Affected by a significant number of recent major medical device recalls, Medtronic claims it is toughening internal evaluations for purchasing new goods.
The firm, which has its operations headquarters in Fridley, has seen an unusually high number of Class I recalls: 11 in 2022 and 12. The most severe, life-threatening medical device issues are given Class I designation by the US Food and Drug Administration.
For instance, Medtronic had an annual average of five Class I recalls between 2017 and 2020.
The HeartWare Ventricular Assist Device (HVAD), which Medtronic purchased in 2016, has been the subject of seven of the company’s 23 recalls over the last two years. Three of the recalls happened this year, and four occurred in 2021.
According to Erika Winkels, a Medtronic spokesperson, “Acquired devices (such as HVAD) have been the major driver to Class I… growth.” “Our approach for evaluating and integrating acquired items has been improved to limit the impact of acquired products to product quality concerns going ahead,” the statement reads.
14 fatalities have been attributed to HVAD device flaws as of June 2021, when Medtronic discontinued sales of the troubled product. The 2022 recalls from Medtronic have so far been connected to a few fatalities.
Many people are alarmed by the increase of recalls at the biggest manufacturer of medical devices worldwide.
The National Center for Health Research, a nonprofit organization based in Washington, DC, that works to increase the safety and efficacy of medical products, said Diana Zuckerman: “Clearly there’s a problem when a company has this many recalls — Class I recalls on important, potentially life-saving devices.
When Medtronic paid $1.1 billion to purchase HeartWare International Inc. of Massachusetts, it made a significant wager on HVAD technology. However, unraveling the product’s series of legal and regulatory issues has cost Medtronic just as much. Medtronic has incurred costs related to leaving the HVAD business of $1.1 billion, according to information in a financial statement made earlier this year.
According to Zuckerman, Medtronic is still accountable for the safety of its devices even after acquiring technologies from other businesses. One problem, according to her, is caused by the way the FDA regulates medical devices, many of which, unlike medicines, are not required to submit any clinical trial data before clearance.
It does put the onus on the firm, but it is a recognized shortcoming of the FDA, she added. Companies should take extra precautions to ensure that their product is safe, regardless of what the FDA expects of them.
With the exception of situations deemed mission vital, the FDA ceased the majority of domestic and overseas inspections when the pandemic struck.
According to Rachna Shah of the Carlson School of Management at the University of Minnesota, who specializes in studying medical device and pharmaceutical recalls, Class I medical device recalls are rising across the board in the sector.
Shah said that recalls “are often greater.” According to her, one reason for more major recalls might be because device manufacturers relaxed their standards for product safety evaluations as the FDA performed less inspections.
She anticipates that by the end of the next year, recalls will remain somewhat higher.
However, Medtronic has much more recalls than its rivals. Abbott, situated in Illinois, has only seen one recall this year. Boston Scientific Corp., situated in Massachusetts, has not issued any recalls in 2022. Baxter International, located in Illinois, has had five recalls. These three businesses are all active in Minnesota.
Due to the fact that it produces more medical devices than any other company in the market—31.7 billion dollars in fiscal 2022—Medtronic is at a greater recall risk.
Among its many business divisions, $14.4 billion in medical device sales were made by Abbott in 2021. Boston Scientific reported $11.9 billion in sales. Baxter’s medical equipment sales last year were $10.5 billion, excluding its pharmaceutical business. The total revenues of those three firms and 86% of Medtronic’s revenue.
According to Medtronic’s Winkels, the amount of Class 1 recalls in recent years is unusual for the company.
A patient safety and risk board has also been introduced by Medtronic, who have developed a central medical safety organization. The board, which oversees patient safety decisions, is made up of top professionals from a number of departments, including medical safety, quality, regulatory, and legal. Both were put into action in 2022.
Noel Colon, chief quality officer of Medtronic, said, “We have analyzed our end-to-end quality performance, and we are focused on achieving lasting improvements. In areas including risk assessment, product design, and integration of acquired medicines and solutions, he said the corporation has enhanced control.
Recalls of medical equipment often start with the manufacturer, which notifies physicians and patients when a problem is found. A recall that appears on the FDA’s index for 2022 may have been initiated by the firm in 2021, since the FDA normally does not identify the severity of the recall — Class I, II, or III — until a few months later.
In contrast to recalls of foods and consumer goods, those of medical devices may not always include the removal of the gadget from the patient and its return to the manufacturer. Recalls may entail making changes to device settings, software upgrades, or product labeling.
When a recall occurs, Medtronic conducts a thorough investigation to address the problem and stop it from happening again, according to Winkels.
Due to the large number of recalls this year, Medtronic has put new strategies and processes in place, including a more thorough examination of a device’s risk assessment.
Winkels said that the business “used external specialists to enhance internal Medtronic resources and for independent viewpoint and subject area knowledge.”
The FDA classified the business’s recall of NIM endotracheal tubes as a Class I case in September. Between March 31, 2020, and March 31, 2022, Medtronic documented 15 complaints, two fatalities, and three injuries associated with the device.
In August, the FDA announced a Class I recall for the Cobalt, Cobalt XT, and Crome defibrillators owing to the possibility of giving the patient fewer shocks than required. A software update was released to fix the problem. There were 27 complaints sent to Medtronic, but no fatalities or injuries.
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