Adhesives are vital and ever-expanding in the medical device manufacturing industry. Cyanoacrylate adhesives, commonly known as "super glues", allow for the construction of precision equipment and medical devices that can be lifesaving for many patients. Medical devices are used in the most critical situations - and this calls for an adhesive that is safe, tested, and dependable. Our society and medical needs are changing rapidly, when you choose a medical grade super glue, 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 very similar to their non-medical grade counterparts. In fact, they can often be exactly the same with one exception. Medical Grade cyanoacrylates are manufactured and tested to a more stringent standard. Most medical grade cyanoacrylates get the name "Medical Grade" by adhering biocompatibility standards of USP Class VI or ISO 10993 standards with ISO 10993 being more common.
Put simply, these products are testing during and after manufacturing to meet highly regulated quality standards. This isn't to say standard super glues wouldn't pass but when it comes to medical device manufacturing, certifications and tests like this help insure product quality.
Why Are Cyanoacrylates Used So Often with Medical Devices?
There's a lot of reasons to love cyanoacrylate super glues for medical device manufacturing.
Cyanoacrylates Are Super Strong
That's right, it's not just a clever name. Industrial super glues (not your craft store adhesive) are incredibly strong and bond to a wide range of substrates including rubbers, plastics, metals and more.
Cyanoacrylates Are Safe and Durable
Once fully cured, cyanoacrylate super glues are highly resistant to a wide range of chemicals and solvents. This means that if used for the assembly of a medical device, there is no need to be concerned about reactions with medicines or sterilizing agents that the device may come into contact with during the course of its use. They also enter a post-cure "plastic state" which offers a strong, durable bond without any long term chemical residues.
Cyanoacrylates Are Easy to Use and Dispense
Cyanoacrylates are used in a lot of applications because they are so easy to dispense and cure very quickly. There is no special mixing or dispensing equipment required, simply apply from a bottle or syringe and you're off to the races. Cyanoacrylates are also very fast curing and can be paired with super glue accelerators for faster, more complete 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
Why Choose Infinity Bond Medical Grade Cyanoacrylate Super Glues?
Infinity Bond manufactures a wide range of cyanoacrylate super glues which are produced right here in the USA all to the highest quality standards. The Infinity Bond motto is "better glue for less" which is exactly what they bring to their complete line of cyanoacrylate adhesives. Don't let the prices fool you, Infinity Bond super glue's are every bit as good as the 'big guys' but they don't make you pay for simply having a big brand logo on the bottle.
Infinity Bond medical grade cyanoacrylates meet the same biocompatibility standards for ISO 10993 and USP Class VI and are compatible with almost all sterilization methods. Contact us with questions or for help with your choosing the perfect medical grade cyanoacrylate super glue for your next medical device or product assembly application.
Understanding VI and ISO Certification
For biocompatibility testing, most suppliers have moved from the United States Pharmacopeia (USP) Class VI standard to ISO-10993. The two standards specify slightly different tests and follow different test methods. For example, USP testing requires a physicochemical test not normally included in ISO testing. Moreover, establishing a USP Class VI rating has little bearing on whether the product will win approval from the Food and Drug Administration (FDA). The Class VI rating merely states that the product exhibits a low level of toxicity under the test conditions.
ISO-10992 Biocompatibility Testing Can Include:
- Intracutaneous injection tests to evaluate the irritation potential of the material.
- Acute systemic injection tests to evaluate the material for potential toxic effects as a result of single-dose systemic injection.
- Cytotoxicity tests to evaluate the hemolytic potential of the material with rabbit blood. In vitro hemocompatibility tests ensure that the test material extract does not adversely affect the cellular components of blood.
Biocompatibility compliance certification is just a guideline. Adhesive suppliers are not required by federal regulations to screen or test their products. It is done as a courtesy to say "Hey, if you're going to select one of our adhesives... we are confident that it won't have a negative impact on your end device."
Before placing a medical device product on the market, medical device manufacturers go through an extensive process of evaluating the various materials that will make up the device - this includes adhesives! This is to determine if the materials are safe. Afterward, the Food and Drug Administration still has to have it's say. After all is said and done, a great amount of time, effort and money will be expended to get the product to market. The last thing that a medical device manufacturer needs is to have its adhesive formulation changed. A dramatic change, such as a new raw material or new process for making it, might mean that the manufacturer has to resubmit the product for approval.
Where are Medical Grade Cyanoacrylates Used?
Medical super glues can be used in the assembly of a wide range of medical devices. They are useful for bonding or coating interior joints, as well as exterior surfaces.
Some common uses of medical super glues include the productions of many single-use items that are required in large quantities, such as catheters, respiratory and anesthesia masks, syringes, needles and cannulas. They are often used in lifesaving pieces of equipment, such as resuscitation tubes, respirators and blood filters.
As well as devices that may only be used for short-term applications, medical super glues are also suitable for the creation of much longer-lived items, such as prosthetic joints.
With such a wide range of applications possible, it is important that medical super glues have a wide range of properties so they are suitable for any of the uses required.
Super glue has a long track record of fixing things that are broken - what happens when that broken thing is you? First and foremost, if you have been injured, it is recommended that you seek proper medical attention. Many Emergency Departments and first responders have have been using a medical grade super glue (skin adhesive) in place of stitches to close a wound. Here's why:
- 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 adhesive is an alternative that can be as effective as stitches when used on the appropriate wound. Usually, that means a small wound; not very deep or wide; not "dirty" or prone to infection; and not on highly mobile parts, such as joints. If the cut meets these criteria, an option for treatment is to use skin adhesive in order to close the wound.
Adhesive use on the face is especially helpful cosmetically. Because the skin on the face isn't as tight as it is in other places, skin adhesive seals wounds without increased risk of unsightly scarring in the end.
Medical Grade Cyanoacrylates and COVID-19
Medical technology companies have increased the production of ventilators by more than 40% due to the global coronavirus (COVID-19) outbreak and to cater to the increase of demands of patients and healthcare systems across the world.
Medical devices such as ventilators play a critical role in the management of patients with a severe respiratory illness such as COVID-19. They allow patients who cannot breathe effectively to rest and recover while supplying oxygen and simulating breathing.