Federal regulation of single-use medical devices: a revised FDA policy

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

Bacterial signaling can occur within bacteria (intracellular) or between bacteria (intercellular). At times, a group of bacteria behaves like a community. To achieve this, they engage in quorum sensing, the perception of higher cell density that causes changes in gene expression. Quorum sensing involves both extracellular and intracellular signaling. The signaling cascade starts with a molecule called an autoinducer (AI). Individual bacteria produce AIs that move out of the bacterial cell...

Cleaning, disinfection, and sterilization are the methods that help to break the infection chain and prevent disease.
Cleaning
The cleaning process usually involves using water with detergents or enzymatic cleaner and removing foreign material from objects and surfaces, including organic material such as body fluids or inorganic material like soil. Cleaning is performed before high-level disinfection and sterilization because foreign materials on the cover of the devices interfere with process...

Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with a...

In healthcare, the chemical method of sterilization uses chemical sterilants to treat surgical instruments and medical supplies to help prevent the transmission of infectious pathogens to patients. Due to heat sensitivity, most medical supplies and equipment should not be exposed to high temperatures. These parts include rubber, plastic, glass, and other similar elements.
Using chemical sterilization rather than heat to clean out equipment is recommended. It eradicates and removes all bacteria,...