health implications. The ventricles act as muscle chambers and help pump blood from the heart to the rest of the body’s cells.
Like most medical devices, IABPs require various supporting materials to be assembled and ready for use. So Getinge told how he dealt with health care providers in November. Broader supply chain challenges It was jeopardizing our ability to produce items and fulfill orders.
Getinge product Jennifer Paradise says: In a letter obtained by Medtech Dive.
A combination of factors that plague production
The letter does not say which specific raw materials are jeopardizing a manufacturer’s ability to produce high volumes, but it does name other factors that contribute to the problem. including demand and limited availability of “device components, parts, or accessories.”
It also did not predict when Getinge could ramp up production, but noted that it continued to manufacture IABPs, but not at the pace it hoped to meet growing demand. . Meanwhile, the FDA says the shortage will last until next year.
Regarding potential workarounds, Paradise said it provides guidance on proper maintenance to ensure IABP is working properly and avoiding potential malfunctions. The FDA noted on its website what it is doing to remedy the situation, adding that it will continue to monitor the latest developments and report updates as needed.
This isn’t the first time Getinge’s own device has made headlines. Last year, the FDA issued a recall It was used in an intra-aortic balloon pump after being advised by a Swedish manufacturer that the battery could fail and compromise patient safety and well-being. At the time, the recall affected more than 4,300 of his devices in the United States manufactured between early March and late October 2021.
