ISO 16054:2000 Implants for surgery minimum data sets for surgical implants

Courtesy: ISO 16054:2000 Implants for surgery minimum data sets for surgical implants

Cardiovascular

Cardiovascular medical devices are implanted in cases where the heart, its valves, and the rest of the circulatory system is in disorder. They are used to treat conditions such as heart failure, cardiac arrhythmia, ventricular tachycardia, valvular heart disease, angina pectoris, and atherosclerosis. Examples include the artificial heart, artificial heart valve, implantable cardioverter-defibrillator, artificial cardiac pacemaker, and coronary stent.

Orthopedic

Orthopaedic implants help alleviate issues with the bones and joints of the body. They are used to treat bone fractures, osteoarthritis, scoliosis, spinal stenosis, and chronic pain. Examples include a wide variety of pins, rods, screws, and plates used to anchor fractured bones while they heal.

Metallic glasses based on magnesium with zinc and calcium addition are tested as the potential metallic biomaterials for biodegradable medical implants.

Patient with orthopaedic implants sometimes need to be put under magnetic resonance imaging (MRI) machine for detailed musculoskeletal study. Therefore, concerns have been raised regarding the loosening and migration of implant, heating of the implant metal which could cause thermal damage to surrounding tissues, and distortion of the MRI scan that affects the imaging results. A study of orthopaedic implants in 2005 has shown that majority of the orthopaedic implants does not react with magnetic fields under the 1.0 Tesla MRI scanning machine with the exception of external fixator clamps. However, at 7.0 Tesla, several orthopaedic implants would show significant interaction with the MRI magnetic fields, such as heel and fibular implant.

Electric

Electrical implants are being used to relieve pain from rheumatoid arthritis. The electric implant is embedded in the neck of patients with rheumatoid arthritics, the implant sends electrical signals to electrodes in the vagus nerve. The application of this device is being tested an alternative to medicating people with rheumatoid arthritis for their lifetime.

Contraception

Contraceptive implants are primarily used to prevent unintended pregnancy and treat conditions such as non-pathological forms of menorrhagia. Examples include copper- and hormone-based intrauterine devices.

Cosmetic

Cosmetic implants — often prosthetics — attempt to bring some portion of the body back to an acceptable aesthetic norm. They are used as a follow-up to mastectomy due to breast cancer, for correcting some forms of disfigurement, and modifying aspects of the body (as in buttock augmentation and chin augmentation). Examples include the breast implant, nose prosthesis, ocular prosthesis, and injectable filler.

Other organs and systems

AMS 800 and ZSI 375 artificial urinary sphincters

Other types of organ dysfunction can occur in the systems of the body, including the gastrointestinal, respiratory, and urological systems. Implants are used in those and other locations to treat conditions such as gastroesophageal reflux disease, gastroparesis, respiratory failure, sleep apnea, urinary and fecal incontinence, and erectile dysfunction. Examples include the LINX, implantable gastric stimulator, diaphragmatic/phrenic nerve stimulator, neurostimulator, surgical mesh, artificial urinary sphincter and penile implant.

Classification

United States classification

Medical devices are classified by the US Food and Drug Administration (FDA) under three different classes depending on the risks the medical device may impose on the user. According to 21CFR 860.3, Class I devices are considered to pose the least amount of risk to the user and require the least amount of control. Class I devices include simple devices such as arm slings and hand-held surgical instruments. Class II devices are considered to need more regulation than Class I devices and are required to undergo specific requirements before FDA approval. Class II devices include X-ray systems and physiological monitors. Class III devices require the most regulatory controls since the device supports or sustains human life or may not be well tested. Class III devices include replacement heart valves and implanted cerebellar stimulators. Many implants typically fall under Class II and Class III devices.