According to the US Food and Drug Administration (FDA), a ‘device recall’ is defined as, “when a manufacturer takes a correction or removal action to address an issue with the medical device that violates the FDA law”1.
According to the FDA, a recall measure can be classified as1:
Class I recall type is considered as the most serious type since these devices would result in serious injuries or death. Here, we elucidate this based on some real-life examples.
Some of the Recent Medical Device Recalls
The unique selling property of the Emblem subcutaneous Implantable Cardioverter Defibrillator (S-ICD) electrode (Boston Scientific) was that the lead is implanted just under the skin along the sternum, thus requiring a minimally invasive procedure. In the conventional ICD systems, the leads pass through the large veins from the surgically implanted device into the heart.
Boston Scientific is recalling the Emblem S-ICD electrode as it is associated with increased rate of fractures at a specific point distal to the proximal sensing ring (see image above). Death can occur due to cardiac arrest as with the fractured device it is impossible to provide therapy for slowing down very fast heartbeats. The FDA reported 27 complaints of electrode body fractures, of which 26 were serious injuries and one death. Thereby, announcing a Class I recall on the Boston Scientific Emblem S-ICD electrode. This measure led to a recall of 19,919 devices that were manufactured and distributed in market between March 2016 to November 2020 2.
In another recent recall case, the manufacturing company (Philips) has voluntarily recalled its ventilator and other breathing devices indicated for patients with sleep apnoea since they posed a significant health risk. These devices were in market since 2009; however, the manufacturing company (Philips) received few complaints about the device around 2020. Further investigations revealed that these complaints rose due to the polyester-based polyurethane (PE-PUR) sound-reducing foam associated to reduce sound and vibration in these devices, which may penetrate to the device’s air pathway and, ultimately find a way to enter the body of the user either via inhalation or ingestion. In addition, the foam tends to off-gas certain chemicals which could be harmful during operation. The manufacturing company has received complaints about instances where presence of black debris/particles were observed in some of these device parts such as outlet, humidifier, tubing, and mask. These instances elevated the risk of particulate exposure in the user which irritates the skin, eye, and respiratory tract leading to headache, asthma, and adverse effects to kidneys and liver as well as possible toxic carcinogenic effects. With respect to off-gassing, the potential risks include headache/dizziness, irritation, hypersensitivity, nausea and vomiting along with possibility of toxic and carcinogenic effects. Although these issues sound serious and could be life-threatening, to date, no death has been reported due to these. The manufacturer eventually decided to recall about 4 million ventilators and breathing machines which were in market between 2009 and April 26, 20213.
Among the two examples, the first one is a typical case of a Class I type recall by FDA since there were reports of serious events and death, whereas the second one showcases that the manufacturing company was alert enough to voluntarily recall their devices on noticing complaints associated with it. Cited here were just the few examples of the recalls that were announced this year. In order to view the detailed list of all the devices that were recalled please check the below link
How does FDA Ensure Patient Safety?
One of the pivotal roles and responsibilities of FDA include protection of public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. With respect to medical devices, FDA executes a robust program at every stage of a device’s life cycle to evaluate the safety of medical devices 4.
The FDA supervises the adverse event reports and other issues related to medical devices. Since the medical device market is enormous, to monitor all medical devices seamlessly, the devices are classified based on their potential risk as follows4:
To protect and promote public health, FDA’s Center for Devices and Radiological Health (CDRH) improvises its regulatory monitoring strategies now and then, to ensure the best effective use of the medical devices available on the US market without compromising on the quality and safety measures.
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- FDA. What is a Medical Device Recall? 2021 [Available from: https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall.
- FDA. Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures 2021 [Available from: https://www.fda.gov/medical-devices/medical-device-recalls/boston-scientific-recalls-emblem-s-icd-subcutaneous-electrode-model-3501-due-risk-fractures.
- FDA. Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication 2021 [Available from: https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks.
- FDA. Medical Device Safety Action Plan: Protecting Patients and Promoting Public Health [Available from: https://www.fda.gov/files/about%20fda/published/Medical-Device-Safety-Action-Plan–Protecting-Patients–Promoting-Public-Health-%28PDF%29.pdf.