Q: What are the different classes of medical products?

Class I devices represent the lowest risk; for example, dental floss and adhesive bandages fall under this category. Other examples include enema kits, elastic bandages, manual stethoscopes, and bedpans. Class II devices with higher risk and, according to FDA guidelines, “require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness.” Blood pressure kits, powered wheelchairs, and some pregnancy test kits, for example, comprise Class II devices. Class III devices represent the higher risk category and include items such as knee prostheses and replacement heart valves (devices under this category usually require FDA approval before they are allowed to be marketed). Finally, implantable devices are items such as pacemakers or breast implants.

Question 1

What is UDI labeling?

Accepted Answer

Unique Device Identificaion labeling are regulations set forth to provide an international framework for indentifying, tracking, and monitor the safety and efficacy of medical devices.

Question 2

What are the benefits of UDI?

Accepted Answer

Faster discovery of potential flawed medical device information by health authorities
Quicker access to recall information and visibility into current inventory
A reduction in medical errors by providing product expiration dates in the barcode
Identify counterfeit products being used
Ensuring that information regarding an implanted device is safely retained and traceable

Question 3

What are the different classes of medical products?

Accepted Answer

Class I devices represent the lowest risk; for example, dental floss and adhesive bandages fall under this category. Other examples include enema kits, elastic bandages, manual stethoscopes, and bedpans.
Class II devices with higher risk and, according to FDA guidelines, “require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness.” Blood pressure kits, powered wheelchairs, and some pregnancy test kits, for example, comprise Class II devices.
Class III devices represent the higher risk category and include items such as knee prostheses and replacement heart valves (devices under this category usually require FDA approval before they are allowed to be marketed). Finally, implantable devices are items such as pacemakers or breast implants.

Question 4

Why are countries implementing UDI coding for medical devices?

Accepted Answer

UDI coding increases patient safety through the traceability of medical devices and products with unique tracking codes. It helps assure patients that health products are safe. And the ultimate goal of developing a medical device is to help patients. If your device isn't safe, you'll risk patients getting hurt.

Question 5

What is the best way to print a UDI code on medical products?

Accepted Answer

Realistically there is no one best way. It depends on the product/device. Inkjet offers the widest range of applications. Whether selecting industrial inkjet, laser, pad, or screen printing, an experienced coding solution provider can guide you to the optimal technology for UDI coding on your medical devices or packaging.

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