Medical device failures can potentially have harmful and costly results for healthcare professionals and patients.
It is essential to avoid medical device failures as they can be the difference between life and death. Medical devices are used by millions worldwide every day and, when failures happen, the responsible business will have to recall all affected devices and/or advise customers on the potential problems the device could cause.
Some of these recalls are recorded, classified and published online by the US Food and Drug Administration (FDA).
The FDA assigns each recall a classification, Class I, Class II or Class III. Class I recalls pose the most serious health hazard, making the removal of the device from the market, hospitals and homes the highest priority for the FDA. The FDA only assign a Class I recall to a device where use of the device may cause serious injury or death.
In this blog, we will look at five medical devices that have been medical device failures and have required intervention by the FDA.
Allergan breast implants
Breast implants are used in breast augmentation surgery and breast reconstruction from trauma and cancer.
In July 2019, Allergan recalled a large number of its Natrelle BIOCELL textured breast implants.
The recall was requested by the FDA after they discovered the breast implants were linked to a form of cancer called breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL).
FDA analysis found that Allergan's Natrelle BIOCELL products were much more likely to cause BIA-ALCL compared to the other related medical device products on the market.
The FDA reported that there have been over 500 cases of BIA-ALCL that are directly linked to this specific brand of textured breast implant manufactured by Allergan. Allergan accepted the FDA’s recall request in an effort to minimise the number of deaths caused by their breast implants.
The FDA agency confirmed that at least 33 patients died from BIA-ALCL cancer caused by Allergan's breast implants and news of the recall was reported world-wide, making this one of the most well-known medical device failures.
Medtronic MiniMed Insulin Pumps
In 2020, two models of Medtronic MiniMed insulin pumps and had to be recalled by the FDA. The device was intended for use by people with Type 1 diabetes in managing their disease.
However, due to a defect in the retainer ring of both devices that led to an increased risk of it breaking and detaching from the insulin pump, over 450,000 of the pumps had to be recalled in the U.S. alone. This failure meant that if the user injected themselves from the insulin reservoir, under or over delivery of insulin could occur, potentially causing life-threatening complications.
By the time the Medtronic MiniMed Insulin Pump recall went to lawsuit, the FDA had received 26,421 error reports, including 2,175 injuries and one death linked to the recalled pumps.
The Medtronic MiniMed Insulin Pumps medical device has had a history of recalls from errors to cybersecurity and hacking concerns.
Stryker Neurovascular Trevo XP ProVue Retriever
In September 2020, the FDA issued a Class I recall to the Stryker Neurovascular Trevo XP ProVue Retriever due to a flaw in it’s design. This Medical Device was intended to assist with blood flow or remove blood clots in the blood vessels of patient’s brains in the event of ischemic stroke.
However, it was discovered that the device posed a severe risk of injury or death to patients, as the core wire was susceptible to breaking or separating off from the device when retracted during routine use, leaving the wire trapped inside the patient's blood vessels.
In total 1,258 devices have been recalled to date, and there were eleven reports of injury and one death related to the failure of this medical device.
West Pharma recall of Vial2Bag fluid transfer systems
In January 2019, the biggest recall of a medical device to date was initiated when West Pharmaceutical recalled 38.8 million units of their Vial2Bag fluid transfer systems due to a functional issue. The Vial2Bag fluid transfer system was designed to connect a vial to an intravenous therapy bag and allow the mix of medication with the IV fluid.
Although the device worked in delivering and mixing medicine with IV fluids, a failure with the device meant that there was a risk that an incorrect volume of medicine would transfer from the vial to the bag, leading to a serious risk of patients over-dosing or under-dosing on their medication.
The FDA reported in February 2019 that the federal watchdog had received 16 complaints of serious adverse health effects related to consequences of the use of this series of devices during administration of oxytocin to pregnant women, leading them to issue a Class I recall for the Medical Devices.
In January 2017, the American designed LIFEPAK 15 monitor/defibrillator was recalled, affecting 139 of their devices.
The intended use of Physio-Control LIFEPAK 15 heart monitor and defibrillator was to administer electric shocks that would help reset the heartbeat of patients that were suffering from cardiac arrest.
However, the device was discovered to have a unacceptable risk of malfunction in delivering the shock to the patient, and was found by the FDA to be highly dangerous to patients health.
Authorities now require that there be daily tests on Physio-Control defibrillators, to immediately detect and replace any broken or unresponsive units.
This blog highlights just a few of the many medical device failures that happen each year and the potentially life-threatening consequences they could have on patients. In addition to the threat of harm to users, the monetary cost of a recall and the damage to brand reputation can be a huge detriment to a business.
At Patient Guard, it is our mission to provide the best Regulatory Affairs and Quality Assurance services to the medical device and cosmetics industries.
Want to avoid your device being the next big medical device failure on this list? Learn more at www.patientguard.com!
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