Custom-made Medical Device
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Custom-made Medical Device
A custom-made medical device, commonly referred to as a custom-made device (CMD) (Canada, the European Union, the United Kingdom) or a custom device (United States), is a medical device designed and manufactured for the sole use of a particular patient. Examples of custom-made medical devices include auricular splints, dentures, orthodontic appliances, orthotics and prostheses. Definition There is no globally agreed definition, but a custom-made medical device can be broadly defined as a medical device that has been designed and manufactured in accordance with a prescription from an appropriately qualified person for the sole use of a particular patient to meet their specific needs. Mass-produced medical devices that have been adapted for specific patient requirements such as customised wheelchairs, hearing aids, and spectacle frames do not typically fall within the definition of a custom-made medical device. Definitions by jurisdiction Types Depending on the jurisdiction, ...
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Medical Device
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. Discovery of what would be considered a medical device by modern standards dates as far back as in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of Archaeology, archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it was not until the Federal Food, Drug, and Cosmetic Act ( ...
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Anaplastology
Anaplastology (''Gk. ''ana''-again, a new, upon ''plastos''-something made, formed, molded ''logy''-the study of'') is a branch of medicine dealing with the prosthetic rehabilitation of an absent, disfigured or malformed anatomically critical location of the face or body. The term ''anaplastology'' was coined by Walter G. Spohn and is used worldwide. An anaplastologist (also known as a maxillofacial prosthetist and technologist in the United Kingdom) is an individual who has the knowledge and skill set to provide the service of customizing a facial (craniofacial prosthesis), ocular or somatic prosthesis. In locations around the world that facial, ocular and somatic prostheses are not readily available, a dentist who specializes in maxillofacial prosthetics (prosthodontics), or a dental technician or an ocularist, may also be titled an anaplastologist. In urban or more developed locations, an individual referred to as an anaplastologist is one who solely works with facial, ocular ...
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Auricular Splint
An auricular splint (AS) or ear splint is a custom-made medical device that is used to maintain auricular projection and dimensions following second stage auricular reconstruction. The AS is made from ethylene-vinyl acetate (EVA), which is typically used to make custom-made mouthguards and was developed by a team from Great Ormond Street Hospital in the United Kingdom. History The auricle is typically reconstructed using autogenous cartilage, which is the most reliable material for producing the best results with the least complications. Cartilage from the knee and contralateral auricular cartilage from the concha have also been reported but costal cartilage is typically used as it is the only donor site that provides sufficient tissue to fabricate the complete auricular framework. The four main elements to consider when assessing the final reconstructed auricle are: * The symmetry of size of the auricle * The projection of the auricle * The adequacy of the temporoauricular su ...
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Oral And Maxillofacial Surgery
Oral and maxillofacial surgery (OMFS) is a surgical specialty focusing on reconstructive surgery of the face, facial trauma surgery, the Human mouth, mouth, Human head, head and neck, and jaws, as well as facial plastic surgery including cleft lip and cleft palate surgery. Specialty An oral and maxillofacial surgeon is a specialist surgery, surgeon who treats the entire Craniofacial, craniomaxillofacial complex: Anatomy, anatomical area of the Human mouth, mouth, jaws, face, and Human skull, skull, head and neck as well as associated structures. Depending upon the national jurisdiction, oral and maxillofacial surgery may require a degree in medicine, dentistry or both. United States In the U.S., oral and maxillofacial surgeons, whether possessing a single or dual degree, may further specialise after residency, undergoing additional one or two year sub-specialty oral and maxillofacial surgery fellowship training in the following areas: *Cosmetic surgery#Cosmetic surgery, C ...
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Orthognathic Surgery
Orthognathic surgery (), also known as corrective jaw surgery or simply jaw surgery, is surgery designed to correct conditions of the jaw and lower face related to structure, growth, airway issues including sleep apnea, TMJ disorders, malocclusion problems primarily arising from skeletal disharmonies, and other orthodontic dental bite problems that cannot be treated easily with braces, as well as the broad range of facial imbalances, disharmonies, asymmetries, and malproportions where correction may be considered to improve facial aesthetics and self-esteem. The origins of orthognathic surgery belong in oral surgery, and the basic operations related to the surgical removal of impacted or displaced teeth – especially where indicated by orthodontics to enhance dental treatments of malocclusion and dental crowding. One of the first published cases of orthognathic surgery was the one from Dr. Simon P. Hullihen in 1849. Originally coined by Harold Hargis, it was more widely popul ...
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Splint (medicine)
A splint is defined as "a rigid or flexible device that maintains in position a displaced or movable part; also used to keep in place and protect an injured part" or as "a rigid or flexible material used to protect, immobilize, or restrict motion in a part". Splints can be used for injuries that are not severe enough to immobilize the entire injured structure of the body. For instance, a splint can be used for certain fractures, soft tissue sprains, tendon injuries, or injuries awaiting orthopedic treatment. A splint may be static, not allowing motion, or dynamic, allowing controlled motion. Splints can also be used to relieve pain in damaged joints. Splints are quick and easy to apply and do not require a plastering technique. Splints are often made out of some kind of flexible material and a firm pole-like structure for stability. They often buckle or Velcro together. Uses * By the emergency medical services or by volunteer first responders, to temporarily immobilize a fractu ...
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Medical Device
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. Discovery of what would be considered a medical device by modern standards dates as far back as in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of Archaeology, archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it was not until the Federal Food, Drug, and Cosmetic Act ( ...
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Orthopaedics
Orthopedic surgery or orthopedics ( alternative spelling orthopaedics) is the branch of surgery concerned with conditions involving the musculoskeletal system. Orthopedic surgeons use both surgical and nonsurgical means to treat musculoskeletal trauma, spine diseases, sports injuries, degenerative diseases, infections, tumors and congenital disorders. Etymology Nicholas Andry coined the word in French as ', derived from the Ancient Greek words ("correct", "straight") and ("child"), and published ''Orthopedie'' (translated as ''Orthopædia: Or the Art of Correcting and Preventing Deformities in Children'') in 1741. The word was assimilated into English as ''orthopædics''; the ligature ''æ'' was common in that era for ''ae'' in Greek- and Latin-based words. As the name implies, the discipline was initially developed with attention to children, but the correction of spinal and bone deformities in all stages of life eventually became the cornerstone of orthopedic pra ...
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Optometry
Optometry is the healthcare practice concerned with examining the eyes for visual defects, prescribing corrective lenses, and detecting eye abnormalities. In the United States and Canada, optometrists are those that hold a post-baccalaureate four-year Doctor of Optometry degree. They are trained and licensed to practice medicine for eye related conditions, in addition to providing refractive (optical) eye care. Within their scope of practice, optometrists are considered physicians and bill medical insurance(s) (example: Medicare) accordingly. In the United Kingdom, optometrists may also provide medical care (e.g. prescribe medications and perform various surgeries) for eye-related conditions in addition to providing refractive care. The Doctor of Optometry degree is rarer in the UK. Many optometrists participate in academic research for eye-related conditions and diseases. In addition to prescribing glasses and contact lenses for vision related deficiencies, optometrists are ...
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Ophthalmology
Ophthalmology (, ) is the branch of medicine that deals with the diagnosis, treatment, and surgery of eye diseases and disorders. An ophthalmologist is a physician who undergoes subspecialty training in medical and surgical eye care. Following a medical degree, a doctor specialising in ophthalmology must pursue additional postgraduate residency training specific to that field. In the United States, following graduation from medical school, one must complete a four-year residency in ophthalmology to become an ophthalmologist. Following residency, additional specialty training (or fellowship) may be sought in a particular aspect of eye pathology. Ophthalmologists prescribe medications to treat ailments, such as eye diseases, implement laser therapy, and perform surgery when needed. Ophthalmologists provide both primary and specialty eye care—medical and surgical. Most ophthalmologists participate in academic research on eye diseases at some point in their training and many inc ...
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Dental Technician
A dental technician is a member of the dental team who, upon prescription from a dental clinician, constructs custom-made restorative and dental appliances. There are four major disciplines within dental technology. These are ''fixed prosthesis'' including Crown (dentistry), crowns, bridge (dentistry), bridges and Dental implant, implants; ''removable prosthesis'', including dentures and removable partial dentures; ''maxillofacial prosthesis'', including ocular prosthesis and craniofacial prosthesis; and ''orthodontics and auxiliaries'', including orthodontic technology, orthodontic appliances and mouthguards. The dentist communicates with the dental technician with prescriptions, drawings, and measurements taken from the patient. The most important aspect of this is a Impression (dental), dental impression into which the technician flows a Plaster#In medicine, gypsum dental stone to create a replica of the patient's anatomy known as a dental cast. A technician can then use this ...
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