Reasons Why Medical Devices Fail

Over time, medical devices became an integral part of providing care. Today, every patient has the right to top-notch medical attention with innovative technology and gadgets.

Did you know that 1,08,275.5 thousand surgical procedures took place in 2023? Unfortunately, not all of them helped resolve the patient’s health issues.

Why do you think that happened? Well, that’s mostly because of medical device failure. In most cases, the patient and their family will sue the manufacturing company for failing to warn about the dangers. However, doctors might also face medical malpractice lawsuits.

Would you like to understand why such devices malfunction? In this blog, we will discuss three reasons why medical devices can fail.

#1. Improper Testing

Comprehensive testing ensures that the manufacturers mitigate any potential malfunction in the gadget. That’s the only way a medical device can succeed in this competitive environment.

Sometimes, manufacturers rush the testing process to introduce the device to the market for a quick profit. As a result, it affects the patients as they develop serious health consequences. Improper testing also leads to issues with the device’s quality control. For instance, the medical device won’t be functional or remain intact during usage.

The copper intrauterine (IUD) devices by Teva Pharmaceuticals are a good example of this. This company pushed the release of these non-hormonal IUDs without proper testing or quality control. That’s why the device unfortunately fractured upon removal and migrated inside the patient’s body.

Women suffered health consequences like organ perforation, infections, and internal bleeding. Eventually, the manufacturer faced lawsuits for failing to warn about the potential side effects.

That’s why companies should perform testing throughout the manufacturing process. Doing this ensures that their devices comply with medical standards and won’t cause any damage. Moreover, failing to devote attention to the testing phase will only lead to legal trouble.

#2. Use of Low-Quality Materials

Did you know that the use of improper materials to manufacture these devices can threaten a patient’s life? Yes, low-quality substances can lead to medical device malfunctions. The Bard PowerPort failure is a good example of this.

The manufacturers used a combination of polyurethane and barium sulfate in this catheter. Using these caused the device to become brittle, eventually fracturing and breaking underneath the patient’s skin.

The patients suffered from deep vein thrombosis, blood clots, hematosis, tachycardia, etc., due to catheter migration. They also needed to undergo expensive medical interventions that affected their quality of life.

As a result, the victims filed a Bard PowerPort lawsuit to hold the manufacturers liable for intentionally using bad-quality products. To win this litigation, their lawyers will help by:

  • Gathering incriminating evidence like medical records, witness testimony, etc.
  • Assessing the damages and injuries to calculate the deserved compensation.
  • Determining the liability to build a strong case in front of the jury or judge.

They’ll also help the victims navigate the litigation process and get compensation for their injuries.

According to TorHoerman Law, the legal industry estimates a settlement amount between USD 10,000 and USD 250,000 or more. However, the individual payouts will depend on the plaintiff’s injuries, the proof provided, and their lawyer’s negotiation skills.

This incident proves the importance of material selection when manufacturing medical equipment. That’s why companies should carefully research their vendors to analyze such crucial components.

#3. Human Error

Did you know that human errors can be the reason why medical devices fail? Unfortunately, these can lead to severe consequences. A fictional character, Dr. Lisa Cuddy, from the TV show House M.D., said: “If doctors make mistakes, people die.”

Sometimes, medical devices won’t work due to mistakes made during implantation. For example, doctors improperly implanted a pacemaker in a 45-year-old woman, leading to device failure. It led her to develop infections, gastrointestinal disorders, and weakness. She later filed a lawsuit against the doctors for medical malpractice due to their negligent implantation tactics.

Research suggests that human errors in medicine are classified into two types. These include the following:

  • Latent errors: These are errors in system design, administrative decisions, and the quality of the medical equipment.
  • Active errors: These are the failure to detect errors in medical devices and procedures while providing care.

Unfortunately, both of these errors can be catastrophic to the patient’s health. That’s why doctors need to be extra careful and attentive when using medical devices to treat patients.

In conclusion, failed medical devices can exacerbate any patient’s health conditions and cause them harm. That’s why doctors must use high-quality gadgets that have undergone proper testing. Similarly, they must ensure there aren’t any human errors or contamination incidents.

Manufacturers can also employ new healthcare management techniques and a maintenance strategy to avoid device failure. With all these, doctors and manufacturers won’t face medical malpractice, product liability, and personal injury lawsuits.

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