Choosing a Medical Device Adhesive

Medical device adhesives are ‘adhesives that are marketed to medical device manufacturers’. Unlike food grade adhesives, medical device adhesives contain no special approval from the FDA. Often, bio-compatibility testing is performed on the adhesive as a marketing tool to increase the buyer’s trust in the product. Types of bio-compatibility testing include cyto-toxicity, USP Class VI, and IS010993. Even then, the assessment does not replace the testing required of the device manufacturer by the FDA. Device manufacturers are required to prove that the device they manufacture is bio-compatible and effective.

The logical path is:
• Adhesives are tested for bio-compatibility after they are cured;
• Lack of proper curing can affect bio-compatibility;
• Curing occurs within the device manufacturer’s assembly process.

Therefore:
• Bio-compatibility can only be determined on the finished medical device.

Generally, the term ‘medical device adhesives’ refers to those adhesives used on medical devices that come into contact with the body, body fluids or delivery systems. As such, the adhesives are designed to bond the plastics and other materials common to the industry. So a UV curable adhesive used to bond an oxygen mask together is likely considered a medical device adhesive. But the epoxy, threadlockers and, structural acrylics used in the manufacture of an x-ray machine are not considered medical device adhesive. However, if you use the same epoxy used in the x-ray machine to bond a needle into the hub of a hypodermic needle…well, now there is a medical device adhesive!

So, choose the adhesive that meets your requirements, regardless of whether it is termed a medical device adhesive or not.