Fasteners are crucial to daily life. From the bolts that strengthen buildings and bridges to the washers in your car, fasteners make our modern world possible. They play a vital role in manufacturing, technology and more. And they are increasingly vital to medical devices and technology.
Medical devices range in size from nearly microscopic to as large as rooms. Consider insulin pumps, which deliver subcutaneous insulin to people with diabetes. Small screws hold these devices together, ensuring proper functionality that saves lives. Stepping up in scale, wheelchairs and other mobility aids rely on fasteners for appropriate sizing to meet individuals’ needs. On a larger scale, magnetic resonance imaging (MRI) machines require countless fasteners to perform life-saving imagining tests.
Without fasteners, these and other medical devices wouldn’t work. Here are just a few medical devices that require fasteners to function:
- Surgical instruments. Scalpels, forceps, scissors and other devices used for surgery require fasteners for effective operation. These include ophthalmic surgical instruments, such as microscopes and laser systems for eye surgery.
- Implantable devices. Pacemakers, defibrillators and other implantable devices use fasteners for securing internal components. Orthopedic implants to repair broken bones and joints, like joint replacements, plates and screws, also require fasteners.
- Diagnostic equipment. Blood pressure monitors and thermometers use fasteners for assembly.
- Intravascular devices. These devices include catheters and stents, which help fluids move throughout and out of the body.
Fortunately, Global Certified Fasteners provides hundreds of exceptional, well-crafted fasteners to help you produce and manufacture high-quality, functional medical devices. Choosing a fastener for your medical devices can be challenging, especially when medical devices are so advanced and have unique considerations. Below, the experts at Global Certified Fasteners cover seven essential factors to consider when choosing fasteners.
7 Important Factors When Choosing Fasteners for Medical Devices
Biocompatibility: Depending on the type of medical device, biocompatibility is crucial. Biocompatibility is the ability of medical technology and medical instruments to integrate safely with human or animal subjects. For example, pacemakers are placed in the body to help keep heart rhythms in check (i.e., to “pace” them). Because they are constantly exposed to blood and interstitial fluids, the biocompatibility of every piece of a pacemaker is essential.
Corrosion resistance: Corrosion occurs when metals break down because of chemicals, water or other materials. Implantable devices, surgical instruments and dental implants are especially susceptible to corrosion because of their constant exposure to fluids. Corrosion resistance can help increase the longevity and functionality of medical devices, so manufacturers must choose fasteners with high corrosion resistance.
Precision: Reliability is instrumental in patient safety. That’s why all fasteners used in medical devices, from surgical instruments to pacemakers, must be tested for reliability and precision. The manufacturing process for medical fasteners requires high precision to meet strict specifications. Reliability can prevent any failure that could compromise the performance of medical devices.
Sterilization: Many medical devices, especially tools used in surgery and medical procedures, are constantly sterilized. Sterilization removes germs, biohazards and other materials from objects, making them safe to use again. Choosing fasteners made from appropriate materials that can be sterilized repeatedly is crucial. For example, fasteners likely to corrode are not ideal for sterilization procedures, which can increase corrosion rates.
Tracking: Because fasteners can fail or medical devices can malfunction, it is vital for all pieces of a medical device – including small parts like fasteners – to be easily tracked. For example, if a fastener has a flaw, manufacturers want to quickly and accurately identify other fasteners made at or around the same time, typically in batches, to make quick and life-saving recalls of larger medical devices with the same faulty fasteners. If the tracking metrics are flawed or not thorough, there can be worse outcomes
Regulations: The Food and Drug Administration (FDA) oversees regulations that strengthen the quality, effectiveness and reliability of medical devices. As the governing bodies of medical device safety, these organizations have stringent regulations for every piece involved in manufacturing and distributing medical devices. When choosing fasteners for medical devices, always check for regulations and compliance.
Environments: The final important consideration for medical device fasteners is the environment. Medical equipment is used in many environments, and those environments can shape what type of fastener works best. For example, MRIs use large magnets to create images of soft tissues in the body. Any medical devices used in the same room as an MRI machine must not be magnetized; titanium, copper and stainless steel are non-magnetic metals often used in this environment.
Expert Guidance to Help You Choose Fasteners
With so much to consider when choosing fasteners for medical devices, it can be difficult to make a sound plan. Fortunately, the experts at Global Certified Fasteners can help you select the best fastener for your medical device. Our intense quality standards ensure you get the best product for your project. Contact us today to get started.