Medical device failures
Medical device failures can potentially have harmful results for healthcare professionals and patients.
It is integral to avoid medical device failures as they can be the difference between life and death and are used by millions worldwide every day. When medical device failures happen, the business will have to recall all affected devices or advise customers on the potential problems the device could cause to patients.
These recalls are recorded, classified and published online by the US Food and Drug Administration (FDA).
The FDA assigns each recall one of three types of classification, Class I, Class II or Class III. Class I recalls pose the most serious health hazard which makes the FDA’s removal of the device from the market, hospitals and homes the highest priority. Use of these devices 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. However there are thousands of medical devices that get recalled every year that could of appeared on this list.
Allergan breast implants
The Allergan 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 are linked to a form of cancer called breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL).
The 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 is directly related to breast implants. Allergan accepted the FDA’s recall request to minimise the number of deaths caused by breast implants.
The FDA agency confirms that at least 33 patients died from the BIA-ALCL cancer caused by Allergan’s breast implants which is one of the most well-known medical device failures.
Medtronic MiniMed Insulin Pumps
A recent medical device failure in 2020 was the Medtronic MiniMed insulin pumps and had to be recalled by the FDA.
The device was intended for use by people with Type 1 diabetes for the management of their disease.
However, the device was recalled due to the risk of the retainer ring breaking and detaching from the insulin pump. This failure meant that if the user proceeded to inject themselves with the reservoir, it could cause a large infusion that could cause injury or death.
The Medtronic MiniMed Insulin Pump Lawsuit overview case demonstrated that the FDA received 26,421 error reports including 2,175 injuries and one death that is 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 Stryker Neurovascular Trevo XP ProVue Retriever was recalled due to a flaw in the design that made the medical device failure be classified as a Class I recall.
The Stryker Neurovascular Trevo XP ProVue Retriever device is intended to assist with blood flow or remove patients blood clots in the brains blood vessel during an ischemic stroke.
However, the medical device was recalled due to the device being a risk as the core wire may break or separate when the core wire is retracted. The consequence of this issue is the device could get entrapped inside the patient’s blood vessel and cause injury or death.
In total 1,258 devices have been recalled to date and there have been 11 reports of injury and one death related to the medical device failure of the Stryker Neurovascular Trevo XP ProVue Retriever.
West Pharma recall of Vial2Bag fluid transfer systems
The Vial2Bag fluid transfer system’s purpose is to connect a vial to an intravenous therapy bag and allow the mix of medication with the IV fluid.
Although the device worked, there was a risk of an incorrect volume transfer of the medicine from the vial to the bag that led to patients having an overdose or underdose of the medication.
Since the creation of the device there the FDA has received numerous complaints against the Viral2Bag device for the risk of life-threatening consequences in pregnant women.
The FDA found a medical device failure in January 2017, as the American designed portable defibrillation company recalled 139 of the devices.
The intended use of Physio-Control LIFEPAK 15 heart monitor and defibrillator was to administer electric shocks that would help restart the heart of patients that had suffered a cardiac arrest.
However, the device was discovered to malfunction in delivering the shock to the patient and was found by the FDA to be dangerous to patients health.
The outcome of the medical device failures is that there must be daily tests on Physio-Control defibrillators and immediately replaced if broken or unresponsive.
In conclusion, this blog highlights just a few of the many medical device failures that happen every year and the potentially life-threatening consequences it has on patients wellbeing. Additionally, the cost of recall and the damaging effect that recall has on brand reputation is a significant risk to a business.
At Patient Guard, it is our mission to provide the best regulatory affairs and quality assurance services to the medical device, cosmetics and PPE industries, to avoid the many medical device failures.
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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