Innovation has brought one negative thing to the medical industry. That’s the failure and malfunction of medical gadget.

Statistics suggest the medical device industry will grow at a CAGR of 6.1%, reaching USD 291.04 billion by 2030. Some manufacturers use improper techniques to generate profit from this growing market. 

The Paragard IUD failure is one such example. Teva Pharmaceuticals knew that their copper IUD could break, leading women to develop internal bleeding and infections. However, the company didn’t warn users since it was garnering profit. They now have to pay thousands of dollars as compensation for this. 

In this blog, we’ll discuss the reasons behind failed devices, ways to prevent them from happening, and more.

Explaining a Failed Medical Device: The Bard PowerPort Malfunction

A medical device is considered to have failed when its functionality is compromised. Science Direct reports that device malfunctions can lead patients to develop serious health consequences. Let’s take the Bard PowerPort device as an example. 

This medical device was used to administer intravenous medications to patients requiring dialysis and chemotherapy. It comes with a port catheter that less invasively administers medications and draws blood. 

However, many patients with a Bard PowerPort experienced Port-a-Catheter migration. That means the catheter slowly migrated to a different position. The Port-a-Catheter migration symptoms include the following:

  • Localized swelling and extreme pain
  • Changes in the functionality of the catheter
  • Palpable port movement 
  • Unusual discomfort and sensation

This device fractured and migrated from the original port site. As a result, victims suffered embolisms and vessel damage. Some even required immediate medical interventions. These include the surgical retrieval of the migrated catheter. 

TorHoerman Law states that the affected individuals soon filed a Bard PowerPort lawsuit to seek justice. This litigation covers injuries like deep vein thrombosis, necrosis, blood clots, etc. Plaintiffs are eligible to get payouts ranging between USD 10,000 and USD 100,000.

3 Reasons Behind Failed Medical Gadgets

Based on material testing and failure analysis, here are the three reasons medical gadget malfunction:

#1. Bad Quality Materials Used

Device manufacturers try to cut corners when choosing materials. They do this to rush the product into the market for profit. Most of the time, these lead to design flaws and quality control problems. 

How do you think improper-quality materials cause medical gadget failure? Well, the device malfunctions because of the following reasons: 

  • The strength and durability of the device are compromised.
  • The use of low-quality materials leads to early wear and tear because they cannot withstand daily use.
  • Users might be exposed to harmful chemicals that might leak from the device.
  • The material might not have the necessary adhesives or coatings to make the device functional.
  • It can also affect the consistency and potency of the drug administered using the gadget.

#2. In-Service Degradation

In the medical industry, in-service degradation means the device breaks down faster than expected. A medical device goes through in-service degradation because of the following situations:

  • Used in a harsher environment than anticipated 
  • Chemical exposure and contamination 
  • Improper storage, usage, and rough handling

All these can lead to device overstress and cause material degradation during usage.

The transvaginal mesh used for pelvic organ prolapse (POP) in women faced a similar issue. It prematurely eroded and broke into pieces inside the woman’s body. As a result, the fragments migrated to different organs, leading to pain and infections.

#3. Improper Manufacturing Process

Sometimes, the manufacturing process is incompatible with the device materials. For instance, certain gadgets require extra stringent development as compared to others. That means a particular device will fail or malfunction if a company doesn’t understand the specific requirements.

Improper manufacturing processes include the following instances: 

  • Failure to test the device properly before releasing 
  • Use of faulty and cheap materials to cut costs
  • Contamination issues caused by the lack of quality control
  • Human errors like inefficient care and maintenance during development

Let’s say a company built a medical device with an improper molding design. In that case, the product will fail the moment it’s under environmental stress. Moreover, sterilization issues during manufacturing can also lead to degradation and failure.

Also Read: 17th Century Clothing – Full Overview Information Report

How Can Manufacturing Companies Prevent Device Malfunction?

Medical device manufacturers must be extra careful before releasing their products. They need to follow these tips to prevent malfunctions in the devices they research and develop:

  • Use a proactive framework that includes design, material analysis, process engineering, testing, etc.
  • Create an inventory of the medical equipment to track developmental success.
  • Ensure to maintain, test, and inspect each device before initial use.
  • Monitor the negative incidents and report them to the authorities.
  • Follow stringent policies to ensure the safety and functionality of the devices.
  • Offer instructions to help doctors and patients use the equipment properly.

This way, manufacturers can ensure that advanced technology and devices become an asset instead of a failure in the medical industry. With proper planning, these gadgets can help enhance patient safety and the quality of care offered.

Every company should have alternative and backup medical equipment when the released product malfunctions. They should also record possible issues based on the prevalence of harm. When asked, the manufacturing companies must provide maintenance and incident histories.

Other than that, medical professionals must also uphold certain factors. For instance, they must understand how the equipment works and follow instructions.

They should educate and train staff properly. Moreover, they must follow the best practices for storing and removing the gadget. Reporting issues with the device will also help catch malfunctions before it becomes too late. 

All in all, the entire medical industry must come together to prevent device failures.

In conclusion, technology is bound to have trial-and-error and intricate research-and-development processes. Without proper manufacturing, healthcare gadgets will surely fail. 

These failures are usually structural. You’ll see device erosions, malfunctions, migrations, etc. All of that happens due to degrading quality and improper manufacturing. 

That’s why the medical industry must prevent these malfunctions. They can do this by implementing stringent manufacturing standards and taking safety precautions.