Advice
Technology overview
Technology overview
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.
About the technology
The Arrow OnControl powered bone biopsy system (referred to as the OnControl system) can perform both bone marrow aspiration and bone marrow biopsy. It is a battery‑powered driver device that drills through the outer bone to make it easier to reach the bone marrow. A single‑needle technique is used to perform either aspiration alone or a combined aspiration and biopsy procedure.
For procedures using the OnControl system, the patient lies prone or on one side with knees bent up towards the chest. The skin over the pelvis is cleaned with an alcohol solution, and a local anaesthetic is injected. Once the area is numb a small incision is made in the skin above the bone that is to be biopsied. The health care professional performing the procedure attaches a needle set to the powered driver and pierces the soft tissue at an appropriate angle above the target bone. The needle is then driven into the medullary cavity of the posterior or anterior iliac crest.
CE marking
The Arrow OnControl powered bone biopsy system (referred to as the OnControl system), including powered driver, sterile connectors, trays and needle sets, was CE‑marked as a class IIa medical device to Vidacare (now part of Teleflex) in April 2005. Current certification is valid until April 2015.
Description
The OnControl system consists of 3 main components:
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A reusable, lithium battery‑powered driver similar in appearance to a handheld drill. The battery is non‑replaceable and non‑rechargeable, with a 10‑year shelf life. When pressing the trigger, a battery status indicator lights up solid green when the driver has enough power to perform the procedure, and flashes red when power is down to 10%. Battery life expectancy is approximately 200 uses, dependent on storage, frequency of use and actual usage (including patient bone density and insertion time). A cradle is provided to store the driver when not in use.
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A sterile, single use, disposable connector with integrated sterile sleeve used to fully enclose and seal the powered driver and then couple it to the needle set.
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Single‑use, sterile needle sets with depth markings, specifically designed for either bone marrow aspiration alone or combined aspiration and biopsy. Aspiration needles are colour‑coded purple and have a 15‑gauge (1.83 mm) outside diameter, and are available in lengths of 25, 68 and 90 mm. Biopsy needles capable of taking both aspiration and biopsy samples are colour‑coded orange and have a wider 11‑gauge (3.05 mm) outside diameter, and are available in lengths of 102 and 152 mm.
Needle sets consist of an inner, bevel‑tipped stylet used to penetrate the cortex of the bone, within an outer cannula. The user gently squeezes the trigger on the driver until the needle drills through the bone and reaches the location to be aspirated or biopsied.
A combined bone marrow aspiration and biopsy procedure is performed as follows. To obtain the aspiration sample, the driver is detached, the inner stylet is removed, and a syringe is connected to the outer cannula to aspirate the bone marrow. To obtain the biopsy sample, the driver is reattached and a depth gauge is positioned on the outer cannula to guide the operator. The cannula is then powered into the cavity to the desired depth to obtain the bone marrow core specimen, and then withdrawn. An ejector rod with an alignment guide is then used to push the core biopsy sample from the cannula into a sterile sample container.
All single‑use components needed for either procedure can be supplied individually, in multi‑packs or in kit form, presented in sterile procedure trays. Comprehensive procedure tray kits are also available, containing additional towel, drape, gauze, dressing, syringe and scalpel components. There are also optional training accessories, including non‑sterile aspiration and biopsy needle sets and trays, and laminated blocks and manikins to simulate patients with hard bone cortex.
Training is provided by the manufacturer which provides new users with a detailed explanation and demonstration of the system. The technique is taught on training blocks that resemble the bone cortex and the bone marrow cavity. The blocks must be purchased but the training is provided free. Once the healthcare professional is familiar with the technique and feels comfortable with the system, it can be used on patients. During the first use with a patient, a clinical specialist from Teleflex will provide on‑site support for the healthcare professional.
Intended use
The OnControl powered bone biopsy system is intended for bone marrow aspiration and bone marrow biopsy of the iliac crest area of the pelvis for adults. For infants and younger children, use is limited to bone marrow aspiration. The OnControl bone lesion biopsy system is beyond the scope of this briefing.
Setting and intended user
The OnControl system is intended for use in secondary care in day‑case, inpatient and outpatient settings. The system is intended for use by qualified clinicians, including oncologists, haematologists, nurses or clinical technologists. Users should be familiar with bone marrow aspiration and biopsy procedures and specifically trained to use the OnControl system.
Costs and use of the technology
The cost of the powered device and consumables are:
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The Arrow OnControl power driver with cradle: £260.00
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OnControl biopsy:
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system tray (includes sleeve and connector) and 102 mm or 152 mm single‑use needles: £60.00
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6‑pack of single‑use 102 mm or 152 mm needles: £240.00 and £246.00 respectively
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individual single‑use 102 mm or 152 mm needles: £40.00 and £41.00 respectively
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OnControl aspiration:
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6‑pack of single‑use 25 mm, 68 mm or 90 mm needles: £246.00
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individual single‑use 25 mm, 68 mm or 90 mm needles: £41.00
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Individual OnControl connector: £6.00.
The powered driver can be used approximately 200 times. The mean cost per use ranges between £1.04 with 250 uses, £1.30 with 200 uses and £1.73 with 150 uses.
The average costs of the powered driver plus consumables for a biopsy or a combined examination are £61.30 (£60.00 for the system tray plus the usage cost of £1.30), assuming the powered driver is used 200 times. If the driver is only used 150 times before replacement, the costs are £61.73, if the driver is used 250 times the cost is £61.04.
In the UK standard practice manual procedure, a typical single‑use biopsy needle (in 10.0 cm, 11.0 cm and 15.0 cm lengths) from Depuy Synthes costs £85.86 (NHS Supply Chain 2014).
When using the OnControl system, centres must also purchase some of the following training accessories:
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non‑sterile biopsy training tray: £14.00
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non‑sterile aspiration training needle set: £5.00
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non‑sterile biopsy training needle set: £9.00
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full pelvis model with carrying case: £95.00
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training blocks: £12.00.
Some hospitals offer sedation to children and young people having bone marrow tests, the cost of which ranges from £156 to £218 (2010 prices; taken from the NICE guideline on sedation in children and young people).
Other costs, for example the cost of alcohol solution to clean the site and pressure dressings for the incision, are assumed to be similar for OnControl and manual needle insertion.
Likely place in therapy
The OnControl system would be used in place of standard manual bone marrow aspiration and biopsy devices.
Specialist commentator comments
One specialist commentator reflected that in his experience there has been a substantial increase in the number of bone marrow biopsies being performed, but a reduction in the quality of the biopsies obtained. They attributed this to an increased number of inexperienced operators performing bone marrow biopsies. In this context, if the powered system is easier to use then it could improve the patient experience and quality of biopsies in general haematology clinical practice.
A second specialist commentator noted that replacing the current method with the OnControl system may improve the efficiency of the procedure.
A third expert noted that in routine practice with the current biopsy process, very few patients need, or are offered, sedation. They also considered that the length of trephine biopsy usually depends on the operator and may not be related to differences in devices. One expert was concerned that the OnControl system did not feature a guard to limit the depth that the needle can penetrate into the bone.
Equality considerations
NICE is committed to promoting equality and eliminating unlawful discrimination. In producing NICE guidance, NICE aims to comply fully with all legal obligations to:
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promote race and disability equality and equality of opportunity between men and women
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eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, pregnancy and maternity (including women post‑delivery), sexual orientation, and religion or belief (these are protected characteristics under the Equality Act 2010).
One equality consideration was identified with the OnControl system. The system is indicated for use for bone marrow aspiration in children, young people, and adults, but trephine biopsy in young people and adults only, excluding children from the potential benefits of the powered biopsy procedure.
Patient and carer perspective
The patient groups Leukaemia CARE and Myeloma UK gave the following patient perspectives.
Many patients experience severe pain during manual bone marrow biopsy procedures. This degree of pain causes anxiety and fear, which can be particularly problematic for patients who need multiple bone marrow biopsies. The OnControl system would be welcomed by patients if it could reduce the pain and the emotional impact of the procedure without increasing the risk of adverse events.
Patient experience currently varies, and this partly relates to the skill of the person performing the bone marrow biopsy. Introducing a new device such as the OnControl system offers an opportunity to ensure standardisation of care and the sharing of best practice, improving consistency across services.
Using the OnControl system may result in savings from reduced use of sedation. However, patients generally report improved experiences when sedation is used.
Patients highlighted that increased use of the OnControl system could lead to a reduced ability of health care professionals to perform manual bone marrow biopsies when these are still needed, such as in children and young people.
The patient group added that some patients are currently deterred from entering clinical trials that include bone marrow biopsies, because of the pain and anxiety experienced with this procedure. Any device that reduces pain could potentially increase the level of involvement in clinical trials.