Manufacturing of medical devices more and more relies on lot process control, internal and after-market traceability, and, in some cases, anticounterfeiting protections to ensure the integrity of everything from surgical tools to pacemakers.
Such tracking and recordkeeping capabilities help manufacturers comply with government regulations, avoid production errors, reduce costs, and even defend against lawsuits. To maintain such records on products as they move through production and distribution, manufacturers must mark a permanent number, bar code or 2D code on the composites, metals, and polymers that are used to make and package products.
Traditional marking methods present some problems. For example, ink-based technology is messy, poses environmental concerns, and is limited in material application. Hot stamping or dot peening methods cannot be used to mark medical devices because they create inclusions on the material, providing a home for bacteria. Chemical etching is cumbersome, inflexible, and slow.
Lasers have become the preferred means of marking medical products because of their precision, reliability, throughput, cleanliness, and low maintenance requirements.
Laser marking is resistant to heat, steam as well as chemicals, which permits a safe cleaning and sterilization, and guarantees the traceability of marked objects. Moreover the unique annealing effect on stainless steel ensures that surfaces remain smooth and unchanged after the marking process, and that no bacteria or dirt will multiply or accumulate.