Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare purposes. BME is also traditionally known as "bioengineering", but this term has come to also refer to biological engineering. This field seeks to close the gap between engineering and medicine, combining the design and problem-solving skills of engineering with medical biological sciences to advance health care treatment, including diagnosis, monitoring, and therapy. Also included under the scope of a biomedical engineer is the management of current medical equipment in hospitals while adhering to relevant industry standards. This involves making equipment recommendations, procurement, routine testing, and preventive maintenance, a role also known as a Biomedical Equipment Technician (BMET) or as clinical engineering.
Medical software is any software item or system used within a medical context, such as:
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
SEMI is an industry association comprising companies involved in the electronics design and manufacturing supply chain. They provide equipment, materials and services for the manufacture of semiconductors, photovoltaic panels, LED and flat panel displays, micro-electromechanical systems (MEMS), printed and flexible electronics, and related micro and nano-technologies.
Health technology is defined by the World Health Organization as the "application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives". This includes pharmaceuticals, devices, procedures, and organizational systems used in the healthcare industry, as well as computer-supported information systems. Predictive analytics also has been instrumental in helping healthcare organisations analyse resource shortage and other aspects ahead of time. In the United States, these technologies involve standardized physical objects, as well as traditional and designed social means and methods to treat or care for patients.
A biomedical engineering/equipment technician/technologist or biomedical engineering/equipment specialist is typically an electro-mechanical technician or technologist who ensures that medical equipment is well-maintained, properly configured, and safely functional. In healthcare environments, BMETs often work with or officiate as a biomedical and/or clinical engineer, since the career field has no legal distinction between engineers and engineering technicians/technologists.
Clinical engineering is a specialty within biomedical engineering responsible for using medical technology to optimize healthcare delivery.
A patient safety organization (PSO) is a group, institution, or association that improves medical care by reducing medical errors. Common functions of patient safety organizations are data collection and analysis, reporting, education, funding, and advocacy.
Dental laboratories manufacture or customize a variety of products to assist in the provision of oral health care by a licensed dentist. These products include crowns, bridges, dentures and other dental products. Dental lab technicians follow a prescription from a licensed dentist when manufacturing these items, which include prosthetic devices and therapeutic devices. The FDA regulates these products as medical devices and they are therefore subject to FDA's good manufacturing practice ("GMP") and quality system ("QS") requirements. In most cases, however, they are exempt from manufacturer registration requirements. Some of the most common restorations manufactured include crowns, bridges, dentures, and dental implants. Dental implants is one of the most advanced dental technologies in the field of dentistry.
The Professional Regulation Commission, otherwise known as the PRC, is a three-man commission attached to Department of Labor and Employment (DOLE). Its mandate is to regulate and supervise the practice of the professionals who constitute the highly skilled manpower of the country. As the agency-in-charge of the professional sector, the PRC plays a strategic role in developing the corps of professionals for industry, commerce, governance, and the economy.
The American Society of Radiologic Technologists (ASRT), located in Albuquerque, New Mexico, is a professional membership association for medical imaging technologists, radiation therapists and radiologic science students.
Medical equipment management is a term for the professionals who manage operations, analyze and improve utilization and safety, and support servicing healthcare technology. These healthcare technology managers are, much like other healthcare professionals referred to by various specialty or organizational hierarchy names.
Eucomed was the organisation that represented the interests of the medical device industry in Europe. It represents directly and indirectly 4,500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and management of disease and disability. Eucomed represents a total of 11,000 legal entities in Europe. It is now part of MedTech Europe.
The Information Technology Industry Council (ITI) is a Washington, D.C.-based trade association that represents companies from the information and communications technology (ICT) industry. As an advocacy organization, ITI works to influence policy issues aimed at encouraging innovation and promoting global competitiveness.
Medical device connectivity is the establishment and maintenance of a connection through which data is transferred between a medical device, such as a patient monitor, and an information system. The term is used interchangeably with biomedical device connectivity or biomedical device integration. By eliminating the need for manual data entry, potential benefits include faster and more frequent data updates, diminished human error, and improved workflow efficiency.
The central sterile services department (CSSD), also called sterile processing department (SPD), sterile processing, central supply department (CSD), or central supply, is an integrated place in hospitals and other health care facilities that performs sterilization and other actions on medical devices, equipment and consumables; for subsequent use by health workers in the operating theatre of the hospital and also for other aseptic procedures, e.g. catheterization, wound stitching and bandaging in a medical, surgical, maternity or paediatric ward.
MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure. It represents Diagnostics and Medical Devices manufacturers operating in Europe. It is born as an alliance of two European medical technology associations, EDMA and Eucomed, representing the European IVD and medical device industries, respectively. It was established with the aim to represent the common policy goals of both organisations more effectively, promoting the interests of its members and of the medical technology industry in general.
Integrated Medical Systems International, Inc., (IMS) is a surgical instrument management and clinical consulting company specializing in repair management, sterile process management, tracking, and other services related to surgical and endoscopic devices and instruments. Today the company operates repair facilities in Alabama, Florida, and Maryland. IMS has more than 1,200 employees nationwide.
Andhra Pradesh MedTech Zone(AMTZ) is India's premier medical technology park with Common Manufacturing Facilities & Common Scientific Facilities that include specialized laboratories, warehousing and testing centers such as the Center for Electromagnetic compatibility and safety testing, Center for Biomaterial Testing, Center for 3-D printing, Centers for Lasers, MRI Magnets, Gamma Irradiation, Molds, and many other industrial service centers.
