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62-497: [REDACTED] Look up -lma in Wiktionary, the free dictionary. LMA may refer to: Medicine [ edit ] Laryngeal mask airway , a mask used in anaesthesia and emergency medicine Science [ edit ] Laban movement analysis , a language for describing, visualizing, interpreting and documenting human movement Land-mammal age Leaf mass per area ,

124-817: A CA. In Italy it is the Ministero Salute (Ministry of Health) Medical devices must not be mistaken with medicinal products . In the EU, all medical devices must be identified with the CE mark . The conformity of a medium or high risk medical device with relevant regulations is also assessed by an external entity, the Notified Body , before it can be placed on the market. In September 2012, the European Commission proposed new legislation aimed at enhancing safety, traceability, and transparency. The regulation

186-410: A European Council Resolution of May 1985, represents an innovative way of technical harmonisation. It aims to remove technical barriers to trade and dispel the consequent uncertainty for economic operators, to facilitate free movement of goods inside the EU. The previous core legal framework consisted of three directives: They aim at ensuring a high level of protection of human health and safety and

248-538: A broadcast media outlet licensed to a different owner Luftmine Typ A , a type of German WWII naval mine Topics referred to by the same term [REDACTED] This disambiguation page lists articles associated with the title LMA . If an internal link led you here, you may wish to change the link to point directly to the intended article. Retrieved from " https://en.wikipedia.org/w/index.php?title=LMA&oldid=1238362400 " Category : Disambiguation pages Hidden categories: Short description

310-406: A conformity test carried out by a European Notified Body. Class IIb Devices: Slightly more complex than IIa devices, class IIb devices are generally medium to high risk and will often be devices installed within the body for periods of 30 days or longer. Examples include ventilators and intensive care monitoring equipment. Identical compliance route to Class IIa devices with an added requirement of

372-411: A device type examination by a Notified Body. Class III Devices: Class III devices are strictly high risk devices. Examples include balloon catheters, prosthetic heart valves, pacemakers, etc. The steps to approval here include a full quality assurance system audit, along with examination of both the device's design and the device itself by a European Notified Body. The authorization of medical devices

434-635: A function) can be marketed purely by self-certification. The European classification depends on rules that involve the medical device's duration of body contact, invasive character, use of an energy source, effect on the central circulation or nervous system, diagnostic impact, or incorporation of a medicinal product. Certified medical devices should have the CE mark on the packaging, insert leaflets, etc.. These packagings should also show harmonised pictograms and EN standardised logos to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, do not reuse, etc. In November 2018,

496-704: A greater potential risk and are subject to in-depth scrutiny. A guidance document for device classification is published by Health Canada. Canadian classes of medical devices correspond to the European Council Directive 93/42/EEC (MDD) devices: Examples include surgical instruments (Class I), contact lenses and ultrasound scanners (Class II), orthopedic implants and hemodialysis machines (Class III), and cardiac pacemakers (Class IV). Medical devices in India are regulated by Central Drugs Standard Control Organisation ( CDSCO ). Medical devices under

558-425: A human being; the restoration, correction or modification of a body function or the body structure of a human being; the diagnosis of pregnancy in a human being; or the care of a human being during pregnancy and at and after the birth of a child, including the care of the child. It also includes a contraceptive device but does not include a drug." The term covers a wide range of health or medical instruments used in

620-521: A larger share, Japan has the second largest country market share. The largest market shares in Europe (in order of market share size) belong to Germany, Italy, France, and the United Kingdom. The rest of the world comprises regions like (in no particular order) Australia, Canada, China, India, and Iran. This article discusses what constitutes a medical device in these different regions and throughout

682-423: A laryngeal mask in 23 patients was conducted at London Hospital in 1982. Insertion and ventilation using the laryngeal mask in 16 anaesthetised, paralysed female patients was successful, achieving a seal greater than 20 cm H 2 O in all patients. Emergence from anaesthesia was also noted to be uneventful and only 3 patients complained of a sore throat, a marked contrast to endotracheal tube anaesthesia. Following

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744-419: A material that would give him design flexibility before the next set of silicone moulds were cast. In 1986, Brain continued to make prototypes from latex with a range of modifications; the inclusion of an inflation line, a thin-walled elliptical ring in the cuff which resulted in equal expansion of the cuff, the creation of a larger size to increase the reliability of cuff seal pressure and a moulded back plate for

806-666: A medical device by modern standards dates as far back as c.  7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings . Study of 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 (FD&C Act) in 1938 that medical devices were regulated. Later in 1976,

868-1095: A potential, unreasonable risk of illness or injury and require premarket approval . Examples of Class III devices include implantable pacemakers, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants. The classification of medical devices in the European Union is outlined in Article IX of the Council Directive 93/42/EEC and Annex VIII of the EU medical device regulation . There are basically four classes, ranging from low risk to high risk, Classes I, IIa, IIb, and III (this excludes in vitro diagnostics including software, which fall in four classes: from A (lowest risk) to D (highest risk)): Class I Devices: Non-invasive, everyday devices or equipment. Class I devices are generally low risk and can include bandages, compression hosiery, or walking aids. Such devices require only for

930-448: Is different from Wikidata All article disambiguation pages All disambiguation pages Laryngeal mask airway A laryngeal mask airway ( LMA ), also known as laryngeal mask , is a medical device that keeps a patient's airway open during anaesthesia or while they are unconscious. It is a type of supraglottic airway device. They are most commonly used by anaesthetists to channel oxygen or inhalational anaesthetic to

992-493: Is essential for maintaining patient and staff safety while simultaneously facilitating the marketing of medical products. By establishing different risk classifications, lower risk devices, for example, a stethoscope or tongue depressor, are not required to undergo the same level of testing that higher risk devices such as artificial pacemakers undergo. Establishing a hierarchy of risk classification allows regulatory bodies to provide flexibility when reviewing medical devices. Under

1054-613: Is guaranteed by a Declaration of Conformity. This declaration is issued by the manufacturer itself, but for products in Class Is, Im, Ir, IIa, IIb or III, it must be verified by a Certificate of Conformity issued by a Notified Body . A Notified Body is a public or private organisation that has been accredited to validate the compliance of the device to the European Directive. Medical devices that pertain to class I (on condition they do not require sterilization or do not measure

1116-821: Is risk-based and defines four levels: A - Low Risk, B - Low to Moderate Risk, C - Moderate – High Risk, and D - High Risk. The classification of medical devices in Australia is outlined in section 41BD of the Therapeutic Goods Act 1989 and Regulation 3.2 of the Therapeutic Goods Regulations 2002, under control of the Therapeutic Goods Administration . Similarly to the EU classification, they rank in several categories, by order of increasing risk and associated required level of control. Various rules identify

1178-523: Is typically larger and more obstructive than tracheal intubation , it is generally not used for surgery of the mouth and throat . It should not be used for conscious patients because of the risk of stimulating the gag reflex. A laryngeal mask leaves more anatomical dead space in the trachea than with tracheal intubation . This can decrease the oxygenation of the lungs and the removal of carbon dioxide . It also slightly increases airway resistance. More serious complications include vomiting while

1240-487: The Federal Administrative Court of Switzerland decided that the "Sympto" app, used to analyze a woman's menstrual cycle, was a medical device because it calculates a fertility window for each woman using personal data. The manufacturer, Sympto-Therm Foundation, argued that this was a didactic, not a medical process. the court laid down that an app is a medical device if it is to be used for any of

1302-495: The Federal Food Drug & Cosmetic (FD&C) Act defines a device as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for

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1364-1265: The Food, Drug, and Cosmetic Act , the U.S. Food and Drug Administration recognizes three classes of medical devices, based on the level of control necessary to assure safety and effectiveness. The classification procedures are described in the Code of Federal Regulations , Title 21, part 860 (usually known as 21 CFR 860). Class I devices are subject to the least regulatory control and are not intended to help support or sustain life or be substantially important in preventing impairment to human health, and may not present an unreasonable risk of illness or injury. Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments. Class II devices are subject to special labeling requirements, mandatory performance standards and postmarket surveillance . Examples of Class II devices include acupuncture needles, powered wheelchairs, infusion pumps, air purifiers, surgical drapes, stereotaxic navigation systems, and surgical robots. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present

1426-845: The Drugs & Cosmetics Act. Section 3 (b) (iv) relating to definition of "drugs" holds that "Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals" are also drugs. As of April 2022, 14 classes of devices are classified as drugs. The regulatory authorities recognize different classes of medical devices based on their potential for harm if misused, design complexity, and their use characteristics. Each country or region defines these categories in different ways. The authorities also recognize that some devices are provided in combination with drugs, and regulation of these combination products takes this factor into consideration. Classifying medical devices based on their risk

1488-1089: The Medical Device Amendments to the FD&;C Act established medical device regulation and oversight as we know it today in the United States. Medical device regulation in Europe as we know it today came into effect in 1993 by what is collectively known as the Medical Device Directive (MDD). On May 26, 2017, the Medical Device Regulation (MDR) replaced the MDD. Medical devices vary in both their intended use and indications for use. Examples range from simple, low-risk devices such as tongue depressors , medical thermometers , disposable gloves , and bedpans to complex, high-risk devices that are implanted and sustain life. One example of high-risk devices are those with embedded software such as pacemakers , and which assist in

1550-631: The Medical Devices Rules, 2017 are classified as per Global Harmonization Task Force (GHTF) based on associated risks. The CDSCO classifications of medical devices govern alongside the regulatory approval and registration by the CDSCO is under the DCGI. Every single medical device in India pursues a regulatory framework that depends on the drug guidelines under the Drug and Cosmetics Act (1940) and

1612-544: The United States. The anaesthesia community had been calling for practice guidelines and in 1992 the ASA commissioned a task force to establish practice guidelines for managing difficult airway situations. The ASA algorithm for difficult airways was published in 1993 and stressed an early attempt at insertion of the laryngeal mask if face mask ventilation was not adequate. The laryngeal mask revolutionised anaesthetic practice and by 1995 had been used in excess of 100 million patients and

1674-509: The achievement of its primary intended purposes. The term 'device' does not include software functions excluded pursuant to section 520(o)." According to Article 1 of Council Directive 93/42/EEC, 'medical device' means any "instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by

1736-409: The article these regions will be discussed in order of their global market share. A global definition for medical device is difficult to establish because there are numerous regulatory bodies worldwide overseeing the marketing of medical devices. Although these bodies often collaborate and discuss the definition in general, there are subtle differences in wording that prevent a global harmonization of

1798-418: The conduct of medical testing , implants , and prostheses . The design of medical devices constitutes a major segment of the field of biomedical engineering . The global medical device market was estimated to be between $ 220 and US$ 250 billion in 2013. The United States controls ≈40% of the global market followed by Europe (25%), Japan (15%), and the rest of the world (20%). Although collectively Europe has

1860-482: The cuff. By December 1986, Brain was ready to conduct the first wholly independent trial and chose John Nunn to be the recipient of the silicone prototypes to conduct the trial. "There were three outstanding advantages of the LMA in patients who breathed spontaneously. Firstly, excellent airway patency was obtained in 98% of patients and did not deteriorate during the course of the anaesthetic. Secondly, as no manual support of

1922-445: The definition of a medical device, thus the appropriate definition of a medical device depends on the region. Often a portion of the definition of a medical device is intended to differentiate between medical devices and drugs , as the regulatory requirements of the two are different. Definitions also often recognize In vitro diagnostics as a subclass of medical devices and establish accessories as medical devices . Section 201(h) of

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1984-420: The device's category The Medical Devices Bureau of Health Canada recognizes four classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Class I devices present the lowest potential risk and do not require a licence. Class II devices require the manufacturer's declaration of device safety and effectiveness, whereas Class III and IV devices present

2046-500: The epiglottis falling into the distal aperture. The silicone prototype was also smooth and deflated into a wafer thin ellipse, however, the silicone mask was unable to retain the desired bowl shape and it was no longer possible to make rapid adjustments to the design. The silicone Dunlop prototype was superior to the Goldman prototype, one of Brain's first prototypes created from the cuff of a latex Goldman dental mask, however Brain needed

2108-498: The glottis) allowing a secure airway to be managed by a health care provider. The laryngeal mask was invented by British anaesthesiologist Archibald Brain in the early 1980s, and in December 1987 the first commercial laryngeal mask was made available in the United Kingdom. The laryngeal mask is still widely used today worldwide, and a variety of specialised laryngeal masks exist. It channels oxygen and inhalational anaesthetic to

2170-479: The good functioning of the Single Market. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47 EC. The government of each Member State must appoint a competent authority responsible for medical devices. The competent authority (CA) is a body with authority to act on behalf of

2232-696: The governing body for the sport of athletics in Martinique Liverpool Media Academy , a media, music and performing arts college in Liverpool, England Loan Market Association , a UK-based organisation formed to support the secondary loan market in Europe Lockheed Martin Aerospace , formally Lockheed Martin Corporation, a major US aerospace corporation London Metropolitan Archives ,

2294-639: The inverse of Specific leaf area Levenberg–Marquardt algorithm , a mathematical procedure Organisations [ edit ] Ladies' Memorial Association , Southern local organizations dedicated to the Confederate dead League Managers Association , an organization representing managers of English football clubs Lebanese Muslim Association , Sydney, Australia Light Miniature Aircraft , an aircraft design firm based in Okeechobee, Florida, United States Ligue de Martinique d'Athlétisme ,

2356-565: The jaw was necessary the hands of the anaesthetist were freed for monitoring, record keeping and other tasks. Thirdly, it was possible to maintain a clear airway throughout transfer of the patient to the recovery room." The publication of this trial in 1989 was critical in kickstarting the uptake of the laryngeal mask in the UK". On 5 December 1987, Brain received the first case of all-factory-made, silicone cuffed, LMA Classic laryngeal mask distributed by The Laryngeal Mask Company Limited. The LMA Classic

2418-492: The laryngeal mask ". By 1985, experience with the laryngeal mask prototype had reached 4000 cases. Brain published a case series in Anaesthesia in 1985 describing the management of 3 difficult airway patients, illustrating the use of the laryngeal mask for airway rescue. Brain with 5 co-authors published a second paper in anaesthesia describing the use of the laryngeal mask in over 500 patients, adding considerable credence to

2480-433: The laryngeal mask airway is in place (potentially leading to aspiration of stomach contents). Although the laryngeal mask airway is specifically designed to be easy to place, it is possible for the ventilation it provides to be inadequate. This may be due to variations in neck anatomy, abnormal neck position, dislodgement of the cuff, the mask not being long enough to reach the larynx (or more rarely too long), or folding of

2542-468: The laryngeal mask concept. However the limitation of the prototypes remained, a new material was urgently needed. Following the realisation that a new material was needed, Brain looked at a number of options; polyvinyl chloride was too rigid and synthetic foam did not lend itself to re-use. Silicone prototypes looked promising as what was produced was an ellipse with a flat central web which, if cut correctly, could be used to create an aperture bar to prevent

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2604-419: The lungs during surgery and in the pre-hospital setting (for instance by paramedics and emergency medical technicians ) for unconscious patients. A laryngeal mask is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through

2666-456: The lungs. It can be used during anaesthesia, or while a patient is unconscious. Laryngeal mask airways are designed to be an easy way to secure the airway and ventilate a patient – they are easier to place than tracheal intubation due to the lack of muscle relaxants and laryngoscopy . They are also less likely to damage teeth or the larynx itself. It may form an air-tight seal. Cuffs are available in multiple sizes. LMAs can be alternatives to

2728-554: The main repository for archives pertaining to Greater London Places [ edit ] Longwood Medical and Academic Area , Boston, United States Minchumina Airport , Alaska, United States Other [ edit ] LaMarcus Aldridge (born 1985), American former basketball player Late Middle Ages , a period in history Live Music Archive , a subsection of the Internet Archive Local marketing agreement , an agreement whereby an entity operates

2790-524: The manufacturer must provide a technical file and be certified by a European Notified Body for manufacturing in accordance with metrology regulations. Class IIa Devices: Class IIa devices generally constitute low to medium risk and pertain mainly to devices installed within the body in the short term. Class IIa devices are those which are installed within the body for only between 60 minutes and 30 days. Examples include hearing-aids, blood transfusion tubes, and catheters. Requirements include technical files and

2852-486: The manufacturer to be used for human beings for the purpose of: and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;" Based on the New Approach , rules that relate to safety and performance of medical devices were harmonised in the EU in the 1990s. The New Approach , defined in

2914-678: The manufacturer to complete a Technical File. Class Is Devices: Class Is devices are similarly non-invasive devices, however this sub-group extends to include sterile devices. Examples of Class Is devices include stethoscopes, examination gloves, colostomy bags, or oxygen masks. These devices also require a technical file, with the added requirement of an application to a European Notified Body for certification of manufacturing in conjunction with sterility standards. Class Im Devices: This refers chiefly to similarly low-risk measuring devices. Included in this category are: thermometers, droppers, and non-invasive blood pressure measuring devices. Once again

2976-433: The mask conforms to the anatomy with the bowl of the mask facing the space between the vocal cords . The tip of the laryngeal mask sits in the throat against the upper oesophageal sphincter. Archie Brain began studying the anatomy and physiology of the upper airway in relation to existing airways. Brain concluded that current techniques for connecting artificial airways to the patient were not ideal. He reasoned that if

3038-515: The mask in the pharynx. For these reasons, radiology can be used to ensure that the laryngeal mask airway is in the correct position. A laryngeal mask airway has an airway tube that connects to an elliptical mask with a cuff. The cuff can either be an inflating type (achieved after insertion using a syringe of air), or self-sealing. A laryngeal mask airway must first be completely sterilised (it may be reused many times). Standard checks for common use defects should be performed (such as cracks in

3100-575: The medical purposes provided by law, and creates or modifies health information by calculations or comparison, providing information about an individual patient. Medical devices (excluding in vitro diagnostics) in Japan are classified into four classes based on risk: Classes I and II distinguish between extremely low and low risk devices. Classes III and IV, moderate and high risk respectively, are highly and specially controlled medical devices. In vitro diagnostics have three risk classifications. For

3162-499: The member state to ensure that member state government transposes requirements of medical device directives into national law and applies them. The CA reports to the minister of health in the member state. The CA in one Member State has no jurisdiction in any other member state, but exchanges information and tries to reach common positions. In the UK, for example, the Medicines and Healthcare products Regulatory Agency (MHRA) acted as

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3224-438: The need for packing was much reduced and more impressively the larynx was completely protected from surgical debris. Brain realised the exciting possibility that the laryngeal mask could be applied to head and neck surgery and also observed that "In two patients the anatomy was such as to suggest that endotracheal intubation might have presented at least moderate difficulty. Neither presented difficulty with regard to insertion of

3286-421: The plastic). For an inflatable cuff, the cuff should be inflated and deflated outside the patient to ensure it is functional. A pen-like grip is used to move it through the patient's mouth and throat, preferably when their head is extended to straighten the airway. The laryngeal mask airway should be lubricated so that it can be placed more easily. Once inserted correctly (and the cuff inflated where relevant),

3348-481: The remaining regions in the world, the risk classifications are generally similar to the United States, European Union, and Japan or are a variant combining two or more of the three countries' risk classifications. The ASEAN Medical Device Directive (AMDD) has been adopted by several southeast Asian countries. The nations are at varying stages of adopting and implementing the Directive. The AMDD classification

3410-441: The respiratory tree is seen as a tube ending at the glottis and the objective is to connect this tube to an artificial airway, the most logical solution was to create a direct end-to-end junction. Existing airway devices failed to form this junction; the face-mask sealed against the face, and the endotracheal tube penetrated too far so that the junction was created within the trachea, instead of at its beginning. The first study of

3472-406: The structure or functions of the body of man or other animals." The term medical device, as defined in the Food and Drugs Act , is "any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in: the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in

3534-408: The success of the initial study, Brain successfully inserted and ventilated 6 anaesthetised, non-paralysed patients. Finding no difference between the first and second group of patients, Brain realised that muscle relaxation was not required for insertion. Finally, Dr Brain used the device in a dental extraction patient, he realised that because the space in and around the glottis was filled by the mask,

3596-568: The treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Health Canada reviews medical devices to assess their safety, effectiveness, and quality before authorizing their sale in Canada. According to the Act, medical device does not include any device that is intended for use in relation to animals. India has introduced National Medical Device Policy 2023. However, certain medical devices are notified as DRUGS under

3658-419: The use of a face mask when using a bag-valve-mask device to prevent gastric insufflation. A laryngeal mask airway is generally not used in surgeries where there is a high risk that stomach contents may be aspirated. This is particularly for surgeries that last longer than 2 hours. It often uses low inflation pressures, so may not be appropriate in patients with illnesses that cause low lung compliance . As it

3720-648: Was adopted in 2017. The currct core legal framework consists of two regulations, replacing the previous three directives: The two regulations are supplemented by several guidances developed by the Medical Devices Coordination Group (MDCG). Article 2, Paragraph 4, of the Pharmaceutical Affairs Law (PAL) defines medical devices as "instruments and apparatus intended for use in diagnosis, cure or prevention of diseases in humans or other animals; intended to affect

3782-566: Was available in more than 80 countries throughout the world. The laryngeal mask had now been widely accepted as a form of airway management. From 1988 to 2017, more than 200 million patients used laryngeal mask. Between 1989 and 2000 a variety of specialised laryngeal masks were released which included the LMA Flexible (1990), LMA Fastrach (1997), LMA Unique (1997) and LMA ProSeal (2000), all offered by The Laryngeal Mask Company. Medical device Discovery of what would be considered

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3844-456: Was launched in the UK and the British anaesthesia community were quick to realise the potential benefits of the laryngeal mask. Within 3 years of launch in the UK, the device had been used in at least 2 million patients and was available in every hospital. By 1992, the laryngeal mask was approved for sale and being sold in Australia, New Zealand, South Korea, Hong Kong, Taiwan, Malaysia, India and

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