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93-741: The North West Ambulance Service NHS Trust ( NWAS ) is the ambulance service for North West England . It is one of ten ambulance trusts providing England with Emergency medical services , and is part of the National Health Service , receiving direct government funding for its role. NWAS was formed on 1 July 2006, following the merger of four previous services (Cumbria Ambulance Service; Lancashire Ambulance Service; Cheshire and Mersey Ambulance Service ; and Greater Manchester Ambulance Service) as part of Health Minister Lord Warner's plans to combine ambulance services. Based in Bolton ,

186-508: A lightbar or in special flush-mount designs (as seen on the Danish ambulance to the right), or may be hidden in a host light (such as a headlamp ) by drilling a hole in the host light's reflector and inserting the emergency light. These hidden lights may not be apparent until they are activated. Additionally, some of the standard lights fitted to an ambulance (e.g. headlamps , tail lamps) may be programmed to flash. Flashing headlights (typically

279-409: A type of cake ), chevrons (arrowheads – often pointed towards the front of the vehicle if on the side, or pointing vertically upwards on the rear) or stripes along the side (these were the first type of retro-reflective device introduced, as the original reflective material, invented by 3M , only came in tape form). In addition to retro-reflective markings, some services now have the vehicles painted in

372-817: 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

465-410: 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

558-489: A bright (sometimes fluorescent ) yellow or orange for maximum visual impact, though classic white or red are also common. Fire department-operated ambulances are often painted red to match the fire apparatuses. Another passive marking form is the word ambulance (or local language variant) spelled out in reverse on the front of the vehicle. This enables drivers of other vehicles to more easily identify an approaching ambulance in their rear view mirrors . Ambulances may display

651-406: 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

744-411: 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

837-704: A fully qualified doctor on board. Most ambulance services require at least two crew members to be on every ambulance (one to drive, and one to attend the patient). It may be the case that only the attendant need be qualified, and the driver might have no medical training. In some locations, an advanced life support ambulance may be crewed by one paramedic and one technician, or in countries like Australia advanced life support registered paramedics. Common ambulance crew qualifications are: Military ambulances have historically included vehicles based on civilian designs and at times also included armored, but unarmed, vehicle ambulances based upon armoured personnel carriers (APCs). In

930-635: 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,

1023-606: A gasoline engine in order to meet emissions requirements. In the United Kingdom, the National Health Service has set a target for all ambulances to be fully electric as part of the Net Zero campaign by 2045. Many regions have prescribed standards which ambulances should, or must, meet in order to be used for their role. These standards may have different levels which reflect the type of patient which

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1116-704: 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

1209-425: 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

1302-457: 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

1395-429: A left -> right pattern for use when the ambulance is parked on the left hand side of the road, indicating to other road users that they should move to the right (away from the ambulance)). Incandescent and LED lights may also be programmed to burn steadily, without flashing, which is required in some provinces. Emergency lights may simply be mounted directly on the body, or may be housed in special fittings, such as in

1488-666: 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,

1581-554: A number of its Merkava main battle tanks with ambulance features in order to allow rescue operations to take place under heavy fire in urban warfare . The modifications were made following a failed rescue attempt in which Palestinian gunmen killed two soldiers who were providing aid for a Palestinian woman in Rafah . Since M-113 armored personnel carriers and regular up-armored ambulances are not sufficiently protected against anti-tank weapons and improvised explosive devices , it

1674-460: A per-accident basis, ambulance collisions tend to involve more people, and result in more injuries. An 11-year retrospective study concluded in 2001 found that although most fatal ambulance crashes in the United States occurred during emergency runs, they typically occurred on improved, straight, dry roads, during clear weather. Furthermore, paramedics are also at risk in ambulances while helping patients, as 27 paramedics died during ambulance trips in

1767-538: A perfectly serviceable body or vehicle (or both) separated from the other and reused. Toronto City Council operates a "Caravan of Hope" project to give retired Toronto ambulances a second life by donating them to the people of El Salvador . Since Ontario laws require ambulances to be retired after just four and a half years in service, the City of Toronto decommissions and auctions around 28 ambulances each year. Medical device Discovery of what would be considered

1860-1095: 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

1953-644: A red traffic light or stop sign as a yield sign ('give way'), or be permitted to break the speed limit. Generally, the priority of the response to the call will be assigned by the dispatcher, but the priority of the return will be decided by the ambulance crew based on the severity of the patient's illness or injury. Patients in significant danger to life and limb (as determined by triage ) require urgent treatment by advanced medical personnel, and because of this need, emergency ambulances are often fitted with passive and active visual and/or audible warnings to alert road users. Passive visual warnings are usually part of

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2046-418: A result, medics and other medical personnel attached to military ambulances are usually put through basic military training , on the assumption that they may have to use a weapon. The laws of war do allow non-combatant military personnel to carry individual weapons for protecting themselves and casualties. However, not all militaries exercise this right to their personnel. The Israeli Defense Forces modified

2139-550: A stopped ambulance in a dangerous position on the road. Common colours for ambulance warning beacons are blue, red, amber, and white (clear). However the colours may vary by country and sometimes by operator. There are several technologies in use to achieve the flashing effect. These include flashing a light bulb or LED , flashing or rotating halogen , and strobe lights , which are usually brighter than incandescent lights. Each of these can be programmed to flash singly or in groups, and can be programmed to flash in patterns (such as

2232-533: Is a major factor in their effective use. When an ambulance is retired, it may be donated or sold to another EMS provider. Alternately, it may be adapted into a storage and transport vehicle for crime scene identification equipment, a command post at community events, or support vehicle, such as a logistics unit. Others are refurbished and resold, or may just have their emergency equipment removed to be sold to private businesses or individuals, who then can use them as small recreational vehicles . They may also have

2325-693: Is a van chassis-cab with a custom-made rear compartment, used for ALS and rescue. Type IV is for ad hoc patient transfer using smaller utility vehicles selected for maneuverability in special environments such as dense crowds at events; these are uncommon and are not subject to federal regulations in the United States. The move towards standardisation is now reaching countries without a history of prescriptive codes, such as India, which approved its first national standard for ambulance construction in 2013. Ambulances, like other emergency vehicles , are required to operate in most weather conditions, including those during which civilian drivers often elect to stay off

2418-530: Is based on a heavy truck chassis-cab with a custom rear compartment that is often referred to as a "box" or "module", primarily used for Advanced Life Support (ALS) or Mobile Intensive Care Unit (MICU), as well as rescue work. Type II is based on a commercial heavy-duty van with few modifications except for a raised roof and a secondary air conditioning unit for the rear of the vehicle, primarily used for Basic Life Support (BLS) and transfer of patients, though they are occasionally also used for ALS and rescue. Type III

2511-493: 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

2604-613: 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

2697-409: Is provided to the patient during the transport. Ambulances are used to respond to medical emergencies by emergency medical services (EMS), and can rapidly transport paramedics and other first responders , carry equipment for administering emergency care , and transport patients to hospital or other definitive care. Most ambulances use a design based on vans or pickup trucks , though others take

2790-551: Is put on to the empty chassis of the ambulance, and then finished off. Modern ambulances are typically powered by internal combustion engines , which can be powered by any conventional fuel, including diesel , gasoline or liquefied petroleum gas , depending on the preference of the operator and the availability of different options. Colder regions often use gasoline-powered engines, as diesels can be difficult to start when they are cold. Warmer regions may favor diesel engines, as they are more efficient and more durable. Diesel power

2883-821: 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

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2976-533: Is similar to the KKK-A-1822F and NFPA 1917–2019 specifications. The decision on which of the current (3) standards to require is left up to each individual state legislature or EMS director. Some states have no specific requirement, while others specify which standard is acceptable. Others, yet, allow the end user to decide which standard to comply to. In the United States and Canada, there are four types of ambulances: Type I, Type II, Type III, and Type IV. Type I

3069-468: Is sometimes chosen due to safety concerns, after a series of fires involving gasoline-powered ambulances during the 1980s. These fires were ultimately attributed in part to gasoline's higher volatility in comparison to diesel fuel. The type of engine may be determined by the manufacturer: in the past two decades, Ford would only sell vehicles for ambulance conversion if they are diesel-powered. Beginning in 2010, Ford will sell its ambulance chassis with

3162-412: Is unable to alert pedestrians, those not using a compatible radio or even have it turned off. In the United States, the cost of an ambulance ride may be paid for from several sources, and this will depend on the local situation type of service being provided, by whom, and to whom. There are differing levels of qualification that the ambulance crew may hold, from holding no formal qualification to having

3255-576: Is usually sufficient. Since laws of war demand ambulances be marked with one of the Emblems of the Red Cross not to mount offensive weapons , military ambulances are often unarmed. It is a generally accepted practice in most countries to classify the personnel attached to military vehicles marked as ambulances as non-combatants ; however, this does not always exempt medical personnel from coming under fire – accidental or deliberate. As

3348-511: The 2023 Eurovision Song Contest . In 2017, NWAS began using 26 BMW i3 electric cars for use as rapid response vehicles. The rollout of electric vehicles in the NWAS fleet expanded with the delivery of seven Mercedes-Benz eVito mental health ambulances in 2022. The trust currently operates from 104 ambulance stations across the North West. The most northerly station is at Carlisle , and

3441-592: The Care Quality Commission (CQC) gave the following ratings on a scale of outstanding (the service is performing exceptionally well), good (the service is performing well and meeting our expectations), requires improvement (the service isn't performing as well as it should) and inadequate (the service is performing badly): Ambulance An ambulance is a medically-equipped vehicle used to transport patients to treatment facilities , such as hospitals . Typically, out-of-hospital medical care

3534-1076: The Crimean War . The history of the ambulance begins in ancient times , with the use of carts to transport incurable patients by force. Ambulances were first used for emergency transport in 1487 by the Spanish, and civilian variants were put into operation during the 1830s. Advances in technology throughout the 19th and 20th centuries led to modern self-powered ambulances. Ambulances can be grouped into types depending on whether or not they transport patients, and under what conditions. In some cases, ambulances may fulfill more than one function (such as combining emergency ambulance care with patient transport: Ambulances can be based on many types of vehicle although emergency and disaster conditions may lead to other vehicles serving as makeshift ambulances: Ambulance design must take into account local conditions and infrastructure. Maintained roads are necessary for road-going ambulances to arrive on scene and then transport

3627-487: 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

3720-495: 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

3813-1265: 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

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3906-538: The Order of St John , the Order of Malta Ambulance Corps and Malteser International often use the Maltese cross to identify their ambulances. This is especially important in countries such as Australia, where St. John Ambulance operate one state and one territory ambulance service, and all of Australia's other ambulance services use variations on a red Maltese cross. Fire service operated ambulances may display

3999-603: The Second World War vehicles such as the Hanomag Sd Kfz 251 half-track were pressed into service as ad hoc ambulances , and in more recent times purpose-built AFVs such as the U.S. M1133 medical evacuation vehicle serve the exclusive purpose of armored medical vehicles. Civilian based designs may be painted in appropriate colors, depending on the operational requirements (i.e. camouflage for field use, white for United Nations peacekeeping , etc.). For example,

4092-951: The United States military currently employs the M113, the M577 , the M1133 Stryker medical evacuation vehicle (MEV), and the RG-33 heavily armored ground ambulance (HAGA) as treatment and evacuation vehicles, with contracts to incorporate the newly designed M2A0 armored medical evacuation vehicle (AMEV), a variant of the M2 Bradley fighting vehicle (formerly known as the ATTV). Some navies operate ocean-going hospital ships to lend medical assistance in high casualty situations such as wars or natural disasters. These hospital ships fulfill

4185-509: The Anfield site. Over recent years, the trust has combined many of their older ambulance stations into purpose-built facilities shared with other emergency services, including Greater Manchester Fire and Rescue , Lancashire Fire and Rescue and Greater Manchester Police . NWAS was the first ambulance trust to be inspected by the Care Quality Commission (CQC), in August 2014. The CQC found

4278-535: The British Royal Army Medical Corps has a fleet of white ambulances, based on production trucks. Military helicopters have also served both as ad hoc and purpose-built air ambulances since they are extremely useful for MEDEVAC . In terms of equipment, military ambulances are barebones, often being nothing more than a box on wheels with racks to place manual stretchers, though for the operational conditions and level of care involved this

4371-452: The Cross of St. Florian (often incorrectly called a Maltese cross) as this cross is frequently used as a fire department logo (St. Florian being the patron saint of firefighters ). The active visual warnings are usually in the form of flashing lights. These flash in order to attract the attention of other road users as the ambulance approaches, or to provide warning to motorists approaching

4464-845: 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

4557-1089: 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

4650-631: 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

4743-504: The Red Cross member organization use a red Star of David , but this does not have recognition beyond Israeli borders, where they must use the Red Crystal. The Star of Life is widely used, and was originally designed and governed by the U.S. National Highway Traffic Safety Administration , because the Red Cross symbol is legally protected by both National and international law. Ambulance services with historical origins such as

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4836-755: The Spanish forces during the siege of Málaga by the Catholic Monarchs against the Emirate of Granada. During the American Civil War vehicles for conveying the wounded off the field of battle were called ambulance wagons. Field hospitals were still called ambulances during the Franco-Prussian War of 1870 and in the Serbo-Turkish war of 1876 even though the wagons were first referred to as ambulances about 1854 during

4929-754: The US between 1991 and 2006. In addition to the equipment directly used for the treatment of patients, ambulances may be fitted with a range of additional equipment which is used in order to facilitate patient care. This could include: In parts of the world that lack a high level of infrastructure, ambulances are designed to meet local conditions, being built using intermediate technology . Ambulances can also be trailers, which are pulled by bicycles, motorcycles, tractors, or animals. Animal-powered ambulances can be particularly useful in regions that are subject to flooding. Motorcycles fitted with sidecars (or motorcycle ambulances ) are also used, though they are subject to some of

5022-676: The United States, standards for ambulance design have existed since 1976, where the standard is published by the General Services Administration and known as KKK-A-1822. This standard has been revised several times, and is currently in version 'F' change notice #13, known as KKK-A-1822F. The National Fire Protection Association has also published a design standard, NFPA 1917 , which offers an alternative to KKK-A-1822F. The Commission on Accreditation of Ambulance Services (CAAS) has published its Ground Vehicle Standard for Ambulances v2.0, effective July 2019. This standard

5115-509: 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

5208-502: The ambulance is expected to transport (for instance specifying a different standard for routine patient transport than high dependency), or may base standards on the size of vehicle. For instance, in Europe, the European Committee for Standardization publishes the standard CEN 1789 , which specifies minimum compliance levels across the build of ambulance, including crash resistance, equipment levels, and exterior marking. In

5301-494: The ambulance that may interfere with patient care and radio communications. Ambulances can additionally be fitted with airhorn audible warnings to augment the effectiveness of the siren system, or may be fitted with extremely loud two-tone air horns as their primary siren. A recent development is the use of the RDS system of car radios . The ambulance is fitted with a short range FM transmitter, set to RDS code 31, which interrupts

5394-487: The appropriate hospital of the ambulance's pending arrival, or, in cases where physicians do not form part of the ambulance's crew, to confer with a physician for medical oversight. Ambulances often have two stages of manufacturing. The first is frequently the manufacture of light or medium truck chassis-cabs or full-size vans (or in some places, cars) such as Mercedes-Benz , Nissan , Toyota , or Ford . The second manufacturer (known as second stage manufacturer ) modifies

5487-409: 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

5580-418: 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

5673-616: The crew of emergency ambulances. Conversely, EMS agencies may also have nontransporting EMS vehicles that cannot transport patients. The term ambulance comes from the Latin word ambulare as meaning 'to walk or move about' which is a reference to early medical care where patients were moved by lifting or wheeling. The word originally meant a moving hospital, which follows an army in its movements. Ambulances ( ambulancias in Spanish) were first used for emergency transport in 1487 by

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5766-497: The criteria of an ambulance (transporting the sick or injured), although the capabilities of a hospital ship are more on par with a Mobile Army Surgical Hospital . In line with the laws of war , these ships can display a prominent Red Cross or Red Crescent to confer protection under the appropriate Geneva Convention . However, this designation has not always protected hospital ships from enemy fire. Ambulettes provide patient transport service for non-emergency situations. Scheduling

5859-445: 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

5952-559: The design becomes more important, as does the nature of the skills required to properly operate the vehicle. Cost-effectiveness can be a high priority. Emergency ambulances are highly likely to be involved in hazardous situations, including incidents such as a road traffic collision , as these emergencies create people who are likely to be in need of treatment. They are required to gain access to patients as quickly as possible, and in many countries, are given dispensation from obeying certain traffic laws. For instance, they may be able to treat

6045-416: The design of the vehicle, and involve the use of high contrast patterns. Older ambulances (and those in developing countries ) are more likely to have their pattern painted on, whereas modern ambulances generally carry retro-reflective designs, which reflects light from car headlights or torches. Popular patterns include 'checker board' (alternate coloured squares, sometimes called ' Battenburg ', named after

6138-420: 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

6231-583: The form of motorcycles , buses , hearses , aircraft and boats . Ambulances are generally considered emergency vehicles authorized to be equipped with emergency lights and sirens . Generally, vehicles count as an ambulance if they can transport patients. However, it varies by jurisdiction as to whether a non-emergency patient transport vehicle (also called an ambulette ) is counted as an ambulance. These vehicles are not usually (although there are exceptions) equipped with life-support equipment, and are usually crewed by staff with fewer qualifications than

6324-467: The front are often fitted as well to increase visibility for the driver. In order to increase safety, it is best practice to have 360° coverage with the active warnings, improving the chance of the vehicle being seen from all sides. In some countries, such as the United States, this may be mandatory. The roof, front grille, sides and rear of the body, and front fenders are common places to mount emergency lights. A certain balance must be made when deciding on

6417-421: The front or roof of the ambulance. Most modern ambulances are now fitted with electronic sirens, producing a range of different noises which ambulance operators can use to attract more attention to themselves, particularly when proceeding through an intersection or in heavy traffic. The speakers for modern sirens can be integral to the lightbar, or they may be hidden in or flush to the grill to reduce noise inside

6510-423: The furthest south is at Crewe . It also maintains three Emergency Operations Centres (EOCs) for the handling of 999 calls and dispatch of emergency ambulances. In 2017, NWAS signed an agreement to purchase a new EOC and area office for £2.9   million at Liverpool International Business Park next to Liverpool John Lennon Airport As of 2019, this building has been converted and services have now migrated from

6603-479: 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

6696-402: The high beams, flashed alternately) are known as a wig-wag . Additional white lights may be placed strategically around the vehicle to illuminate the area around it when it is dark, almost always at the rear for loading and unloading stretchers and often at the sides as well. In areas very far North or South where there are times of year with long periods of darkness, additional driving lights at

6789-524: 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

6882-486: 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

6975-678: 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

7068-575: 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

7161-547: 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

7254-585: The name of their owner or operator, and an emergency telephone number for the ambulance service. Ambulances may also carry an emblem (either as part of the passive warning markings or not), such as a Red Cross, Red Crescent or Red Crystal (collective known as the Protective Symbols ). These are symbols laid down by the Geneva Convention , and all countries signatory to it agree to restrict their use to either (1) Military Ambulances or (2)

7347-434: The national Red Cross or Red Crescent society. Use by any other person, organization or agency is in breach of international law. The protective symbols are designed to indicate to all people (especially combatants in the case of war) that the vehicle is neutral and is not to be fired upon, hence giving protection to the medics and their casualties, although this has not always been adhered to. In Israel, Magen David Adom ,

7440-494: The number and location of lights: too few and the ambulance may not be noticed easily, too many and it becomes a massive distraction for other road users more than it is already, increasing the risk of local accidents. In addition to visual warnings, ambulances can be fitted with audible warnings , sometimes known as sirens , which can alert people and vehicles to the presence of an ambulance before they can be seen. The first audible warnings were mechanical bells, mounted to either

7533-500: The patient to a hospital, though in rugged areas four-wheel drive or all-terrain vehicles can be used. Fuel must be available and service facilities are necessary to maintain the vehicle . Methods of summoning (e.g. telephone) and dispatching ambulances usually rely on electronic equipment, which itself often relies on an intact power grid . Similarly, modern ambulances are equipped with two-way radios or cellular telephones to enable them to contact hospitals, either to notify

7626-479: The radio of all cars within range, in the manner of a traffic broadcast, but in such a way that the user of the receiving radio is unable to opt-out of the message (as with traffic broadcasts). This feature is built into every RDS radio for use in national emergency broadcast systems, but short-range units on emergency vehicles can prove an effective means of alerting traffic to their presence. It is, however, unlikely that this system could replace audible warnings, as it

7719-840: The region, and in 2013/2014 carried out 1.2   million such journeys. Since 2016, the PTS in Cheshire, Warrington and Wirral has instead been carried out by West Midlands Ambulance Service . NWAS utilise a mixed fleet of emergency and patient transport ambulances. As a member of the Northern Ambulance Alliance, the trust shares a common fleet of Fiat Ducato dual crewed ambulances and Škoda Octavia and Volkswagen Passat rapid response cars . In Greater Manchester, some paramedics respond on specially converted bicycles ; cycle responders were also trialled in Liverpool during

7812-481: 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

7905-493: The road. Also, the ambulance crew's responsibilities to their patient often preclude their use of safety devices such as seat belts . Research has shown that ambulances are more likely to be involved in motor vehicle collisions resulting in injury or death than either fire trucks or police cars . Unrestrained occupants, particularly those riding in the patient-care compartment, are particularly vulnerable. When compared to civilian vehicles of similar size, one study found that on

7998-415: The same limitations as more traditional over-the-road ambulances. The level of care provided by these ambulances varies between merely providing transport to a medical clinic to providing on-scene and continuing care during transport. The design of intermediate technology ambulances must take into account not only the operation and maintenance of the ambulance, but its construction as well. The robustness of

8091-406: 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

8184-568: 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

8277-458: The trust provided safe and effective services which were well-led and with a clear focus on quality but it was criticised for taking too many callers to hospital and for sending ambulances when other responses would have been more appropriate. The trust was subsequently inspected in 2018 and was found to have improved with a rating of "Good" In its last inspection of the service in February 2020,

8370-762: The trust provides services to over 7   million people in Greater Manchester , Cheshire , Merseyside , Lancashire , Cumbria , and the North Western fringes of the High Peak district of Derbyshire (covering the towns of Glossop and Hadfield ) in an area of 5,500 square miles (14,000 km). NWAS provides emergency ambulance response via the 999 system, as well as operating the NHS 111 advice service for North West England. They also operate non-emergency patient transport services (PTS) for part of

8463-403: The vehicle (which is sometimes purchased incomplete, having no body or interior behind the driver's seat ) and turns it into an ambulance by adding bodywork, emergency vehicle equipment , and interior fittings. This is done by one of two methods – either coachbuilding , where the modifications are started from scratch and built on to the vehicle, or using a modular system, where a pre-built 'box'

8556-648: 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

8649-464: Was decided to use the heavily armored Merkava tank. Its rear door enables the evacuation of critically wounded soldiers. Israel did not remove the Merkava's weaponry, claiming that weapons were more effective protection than emblems since Palestinian militants would disregard any symbols of protection and fire at ambulances anyway. For use as ground ambulances and treatment & evacuation vehicles,

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