Advice
The technology
The technology
HemaClear (Oneg HaKarmel Limited) is a sterile elastic tourniquet designed to stop severe loss of blood during limb surgery. It was previously marketed as S‑MART (Oneg HaKarmel Limited), which was functionally identical to HemaClear. HemaClear consists of an elastic silicone ring, a stockinette and straps with handles. By pulling on the straps, it can be unrolled along the limb proximal to the surgical area. The device squeezes blood into the central circulation and prevents blood re-entering the limb. The stockinette can be cut where surgery needs to be done, providing a surrounding sterile field. The company state it can be used for all surgical procedures involving limbs where a bloodless field is needed, including trauma, orthopaedic, hand, foot and ankle, plastic and vascular cases.
The device comes in a variety of models for different limb circumferences (14 cm to 85 cm) and different systolic blood pressure limits (less than 130 mmHg, less than 160 mmHg and less than 190 mmHg).
Current care pathway
There is no widely agreed standard care and current practice varies. According to the company, most limb surgeries in the UK use pneumatic tourniquets. In most cases, a non-sterile tourniquet cuff is used, however some institutions have started to use sterile tourniquet cuffs. Some surgeons do not use pneumatic tourniquets because of concerns about adverse events. Pneumatic tourniquets used in the UK come as sterile or non-sterile and are designed for multi-patient use. They include a limb exsanguinator device, such as a Rhys-Davies device or Esmarch bandage, a tourniquet cuff, a pneumatic pump and padding. The cuff is applied over the padding proximal to the surgical site, connected to the pump tubing and the limb exsanguination device is applied to drain blood from the extremity. The cuff is then inflated to the pressure needed.
The Association of periOperative Registered Nurses (AORN) have produced recommended practices for the use of the pneumatic tourniquet in the perioperative practice setting. AORN highlights that it is the responsibility of the perioperative registered nurse to assess the patient before surgery for risks and contraindications against using pneumatic tourniquets. Surgeons and anaesthetists should work together, monitoring inflation time and patient condition throughout. Patient safety should be the main consideration when choosing the pneumatic tourniquet. Safe use of tourniquets includes adequate padding beneath the tourniquet, staying within the safe limit of tourniquet pressure, not exceeding maximum duration of use and providing adequate analgesia. NICE's guideline on surgical site infections recommends earlier intravenous antibiotic prophylaxis (before starting anaesthesia) in cases when a tourniquet has been used, to reduce the risk of surgical site infection.
Innovations
HemaClear is a single-use sterile device, which the company claims provides better limb exsanguination and fewer side effects, such as tourniquet-induced skin damage, neuropraxia and pain, compared with pneumatic tourniquet devices. It could also reduce tourniquet time, thereby reducing surgery time.
Population, setting and intended user
HemaClear can be used in the operating theatre for trauma, orthopaedic, plastic and vascular cases. The company also claims that HemaClear could be used in a procedure room or accident and emergency departments rather than operating theatre for minor operative cases. The company identified the following groups of patients who may benefit most from HemaClear:
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patients who are obese (BMI over 35 kg/m2) and having knee surgery
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children
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patients having surgery on the elbow and above
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patients who are immune-compromised (for example, those with HIV or diabetes mellitus, or those having chemotherapy)
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patients having endoscopic procedures (for example, endoscopic carpal tunnel release).
Surgeons should use HemaClear with the help of nurses or other operating theatre staff. Because of its effect on the cardiovascular system, anaesthetists should also be involved. The company states that the device should not be used in patients with an existing deep vein thrombosis, poor peripheral blood flow, oedema, an infected limb or limb with malignancy. It should also not be used directly on fragile skin or skin with significant lesions. HemaClear should not be applied directly over the ulnar nerve (at the elbow) or peroneal nerve (at the upper part of the tibia). The device should not be left on a patient's limb for more than 120 minutes.
Staff training, which lasts about 20 to 25 minutes, is recommended by the company every 2 to 3 years and is included in the cost of the device.
Costs
Technology costs
HemaClear costs between £15.95 and £41.80 (excluding VAT) depending on the model (see table 1). Each model is sold in boxes of 10 to 12.
Table 1 Costs of HemaClear models
|
Description |
Cost (excluding VAT) |
Limb circumference (cm) |
Systolic blood pressure limit (mmHg) |
Additional information |
|
HemaClear-Small (pink) |
£30.25 |
Less than 130 |
For use in paediatric orthopaedic surgeries. |
|
|
HemaClear-Medium (green, red, yellow) |
£32.45 |
24 to 40 |
Green: less than 130 Red: less than 160 Yellow: less than 190 |
– |
|
HemaClear-Large (brown, orange, blue) |
£39.60 |
30 to 55 |
Blue: less than 130 Orange: less than 160 Brown: less than 190 |
– |
|
HemaClear-Extra Large (black and white) |
£41.80 |
50 to 85 |
Less than 160 |
– |
|
HemaClear-Model-A (silver) |
£23.08 |
22 to 32 |
Less than 160 |
For the ankle. |
|
HemaClear-Model-F (white) |
£15.95 |
14 to 34 |
Less than 160 |
For the forearm. |
Costs of standard care
Company estimates of costs associated with the pneumatic tourniquet system are in table 2.
Table 2 Costs of pneumatic tourniquet system
|
Description |
Cost |
Additional information |
|
Pneumatic tourniquet device |
£3,000.00 to £5,000.00 |
Capital cost for device. Company estimate 600 uses per year for 5 years (3000 uses). |
|
Annual service cost of pneumatic tourniquet device |
£300.00 to £500.00 |
− |
|
Periodic pump calibration |
£200.00 to £300.00 |
Figure represents calibration done by external company. |
|
Tourniquet cuff |
£20.00 to £25.00 |
– |
|
Esmarch bandage |
£3.00 to £5.00 |
Cost dependent on width. 2 may be needed per case. |
|
Padding/stockinette |
£5.00 to £8.00 |
– |
Resource consequences
The company states that there are around 50 UK organisations who are currently using HemaClear. The company claims that HemaClear is likely to result in cost savings because of reduced adverse events, such as surgical site infection, post-operative tourniquet pain and neuropraxia. Although Jenny et al. (2016) showed fewer complications in patients using HemaClear, Pereira et al. (2015) estimate the cost per patient of using HemaClear as 30€ more than the pneumatic tourniquet. The company also claims a reduction in theatre time and overall hospital stay. Pereira et al. 2015 and Jenny et al. 2016 note substantial reductions in operative time with HemaClear compared with pneumatic tourniquet.