1. What is the most important thing to remember when using EpiFaith?
It is important that the plunger is pushed until the colored ring is covered. This ensures generation of a positive pressure within the barrel, which is essential for all loss-of-resistance, LOR, techniques.
Similar to a traditional low-friction syringe, EpiFaith cannot provide a signal of LOR if the plunger has not been pushed forward to induce a positive pressure. However, the difference with EpiFaith is that the plunger only needs to pushed once and the presence of a fixator helps to maintain the pressure by fixing the position of the plunger. Therefore, you can use both hands to control the needle with continuous and real-time detection of LOR.
2. Can I use EpiFaith if I often use air to perform epidural injection?
Yes, you can. EpiFaith is based on a continuous LOR technique and is compatible with both air and saline. When air is used, we suggest that the plunger is pushed until the color ring is just covered to begin LOR detection, as shown in Figure 1. This can prevent from overpressure, which may lead to the leakage of air through the needle passage and a higher false-positive rate.
3. Can I use EpiFaith if I often use saline to perform epidural injection?
Yes, you can. EpiFaith is based on the continuous LOR technique and is compatible with both air and saline. The sensing mechanism is fully actuated if the color ring is covered. Thus, no matter air or saline is used, please make sure the color ring is covered before advancing the needle.
However, if saline is used, it is acceptable and may be beneficial to advance the plunger further. Please see Question 4 for further details.
4. How far should I push the plunger? What is the influence of the sensing pressure?
The pressure inside the barrel increases when the relative distance between the black piston rubber and the plunger, blue or yellow, decreases. Therefore, if saline is used, a faster response of the visual indicating signal can be induced by pushing the plunger further to cover most of the white region of the rubber shaft, as shown in Figure 2.
However, the above is not recommended if air is used or if the procedure is performed on a patient with high BMI. In these situations, it is suggested that a lower pressure is used to avoid the false-positive signals.
Overall, the pressure used should be determined by considering the technique of the operator and characteristics of the patient.
5. Should I keep pushing the plunger while advancing the needle?
No, you do not need to continue pushing the plunger.
After the plunger is pushed once, the fixator (a black rubber ring) can help maintain the position of the plunger. It allows the operator to place both hands on the needle or even operate other instruments simultaneously. For example, using one hand to hold an ultrasound probe.
6. Is EpiFaith compatible with current accessories?
EpiFaith is compatible with 16–18-guage epidural needles. Two variants of EpiFaith, with either an Luer Slip or NRFit connector, are available.
7. Is training required before using EpiFaith?
We suggest that new users are trained using a teaching video.
Although the operating of EpiFaith is intuitive, prior training before use can be beneficial. Therefore, we provide a teaching video to simplify the training process. In the video, in addition to the step-by-step demo of using EpiFaith, an explanation of the principle of EpiFaith is provided, suggestions of methods to reduce false-positive rates, and the processes required if false-positives occur. Watching this video can improve the ease and efficacy of your initial procedures.
8. Can the black piston rubber start to move before the needle tip arrives at the epidural space?
EpiFaith is based on continuous LOR technique; thus, slight leakage of the contained air or saline before arriving at the epidural space is possible. This will lead to slow and slight movement of the piston. However, compared with rapid movement of LOR, this slow and slight movement is identifiable. Please note that, as described in the instruction for use, the appearance of the color ring is the final warning signal. The needle must be stopped from advancing further to avoid accidental dural puncture when the color ring is not covered.
If you think the slight movement may result in confusion, the following can help to eliminate or decrease the movement related to the soft tissue layer.
1. Use a low pressure to detect the LOR, which means pushing the plunger to cover the color ring only.
2. Use saline rather than air for pressure sensing.
3. Begin pressure sensing after the needle tip arrives at the ligament flavum.
9. Can I use the feedback sensation on the hand with the visual indication of EpiFaith?
EpiFaith is designed for visual indicating. Therefore, the physical feedback felt on the hand has been transferred and replaced by a visual signal. We understand that experienced users may feel uncertain if the syringe plunger cannot provide physical hand feedbacks, however, the use of EpiFaith will not lead to conflicts with previous experience. We encourage you to try EpiFaith to understand its differences and similarities from traditional devices and the benefit provided by the clear visual signal.
10. Can I use EpiFaith if I am a health care provider with limited experience of LOR technique?
With EpiFaith, the subjective and unclear physical feedback on the hand is replaced by an objective visual signal, which is user-friendly and can provide the following benefits in training:
A. The visual signal can be seen by everyone in view of the device. It allows clear understanding of the signal that leads to stopping the needle from advancing or other operation processes.
B. EpiFaith allows the user to use both hands to control the needle and focus on identifying the route, resulting in the controlled speed of needle advancement that can reduce the risk of accidental puncture of the epidural space.
C. EpiFaith provides continuous real-time pressure sensing. Accidental puncture related to non-sensing period of intermittent technique is eliminated.
11. Will false-positives happen during the use of EpiFaith? What should I do to handle false-positive results?
EpiFaith cannot completely eliminate the occurrence of false-positives. Due to tissue characteristics, the contained air or saline may be injected when the needle tip enters a fake cavity or particular soft tissue inducing a false signal. Therefore, it is recommended that the plunger is pushed again after the signal occurs. If the color ring cannot be recovered, it means the volume of the cavity is big enough. An attempt at catheter insertion should be made to check whether the needle has been anchored in the correct region. If the color ring is recovered again, the needle can be slowly advanced until the visual signal appears. (Note: although the movement resulting from false-positives and the epidural space is different, we suggest the use the above mentioned process to identify whether it is a false-positive or not.)
12. What options do I have if the catheter cannot be inserted when I believe the needle tip has arrived at the epidural space?
In this situation, we suggest to attach the syringe and push the plunger again to confirm the signal. Please observe the moving speed of the piston rubber and carefully advance the needle. When the needle opening completely enters the epidural space, the moving speed will increase due to the lower flow resistance.
Here’s the results of this issue. If the protruding distance of the needle from the ligament flavum is insufficient, it may not allow the catheter to pass the needle opening even if the needle tip has arrived. In fact, because the LOR-related devices must provide a warning, either via hand feedback or visual signal, when the epidural space is reached, this issue is mostly related to the needle design and user habits rather than the technique itself. Therefore, training can reduce the occurrence of this problem.
13. Has EpiFaith been approved by the government?
EpiFaith has been approved by the EU. (CE)
U. S. FDA 510k approval is expected in early 2019.
14. Can I have a sample to try?
We look forward to providing this novel device to everyone. However, the provision is dependent on geographical region. Please contact us for more information.
15. Where is the factory located?
EpiFaith is produced by a professional medical device manufacture in Taiwan. The factory is certified by both ISO13485:2016 and the Taiwanese government. It also strictly follows the rules of medical device good manufacturing practice, GMP.
16. How much does EpiFaith cost?
This is dependent on your geographical region. Please contact us for more information.
17. Is an epidural tray included with the EpiFaith syringe?
Currently, we offer a single syringe without accessories. The all-in-one epidural tray will be available in 2020. However, your local distributor may offer pre-bundled trays. Please contact us for more information.
18. What is the minimum package quantity (MPQ) of EpiFaith?
The unit package of EpiFaith is 50 pcs per case. Please contact us if you require further information regarding the MPQ