Risk-Based Classification of Medical Devices

Clinical trials for new drugs are conducted in a structured, multi-phase process. Phase I assesses safety and dosage in a small group of healthy volunteers. Phase II evaluates efficacy and side effects in a larger group of patients. Phase III confirms efficacy, monitors side effects, and compares it to standard treatments in a large patient population before regulatory submission.

Spontaneous Reporting Systems (SRS) are a cornerstone of post-marketing drug safety surveillance. Healthcare professionals and patients voluntarily submit reports of suspected adverse drug reactions (ADRs) to a central database. While subject to under-reporting and bias, these systems are crucial for detecting rare, unexpected, or long-latency ADRs that may not be identified during pre-market clinical trials.

Bioactive materials are a class of biomaterials designed to elicit a specific, positive biological response at the material-tissue interface, resulting in the formation of a bond between them. Unlike bioinert materials that aim for minimal interaction, bioactive materials actively participate in healing processes. A classic example is Bioglass, which forms a hydroxyapatite layer on its surface, bonding directly to bone.

An implantable cardioverter-defibrillator (ICD) is a small, battery-powered device placed in the chest to monitor heart rhythm and detect life-threatening arrhythmias like ventricular tachycardia or fibrillation. When an abnormal rhythm is detected, the ICD can deliver a precisely calibrated electrical shock (defibrillation) to restore a normal heartbeat, preventing sudden cardiac death.

A tissue engineering scaffold is a porous, three-dimensional biomaterial structure that serves as a temporary template for tissue regeneration. It is designed to support cell attachment, migration, proliferation, and differentiation, guiding the formation of new functional tissue. Key properties include biocompatibility, biodegradability, appropriate mechanical strength, high porosity, and an interconnected pore network to allow nutrient and waste transport.

Biocompatibility is the property of a material to perform with an appropriate host response in a specific application. For medical implants, this means avoiding toxic, injurious, or immunological reactions from the body. Materials like titanium, silicone, and certain polymers are chosen for their inertness and ability to integrate with biological tissues without causing significant adverse effects.

Osseointegration is the direct structural and functional connection between living bone and the surface of a load-bearing artificial implant, typically made of titanium. Discovered by Per-Ingvar Brånemark, this phenomenon occurs without the growth of fibrous soft tissue at the bone-implant interface, creating a stable and lasting anchor for prosthetics like dental implants and artificial joints.

Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding, and prevention of adverse effects, particularly long-term and short-term side effects of medicines. It is a continuous process that begins during clinical trials and extends throughout the entire life cycle of a drug, focusing on post-marketing surveillance to identify rare or previously unknown adverse drug reactions (ADRs).

A cochlear implant is a surgically implanted neuroprosthetic device that provides a sense of sound to a person with severe to profound sensorineural hearing loss. Unlike hearing aids, which amplify sound, cochlear implants bypass damaged portions of the ear (the hair cells) and directly stimulate the auditory nerve with electrical impulses, which the brain interprets as sound.

Biocompatibility refers to the ability of a material to perform with an appropriate host response in a specific application. It is not an intrinsic property of a material but is defined by the situation. Key factors include the material's surface chemistry, topography, and mechanical properties, which dictate the biological response, such as protein adsorption, cell adhesion, inflammation, and fibrous encapsulation.