Maryland Defective Medical Device Attorney

How Medical Devices Are Classified

According to the U.S. Food and Drug Administration, medical devices are defined as items used to treat ailments, alleviate symptoms or aid in the diagnosis of maladies. They are distinct from medications (which are also reviewed and regulated by the FDA) in the sense that they cannot be absorbed and typically do not produce a chemical reaction in the body. Furthermore, devices used during the course of treatment are included in the United States Pharmacopoeia and National Formulary.

A wide variety of items can be classified as medical devices, ranging from very simple designs to more complex creations. For instance, lab testing kits, pacemakers, ultrasounds, x-ray equipment and surgical lasers are all considered to be medical devices.

Examples of Devices Linked to Patient Injuries

A number of medical devices currently in use today have been associated with instances of patient injury. The National Center for Biotechnology Information lists some of the potential risks associated with metal hip replacements, which have been linked to instances of increased medical toxicity. A review of adverse event reports show that some patients outfitted with the prosthetic hip implants suffered from a number of effects, including vision problems, diminished cognitive function and thyroid issues.

As described by the Chicago Tribune, power morcellators have also come under fire. To keep hysterectomies as simple a procedure as possible, doctors often rely on a power morcellator to chop up any uterine fibroids or other tissue. This makes it easier for them to remove the tissue through a small incision. However, because the tissue is now in tiny pieces, it is fairly easy for some of those pieces to travel out of the uterus and to other parts of the body. If the tissue is cancerous, then the woman’s chances of developing cancer increase.

Device Approval Process Raises Concerns

The Washington Post points to issues with the FDA’s current approval process for medical devices. Patient advocates feel the high number of device recalls taking place over a four-year period proves that the approval process is much too quick. In many of those cases, the devices received government approval in just 90 days through a fast-track program. Additionally, the majority of these recalls were linked to patient conditions that were described as “life-threatening,” which has many calling for a revamping of the approval system.

Conversely, companies involved in the creation of medical devices allege that the FDA’s process is far slower than other agencies. This has to do with the fact that the FDA reviews devices for their treatment efficacy, as opposed to simply determining whether they function as intended and are safe for patients to use.