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Thinking of Buying...Wrong-site Surgery Prevention Products
Here's a collection of safety aids to help you mark the correct site.
Peter Angood
Publish Date: December 14, 2007   |  Tags:   Patient Safety

In theory, one of the most serious surgical errors should be the easiest one to prevent. In practice, though, the variables that can risk a patient's safety always exist in the OR. While the Joint Commission's Universal Protocol to prevent wrong-site, wrong-patient and wrong-procedure surgery includes just three simple steps, those steps are all about human beings and human behavior.

As humans, our processes benefit from systematic and interactive reminders. To that end, products are available that assist in the prevention of these types of surgical errors. Here's a reminder of their proper uses.

Three steps to safety
As you'll recall, the Universal Protocol involves a process of pre-operative verification, surgical site marking and mandatory timeouts for every operative procedure.

  • During the pre-operative verification, surgical personnel should review all the medical records pertaining to the procedure the patient is about to undergo, confirming that they are consistent with themselves as well as with what the patient and the surgical team understand is to take place. If information is missing or disputed, you must resolve these concerns before the procedure begins.
  • The patient's surgical site should be marked, clearly and unambiguously, to distinguish whether an incision or insertion will occur on a right or a left body part; on a specific finger, toe or other multiple structure; or on a specific spinal level. The marking should be visible even after prepping and draping.
  • A designated member of the surgical team should call a timeout immediately before the procedure begins in order to verify, one last time, the patient's identity, the procedure to be undertaken and the site where it will occur. Communication among surgical personnel is key. Anyone should be able to voice final concerns, and should be heard. The procedure shouldn't begin until those concerns are addressed.

Products to assist
The decision to purchase products that augment the Universal Protocol is, of course, up to the administrators of each facility. Keep in mind, however, that the users themselves will likely determine which products are most effective in alerting surgical personnel to safety requirements.

Any type of activity that standardizes into a repetitive action can be useful for complying with the Universal Protocol, but the basic steps mentioned above remain paramount. The surgical team should become accustomed to the verification, marking and timeout strategy first — to the point at which it's uncomfortable for the participants when this regular routine isn't met — and the particular products in aid of the strategy second.

Most of the products depicted in the sidebar to this column involve the Universal Protocol's pivotal second step, marking the site, whether they're ink pens or adhesive-type markers. Each plays a role in protocol compliance. In terms of their use, the Joint Commission dictates that "the person performing the procedure should do the site marking." It should be done before the patient is sedated, so as to involve his input in the process, and before he's been moved to the OR. If it's not feasible or possible for the surgeon to mark the site, the protocol allows (pending applicable state or local regulations) for another, fully informed surgical participant to do the marking.

Pens and adhesives
The primary marking should be done with a pen, one which is indelible to pre-surgical preps and scrubs and which leaves a distinctive mark that is visible to clinical staff regardless of the patient's skin color. The pen's ink, incidentally, doesn't need to be purple, even though most surgical site marker pens are filled with gentian violet.

As far as the type of mark that's inscribed on the patient, the protocol doesn't spell that out. A line signifying the site of the incision, the surgeon's signature or initials and the word "yes" are acceptable. Some ophthalmic surgery centers use a small mark such as a pinpoint or an arrow over the eye to be operated on. But marking a site with an "X" is discouraged due to its possible interpretation as both confirming and rejecting a site. Whichever method is chosen, the protocol recommends that it be used consistently among a facility's staff, and perhaps even be uniform with the methods of other local facilities if your surgeons operate at more than one venue.

The Universal Protocol allows the use of adhesive site markers, but only as an adjunct to marking the skin with ink. These products can be seen as visual cues, as "speed bumps" or "flags" to encourage the observance of safeguard steps through enforced communication and increased visibility. But above all as backups, since there's always the possibility they'll peel off. The Joint Commission says, "adhesive site markers should not be used as the sole means of marking the site."

A systematic change
The utility and effectiveness of wrong-site surgery prevention products depends on your facility's attitude toward and commitment to its safety regimen. If you take it seriously and are consistent in applying the protocol, they'll serve you well. If you don't, no accessories in aid of safety will. Consider, for instance, the scenario of many institutional process changes. The posters go up heralding the new way of doing things. They last about two weeks before the people in that institution just don't see them anymore. The object here is to make your safety protocols, including the Universal Protocol, a process of continual education and reinforcement.

In order to engage your entire team, that effort must begin at the top. What we have recognized is that, in order for your system to work, the leadership must be engaged and aware. They must be committed to making that change occur through visiting the ORs and procedure rooms, learning the safety steps necessary, witnessing them in action and supporting their staff members. Quite simply, if your leadership is committed to system change, the system changes.

Cardinal Health
CareFusion Transfusion Verification with Rapid Infusion
(571) 521-8900
Price: Not disclosed
FYI: Cardinal's CareFusion Transfusion Verification provides comprehensive transfusion safety functionality at the point of care to help ensure that the correct patient receives the correct blood product, says the company. With its new rapid infusion feature, the application can now accommodate transfusion workflow in ORs and other critical care areas.

CheckSite Medical
The CheckSite System
(314) 667-5720
Price: For hardware components, $5,000 to $15,000, depending on OR size and layout. If procedure volume is greater than 5,000 cases per year, hardware can be provided at no cost. For disposable components, $3 to $4 per patient.
FYI: The CheckSite System uses a bracelet and sensor technology to ensure that patient safety measures are complete before patients leave pre-op, says the company. A microchip in the bracelet triggers an audible reminder if the patient is moved from the area before certain steps such as surgical site marking or other user-defined safety processes are completed.

GI Supply
(800) 451-5797
Price: Box of 10 syringes, $195
FYI: Spot is the first and only non-India-ink-based, FDA-approved product for marking or "tattooing" the GI tract, says the company. Each syringe contains 5cc of a sterile, biocompatible, non-pyrogenic suspension containing highly purified carbon particles. The particles remain in the submucosal injection site, creating a permanent mark that remains visible on the mucosal and serosal surface of the colon.

Health Care Logistics
Correct Site Tattoos
(800) 848-1633
Price: Package of 100, $75
FYI: Among the products that Health Care Logistics offers the medical community is Correct Site Tattoos, five different brightly colored, whimsically drawn applications designed to prevent wrong-site, wrong-patient and wrong-procedure surgery. These tattoos offer surgical facilities an easy, patient-friendly way to mark the skin, says the company. They also comply with Joint Commission and AORN recommendations for correct site marking.

(800) 569-9059
Price: Not disclosed
FYI: Surgichip, an RFID-based technology that aids in eliminating wrong-site surgeries, incorporates a three-step verification process to complement the existing protocols conducted prior to a surgical procedure, says the company. At each step, positive patient identification and critical data pertaining to the surgical procedure are verified and electronically documented, providing a complete audit trail to the verification process.

Skin Markers
Price: Package of 50, $55 to $103 depending on pen specifications
FYI: Medline's skin markers are surgical-prep-resistant with non-smearing, non-toxic ink for correctly marking patients, says the company. The markers use non-irritating gentian violet ink; feature centimeter rulers on the barrel; are available with a regular tip (sterile or non-sterile), fine tip or utility tip (for labeling products); and are individually packaged with a flexible rule and optional labels.

TAT Markers
(866) 307-2757
Price: Box of 100, $50
FYI: OP-marks' TAT Markers are temporary skin laminates that are ideal for site-marking cataract patients with a Joint Commission Universal Protocol-compliant "YES." Once placed, they can't be moved or altered, yet they can be gently removed in the recovery room, even from the fragile skin of an elderly patient, with an alcohol wipe.

RMAC Surgical
Time Out/Surgical Pause Card
(888) 299-2661
Price: $0.25 for VA facilities, $0.35 with purchase of PharmaTags Sterile Medication Label Kits, $1.15 separately.
FYI: The Time Out/Surgical Pause Card was designed by a registered nurse to help her hospital achieve compliance with the Joint Commission's time out requirement, says the company. The card is placed over the scalpels as a reminder to conduct a timeout before incision. A checklist on the card ensures that the proper questions are asked and documented before surgery begins.

Sandel Medical Industries
TimeOut Markers
(866) 764-3327
Price: Varies depending on model and quantity purchased
FYI: Sandel's TimeOut "no-roll" markers come with a removable paper TimeOut sleeve that serves as a reminder for the surgical team to take the Universal Protocol-required timeout before beginning the procedure, says the company. The pens are available in four styles. Sandel's surgical safety supplies also include the TimeOut Reusable Hood, which is placed over the scalpel to remind staff to pause before the first incision is made; temporary tattoos and correct-site stickers.

(800) 345-1244
Price: Package of 60 labels (25 "L," 25 "R," 10 "Do Not Dilate"), $22
FYI: Varitronics' EyeDentifiers are rugged cloth markers with surgical-quality adhesive backing. The green square is marked with an "L" and the red circle with an "R." When used for eye surgery, these stickers can be placed above the appropriate eye as well as on the patient's chart. While designed for ophthalmologists, EyeDentifiers markers can also be used to identify other surgical sites.

Viscot Medical
Pre-Surgical Skin Marker Mini
(800) 221-0658
Price: Not disclosed
FYI: The Viscot Pre-Surgical Skin Marker Mini is designed to provide a cost-effective solution for correct site marking, says the company. Filled with scrub-resistant gentian violet ink, the mini is sized and priced accordingly to drive compliance around single-patient use. The marker is packaged in a convenient plastic container dispenser, allowing visibility and access in pre-op and exam areas.

Xodus Medical
Correct Site Markers
(800) 963-8776
Price: Not disclosed
FYI: Xodus Medical offers a wide variety of correct-site markers to help you comply with Joint Commission standards for safe surgery, says the company. Each marker features indelible, prep-resistant gentian violet ink. You can choose between round tip, fine tip, dual tip and non-rolling. Each marker is latex-free and available sterile or non-sterile.