Surgical Fire Safety

The Issue:

The issue at hand centers on fire safety in operating rooms. A recent study conducted by ECRI Institute and PPSA estimates that 550 to 650 surgical fires occur nationally each year, making the frequency of their occurrence comparable to that of other sentinel events (e.g., wrong-site surgery or retained instruments)1. Based on these numbers, operating room fires are at least 5 times more common than current FDA reports indicate, suggesting that fire events commonly go unreported. Fire risk is especially present in minimally invasive surgery, or MIS. The “O.R. Fire Triad” describes the 3 components necessary for a fire to start in the operating room - heat and ignition sources, fuels, and oxidizers. Currently there is one major identified heat and ignition source used in MIS that is not adequately addressed from a risk management standpoint - surgical light cables. This lack of risk management poses a serious threat to patients, staff, and facilities. 

 

The Problem:

Surgical light cables cause operating room fires2-5. These light cables are used during any surgical procedure involving the use of light sources and scopes, almost always in minimally invasive surgical procedures. When plugged into a standard light source and unattached from a surgical scope, light cables can generate heat greater than 400 degrees Fahrenheit at their distal end. If these cables are in contact with a patient’s drapes, a fire can be ignited on the patient in less than 10 seconds 4. Other hazards include skin burns and fires generated by cable contact with oxygen rich atmospheres or alcohol based skin prepping agents.  

Competition:

Special light sources have been manufactured by large surgical supply companies such as Stryker and Olympus. These light sources come equipped with a “standby” switch that is meant to be utilized at any point during the procedure when a surgical light cable is unattached from a scope. The problem is - they do not work. FDA Maude Database has numerous reports of light cable burns and fires occurring after light sources have been placed on standby5 . In addition, Doctors and other clinicians who are “scrubbed in” to a surgical procedure cannot operate a light source since it is outside of the sterile field. Because of this, they must rely on technicians who are not directly participating in the surgery to operate the device for them, which results in a high frequency of miscommunication and human error. These light sources are also very costly, especially if a hospital were to replace its entire inventory of light sources for every surgical suite.

Relevant Procedures:

Surgical light cables are used in any surgical procedure requiring the use of scopes and light sources. This typically occurs in minimally invasive surgery. Out of the millions of minimally invasive surgeries performed every year in the U.S., a large majority require the use of surgical light cables. The issue of light cable safety is relevant to all of these procedures. However, certain procedures carry higher degrees of risk than others do. For example, head and neck surgeries are identified as high risk procedures for cable fires and burns. This is due to the close proximity of cables, scopes, and administered oxygen around the patient’s head and face. According to PubMed, burn injuries represent 20% of monitored anesthesia care-related malpractice claims, 95% of which involve head/neck surgery6. Surgical light cables are identified as one of the main heat and ignition sources for these burn injuries2.

Our Solution:

SensorMed, Inc. has developed and tested a novel solution to address the issue of fire and burn risk from surgical light cables. Our device, called the CableCap, is a simple and easy to use Teflon plug designed to attach to the distal end of surgical light cables the same way a scope would attach to them. CableCap effectively diffuses the light and heat energy omitted from surgical light cables, making the distal end safe to human touch and preventing the cable from being a burn or fire hazard. The CableCap can be used at any point in a procedure when a surgical cable is unattached from the surgical scope. This typically occurs at the beginning of cases, as well as any point during the case when scopes are switched or unattached for a variety of reasons. The CableCap can be offered as either a disposable or a re-usable device. If disposable, the unit would come pre-sterilized in sterile packaging and offered the same way as other surgical disposables.  A re-usable unit has undergone sterilization validation testing from an FDA recommended laboratory, and can be sterilized with any standard hospital sterilization technique (Autoclave, ETO Gas, Sterrad, etc.) The re-usable unit will be presented as a standard part of the surgical tray for each laparoscopic / endoscopic procedure.

Although there are a large number of endoscopic supply companies, there are only 3 main adaptor types for surgical cables and scopes – Wolf, ACMI (Olympus), and Storz. Because each adaptor type is unique in dimension, there are 3 different CableCap sizes to fit each adaptor type.

SensorMed has a patent pending for the CableCap device, and an office action has been issued. In addition, CableCap received FDA approval in September of 2010.

References:

1.) ECRI Institute and Pennsylvania Patient Safety Authority Report

2.) AORN Journal - Fire in the OR—Prevention and preparedness Liane Salmon AORN Journal July 2004 (Vol. 80, Issue 1, Page 41)

3.) ECRI Institute

4.) American Journal of Otolaryngology Volume 29, Issue 3, May-June 2008, Pages 171-176

5.) 2009 FDA Maude Database Report

6.) PubMed


 

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