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.
The Versajet system was CE marked in 1997. The Versajet II system was CE marked in 2011 and was launched in 2012.
The Versajet II hydrosurgery system is intended for wound debridement (acute and chronic wounds and burns), soft tissue debridement and cleansing of the surgical site if clinicians judge that sharp debridement and pulsed lavage irrigation is needed.
It can be used in adults and children, for indications including pressure, diabetic and foot ulcers, burns and wounds that need plastic surgery, and dehisced and non-healing wounds.
The original Versajet system was similar in construction and had the same indications for use. There are currently no published details about the changes between Versajet and Versajet II, but some information was available from 2 conference posters supplied by the manufacturer: Martin (2012) noted that the console and the hand piece insertion mechanisms have been completely redesigned. Liebert (2011) stated that the Versajet II system was developed to enhance the user experience and to deliver additional functionality.
The Versajet II system, with the Plus and Exact 15° hand pieces, should only be used in operating theatres due to the potential of excessive misting or spraying (Smith and Nephew Medical Ltd, 2012). Only the 45°Exact hand piece is suitable to be used outside an operating theatre. Using the system in an operating theatre may lessen the risk of transmission of infective material because of the universal infection control procedures in operating theatres (Smith and Nephew Medical Ltd, 2012). The Versajet II system must only be used by staff fully trained in its use including nurses, podiatrists and doctors.
The Versajet II system consists of a re-usable console with footswitch, a single use disposable hand piece and a regionally configured power cord. The console pressurises saline or water and causes a very fine jet of fluid to shoot across an aperture at the tip of the hand piece. The speed of the jet creates a localised vacuum, which is claimed to lift only non-viable tissue into the path of the jet. This obliterates the tissue and carries the debris away into a collection canister.
Two styles of hand piece are available: the 'Exact' hand piece for gentle debridement of wounds and the 'Plus' hand piece for more aggressive debridement and excision. The hand pieces are available in different deck heights and channel widths and come in 3 different options: 15°/14mm, 45°/14mm and 45°/8mm. These angled hand pieces are intended to enable the user to remove thin layers of tissue.
The power setting on the Versajet II system is set using a footswitch or a switch on the front panel, and varies between setting 1 (tenuous tissue, gentle resurfacing), through settings 5–6 (medium quality tissue, deeper necrosis), up to setting 10 (major tissue necrosis). At setting 10 the pressure can be up to 15,000 lb per square inch. At higher pressures there is a possibility that viable soft tissue can be damaged.
It is unclear whether the Versajet II system has equivalent clinical functionality to the earlier Versajet system model but it is likely to be similar. The technical differences include an enhanced footswitch incorporating the ability to change power settings, and an improved hand piece designed to enhance the user interface. This means that the Versajet II system may be more responsive to user control and may have different debridement characteristics to the Versajet system. Martin (2012) suggested that the Versajet II system tends to remove tissue more deeply than the Versajet system at the same power settings and angle of cut but within 1 standard deviation. The standard deviations were wide, probably because of the small number of samples taken (12 test areas for each device), and the study was probably underpowered to detect a significant difference.
There are several other ways of debriding wounds (Smith, 2011) including surgical debridement, sharp debridement, autolytic debridement, larval debridement and mechanical debridement. The Versajet II system is intended to be comparable to surgical or sharp debridement.
NICE is not aware of other CE marked devices fulfilling a similar function.
The costs (list price) of the Versajet II system are £5000+VAT for the console and £230+VAT for each single-use hand piece.
It is unclear whether the Versajet system is still available to purchase. In 2009 the cost of a Versajet console was £6000–£7000, and each hand piece was £220–£240 (Sainsbury, 2009). It has been estimated by the manufacturer that the cost per treatment is £264 for the technology and £429 for staff and operating theatre time (Smith & Nephew: personal communication ).
The device costs per treatment of surgical debridement with scalpels and other consumables associated with surgical debridement are considerably less than for the technology because the acquisition costs of scalpels and blades are minimal. However, the costs for staff and operating theatre time per treatment are likely to be similar.
The Versajet II system would be used in the normal pathway of care for patients who need debridement of acute or chronic wounds or burns. Patients would have debridement at the same point of the pathway.
The Versajet II system is a hydrosurgery device used for debridement of wounds. Depending on the wound, different debridement methods are considered. For some wounds sharp or surgical debridement is the most efficient and effective, for example dealing with calluses or hard eschar. When the necrotic tissue consists of adherent, stringy slough, lavage techniques or the Versajet II system may be more effective than sharp or surgical debridement.
The Versajet system may be useful in certain burn scenarios. In superficial burns it could be used before biological dressings (particularly Biobrane). These dressings need a very clean wound bed otherwise there is a high risk of infection. The Versajet system could be a useful way of preparing such a wound bed. In deep dermal burns before skin grafting, the Versajet system may allow for thinner slices of tissue to be removed at each pass (compared with conventional excision). This has 2 consequences: firstly that the correct level can be reached more accurately, preserving as much dermis as possible and therefore improving function and appearance; secondly, it is slower, and so tends to be used only for deep dermal burns in children, and hand or face burns in adults. The Versajet system may not be as useful in full thickness burns as it 'bounces' off the tissue and causes irregular grooves.
In traumatic wounds, the Versajet system could be useful in removing contaminated material that is difficult to remove with conventional tools such as forceps, scissors and scalpels. Because the Versajet system grabs, cuts and sucks up this tissue it allows the surgeon to see exactly where they have been and therefore where they still need to go. For general plastic surgery the Versajet system may be useful in smoothing down tissue to a common level, such as when smoothing out granulation tissue.
The Versajet II system has improved usability and improved debridement efficiency compared with the original Versajet. There is no convincing evidence that the Versajet system is superior to standard methods of debridement with regard to the most desirable outcome, which is healing time.
Training is essential to avoid adverse events (for example, transection of blood vessels or destruction of healthy tissue).