Because medical equipment and medical devices directly impact the patient’s health and safety, any error in manufacturing these products can be costly–even costing the patient’s life. This makes medical device manufacturing incredibly high-risk.
The Importance of Proper Medical Device Labeling
Labeling is a critical part of the medical device manufacturing process. Medical devices must be labeled accurately to gain market access and ensure their safe and proper use by patients and caregivers.
Labeling is also one of the most scrutinized parts of the 510K medical device authorization process. Failing to correctly label a medical device or include all necessary information can cost manufacturers significantly!
Improper use related to incorrect or insufficient labeling can lead to
- Product recalls
- Export bans
- Financial penalties
- Reputational damage
- Delays to market entry
Laser Marking Protects Against Counterfeiters
Counterfeiters copy medical device designs, but cut corners to save money. This costs legitimate manufacturers a lot of money. Worse yet, millions of lives are lost due to substandard devices. Traceability of medical equipment is essential. Laser marking the devices lets doctors know whether they are legitimate or phony.
Traceability Contributes to Continued Safety Measures
In the case of a recall, patients can be notified because their device has been marked with a UDI (Unique Device Identification) System.
Necessary Qualities in Medical Labeling
Labeling medical equipment and devices poses a different set of challenges than labeling soup cans or batteries. Markings on equipment and parts that are used for medical purposes must be able to withstand processes such as sterilization, passivation, centrifuging, and autoclaving, hundred of times while resisting corrosion.Consider surgical instruments and how often they must endure the sterilization process. Yet their markings must remain unchanged. Laser marking is the perfect way to mark medical devices including orthopedic implants. It is also ideal for medical supplies and medical instruments.
Laser Marking Benefits
Lasers produce a mark that is permanent, yet leaves the material’s surface intact. This eliminates additional surface areas where bacteria can grow. Lasers are the ideal way to mark equipment and devices used for medical purposes because the marks are
- Permanent
- Traceable
- Legible
- High-contrast
- Counterfeit-proof
- Hygienic and smooth
What Can Be Marked With Lasers?
Lasers can mark countless materials, including stainless steel, aluminum, and other medical-grade alloys. Common uses are autoclave trays, operating room devices, surgical tools and instruments, cannulas, catheters, tubes, wires, and implantable devices. On these idems, a laser can clearly and permanently serial numbers, 1D and 2D Datamatrix codes, bar codes, dates, lot codes, and other alphanumeric content.
If you have medical equipment or medical devices that need to be marked, laser marking is a fast and affordable solution! Integrated Technology is your parts marking partner.
