This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of healthcare professionals to check the regulatory status of any intended use of the technology in other indications and settings.
AccuVein LLC received a CE mark for the manufacture of non-invasive vein illumination devices on 23 June 2009. The AccuVein AV400 is a non-invasive class 1 active medical device.
The laser in the AccuVein AV400 is a class 2 laser, which generally needs no precautions because the blink reflex is sufficient to protect the eye. However these blink reflexes may be inhibited or reduced by some diseases, drugs or other medical conditions. The manufacturer recommends a protective eye shield for people with an impaired blink reflex. It is also considered unsafe for a person to stare into the laser beam for longer than 0.25 seconds.
The AccuVein AV400 system comprises:
a handheld AV400 unit and rechargeable battery (removable), weighing 275 g
a charging cradle unit and power supply.
The device can be hand held or used with a hands-free option. The hands-free option is needed if a healthcare professional wishes to use the AccuVein AV400 while performing venepuncture. The additional hands free options are:
A clamp and flexible arm kit for supporting the device. This can be attached to a bed rail or other suitable furniture.
A wheeled stand, which can be moved to the patient.
There are no disposable parts.
Superficial veins are detected using an infrared laser light emitted by the device, and an image of the veins in real time is projected back onto the skin surface. The standard projected image is a red illuminated background with the veins shown darker in colour. This can be inverted to improve vein visibility if needed. The device allows improved visualisation of noticeable veins and allows the identification of previously undetected veins in the arm. The maximum depth of vein visible using this technology depends on the patient and it can be affected by factors such as scarring in the area and the presence of adipose tissue. A typical visible depth is 10 mm for the AV400 device. Additionally if the device is not held directly over the vein, the resulting image will be displaced from the true position. Therefore, to position the device correctly to carry out a cannulation, it should be perpendicular to the skin surface, between 10 and 45 cm away and with the vein display light centred above the central line of the vein of interest. The width of the displayed vein may not be the same as the width of the actual vein.
The rechargeable battery lasts for approximately 180 minutes, which is estimated to be around 90 standard viewing procedures. A full charging of the battery is estimated to take 3 hours. The lifespan of the battery pack under normal operational use is expected to be 2 years, and the expected lifespan of the device is 5 years.
The operating manual states that no routine or preventative maintenance is needed with the AccuVein AV400 and that the device contains no user-serviceable parts. Any servicing or repair needed, for example if the vein light window is scratched, would need to be carried out by an authorised AccuVein repair department.
The device is not designed to come into contact with the patient. The lens and optical surfaces on the back of the device can be cleaned using an alcohol wipe or similar. The device body must not be submerged in liquid but can be cleaned using a cloth and alcohol disinfectant, diluted bleach or soapy water. The device cannot be sterilised using heat or pressure.
The model available to the NHS is the AccuVein AV400, which differs from its predecessor, the AV300, in 3 main ways:
The AccuVein AV400 is capable of showing all the veins in the field of view and therefore does not need to be rotated. The AV300 was only able to show those in which blood flowed in the same direction as the long axis of the unit and therefore needed rotating to view all the veins in the field of view.
The AV300 had 3 vein display settings, whereas the AV400 has a single setting. These settings were related to the depth of veins. The AV400 only has the deepest of the 3 settings from the AV300. The manufacturer stated this was the setting most often used. This simplifies the operation of the device.
The AV400 has a fully digitised signal processing chain, whereas the AV300 had analogue electronics. This change to the AV400 should reduce the presence of shadows in the image (Qmed, 2013).
The AccuVein AV400 is intended to help find superficial veins for venepuncture and cannulation.
The technology is marketed for use with any patient and particularly those in whom venous access is difficult, including but not limited to:
children and young people
people with darker skin
people who are obese
people with renal failure
people having intravenous chemotherapy.
The AccuVein AV400 is used in addition to the standard practice of visualisation and palpation, and must be used by a qualified healthcare professional. The manufacturer suggests that it could either be used to identify the most suitable veins before venous access is attempted, or to confirm the location of an identified vein.
The likely setting where the AccuVein AV400 will be used is a hospital. Departments with a higher than average proportion of patients with difficult venous access would be the most likely places to identify a need for the device. These include paediatric and bariatric surgery units.
The AccuVein AV400 can be used by any qualified healthcare professional trained in intravenous cannulation including nurses, surgeons, radiographers and phlebotomists. The distributor provides initial training and education in using the device.
The current standard practice before performing a venepuncture is visualisation of the vein and palpation of the skin. A tourniquet is used to restrict venous flow (Lavery and Ingram, 2005).
Methods used with patients with difficult venous access include clenching of the fist, tapping the skin, warm compresses, positioning the arm below the heart to increase blood volume and ultrasound guidance (Whitehead, 2010; Mbamalu and Banerjee, 1999).
NICE is aware of the following CE marked devices that appear to fulfil a similar function to the AccuVein AV400:
Vasculuminator (deKoningh Medical Products)
VeinViewer (Christie Medical Holdings)
Veinsite (VueTek Scientific).
Information on the cost of using the technology and alternative treatment options has been provided by the device's UK distributor (Q Medical Technologies Ltd). The AccuVein AV400 device has an NHS acquisition cost of £3300 excluding VAT. Additional costs of £285, £400 and £120 (excluding VAT) are needed respectively for a flexible support arm with a bed rail clamp, a 5‑wheeled, hands‑free, powered stand, and additional clamps for use with the flexible arm.
The anticipated lifespan of the device is 5 years. The number of patients on whom the device could be used during its lifespan is not known, so the average cost per treatment could not be estimated.
No practical difficulties have been identified in using or adopting the technology.
Alternative treatment options available in the NHS include visual inspection and palpation, the cost of which is dependent on staff time and consumables for the procedure. Ultrasound guidance needs acoustic coupling gel and contact with the patient, so the injection site needs to be cleaned afterwards. There are no publically available studies comparing the costs involved in using AccuVein AV300 or AccuVein AV400 to other infrared devices or ultrasound scanners for when cannulation is expected to be difficult.
The AccuVein AV400 would be used in addition to the standard practice of visualisation and palpation in the standard clinical pathway for people whose veins are difficult to access. It would either be used to identify the most suitable vein before attempting venous access or to confirm the location of an identified vein.
Although visual inspection may be part of the process of identifying a suitable vein, it is the palpation of that vein that is essential for deciding if cannulation should be attempted.
Some patients have clearly visible veins, but without palpation of vein elasticity or 'bounce', they may be liable to collapse when cannulation is attempted. Palpation is also important in locating and avoiding valves. It is therefore important not to give undue emphasis to visualising a vein, especially if it cannot be palpated.
Devices that facilitate quick and efficient cannulation can be important in reducing anxiety for patients.
If help with imaging is needed, ultrasound is the method of choice and has the advantage of being routinely available in accident and emergency departments.
NICE is committed to promoting equality and eliminating discrimination. As a public authority NICE must also comply fully with legal obligations to promote race and disability equality and equality of opportunity between men and women; and to eliminate unlawful discrimination on the grounds of race, disability, age, sex and gender, sexual orientation, and religion or belief. This is in accordance with the NICE Equality Scheme.
Some of the intended patient populations for the AccuVein AV400 are covered under the Equality Act, 2010. These include older people, children and minority ethnic groups. Using this device may improve clinical care for these groups of people.