Frequently Asked Questions
Safety
Is the Surgi-Sign FDA-approved?
Yes. The Surgi-Sign is registered with the FDA, and the facility in the U.S. where it is made and manufactured is also FDA approved. All inks used are registered with the FDA as “Food Grade Inks” and are 100% non-toxic.
Is the Surgi-Sign made in the USA?
Yes. The Surgi-Sign is made 100% in the USA. The Surgi-Sign is made and manufactured entirely in the USA using only US-based materials.
What is the tattoo made of?
The tattoo is a specially-formulated acrylic copolymer, like the surgical glue used to close incisions. All inks used are registered with the FDA as “Food Grade Inks” and are 100% non-toxic.
Can the tattoo cause a site infection?
No. The tattoo is completely removed from the surgical site with gauze moistened with water or alcohol prior to surgical site prepping.
Does the Surgi-Sign contain latex?
No. The Surgi-Sign does not contain latex and can be safely used on anyone who is allergic to latex.
Is it safe to use on children?
Yes. In fact, we have two fun designs for kids: a rocket and a magical wand. Both will give your team the same visual crosscheck capabilities. The Surgi-Sign is made and manufactured 100% in the U.S. and is entirely safe for use on children.
Application / Removal
How do I apply the tattoo?
Remove the clear plastic covering. Place the color side of the tattoo onto the skin in the surgical site. It is a little sticky and will stay in place on the skin while you cover the entire back of the tattoo with the saline wipe. No need to unfold the wipe. Press and hold the saline wipe on the back of the tattoo for 15 seconds. If placing on top of hair that will not be shaved, e.g., an arm, press and hold for 30 seconds.
Can the tattoo be removed after it's been applied?
No. The Surgi-Sign cannot be moved after it has been applied to the skin.
How long can your temporary tattoo stay on the skin?
The Surgi-Sign can last on the skin between 3–5 days. It is designed to become more adherent on the skin if there is a delay in surgery. This means surgeons can apply the tattoo prior to surgery in their office.
What if the patient can't reach to make a checkmark?
The patient’s healthcare proxy can confirm the correct site has been identified and mark the site.
How do I remove the tattoo?
The Surgi-Sign wipes away in 10–15 seconds using gauze moistened with water or alcohol. All of the team’s surgical pen marks will remain visible on the skin.
What if the tattoo was placed in the wrong area?
Our system is designed to identify this very error. If the wrong site was selected initially, simply remove that tattoo with gauze moistened with water or alcohol and apply a new tattoo on the correct surgical site.
The tattoo is not sticking in areas with a lot of hair.
If placing the tattoo in an area where there is hair that won’t be shaved prior to surgery, press and hold the saline wipe on the back of the tattoo for 30 seconds.
The tattoo is not sticking to the skin. What should I do?
Most of the time, the person applying the temporary tattoo has inadvertently forgot to remove the clear, plastic covering on the tattoo. Note that if you are applying the Surgi-Sign to an area that has a lot of hair you will need to press and hold the saline wipe for 30 seconds for optimal adhesion. Also, if applying to an area with skin lotion, the tattoo will not stick well, wipe the lotion away first.
General Questions
How can I contact you?
You can reach us several ways:
+1 (866) 888-7222
100 Independence Ave., Hyannis, MA 02601
How much does a Surgi-Sign kit cost?
Surgi-Sign kits are sold in dispenser box containing 50 kits for $145.00. We offer clear acrylic wall mounts for mounting in the Pre-OP holding area. Each kit contains a specially-formulated temporary tattoo, a saline wipe to apply the tattoo, and a small, gentian-violet surgical pen.
How is the Surgi-Sign different from other site markers?
The Surgi-Sign is the only marker that standardizes the surgeon’s initials while also actively involving the patient and team in confirming the surgical site. Our most unique feature is that when the tattoo material is wiped away, all of the team marks remain visible on the skin, in the surgical field, ready for a robust time out.
Do wrong-site surgeries really happen 40 times a week?
Yes. And 40x weekly is likely a low estimate for wrong-site surgeries (“WSS”). Mark Chassin, former president of The Joint Commission thinks wrong-site surgeries occur closer to 50 x week.* Also, several states require hospitals and surgery centers to report all wrong-site surgical errors to the state’s department of public health, and this data is published on the internet. For example, in 2019 Massachusetts averaged 1.32 wrong-site surgeries a week; Minnesota averaged .88 WSS a week; and Pennsylvania averaged 1.42 WSS (2015–2019).**
Does the Surgi-Sign replace the Time Out?
No, it enhances your Time Out. The Surgi-Sign is applied in the Pre-Op holding area, where the surgical team and patient crosscheck the correct surgical site and make their marks. In the OR, the yellow tattoo material wipes away in 15 seconds but leaves the marks clearly visible on the skin. Now you are ready for the Time Out.
How can I set up a trial at my hospital?
We have sales representatives across the country and they would be happy to work with you in setting up a trial. To get started please contact:
- sales@surgisign.com
- info@surgisign.com
- +1 (866) 888-7222, ext. 1
My hospital is outside the United States. Do you export?
Yes. Please reach out to discuss export pricing and shipping.
Why don't I read about wrong-site surgeries in the news?
Great question. This is the question we first investigated. Wrong-site surgeries are considered “Never Events,” which means they should never happen because it is a preventable error. Hospitals and surgical centers know that wrong-site surgeries are completely indefensible, and therefore settle with the victim out of court. Occasionally a victim will choose to go to trial, and it is these cases that make the news. Unfortunately, many patients are unaware of wrong-site surgical errors.