Page 7 - Hensler Surgicasl Aqualine SID - 2018

CAPSTONE SURGICAL TECHNOLOGIES
SUCTION IRRIGATION DEVICE – AQUALINE SID™
VALUE ANALYSIS

Abstract:

Neurological, spinal and orthopedic surgical cases often require the removal of bone, tissue, blood and other anatomical matter
from the surgical site during surgery. The optimal outcomes of these surgeries can depend upon the cleanliness of the site, ease of
operating during the surgery, and the visual clarity of the surgical site, amongst other factors. Current aspiration is often
implemented with a Frazier Tip type suction device, which is not intended or designed to perform irrigation; therefore, many
surgeries are not readily equipped to irrigate the surgical site. The surgeon often tasks a resident or technician to irrigate the site
with a syringe of fluid from the open back basin, which is neither convenient nor systematic and does not allow for well-
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controlled irrigation. Furthermore, the back basin has often been found to be non-sterile . The AQUALINE SID™ device provides
suction and irrigation controls at the surgeon’s fingertips and avoids the need for the splash basin by providing sterile irrigation
fluid in a closed-loop system.

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In addition to irrigation issues, another often overlooked significant disruption in current surgical procedures is suction clogging .
Debris of bone and tissue can often get entrapped within suction devices. This material is often difficult to clear during surgery,
adding to surgeon concentration disruption and delayed surgical procedures, often with multiple clogs occurring in a single
operation. The AQUALINE SID™ device has a purge function to help clear such clogs. Furthermore, the disposable nature of the
device avoids the critical issue of re-sterilization failures and contamination .
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Capstone’s Evolutionary Technology: AQUALINE SID™

…Suction, Irrigation & Clogged Tip Clearing

To address the following industry concerns, Capstone Surgical Technologies has developed AQUALINE SID™, adding
substantial value and optimizing suction and irrigation technologies.

AQUALINE SID™ Value Analysis:

 Infection rates. With infection rates becoming increasingly important in the metrics of hospital systems and surgical
centers , along with significant reoperation costs , and with the need to halt, delay or reschedule a surgery to re-sterilize
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an operating room upon discovery of a dirty suction device , having a single-use closed-loop suction/irrigation device
appears to be the responsible decision. The estimated number of surgical site infections that occur each year is nearly
300,000, accounting for $10 Billion in direct costs annually .
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 Back basin contamination. Open-loop irrigation systems in an OR can become contaminated. As was recently
addressed by Salassa and Swiontkowski, splash basin contamination was reported to be as high as 74%. Irrigation from
consecutive operations lasting longer than an hour had positive cultures in 62% of thirteen operations. Surgeons often
irrigate with these contaminated basins. In this study it was indicated there are no known correlation to date between
back table bacterial contamination and surgical site infection . However, Kainer et al. studied macroscopically visible
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black sediment noted in saline-filled silicone shell prosthetic breast implants (SALBIs) in 5 women who had undergone
revision surgery and SALBI removal. Curvularia fungus, a fast-growing dematiaceous fungus commonly found in soil,
was cultured from the implant fluid in all 5 women. They found that one of the factors that contributed to contamination
included the open bowl method, which led to contamination of the saline. This outbreak investigation provides scientific
evidence to support the recommendation that ORs should be at positive pressure relative to the surrounding areas and that
a closed system should be used when injecting sterile saline into SALBIs .
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 Dirty reusable suction devices. In one study, a majority of reusable suction devices cleaned by central sterile
processing contained contaminating matter. Per Eaton, filthy, dangerous medical implements have been showing up in
hospitals and outpatient surgery centers with alarming regularity. A further finding by Eaton, regarding an outbreak at
The Medical Hospital in Houston, was that two likely sources of contamination were in unlikely, yet terrifying spots –
deep inside a hand-held power tool and inside a long narrow metal inflow/outflow cannula, which is used to irrigate and
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suction the surgical site . In addition, Eaton cited Johan Azizi, a risk management clinical engineer at the University of

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