Many patients who get a medical device implanted in their bodies expect that device to last the rest of their lives. Shouldn’t a metal hip replacement last for hundreds of years or more? Unfortunately, even the most advanced medical devices can be prone to problems. Every year, medical devices are recalled for defects that can present a risk of injury to patients.
In an ideal world, any medical devices that are used on patients would be properly designed, manufactured, and detailed for use. Unfortunately, there are manufacturing defects, marketing defects, and design defects that may not be discovered until they cause problems. In some cases, the product developer may know about problems with the device before they are used but cover up the defects based on profit interests.
If you are using a medical device that is having problems, it may be subject to an FDA recall, to repair or replace any defects. However, if a medical device is implanted in your body, you may not know that it has problems and should be replaced. It can be difficult to find information about defective medical devices and there is a lot of misleading information out there. This page is intended to help you understand which medical devices are subject to a recall and what to do if you are at risk of injury from a defective medical device.
FDA Medical Device Recalls
The Food and Drug Administration (FDA) is a federal government agency that uses chemical analysis to monitor agricultural products, food, and drugs. This includes monitoring food safety, dietary supplements, prescription drugs, over-the-counter (OTC) drugs, vaccines, cosmetics, and medical devices. The FDA also has the power to issue a recall of potentially dangerous drugs or devices.
According to the FDA, “when a company learns that there is a problem with one of their medical devices, it proposes a correction or a removal depending on where the action takes place.” Correction is the process of addressing a problem with a medical device where it is used or sold. Removal is for problems with a medical device where it is removed from where it is used or sold. Recall options include:
- Adjusting settings
- Destroying the medical device
- Notifying patients
- Monitoring patients
The FDA can require a recall but more often the company “voluntarily” recalls defective medical devices on their own. The FDA assigns a classification for the recall, as Class I, II, or II.
- Class I: There is a reasonable chance that a product will cause serious health problems or death.
- Class II: A product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death.
- Class III: Where a product is not likely to cause any health problem or injury.
Criticism of the FDA Recall and Approval Process for Medical Devices
The FDA may have the power to approve or deny medical devices or to recall dangerous devices but that does not mean that they always make the right decision. In an investigation published in the Journal of the American Medical Association (JAMA), researchers identified areas of concern in the FDA recall and approval process.
In 1976, the FDA mandate was extended to cover “the public reasonable assurances of safe and effective devices.” This included a process for premarket approval (PMA) for medical devices that was similar to the new drug application.
For approval, companies had to submit evidence of testing, including “valid scientific evidence” that provided “reasonable assurance that the device is safe and effective for its intended use.” This process applied to medical devices that “support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.”
However, because the laws were passed at a time where there were already medical devices in use, there was an alternative provision that could give approval to newer versions of existing medical devices, without the extensive testing. This was known as the 510(k) provision. Under a 510(k), devices that were “substantially equivalent” did not have to show clinical trials or manufacturing inspections.
In 2002, a new law was passed that allowed medical device manufacturers to take a less burdensome approach to medical device approval. The “substantially equivalent” definition was modified to allow for approval of devices that used different materials and even different mechanisms, if they had a similar safety profile. This drastically reduced the safety and inspection requirements for new medical devices. As a result, the FDA only reviews about 1% of medical devices through the stricter PMA process.
According to the study, “from January 2005 through December 2009, the FDA included 115 names of recalled devices (involving millions of units) on their high-risk recall list.” The FDA’s PMA process was only used in 21 of the devices listed as high risk recalls. The devices that never went through PMA included:
- Automated external defibrillators (AEDs)
- Insulin pumps
- Intravenous infusion devices
- Patient lifts
- Anesthesiology devices
- Medical ventilators
- Neurologic devices
Medical Device Manufacturer Recalls
When a medical device manufacturer or distributor learns about a problem with a device, it will notify the FDA and initiate a recall through correction or removal. If the manufacturer refuses to recall a device, the FDA can require the company to recall the device but this is rare. Medical device manufacturers prefer to handle recalls on their own, as a way to control the recall and messaging about the defects.
Notifying Users About Device Recalls
When a device manufacturer or distributor starts a recall, the FDA will publish information about the action in their online Medical Device Recall Database. The FDA may also post company press releases about recalls, market withdrawals, and safety alerts that could pose a risk to users of the medical device. The FDA will notify users about Class I, II, and III recalls with information about the reason for the recall and risks to users.
If you want to know about a medical device recall, you can use the Medical Device Recall Database link. You can search the database by product name, recall class, recall reasons, and recall dates. However, many patients are unaware of the recall class or product name of a device that was implanted in their body. You may need to contact your doctor to find out more about the specific types of medical devices that may have been involved in your health care.
Common Medical Device Recalls
Between January 1, 2021 and December 31, 2021, there were 179 FDA medical device recalls that were classified as a Class I recall, the most serious, where “there is a reasonable chance that a product will cause serious health problems or death.” Some of these medical device recalls included:
- Intra-aortic balloons
- COVID-19 tests
- Flush syringes
- Ultrasound gel
- Embolization devices
- Heart Ventricular Assist Device (HVAD) pumps
- Blood test kits
- Infusion pumps
- Transcatheter aortic valve prosthesis
Non-Implanted Medical Devices
Above are medical devices that are implanted in the body. These can be complex cases where the patient has no idea how the device is working or if it is deteriorating because it is inside the body. However, there are thousands of common medical devices that people use everyday that are not implanted. Some common medical devices include:
- Mobility devices
- Ventilation machines
- CPAP machines
- Glucose monitors
There may be problems with these devices that the consumer is not aware of. The most common problems for these types of systems include infection, inaccurate results, and other hidden dangers. For example, using ventilation machines, CPAPs, or respirators that have a defective design can spread bacterial or viral infections directly into the lungs, leading to pneumonia or other serious respiratory illness.
As another example, a mobility scooter may seem like it is working fine but the manufacturer may have had multiple reports of the battery systems suddenly exploding or setting on fire. The user of a mobility scooter would want to know about the risk of fire before charging the scooter or going for a ride. However, the scooter manufacturer may wait until the FDA forces them to address the issue or announce a recall.
Example of a Device Recall – BiPAP, Ventilator, and CPAP Devices
In 2021, Philips Respironics issued a recall of hundreds of thousands of ventilators, bi-level positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines. According to the FDA, the polyurethane foam used in the devices to reduce sound and vibration could break down over time. Pieces of the phone and chemicals could be inhaled or swallowed by the user. This could lead to serious illness, injury, permanent impairment, and require medical attention.
The FDA also inspected the manufacturing facility to investigate what may have caused the foam issues and review the company’s quality system regulations. This includes reviewing records, staff training, facilities, device production, and product quality systems.
As part of the recall, Philips Respironics developed a plan to repair or replace the recalled devices. By October 18, 2021, the company reported that it had produced approximately 750,000 repair kids and replacement kits. The affected devices are listed on the FDA’s recall notice or through the company’s recall search tools.
However, an investigation found that the company was aware of problems with the foam degradation issues as far back as 2015. In a Philips communication with their foam supplier, they identified the foam degradation. For years, the company was aware of problems with the foam, especially when exposed to high humidity or heat. However, the company did not change the design, stop selling the product, or issue a recall until 2021.
MedWatch and FDA Medical Product Safety
MedWatch is the FDA’s medical product safety reporting program. MedWatch can be used for health professionals, patients, and consumers of regulated products, including medical devices. MedWatch is a voluntary option for healthcare professionals, consumers, and patients. Concerned medical device users or health professionals can file an online report form through the FDA’s website.
Consumers can report problems with medical devices, including any health-related test, tool, or equipment, health-related kits, implants, or other consumer health products. For a patient or consumer who is reporting a problem with a medical device, they can provide the following information:
- Type of problem
- Injury or harm caused by the problem
- Date of the problem
What Happens If Your Medical Device is Recalled?
If you find out your medical device was part of a recall, your options may be limited based on the company’s reaction. As indicated above, recall options are up to the FDA and the company. Recall options include:
- Adjusting settings
In general, the company will provide for the costs of inspecting, repairing, or adjusting a medical device. The company may also cover the cost of replacement for the defective device. However, if the medical device only offers notification or monitoring, you may still want the item replaced or removed. However, it may be at your own cost, inconvenience, and expense. If you want the device manufacturer or developer to take other action, you may have to take legal action to recover compensation.
Contact an Attorney After a Medical Device Recall
Most patients expect that a medical device has been approved by the FDA after careful testing, inspections, and trials. Unfortunately, millions of medical devices are approved for use without being required to submit data about their safety, efficacy, and risks. Unfortunately, it is often up to the patient to take action to protect their own health.
If you are experiencing health problems because of a problem you suspect with a medical device, you can report the problem to the FDA. However, reporting a problem to the FDA will not guarantee that anything will be done. You may want to reach out to an experienced medical malpractice attorney for advice about what you can do to recover compensation, medical bills, and loss of income.
Contact experienced medical malpractice attorneys who can look at your case, answer your questions, and help you understand your legal options to file a claim against a medical device company. Contact Gilman & Bedigian online or at 800-529-6162 for a free consultation.