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Problem

Surgery FireOperating room burns and fires are serious “Sentinel Events” when reported to regulatory agencies. These events are a major and growing concern for surgical hospitals across the nation. The patient safety organization ECRI Institute has listed surgical fires in their list of Top 10 Healthcare Hazards for the past 3 years running. Fire and burn prevention policies are constantly being updated to ensure safety. However, despite these precautions, operating room burns and fires cause serious injury or death to patients and medical staff every year. New and innovative fire and burn prevention tools, accompanied with prevention policies, are necessary to ensure O.R. facilities do not experience these potentially catastrophic events.

Surgical Light Cables

Surgical light cables, which are part of the illumination systems used during laparoscopic and endoscopic surgical procedures, can produce heat readings of approx. 450° F at their distal ends when hooked up to a standard 300W surgical light source. If left unattended and resting against flammable material (such as a patient’s surgical drapes), the cable can ignite a fire or seriously burn a patient’s skin in a matter of seconds. Other dangers include cables coming in contact with oxygen rich atmospheres or other ignition sources such as alcohol-based skin prep agents. According to the FDA Maude database, surgical light cables are one of the main sources for the hundreds of operating room fires that occur every year. Although this number alone is significant, peer reviewed publications such as The American Journal of Otolaryngology note that “Surely, these numbers are a gross underestimate of the total number of adverse events because reporting (of non-lethal and non-injury events) is largely voluntary.” Moreover, such voluntary reporting is discouraged by the fact that it leads to adverse consequences such as increased scrutiny and investigation by regulatory agencies. Consequently- fiber optic light cables pose a serious and largely undocumented fire risk to operating room staff and patients.

Need

Currently, there are no safety devices that directly diffuse the heat from the distal end of fiber optic light cables. Fire safety involving light cables has been a matter of staff training and awareness. Some alternative safety options for light cables have been offered, such as standby switches on light sources that attempt to control the energy emitted from cables when they are left unattached to scopes. However, the FDA Maude database documents incidents of patient burns and O.R. fires from surgical cables placed on “standby”, indicating that these current safety measures are clearly not always effective. A new, more innovative form of fire prevention is necessary to ensure safety in laparoscopic surgical suites where light sources are used.

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Our Product

SensorMed is offering a new laparoscopic safety device, called the CableCap, that will eliminate the risk of fires caused by surgical cables in operating rooms. The simple device acts as a “plug” for the end of activated light cables during surgical procedures. This “plug”, made out of optically translucent PTFE Teflon material, is inserted into the distal end of light cables during phases of minimally invasive surgery when the light cable is left unattached to the scope.Our Product  CableCap effectively diffuses the energy generated by the cables, making them cool to human touch and preventing burn and fire risk. Our product can attach and de-attach from a cable whenever necessary, and is not a permanently fixed component of the cable. It is not meant to be an attachment to any surgical instruments other than the light cables themselves. Since CableCap is a sterile device, it can be handled directly by doctors and nurses who are “scrubbed in” to a surgery. Simply put - CableCap places fire safety control back into the hands of the clinicians who are ultimately responsible for the outcome of a procedure.