HemaClear® - Frequently Asked Questions

1. What is HemaClear® ?

HemaClear® is a blood free sterile surgical tourniquet for orthopedic procedures performed on the wrist, elbow, knee, ankle, foot and hand. HemaClear® provides up to 95% exsanguination (blood removal) compared to 60% with current techniques, and can be used everywhere a traditional cuff is used.

2. Do the surgeons express a specific need for blood free operations?

Yes. Blood free surgery provides a clear surgical field, minimizes the amount of patient`s blood loss, enables the surgeon to be more in control during the procedure, and shortens total OR time. HemaClear® is the first advancement in exsanguination technology since Dr. Esmarch from Germany introduced his exsanguination technique (the Esmarch bandage) in 1870.

3. What is HemaClear® made of?

HemaClear® consists of a silicone ring wrapped in a stockinet sleeve and 2 pull handles.

4. How does HemaClear® work?

The surgeon places the HemaClear® silicon ring on the patient`s fingers or toes and then pulls the handles proximally. The ring rolls up the limb and the stockinet sleeve unfolds. While rolling up the limb, the ring exerts pressure and squeezes the blood away from the limb, performing the exsanguinating (blood removal) function quickly and effectively.

When the ring reaches the occlusion site, the pulling motion is stopped. The ring exerts pressure on the limb at this position, blocking arterial blood flow into the limb and performing the occlusion function.

During the pulling motion over the limb, a stockinet sleeve unfolds and covers the limb up to the occlusion level, providing an immediate sterile cover for the surgical field. The entire motion from fingers or toes to the occlusion location, takes less than 12 seconds.

5. What are the benefits of using HemaClear®?

a) Superior exsanguination: The rolling action of the occlusive silicone ring pushes 95% of the standing blood out of the surgical field, as opposed to 69% with the Esmarch bandage.
b) Creates a sterile field: HemaClear® is a sterile, single use tourniquet that eliminates the need for contaminated reusable cuffs, thus reducing infection rates.
c) Increases the surgical field: At 1” wide, the narrow profile enables a wider and sterile field.
d) Simple and cost-effective: The easy application reduces preparation time and eliminates the need for tourniquet machines, contaminated reusable cuffs and Esmarch bandages.
e) HemaClear is used worldwide: HemaClear® is FDA and CE approved. More than 20 published studies demonstrate the safety, reliability and clinical superiority of HemaClear®.

6. Where is HemaClear® manufactured?

HemaClear® is manufactured in Israel by: OHK Medical Devices, Ltd. 16 Palyam Avenue Haifa 33095, Israel Tel: +972.4.8242369 Fax: +972.4.8346753

7. How is HemaClear® distributed in the US?

HemaClear® is distributed in the US by: OHK Medical Devices, Inc. 2885 Sanford Ave SW #14751 Grandville, MI 49418 Toll Free: 866.503.1470 Tel: 973.623.1800 Fax: 866.430.6132

8. How many employees work for OHK Medical Devices worldwide?

20 employees globally.

9. How many HemaClear® units have been used worldwide?

At present, over 300,000 units have been sold and used in orthopedic surgeries globally.

10. Can HemaClear® be reused?

No. HemaClear® is a sterile single use device for orthopedic surgical care and should not be re-used or re-sterilized.

11. Do the materials that HemaClear® is composed of add to its sterility?

No. The components of HemaClear® (silicon ring, stockinet and pull straps) are non-sterile upon arrival at the OHK factory in Israel. Once the device is assembled, it then undergoes a process of sterilization. Afterwards, the product is sent out as a complete sterilized unit.

12. How is HemaClear® sterilized?

HemaClear® is sterilized with Ethylene Oxide (EtO).

13. What is the shelf life of HemaClear®?

3 years.

14. What happens if the expiration date of HemaClear® passes?

Do not use HemaClear® if the expiration date has passed. After 3 years, the sterility of the device may be compromised. For additional instructions regarding expired devices, please contact info@HemaClear.com.

15. Does HemaClear® come in different sizes?

HemaClear® comes in 4 primary sizes suitable for children and adults with limb circumferences ranging from 14cm - 90cm and maximum systolic blood pressure under 190 mm Hg: HemaClear® is useful for pediatrics as it overcomes problems associated with their short tapered anatomy. The limitations of the use of HemaClear® for children are defined by the circumference of the limb, not the age: Since a child's thigh is usually wider than 24 cm in circumference, HemaClear®/40 can be used for circumferences of 24cm-40cm; for small infants or narrow limbs with a 14cm-28cm circumference the HemaClear®/SM is available.

16. What happens if the wrong HemaClear® size is selected for surgery?

In this case the following might occur: a) Difficulty in applying the device over the limb b) Partial exsanguination and occlusion resulting in blood leaking under the ring. Note: In case the blood leakage does not stop, HemaClear® should be immediately removed.

17. Getting HemaClear® over the heel is difficult; what can be done?

To get HemaClear® over the heel place one handle facing the dorsum of the foot (top) and one handle facing the sole (bottom). This way the bottom handle can assist in getting the ring over the heel. Pull the leg upward with one hand while pulling the bottom strap downward and over the heel.

18. How long can HemaClear® remain on the limb?

As with any other type of tourniquet, HemaClear® can remain on the limb for up to 2 hours.

19. Ischemia of the brain causes irreversible damage after only 6 minutes. How is it possible to keep a limb without any blood supply for 2 hours?

Limb tissues are much less susceptible to ischemia than nerve cells (neurons) in the brain. Their metabolic needs are smaller and their ATP reserves, which come in the form of Creatineine Phosphate and Myoglobin, are substantial. Many studies done on humans and experiments on animals show that no irreversible change can be detected as long as the tourniquet time is no longer than two hours (a list of publications is available upon request). The two hour time limit for the device corresponds to the standard of care of all existing tourniquets.

20. What happens if an operation lasts longer than 2 hours and the surgeon is required to release and reapply the tourniquet?

The time limit of using any tourniquet on a limb is two hours. If a procedure lasts longer than two hours, it is recommended that blood supply to the limb is resumed for a minimum of 20 minutes (references are available). HemaClear® is not different in this respect. If surgery lasts over 2 hours, the device should be removed by safely cutting the silicone ring. After a proper duration of blood flow resumption, a second HemaClear® can be applied. HemaClear® can safely be placed over the surgical incision as it is a sterile device.

21. Surgeons sometimes release the tourniquet pressure during surgery to see if there are any "bleeders". How does HemaClear® address this type of situation?

Following surgeons' experience, to check for "bleeders" we recommend pulling the HemaClear® ring away from the limb with two towel clamps. Once the surgeon is ready, the ring is allowed to return to its original location, thus re-occluding blood flow from the surgical site.

22. Some surgeons release the pressure in the pneumatic tourniquet gradually (in steps) at the end of the procedure. They do so to prevent sudden gush of blood to the heart containing ischemia by-products such as potassium, acidity and CO2 from the ischemic leg. As this cannot be done with HemaClear®, does this present a problem with using the device?

Gradual release of pneumatic tourniquet pressure means that arterial blood enters the leg, while the veins are still blocked (venous occlusion). This has three negative effects: (1) this may increase the bleeding in the operation site, (2) the volume of blood in the leg that now soaks all the ischemia by-products is large, and (3) It has the tendency to lower the patient's blood pressure. When the tourniquet is completely deflated the blood pool in the veins of the leg quickly enters back into the central circulation and the heart, actually worsening the load on the patient's heart. In fact, we are not aware of any publication that supports the practice of gradual tourniquet release.

HemaClear®, on the other hand, exsanguinates far better than other methods. This means that no blood is left behind. Thus, the ischemia by-products stay in the tissue and do not accumulate in the blood. When the ring is cut and new blood enters the leg, the ischemia products are gradually washed out with no sudden flooding of the central circulation and the heart. In fact, anesthesiologists feel that the drop in blood pressure upon releasing the tourniquet is less common while using the HemaClear® device.

23. If the surgical field is bloodless, might there not be a danger of inadvertent blood vessel damage?

In order to prevent such damage, many surgeons perform homeostasis and suture the surgical incision after opening the tourniquet. This way they can make sure no blood vessels have been harmed.

24. How much pressure is applied by HemaClear®?

The pressure exerted by the HemaClear® sterile surgical tourniquet is comparable to pneumatic tourniquets at approximately 200 to 250 mm Hg for the upper limbs and 300 to 350 mm Hg for lower limbs. The exact pressure depends on the model used, limb circumference at the occlusion site, and the distance from the fingers or toes. To find the exact pressure, use the reference tables available. Exact pressure information is available in the pressure tables included in the instructions manual. Model HemaClear® /28 Pink HemaClear® /40 Green Red Yellow HemaClear® /60 Blue Orange Brown HemaClear® /90 B&W

25. HemaClear® applies a strong pressure in a small area. Can this pressure cause damage to the limb?

Over 300,000 HemaClear® units have been sold and there have been no reports of tissue damage following use of HemaClear®.

• HemaClear® does not cause any adverse reactions on the skin. No padding is required with the use of HemaClear®. There is no pinching, folding or burning of the skin by HemaClear®. There are no adverse reactions resulting from the pressure of HemaClear® combined with the chemical reaction of antiseptic solutions applied to the skin.
• The pressure developed inside the limb from the HemaClear® device is equivalent to the pressure developed by the pneumatic tourniquet. Therefore, pressure occlusion levels that have been determined to be safe with conventional tourniquet cuffs are also safe with HemaClear®.

26. It is known that wider cuffs are better than narrow cuffs. HemaClear® is ultra narrow. Does this present a problem?

To stop blood flow, it is sufficient to occlude the artery over a short segment, which is efficiently achieved by the HemaClear® device. Compressing a much larger volume of tissue is not necessary and may actually be detrimental. The lower pressure needed to occlude blood flow with a wide cuff, relative to a narrow one, does not balance out the greater area that experiences external tissue compression. Furthermore, the wide cuff elongates the nerves which may cause telescoping and damage. According to information published in the JBJS, nerve related injury was 12 times more prevalent when using the wide cuff.

Source: Surgical Tourniquets in Orthopedics, Gavriely N, Journal of Bone & Joint Surgery, MD, DSc, Vol. 92-A, Number 5, May 2010.

27. At the end of the surgery, the surgeon cuts the silicone ring to remove the HemaClear® device. Is the inside of the silicone ring sterile?

Yes, the inside of the silicone ring is sterile.

28. Tourniquet machines have built-in safety measures to prevent over pressurization. What safety measures does HemaClear® offer?

The most important 'safety feature' of HemaClear® is that it is accurately factory calibrated with no concern of inadvertent over-pressurizing of the tourniquet. The HemaClear® device cannot reopen spontaneously and the pressure cannot suddenly drop or rise due to malfunction.

29. With the pneumatic cuff I can easily release pressure for reperfusion after 120 minutes. This is not possible with HemaClear®.

The practice of temporary tourniquet release for reperfusion after 90 to 120 minutes has significant problems associated with it. A serious problem with this approach is that deflating and inflating a pneumatic tourniquet without adequate exsanguination prior to re-inflation is associated intravascular clotting and its consequences. If needed, HemaClear® can be reapplied once reperfusion has occurred due to the product being completely sterile.

Source: Cerebral Microembolism Diagnosed by Transcranial Doppler during Total Knee Arthroplasty, Sulek CA, et al., Anesthesiology 1999; 91:672-6.

30. I am concerned that the pressure cannot be regulated. What should I do?

The pressure for the HemaClear® devices are factory calibrated to be suitable for the rated blood pressure of the patient with 130 mm Hg for the pediatric model; 130/160/190 mm Hg for the 40 and 60 model; and 160 mm Hg for XL B&W model. HemaClear® exerts sufficient force on the patient’s limb to provide safe & effective arterial blood flow occlusion; as long as the patient’s systolic blood pressure does not exceed the rated product pressure. As such, there is no need to regulate the pressure during the surgery.

Note: The practice of increasing pump pressure when blood escapes under the pneumatic tourniquet cuff without adequate exsanguination is risky due to clot formation in the blood vessels and its consequences.

31. I am concerned about closing the surgical site before removal. What should I do?

There is an ongoing debated among surgeons whether hemostasis wound closure and packing should be done before or after tourniquet release. This debate is independent of the type of arterial blocking used. In general, the Europeans first close, whereas in the U.S. surgeons prefer to remove the tourniquet and then close. The literature shows that closing and packing prior to release is associated with less blood loss. However with this approach there are occasional cases of significant bleeding and hematoma formation that require re-operation. It is up to the surgeon to decide which method to use.

32. What is the documented infection rate in Total Knee Replacement?

Pneumatic tourniquet infection rates fall somewhere between 1-3%. The rate of revision due to infection is about 1%.

Source: Phillips JE, Crane TP, Noy M et al. The incidence of deep prosthetic infections in a specialist orthopaedic hospital: a 15-year prospective survey. J Bone Joint Surg Br 2006; 88: 943–948.

33. Does the use of HemaClear® in TKR reduce infection rates? How?

A study done at the University of Ankara hospital showed statistically significant results regarding the reduction of infection rates when using HemaClear® in comparison to the pneumatic tourniquet. The study focused on bilateral knee replacement in a total of nearly 500 patients. The authors speculated that this difference was due to the fact that it was sterile whereas the pneumatic tourniquet was not.

34. I know that bacteria such as staphylococcus and MRSA cause infections. I also know that these bacteria are present on the skin in any case. Why then does a tourniquet contaminated with bacteria that exists on the skin in any case increase the chance for surgical site infection (SSI)?

The antigenic configuration of bacteria of the same species may differ from person to person. And as such, the antibodies that a person may have in comparison to 1 subspecies of bacteria (eg.,staphylococcus), may not be effective against that of another person. In addition the setting of an open wound nosocomial bacteria during the stress of surgery may not be adequately detected and removed by the weakened immune system of the patient.

35. What are the common recommendations for HemaClear® use in foot & ankle procedures?

Doctors that want to use HemaClear® for foot & ankle procedures should place the device below the gastrocnemius muscle about 15 cm above the lateral malleolus. Although HemaClear® 40 yellow has been shown to be effective in most cases, we recommend using the wider HemaClear® 60 orange. This is because of the position of the dorsalis pedis artery traversing between the tibia and fibular, which somewhat protects it.

36. How should I take tourniquet time when using HemaClear®?

Tourniquet time is measured from the time HemaClear® is applied until its ring has been cut. While any watch will do, a dedicated stop watch is preferred.

37. Can morbidly obese patients use HemaClear® on their legs?

Yes. Morbidly obese patients can use the product, but extra care must be taken by monitoring their blood pressure. An obese patient has a great deal of blood brought from their larger limbs into central circulation. This "auto-transfusion" can be 2 pints of blood or more for the leg of an obese individual. If pushed into the central circulation very quickly over a few seconds, it is very likely to cause a significant rise in the blood pressure and increase the risk for bleeding during the surgery.

The solution, as proposed by a British anesthesiologist, is as follows: Pull the HemaClear® device up to knee level; pause for 30-90 seconds to give the anesthesiologist a chance to measure the blood pressure and, if needed, to adjust it by injecting a small dose of NTG (Nitro Glycerin); once the blood pressure is under control, the surgeon can continue pulling the device to the upper thigh. This will prevent going over the pre-set value of pressure for the HemaClear® XL (B&W) which is 160 mm Hg. For additional information and questions regarding HemaClear® please contact info@HemaClear.com