Adhesives are very important in the manufacturing of medical devices. Cyanoacrylate adhesives, also known as “super glues,” can be used to make precision equipment and medical devices that can save the lives of many people. You need a strong adhesive for medical devices because they are used in the most important situations. When you buy a medical-grade super glue, you should know exactly what you’re getting. Our society and medical needs are changing quickly, so you should know exactly what you’re getting.
What’s the Difference Between Medical Grade and Standard Cyanoacrylates Super Glues?
Medical-grade cyanoacrylate super glues are almost the same as their non-medical-grade counterparts in terms of how they work. In fact, they can be almost the same, except for one thing. Medical-grade cyanoacrylates are made and tested to a more strict standard than regular cyanoacrylates. Most medical-grade cyanoacrylates are called “Medical Grade” because they meet biocompatibility standards set by the USP Class VI or ISO 10993 standards. ISO 10993 is more common.
These products are tested both during and after they are made to make sure they meet very strict quality standards. This isn’t to say that standard super glues wouldn’t pass, but when it comes to making medical devices, certifications, and tests like this help to make sure the products are safe.
Why Are Cyanoacrylates Used So Often with Medical Devices?
Cyanoacrylate super glues are great for making medical devices, and there are a lot of reasons to love them.
Cyanoacrylates Are Super Strong
A clever name? Not at all. Industrial super glues are very strong and can stick to a lot of different things, like rubbers, plastics, metals, and more.
Cyanoacrylates Are Safe and Durable
As soon as they’re done setting, cyanoacrylate super glues are very strong against a lot of different chemicals and solvents. People who make medical devices don’t have to worry about how they might react to medicines or sterilizing agents when they use them. They also go into a post-cure “plastic state,” which makes a strong, long-lasting bond without leaving behind any chemical residues in the long run.
Cyanoacrylates Are Easy to Use and Dispense
Cyanoacrylates are used in a lot of different things because they are so easy to use and dry quickly. There is no need for special mixing or dispensing equipment. You can just apply from a bottle or syringe and you’re off to the races. When you add super glue accelerators to cyanoacrylates to speed up the process even more, you can make even stronger bonds.
Quick Recap on Why Cyanoacrylates Are a Favorite in Medical Device Manufacturing
- Fast setting
- Easy to dispense – single component
- Once cured (plastic state) they are strong and safe
Understanding VI and ISO Certification
Biocompatibility testing has changed from the USP Class VI standard to the ISO-10993 standard. Most suppliers now use the ISO-10993 standard for this. The two standards set out a few different tests and used different ways to test them. For example, the USP tests require a physicochemical test that isn’t usually part of ISO tests. Getting a USP Class VI rating doesn’t have much to do with whether the product will get approved by the Food and Drug Administration (FDA). The Class VI rating only says that the product has a low level of toxicity when it is tested in the way that it was.
ISO-10992 Biocompatibility Testing Can Include:
- Intradermal injection tests are done to see if the material is likely to be irritating.
- Acute systemic injection tests are done to see if the material is toxic if it is injected into the body in a single dose.
- Cytotoxicity tests are done with rabbit blood to see if the material can break down the blood. In vitro hemocompatibility tests make sure that the extract from the test material doesn’t harm the cell parts of blood.
Certification that your product is safe for people to use is only a guide. They don’t have to check or test their adhesive products under federal law. A polite way to say “Hey, if you decide to use one of our adhesives, we’re sure that it won’t have a bad effect on your end device.”
Before putting a medical device product on the market, medical device manufacturers go through a long process of looking at all of the different materials that make up the device. This includes adhesives! This is to find out if the materials are safe to use. After that, the Food and Drug Administration still has to have a say in what goes on. People are going to put a lot of time and money into getting the product out there. In the last thing that a company that makes medical devices needs is for its adhesive to be changed. The manufacturer might have to resubmit the product for approval if there is a big change, like a new raw material or a new way to make the product.
Where are Medical Grade Cyanoacrylates Used?
They can be used to put together a wide range of medical devices. They can be used to bond or coat both inside and outside surfaces.
Medical super glues are used to make things like catheters, respiratory and anesthesia masks, syringes, needles, and cannulas, which are all single-use items that need to be made in a lot of them. They are used in a lot of things that can save people’s lives, like resuscitation tubes, respirators, and blood filters.
Medical super glues can also be used to make things that last for a long time, like prosthetic joints. They can also be used to make things that only last for a short time.
With so many different ways to use medical super glue, it is important that they have a wide range of properties so they can be used for any of them.
Super glue has a long history of being able to fix things that are broken. What happens when that broken thing is you? If you have been hurt, the first thing you should do is get medical help. Many emergency rooms and first responders have been using a medical-grade super glue (skin adhesive) instead of stitches to close a wound, and it has worked well. Why? Because:
- It is less painful
- There are no needle pokes
- It is a faster procedure
- Often, it does not require a follow-up visit, saving you another trip to the doctor
- It does not require sedation
Skin glue is an alternative to stitches that can be as good as stitches when used on the right wound. WARNING: This text is for adults only. If you are under the age of 18, you should not read or write this text. If the cut meets these conditions, one way to treat it is to use skin adhesive to close the wound.
Adhesive can be very good for people who want to look good. For this reason, skin adhesive can be used to close wounds without causing scarring that looks bad at the end. The face doesn’t have as much tight skin as other parts of the body.
Medical Grade Cyanoacrylates and COVID-19
Because of the global coronavirus (COVID-19) outbreak, medical technology companies have increased production of ventilators by more than 40%. This is so that they can meet the growing needs of patients and healthcare systems around the world.
The use of medical equipment, like ventilators, is very important in the care of people who have a very bad respiratory illness, like COVID-19. They let people who can’t breathe well rest and recover while giving them oxygen and simulating breathing.