Get answers to the most common questions about medical device safety and recalls.
Medical Device Questions
What is a medical device?
According to the U.S. Food & Drug Administration – which regulates the use and marketing of medical devices – a medical device is basically anything that is used to diagnose, cure, treat, or prevent a disease or other medical condition in humans or animals, or which affects the structure or function of a human or animal body. The FDA’s definition excludes chemicals, which are classified as pharmaceuticals (drugs).
What are some examples of a medical device?
Medical devices can come in all forms, sizes, and shapes. They can be include devices used only by physicians or other medical staff in a doctor’s office or hospital, devices used at home by individuals or their caregivers, and even devices that are implanted in the body.
The word “device” can be misleading, as it may imply a complex piece of technology. However, according to the FDA, a device can include even simple first aid items like bandages or gauze.
Here are some examples of the different types of medical devices that exist:
- Hospital beds
- Examination gloves
- Magnetic Resonance Imaging (MRI) equipment
- Oxygen masks
- Dental fillings
- Orthopedic pins
- Joint implants (like artificial knees or hips)
This is just a short list of examples. There are many other types of medical devices on the market. As is seen by this list, the definition of a medical device covers a broad range of objects.
How are medical devices categorized?
The FDA uses a tiered classification system to categorize all medical devices. Each of these classes have to meet general controls; however, Class II and Class III have additional regulatory standards that must be met.
Class I: Lowest risk devices. Includes things like gauze, absorbent pads, thermometers, stethoscopes, tongue-depressors, and non-powered, handheld surgical equipment.
Class II: Medium-risk devices that require special controls (labeling, performance standards, postmarket surveillance, etc.). Includes things like X-ray machines, needles (surgical, acupuncture, etc.), and pumps.
Class III: High-risk devices that are complex or may be used to support or sustain life, and therefore require the strictest standards. Includes things like pacemakers, breast implants,
What questions should I ask my doctor about medical devices?
Depending on the type of device, it may be necessary for you or a caregiver to know how the device operates. Some questions you can ask are:
- What is this device for?
- When/how often should I used the device?
- What could go wrong if I use it incorrectly?
- How does the device work?
- Does the device ever need to be replaced?
- What happens if it stops working?
- What are the dangers of using this device?
- Who makes the device?
- Does the device have a warranty?
- How will this device help me?
- How will this device affect my body?
There may be additional questions you will want to ask based on the specific device being used. Always feel free to ask your doctor about any device that is being used as a part of your treatment. Don’t be afraid to be persistent if the doctor doesn’t answer the question to your satisfaction.
Does the FDA review all medical devices?
Class I devices are typically not included in the regulatory review process overseen by the FDA. These types of devices include things that are least likely to harm users, and they include things like hot water bottles and elastic bandages. According to the FDA, about 95% of Class I devices are exempted from the regulatory process.
All Class II and Class III medical devices undergo a rigorous premarket notification process, also called a 510(k) due to the section of the Food, Drug and Cosmetic Act where the regulation appears.
Who makes medical devices?
Medical devices are primarily made by private companies throughout the world. Some of the biggest international corporations are medical device makers, including:
- Johnson & Johnson
- GE Healthcare (General Electric)
- Siemens AG
- Medtronic Inc.
- Philips Healthcare
- Baxter International Inc.
- Fresenius Medical Care
- Covidien PLC
- Cardinal Health Inc.
- Stryker Corp.
There are many other smaller medical device makers as well, including companies that contract with these larger corporations to make parts or provide services related to medical devices.
Medical Device Safety Questions
Are medical devices safe?
In general, medical devices are safe if they meet all the following conditions:
- Approved by the FDA (when necessary)
- Manufactured following all safety-related rules, regulations, and best practices
- Used properly in accordance with their directions
Unfortunately, sometimes products make it onto the market without meeting the proper conditions. Manufacturers may make mistakes during production, or they may deceive regulators and consumers about the safety of their devices. Other times, inaccurate directions, warnings, or other label information may be printed on the device, causing individuals to use it incorrectly or in an unintended manner.
In the best cases, defective and dangerous devices will be recalled and either removed from the marketplace or replaced with safe versions of the device. However, sometimes unsafe devices can sometimes lead to injuries or even death. In such cases, consumers may have legal rights that they can pursue to receive compensation for the injuries caused to them or their loved ones.
Can people die from a medical device?
While most FDA-approved medical devices are safe to use for their indicated purposes, there are still some dangers tied to certain medical devices. The FDA classes some devices as “significant risk devices,” which includes:
- Implanted devices that can potentially cause serious risks to the health, safety, and welfare of the patient
- Life-support devices
- Otherwise provide
What should I do if my medical device isn’t working properly?
Contact your doctor immediately. If your device performs a life-saving/sustaining function (such as a pacemaker), call an ambulance or have somebody take you to the emergency room.
Is it safe to buy medical devices from other countries?
Devices sold for use in the United States must adhere to U.S. rules and regulations, regardless of where they are manufactured. Therefore, using devices sold in the U.S. generally have the same level of risk as using devices made in other countries.
What should I do if I think I have an unsafe medical device?
The FDA requires manufacturers, importers, and device user facilities (such as hospitals and nursing homes) to report malfunctions of medical devices, whether or not they cause injury or death. This sort of postmarket surveillance allows the FDA to become aware of potential problems with devices and possibly issue a recall if it becomes apparent that the device model has a serious defect.
Individuals may also voluntarily report problematic medical devices to the FDA by submitting a Medical Device Report (MDR). Voluntary reporters can include patients, caregivers, healthcare professionals, and general consumers. Voluntary reports can be made through the MedWatch Online Voluntary Reporting Form.
Have any medical devices been banned?
In extreme cases, the FDA has the authority to issue a ban on certain medical devices if the agency deems that there is an unreasonable or substantial risk of injury, illness, or death from using the device. The FDA may also ban devices if the manufacturer has substantially deceived patients or users about the device’s benefits.
To date, the FDA has banned only one device and issued proposed bans on two other devices:
- Prosthetic hair fibers – ban effective June 3, 1983
- Powdered surgeon’s gloves, powdered examination gloves, and absorbable powder for lubricating a surgeon’s glove – ban proposed March 22, 2016
- Electrical Stimulation Devices (ESDs) used for self-injurious or aggressive behavior – ban proposed April 25, 2016
Do medical devices have warranties?
Some devices may have warranties; however, many do not.
If a medical device fails, the cost of a replacement device may be covered under your medical insurance. Otherwise, you may be able to take legal action to receive compensation for the device failure and any medical effects the failure had on you or your loved one.
Is it safe to take use medical devices while pregnant?
It depends on the type of device. In fact, pregnancy tests are considered by the FDA to be a medical device themselves, and they are certainly safe to use while pregnant.
When talking with your doctor about the possibility of using a new medical device, be sure to mention whether you are pregnant, or if there is a chance that you may be pregnant. Your doctor should be able to warn you about any and all potential dangers related to using medical devices while pregnant.
Also, be sure to read the instruction manuals for any medical devices you may use during your pregnancy. Be sure to follow any cautions or instructions about using the device while pregnant, and talk to your doctor if you have any questions.
Medical Device Recall Questions
When can a medical device be recalled?
Medical devices can be recalled if they violate rules and regulations issued by the FDA. Most often recalls take place if a medical device is defective, or if it might otherwise become a health risk (or both).
What types of recalls can take place?
There are two basic types of medical device recalls:
Corrections are attempts to fix a problem with a medical device right where it is sold or used.
Removal requires a device to be removed from the place where it is sold or used.
Who issues medical device recalls?
In the vast majority of cases, defects are identified by a company involved with the device, such as the manufacturer, importer, distributor, or another responsible party. In these cases, the company itself will issue a device recall voluntarily and report it to the FDA so that the recall can be announced to consumers.
At other times, the FDA may require a company to recall devices based on complaints from consumers and/or testing that indicates the devices may not be safe.
What should I do if a medical device I use is recalled?
The action taken for a medical device recall depends on the defect. Usually, the recall notice from the FDA will identify the specific action that needs to be taken.
In many cases, the device may need to be replaced with a newer model or a substitute that is not defective. In other cases, the device may simply need to be inspected, adjusted, or given a new label that more properly describes its appropriate use.
How can I find information about specific medical device recalls?
You can find information about specific medical device recalls by visiting the Medical Devices section of ConsumerSafety.org and searching for the device you want to know more about.
Where can I find information about legal actions related to medical device recalls?
ConsumerSafety.org provides substantial information about recalls and legal actions related to defective or dangerous medical devices. To find information about a specific device, visit the Medical Devices section of our site and search for the device you want to know more about.
If you are looking for information about the rights you have as a user of medical devices, visit our Legal Rights page.