Performance Testing of Medical Devices

MedTech Outlook | Friday, April 23, 2021

Medical devices used in minimally invasive diagnostic and therapeutic procedures in the cerebrovascular, coronary, and peripheral vascular systems include intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems.

FREMONT, CA: When it comes to medical devices like tubing, catheters, and stents that are inserted into the human body, comfort is more than just a good thing to wish for. In this case, 'comfort' refers to the absence of discomfort. It will never feel like a warm blanket wrapped around or sinking gently into a hot tub to have a piece of plastic or metal inserted into the body, but it is possible to ensure that these critical instruments are doing their job without causing any harm or discomfort.

Coatings' function is described by the FDA as follows:

Medical devices used in minimally invasive diagnostic and therapeutic procedures in the cerebrovascular, coronary, and peripheral vascular systems include intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems. To minimize friction between devices and between device(s) and blood vessels, these devices also have hydrophilic and hydrophobic lubricious coatings (for example, Polyvinylpyrrolidone (PVP), polytetrafluoroethylene, silicone). These coatings are thought to give physicians more maneuverability and reduce blood vessel trauma in patients.

Manufacturers of these devices (those who apply the coatings) are a long way from where the medical goods are actually used in operating rooms and hospitals. However, they are looking for better ways to track the coatings' output so that everyone concerned can rest assured that:

The coatings are well-applied and evenly distributed on the floor.

Blood can essentially wick over the embedded unit or tubing, thanks to the coatings.

The coatings will have a long life and will not reduce the system's efficacy or the patient's comfort when it is in operation.

The performance issues that come under the oversight groups' standards are addressed.

This pain-relieving function is provided by lubricious, hydrophilic coatings on the surface of implantable medical devices.

Performance Testing of Medical Devices

Medical devices are subjected to a variety of tests to demonstrate their dependability, including:

Biocompatibility of the materials used in the devices.

Any products that will come into contact with the patient must be sterile for an extended period of time.

Pyrogenicity that looks at the endotoxin and other pyrogen levels on material surfaces that would cause infections in the patient.

Packaging and storage shelf life ensures that sealed medical devices remain sterile and functional until they are considered expired.

Non-clinical testing of joint tensile strength, size verification, and kink resistance ensures that guidewires do not bend or kink during use.

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