Why Medical Devices Fail
Why Do Medical Devices Fail, And What Are Your Legal Options?
Understanding the top 10 causes of defective medical equipment
When you head to the hospital or emergency room, you expect to receive reliable medical attention that'll help you resolve your immediate health needs. Unfortunately, not every medical procedure goes according to plan. A defective medical device used by your doctor can cause you undue harm and even exacerbate existing health problems.
These failures can also have adverse consequences for general care practitioners. Today, medical device malpractice suits are becoming increasingly common, despite the laws and regulatory organizations that exist to protect American consumers.
So why is this?
Here are the top 10 causes of medical device failure and patient injury.
1. Failure to properly test the device
Comprehensive testing plays a crucial role in the success of a medical device launch. However, most manufacturers tend to rush to introduce their medical equipment to the market. As such, they often ignore the importance of conducting tests and even release the product without rigorous testing.
Generally, testing should be done throughout the manufacturing process before introducing the medical device to the marketplace. The entire testing process is best left for established and approved companies with years of experience in medical device compliance.
2. Using faulty or low-quality materials
Improper material selection is one of the biggest mistakes that can cause device failure and threaten patients' well-being. Material selection is vital to achieving the desired capabilities and properties of the finished medical equipment. However, what might seem like an optimum material may not be compatible with the product's service environment.
For example, resins may end up degrading during the molding process, thus causing the medical device to fail over time, often during use. Size exclusion chromatography (SEC) is the method used to analyze the failing part's resin material to determine the cost of failures.
Manufacturers can avoid all these by carefully researching vendors and visiting their sites before committing to a specific supplier of crucial components.
3. Lack of quality control
Quality control (QS) plays a pivotal role in keeping medical devices intact and functioning correctly according to manufacturer specifications. They rely on manufacturers' analytical expertise alongside various testing capabilities, including tensile and compressive testing and optical microscopy, to identify the problem.
Microscopy methods can examine bond areas, thus essential in evaluating the quality of assembled joints. Failure to devote proper attention to quality control procedures in the manufacturing process can lead to multiple out-of-box equipment failures.
4. Contamination
Contamination caused by either a foreign substance or a chemical attack can be tragic for medical equipment. Luckily, analysts can easily recognize chemical attacks with various analytical techniques. For instance, fourier transform infrared spectroscopy (FT-IR) can effectively examine fracture surfaces and other chemical contaminants on the surface.
In addition, scanning electron microscopy and energy dispersive x-ray identify failures. Plus, it's efficient at determining the presence of a chemical attack and its elements.
5. Poor molding
Medical devices generally feature plastic components that manufacturers mold before final assembly. Unfortunately, molding defects can cause device failure. If the device components have cracks, SEM and optical microscopy are perfect tools for evaluating the fracture surface.
An experienced analyst can conduct imaging and find the crack initiation and determine melt flow and knit lines. If the knit line and the melt flow coincide with the crack point, then a mold defect is present.
6. Stress overload
Stress overload most often causes system failure. Analysts use SEM or light microscopy to examine fracture points and determine whether impact-related overstress is a probable cause of system breakdown.
7. Using accessories not made by the manufacturer
This issue mainly arises once the medical device is in the user's hands. To save money, some device users will often want to use components that aren't specially engineered for use with that medical tool.
Although this technique sometimes works, the device users risk damaging it by replacing components and using generic accessories. This is why manufacturers clearly instruct users to only use proprietary accessories or cables.
8. Human error
Human error is “an omission or action that leads to results that users neither intended nor foresee.” In the medical domain, human error can cause severe injuries and sometimes even death. In fact, human error is among the leading causes of medical device failure. Either the manufacturer failed to design the equipment to minimize human error or the user failed to utilize the device correctly.
9. Reusing devices
Many crucial medical components are deemed single-use because of the issues that can happen if you reuse them. Although FDA regulations constrain reuse, most hospitals still reuse items against the manufacturer's stated use conditions. Whether the item is reusable or not, users try to make the most of them, thus causing medical device failure and patient injury.
10. Insufficient maintenance and care
Just like other appliances, medical devices need regular maintenance. Through rigorous testing and analysis, manufacturers should quickly pinpoint particular maintenance needs and outline a regular maintenance schedule for the medical equipment.
If users fail to undertake this vital step, it can result in system failures and uncertainty about the best way to handle the device.
Get the legal representation you deserve
A product liability lawyer is essential in seeking compensation for the harm caused by a defective medical device. Here at Gilreath & Associates, our experienced attorneys work with toxicologists, design engineers, material experts and others in exposing manufacturing flaws and dangerous products that injure our clients.
Contact us today to schedule your free consultation and we'll help you find the evidence required to prove your claim.