Jeffrey L Eakin. Pioneer Valley Hospital and Jordan Valley Medical Center.
Coupling of energy through the outer insulation of conventional monopolar laparoscopic instruments has been a problem since the inception of minimally invasive surgery (MIS). This stray energy may be coupled through a hole in the instrument’s outer insulation or through intact insulation by capacitive coupling, both of which can burn a patient intraoperatively. These stray energy burns can be catastrophic for patients. Additionally these patient burns cost hospitals a substantial amount of money through CMS penalties, readmissions, and medico-legal expenses. Encision’s new AEM EndoShield™ Protection System completely eliminates the risk of stray energy burns to patients during laparoscopy, improving patient outcomes and adding value to hospitals.
The AEM EndoShield provides the electrical connection between an Electrosurgical Generator (ESU) and a MIS AEM instrument. It actively monitors the AEM instrument’s protective shield throughout a procedure, eliminating the risk of capacitive coupling to the patient by draining the energy away from the patient to the AEM monitor. If an insulation failure occurs, the AEM EndoShield system actively drains the electrosurgical energy away from the patient through this protective shield. In addition the AEM EndoShield immediately shuts down the instrument power, similar to a circuit breaker (GFCI) in the electrical wiring of a house. The AEM EndoShield can be used with any compatible ESU, in any mode, at very high power settings (up to 80 W). This allows physicians complete flexibility to use an ESU’s full capability, generating the tissue effect they need, while guaranteeing the elimination of stray energy burns to patients.
The AEM EndoShield has been shown to completely eliminate stray energy burns to patients, from capacitive coupling and insulation failure. It has passed an independent review for 3rd edition electrical safety testing (IEC 60601-1) and the 510k application for the device was submitted December 31st, 2013. By eliminating stray energy burns to patients, the AEM EndoShield helps physicians improve patient outcomes and avoid readmissions. It also adds value to hospitals by helping avoid CMS HAC reduction penalties, the direct cost of a readmissions, and medico-legal expenses.
The EndoShield is anticipated to be available in late spring 2014. It will initially be launched with a compatibility list that includes the most popular ESUs on the US market. The design of the EndoShield is universal and will allow compatibility with next generation ESUs as well. As new ESUs come out, the EndoShield compatibility list will be expanded through extensive verification and validation testing. This will allow the AEM EndoShield to be implemented in any physician’s OR, providing them with the Encision hold harmless guarantee to eliminate stray energy burns. With the changing face of healthcare, the EndoShield will help physicians and hospitals stay ahead of the curve by improving patient outcomes while also saving money.
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