The safety and quality of our implants is an absolute priority to us. Not only are safe implants necessary for us to keep doing business, but we ourselves implant the products we sell to others in our own bodies.
Safety is something we think about at all stages of an implant life cycle. This starts at the design stage, before any coating materials or components are chosen we evaluate how the implant will function when implanted in the body. This safety evaluation encompasses many things depending on intended function of the implant. Below are some of the common safety decisions Cyberise considers for all of our implants.
One thing to consider when designing implants is where and how they will be manufactured. While it may be cheaper to have products manufactured in a developing country, doing so may impact the safety of the implant. Many developing countries have lower safety standards and more lax regulations than more developed nations. Despite the increased production cost, Cyberise chooses to manufacture our implants in countries with strong regulations and good safety reputations. This is in contrast to some other vendors who have their implants manufactured at the lowest price possible, often in countries such as China and Thailand were quality and safety regulations are weaker. On individual implant product pages you will find tags similar to the example picture below, these tags tell you where the particular implant was manufactured, giving an assurance of the quality manufacturing location.
Implantable products list the country they were made in.
Thinking about how an implant will function long term inside the body impacts how the implant is constructed. One such decision is whether to use rigid or flexible implants. While flexible implants can be nice because of their larger possible size and greater number of implant locations, they also come with a number of drawbacks. Due to the constant movement of the body causing flexible implants to bend and twist, fatigue of the flexible implant components can build up over time, leading to implant stopping working or the coating becoming compromised and the implant needing to be replaced after a year or two. Cyberise builds implants that last, and so prefers rigid implants, without the bending from the body's movement, implants continue working for many decades within the body.
Biological safety is not the only thing to consider when designing a safe implant. Another important aspect is cyber-security. Cybernetic implants contain electronic microchips, which are fully functional tiny computers. You certainly don't want your shiny new implant to be hacked and have your personal data stolen or worse. The Cyberise team includes individuals with many years of information security experience, we design and test the cyber security of our implants with great care to ensure they are as secure as possible.
Planning for standard implant environments is important, but the extremes need to the anticipated as well. All Cyberise implants are designed to be MRI and CT scan safe. In order the confirm the implants preformed as designed, Cyberise members underwent MRI and CT scans at public hospitals. Not only were the implants safe throughout the scans, but the data stored on the chips remained uncorrupted.
One of the most important aspects of an implant's safety is the type of material used to coat the implant. The human body attacks most materials implanted within it, known as a foreign body reaction, this can lead to many problems and means the object must be removed. The medical field has discovered a number of special materials which the body doesn't reject, such as titanium. Cyberise takes great care to use bio-compatible material when creating our implants to make sure they are safe to implant.
Designing safe implantable coating materials is a extremely complex task. Rather than trying to re-invent the wheel, Cyberise uses known safe materials such as bio-compatible glass, titanium and gold. Such materials have proven track records from being used by the medical and body modification communities for many decades. This greatly increases the safety of our implants as we can be certain there are no long term issues caused by our implant coatings within the body.
Once the right materials are chosen, they need to be sourced from a reliable supplier. Cheap poor quality materials are easy to find, but given the importance of implant safety, Cyberise sources all coating material from highly regarded, ISO 9001 certified companies in Germany and the USA. While the material used to construct the implants internal components is less critical since it will not be in contact with the body, it is still important to avoid harmful elements. Cyberise uses CE certified components to ensure our implants do not contain toxic materials.
Using a certified source is important, but the safety of our implants is too important to simply trust. To ensure the quality and safety of the coating materials used, Cyberise uses an external partner to test the coating material used on our implants for heavy metals. For more information on testing of implant coatings, see the Augmentation Limitless blog.
Testing and Verification:
Even with the best designed implant possible, it's not much good if don't we verify the final products are manufactured to a high safety standard. This is why all Cyberise implants under go a thorough testing process before they cleared to be shipped to customers.
In order for implants to be safe they must be completely sealed to prevent blood etc from entering the implant. In order to reliably seal our implants, Cyberise has developed an automated sealing procedure. This results in reliably sealed implants and increases implant safety. Below is a picture of some of Cyberise's implants being sealed
Implants ready to be sealed
In order to verify the strength of the implant coating is up to spec and there are no deformities that could result in the coating breaking if it was put under pressure while inside the body, all implants are placed in a pressure vessel and exposed to 30 PSI, about the same pressure as car tires, and left for an extended period of time. In the rare case where there is a weakness in the coating, the implant cracks or collapses. After the test is complete any damaged implants are discarded.
Once implants are sealed, it is important to verify the sealing was a success and there are no leaks in the implant. Cyberise has developed process for testing implants are properly sealed by first heating the implant to 50 degrees C, has the temperature of implant increases, any air trapped inside the implant expands. The implant's coating is strong enough to easily withstand this increased pressure, but If there is a leak in the coating the air will escape. After implant has reached the correct temperature, it is submerged in cold (5 degrees C) water. If there is a leak in the coating, water is drawn into the implant as the air cools and contracts. Once the implants are fully cooled they are inspected, any containing water are discarded, those that passed the this test move on to the next step. This test ties in well with the previous test as any hair-line cracks caused by the high pressure are detected by water leaking into the implant.
Hermetic seal testing of implants in water
One final test is to run all implants under a powerful digital microscope. Cyberise has developed automated testing software that uses computer version techniques coupled with robotic control to assess each chip as it is moved under the microscope. Image processing detects any defects in the implant coating or the circuitry within. Any implants with anomalies are automatically discarded.
Physical tests of the implant are not the only thing that is needed to ensure high quality. Each implant also undergoes a range of electronic tests to ensure it performs correctly. The exact electronic tests depend on the function of the implant, but most include writing data to the chip and reading it back to confirm it is stored correctly. Where possible other functions such as locking and unlocking the chip are also performed. This is a fully automated procedure, any chips that do not perform as expected are returned to their manufacturer for investigation.
Implants are moved under the antenna one by one, each implant undergoes a set of electronic tests
The final step in making sure the implant is safe to use is to clean it. The manufacturing process can leave residue on the implant's surface. It's important to fully clean the implant before it can implanted to reduce the chance of infection or being exposed to toxins. Cyberise cleans all implants by submerging them in a 99% alcohol solution and using an automated stirring machine to remove and dirt or residue from the implant's surface.
Implants being cleaned after sealing.
Sterilization and Packaging:
The final step in the safety process is to ensure that the implants arrive in a state fit to be used.
The most important step in this process is that the implants are sterilized. In order to avoid infection when the device is implanted under the skin, it needs to be sterile, i.e. be clean of bacteria etc.
Cyberise then uses an autoclave to sterilize all implants before they are ready for customers. This a device that kills bacteria through a process of stream and pressure, autoclaves are commonly used in hospitals for sterilizing medical equipment. Cyberise uses s high grade autoclave that is certified to meet European Class B standards, ensuring it can safely sterilize implants even when they are inside the injector needle.
Implants are loaded into the autoclave for sterilization
Once the implants have been sterilized they are safe to implant, however if exposed to the environment they will become contaminated again. Cyberise uses standard medical sterilization pouches. These pouches allow the implant to be sterilized, but once removed from the autoclave protect the implant from being contaminated. This makes sure it is still sterile and safe to implant when it reaches the customer. The sterilization pouches include a special marker which changes color when the pouch is autoclave'd. Below is a picture showing how this marker looks.
Sterilization pouches. The pouch on the left has not yet been sterilized while the one on the right has
been sterilized. Note the sterilization marker in the upper left corner of the pouch has changed color.
Once inside the injector needle, normal RFID readers are unable to detect the implant because the metal needle blocks the signal. Cyberise uses a special high power reader able to read the chip even through the injector to preform one final test that the chip is working after packaging and sterilization is complete to be sure the implant is working before it is sent to the customer.
Implants undergo a final test using a powerful reader able to read through the metal injector
In order to verify our sterilization process is working properly, Cyberise selected random implants and sent them to a third party lab for culture testing. This is a process where the implants are checked for bacteria by exposing the implant to conditions where bacteria would grow. I.e. simulating the inside of a body. The results showed implants were properly sterilized and no bacteria or viruses remained on or in the implants.
Implant in culture testing petri dish
The implant is now ready to be used by a customer. The implant is then packaged along with a standard injection prep kit, and placed in a Cyberise shipping box to be shipped to the customer. For full shipping details, see our shipping information page.
Packaging cut away image