Frequently Asked Questions
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. (FDA Registration #3013992257).
Does the Surgi-Sign contain latex? No. The Surgi-Sign does not contain latex and can be used safely on anyone who is allergic to latex.
What is the tattoo made of? The tattoo is a specially-formulated acrylic copolymer, which is 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.
Will it cause a surgical site infection. No. The tattoo is completely removed from the surgical site with gauze moistened with water or alcohol prior to surgical site prepping.
Where is the Surgical-Sign made? The Surgi-Sign is made and manufactured in the USA.
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. Cover the tattoo with the saline wipe. No need to unfold the wipe. Press firmly on the entire tattoo for 20 seconds (if placing in an area where there is a lot of hair, hold for 30 seconds).
How do I remove the tattoo? The Surgi-Sign wipes away in 10–15 seconds using gauze moistened with water or alcohol.
Can the Surgi-Sign be moved after it has been applied? No. It cannot be moved once applied.
What if the patient can’t reach the tattoo to write a confirming mark? The patient’s healthcare proxy can confirm the correct site has been identified and mark it for them.
What if the Surgi-Sign was placed in the wrong spot? Our system is designed to identify this very error. If the wrong site was marked initially, simply remove that tattoo with gauze moistened with water or alcohol and apply a new tattoo in the correct surgical site.
Do I have to wear sterile gloves when applying the tattoo? No. The Surgi-Sign is applied in the pre-operative area prior to the procedure and does not require sterile gown or gloves.
The tattoo does not stick well in areas where there is hair. What can I do? If placing the tattoo in an area where there is hair that will not be shaved prior to surgery, press and hold the saline wipe on the back of the tattoo hold for 30 seconds.
How long can the temporary tattoo stay on the skin? The Surgi-Sign can last between 3–5 days. It is designed to become more adherent to a patient’s skin if there is a delay in surgery. This means surgeons can also apply the tattoo prior to surgery in their office.
How is this different from other surgical site temporary tattoo 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 is wiped away, all of the team marks remain visible on the skin, in the surgical field, and you are now ready for a robust Time Out.
How do I arrange for a trial at our institution? Contact us directly. We are happy to work with any hospital or surgical center to set up a trial.