Medical Device Risks Every Patient Should Be Aware Of

Medical devices are an integral element of modern healthcare. Statistics show that nearly 32 million Americans have an implanted device.

These devices offer a lot, from providing innovative solutions for diagnosis to facilitating treatment and management of various medical conditions. While these devices are under strict surveillance by governing bodies like the FDA, things may go wrong from a safety perspective.

According to a report, the number of Class I medical device recalls by the FDA hit a 15-year high in 2022. During the year, 70 Class I recalls were overseen compared to an average of 47 over the preceding five years. The fourth quarter witnessed 18 of the Class I recalls. The spike continued in 2023, with over 83.3 million units coming under the radar.

Besides faulty products, medical errors and lack of hygiene may cause problems for patients using medical devices. In either case, they can cause more harm than good. These facts and numbers underscore the significance of awareness of risks patients may encounter. Being aware is the key to making informed decisions and actively participating in one’s healthcare journey.

In this article, we will highlight the potential medical device risks that every patient should know about before integrating them into their healthcare plan.

Infection Risks

Infection is a significant concern linked with almost all medical devices, from prosthetics to catheters. Research shows that infections related to implanted medical devices are common yet difficult to treat. Shockingly, the five-year mortality rate for patients with prosthetic joint infections exceeds that of breast cancer survivors. That makes it a grave concern for patients and providers alike.

The risk level is comparable for implantable catheters. After all, the introduction of a foreign object into the human body creates a favorable environment for bacterial growth.

The Bard Power Port lawsuit is an instance of patients raising a voice against manufacturers failing to warn patients about the risks related to the device. According to TorHoerman Law, Bard Power Port lawsuits have been consolidated into multidistrict litigation (MDL) in the District of Arizona.

The Bard Power Port lawsuit settlement amount ranges between $10,000 to over $250,000 though it may vary according to individual factors. The amount itself shows the gravity of the risk associated with the device. The high prevalence of such infections is another reason to worry. Experts state that a shockingly large number of patients could file these lawsuits in the future.

Besides researching a device before getting it implanted, patients should be vigilant about proper hygiene practices during the procedure. Additionally, they should pay attention to the signs of infection such as swelling, redness, and increased pain at the device site. Early intervention is essential to prevent dire complications and the need for surgical removal.

Allergic Reactions

The materials used in medical devices may trigger allergic reactions in some patients, depending on individual sensitivity. Studies highlight the prevalence of contact allergens in medical devices. The implantable ones have an even higher risk potential. These reactions may manifest as symptoms such as itching, skin irritation, or more severe responses.

Patients should communicate any history of adverse reactions or allergies to their healthcare providers before opting for procedures involving medical devices. With this information, healthcare teams can select devices with materials less likely to cause allergic responses. Additionally, they can implement appropriate pretreatment measures if necessary.

Mechanical Malfunctions

Medical device malfunctions and failures can cause severe harm to patients. They occur due to manufacturing defects, wear and tear, or improper use. Some of the most serious malfunctions that led the FDA to issue recalls included leading brands like Allergan breast implants, Medtronic’s MiniMed insulin pump, and FLOW-i anesthesia systems.

Such malfunctions and failures may occur unexpectedly, making them even more dangerous. Regular monitoring of device performance is the only way to stay a step ahead of the risk. Moreover, patients should promptly report any unusual symptoms or device behavior. Adherence to maintenance protocols is also critical.

Complications with Implants

Implantable medical devices, such as joint replacements and pacemakers, carry specific risks for patients opting for them. Tissue damage, implant migration, and rejection are the possibilities patients should be aware of.

For example, metal in the knee or hip joints can cause a problem for patients with hypersensitivity to metals, specifically with a nickel allergy. Similarly, the rejection rate during the first year of transplantation of pacemakers is just under 15%.

Patients should be informed about potential complications and understand the red flags that may indicate a problem. It is crucial to attend regular follow-up appointments with healthcare providers for device assessments after the procedure. Timely intervention can reduce the risk of complications and enhance the longevity of the implant.

Cybersecurity Concerns

Cybersecurity has emerged as a significant factor for patients opting for medical devices as they capture data and share it with healthcare networks. The FDA requires medical devices to meet cybersecurity guidelines as hospitals are at risk of hacks and ransomware attacks. Devices such as pacemakers, insulin pumps, and continuous glucose monitors are prone to cyber threats that may compromise patient safety.

Staying informed about the cybersecurity measures in devices should be the top priority for patients. Additionally, they need to follow recommended security practices and promptly report any suspicious activities or device malfunctions to healthcare providers.

Also, all medical device applicants must submit a plan for identifying, monitoring, and addressing cybersecurity issues to match FDA guidelines. They must also create a process for reasonable assurance that the device is protected against potential data theft.

While medical devices continue to enhance patient care, there are risk factors that should not be undermined. Patients must take a proactive approach to understanding the associated risks to make well-informed decisions about their healthcare in the long run.

Besides being aware of the potential complications, they must communicate openly with healthcare providers, adhere to care guidelines, and keep an eye on any signs of complications. With these measures, patients can contribute to a safer use of medical devices, leading to optimal outcomes and improved quality of life.