Medical Device Recall: How does US FDA recall Medical Device work?
Medical devices, unlike prescription drugs, are reviewed by the United States (US) Food and Drug Administration (FDA) under one of two regulatory standards – Premarket approval (PMA), which requires clinical testing and inspections, or the 510(k) process, which does not. The second standard is intended for devices with a low or no risk of failure, as determined by the FDA. The medical device must be similar to a previously marketed device (predicate device).
Introduction
The FDA categorizes medical devices into one of three categories based on the level of control required to ensure the safety and effectiveness of the device and the level of risk the device poses to patients.
Class I devices pose the least risk and are subject to minimal regulation — examples: tongue depressors, bandages, crutches, stethoscopes, and bandages.
Class II devices pose a moderate risk and may be cleared through the 510(k) premarket notification process, which allows them to be marketed if they are substantially equivalent to a predicate device. Examples – electrocardiographs, contact lens solutions, hearing aids, and orthopaedic drills.
(Notably, clinical trials are not required for device classes I and II)
The FDA defines Class III devices as posing the greatest potential risk. They are defined as devices that “support or sustain human life, play a significant role in preventing human health impairment, or pose an unreasonable risk of illness or injury.” Example – implantable pacemakers, stents, heart valves, and human immunodeficiency virus diagnostic tests. Although implants and devices that prevent health impairment are supposed to be Class III, many hip and knee implants are Class II.
The majority of Class I and some Class II devices are exempt from premarket review and the majority of manufacturing practices regulations. For such devices, companies do not need to apply to the FDA for review or clearance of exempt devices; instead, they must simply notify the FDA that they are selling the products. The 510(k) premarket notification process is used for Class II devices considered to be of intermediate risk. According to the FDA, a more stringent premarket approval (PMA) review process is required to ensure the safety and effectiveness of Class III devices.
The FDA initiates recall for products that do not receive approval through the PMA process. Occasionally, the manufacturer discovers a flaw in a medical device and issues a recall.
What is a Recall?
A recall is considered the most effective preventive measure to protect the public when a medical device or any product in that sense is defective or can be harmful to people. According to the FDA, a recall is a process of removing or correcting products that have violated USFDA law by causing harm or deviating from the way they are intended to be used.
Below is the list of products that are subjected to recall by the FDA
- Drugs/Medicines/Vaccines related to Human and animals
- Implantable Medical devices
- Transfusions like Blood and blood products
- Radiation-emitting products
- Transplantable human tissue
- Animal feed
- Cosmetics
- Food
In other words, what happens when you neglect Quality Assurance? This is where patient safety begins. For example, the National Cancer Institute went through one of the worst software disasters when a bug destroyed their radiology equipment. Due to this, their devices administered radiation doses 100 times higher than required.
Quality leaders must invest in proper validation to implement best practices to ensure patient safety. Testing efforts should start as early as possible. Speaking, the sooner we find a bug, the cheaper it will be to fix it
What are the causes of Recall?
The causes of a recall can range from packaging and storage issues to reports of life-threatening and fatal injuries. It can be as simple as returning an expired or damaged pill to the pharmacist or as complex as removing a knee cap or defective implant from a patient’s body during surgery.
Why Medical Device Recall?
Product recalls make us all wonder about the safety of the products we use daily. When products we use, such as cars, toasters, or baby food bottles, are recalled, we are all understandably upset as customers. But what about the products that are implanted permanently within our bodies? They must have been thoroughly tested because they are intended to protect us from impairment. The implanted devices or medical products must ensure that no one is required to bring their thorax to the shop for removal and replacement, which is not always possible. So, to rely on medical device assurance, the FDA devised a review and approval process to ensure the safety of both patients and medical devices.
Who issues a Recall?
Contrary to popular belief, the FDA cannot recall a drug or product; it can only issue a recall when it discovers a device/product that poses a reasonable risk of causing significant harm to the public, but the manufacturer refuses to initiate a recall. If the device violates FDA law, the manufacturer, distributor, or company initiates a product/device recall by issuing a corrective or removal action. However, the FDA initiating a recall is extremely rare.
How does the Recall process work?
When a medical device manufacturer discovers a faulty device, they propose a corrective or removal action based on the device failure and its impact on patients.
- Corrective Action – addresses and corrects the medical device’s problem.
- Removal Action – Considering the impact, remove the medical device from the market where it is sold or from the location where it is used.
When a company takes corrective action to address a problem that has been identified as defective and fixes it or takes a removal action and removes it from the market due to significant harm caused to the public, the term “recall” is used.
Below is the list of actions that are considered for medical device recalls
- Examining the device for flaws
- Making changes to the device
- Changing the device’s settings and design
- Relabelling the device
- Removing the device from the market or where it is used.
- Creating awareness about the problem and educating the patients about its use and impact when misused.
- Inspecting patients for health problems
In most cases, a recall is initiated by the manufacturer or company after the FDA issues one. Before raising a concern, the FDA conducts a health hazard evaluation on the device’s risk management reports. When a medical device fails to function correctly, the FDA recalls it to ensure that it does not violate medical device procedures and specifications. A recall is issued when a device is either defective or significantly harmful, or sometimes both. When the FDA issues a recall, it does not mean that the device should not be used or returned to the manufacturer for compensation. A recall may be issued to correct a device failure or fault and provide a solution.
Below factors are taken into consideration by the Health Hazard Committee while evaluating the device recalls.
- Significant harm or injuries caused by the device or product
- The level of risk or hazards to the vulnerable population of specific segments like elderly or children and its level of impact
- Existing environmental factors contributing to the potential hazard (documented with evidence are taken into consideration)
- The impact caused is long-term or short-term.
How does the FDA notify the public of the recall?
The FDA documents the recall information of the device/product in the Medical Device Recall Database as soon as it issues a recall or when the company initiates a corrective or removal action. Also, it documents the termination recall procedure after completion.
Further, the FDA notifies the public regarding the recalls, market withdrawals, consequences, and significant hazards of using the device through press releases and public notices.
Once the recall classification is done, the FDA post the information in the weekly enforcement report ensuring the public is aware of the consequences of the potential health hazard caused by the device.
FAQ's
What is a Medical Device Recall?
FDA enforced the medical device recall act under 21CFR 7 to protect the public from significant risks of the product. As per this law, when a manufacturer of a medical device understands that there is a problem with the device as it doesn’t work as intended and, when marketed, causes potential harm to the public using the device, will propose a corrective or removal action to address the device issue. For this corrective or removal action, FDA uses the term “Recall” to define it precisely.
What are the three classes of recalls?
Class 1 medical device recall addresses the devices that can cause potential harm or serious effects or death to the consumers. In this case, either the manufacturer should propose the removal action or recall the device from the market and notify the FDA and consumers. The FDA will voluntarily remove the device and inform the consumers of the defect. Class 1 devices violets the FDA enforced medical device regulations.
Class 2 medical device recall addresses the temporary or medically reversible adverse health consequences caused by the device, and the likelihood of the effects are remote.
Class 3 medical device recall is the one in which the use of the device is unlikely to result in adverse effects. Therefore, market withdrawal happens only when the device shows a minor violation and is not subject to FDA legal action.
How many medical devices have been recalled?
Every year, approximately 4,500 drugs and devices are removed/recalled from the shelves of USFDA. All the recalls are raised by the manufacturers and are approved by FDA. Also, most recalled devices are on the market, consumed, injected, or implanted before being recalled. Therefore, although the FDA may identify the device’s issues that violate the regulations ensuring public safety, the manufacturer’s responsibility is to initiate and carry out a corrective or removal action. On the other hand, the FDA can order a device recall.
What is the difference between recall and withdrawal?
Market withdrawal – A product with a minor violation that the company proposes a corrective action and fixes it. And that would not initiate legal action from the FDA.
Recall – the company manufacturer taking action to remove the product that violates the FDA regulation from the market is called recall. Recall action is taken by the manufacturer’s initiative and notifies FDA and consumers, and at times it is initiated by FDA.
Which FDA recall classification is the most serious?
Class1 is the most serious of the FDA recalls among the three classifications. As the class 1 recalls is about the device that violates the FDA regulations and causes adverse effects or death to the consumers.
How do I notify the FDA of a recall?
You, as a manufacturer, get to know that the device is not working as intended, notify FDA immediately by contacting FDA’s Office of Regulatory Affairs (ORA) Division Recall Coordinator.
Which is an example of a class 1 recall?
In 2009, Salmonella content in peanut butter marketed by Peanut Corp. of America reportedly killed several people and sickened hundreds. As a result, thousands of products were recalled that contained potentially tainted peanut butter sold by various companies.
