Healthcare organizations understandably have high expectations for the chromium coatings applied to their stainless-steel and aluminum instruments and devices. None is more critical than biocompatibility.
They want a coating that prevents corrosion, maintains cutting edges and reduces glare from high-intensity light. It should also be smooth-gliding, prevent spalling, fretting, and galling, and keep items looking like new through many use-cleaning-sterilizing cycles.
But first and foremost, a coating must be biocompatible.
Merriam-Webster defines biocompatibility this way: “compatibility with living tissue or a living system by not being toxic, injurious, or physiologically reactive and not causing immunological rejection.” In other words, a biocompatible coating does not harm the people who come into contact with it.
A healthcare provider’s first concern in this regard is its patients. But it is also worth recognizing that biocompatibility also affects the organization’s staff. From the doctors and nurses who use the instruments and devices to the technicians who clean and maintain them, it is critical that a coated item is safe to handle.
With patients, in particular, biocompatibility ensures that their body can focus on recovering from the procedure without having to contend with irritation and other issues caused by coatings that do not meet this standard.
At ME-92 Operations, we are proud to be the first chromium coatings company to take and pass the tripartite guidelines testing for compatibility. Our ME-92® coating meets the current standard, ISO 10993.
We did not have to subject our coating to this testing. However, we felt we owed it to our customers and their patients. And, frankly, we never shy away from a challenge regarding the quality of our coatings and services. We have been a leader in this industry for decades and plan to continue in that role.
Specific tests performed on our ME-92® coating include:
- ISO Systemic Toxicity Study (ISO 10993-11)
- ISO Maximization Sensitization Study (ISO 10993-10)
- ISO Pyrogen Study – Material Mediated (Pyrogenicity) (ISO 10993-11)
- Cytotoxicity Study Using the ISO Elution Method (ISO 10993-5)
- ISO Intracutaneous Study (ISO 10993-10)
- ASTM Hemolysis (ISO 10993-4)
These are rigorous scientific reviews of the coating’s safety and efficacy that we confidently participated in and passed.
Not every healthcare professional who uses instruments and devices we have coated thinks about biocompatibility. They have to focus on the procedure or treatment they are providing. But those who pause to consider the item in their hand are pleased that it has a leading-edge chromium coating that protects them and their patient.
Other Characteristics of Biocompatible Chromium Coatings
In addition to being biocompatible, ME-92® has other characteristics that make it ideal for medical instruments and devices. For example, it offers absolute adhesion to the substrate. It will not chip, flake, or peel. And we can apply it in thicknesses ranging from 0.00004” to 0.001” per side (1,0- 25,0 microns), meaning it can provide unrivaled protection without changing an item’s functional specifications.
In addition, ME-92® has a unique 80Rc surface hardness and stands up to standard sterilization procedures, including:
- Steam autoclave
- STERIS SYSTEM 1
- STERRAD sterilization
- Gamma X-ray
- Bleach exposure
- Detergent scrubbing
- STERIS EtO
What’s more, although we developed ME-92® for stainless-steel substrates, we subsequently created versions ideal for nearly every metal type. This includes tool steels such as S-7 and H-13, bearing steels like 52100 and 8620, cold roll, hot roll, high-carbon and low-carbon steels, cast iron, bronze, copper, brass, and aluminum.
In short, if a medical or ancillary item is made of metal, we can likely coat it!
Our Unwavering Commitment to Innovation
Our pride in developing the first biocompatible chromium coating goes beyond the safety and performance benefits ME-92® provides. While some companies are content leveraging existing materials to complete work that meets customer expectations, our team continually strives to exceed them.
Despite all the positive characteristics of our coatings, we know there is always room for improvement. That is what drives us to continue exploring new formulations and application processes.
We feel that our unwavering commitment to innovation also speaks to the type of relationships we have with medical instrument and device manufacturers, purchasers, and users. ME-92 Operations is more than a coatings provider—we are a coatings collaborator.
Our coatings experts understand that as healthcare evolves, the people “on the front lines” are best positioned to anticipate changing needs and requirements. So, in the same way we worked closely with them on biocompatibility issues, we continue to seek their input on other advances in chromium coatings. And as a result, everyone wins.