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Michigan Health System, who presented at a workshop held by the FDA to address concerns regarding dirty devices in
2011. Azizi described how his team ran a tiny surgical video camera inside 350 surgery-ready suction tips. ALL of the
suctions tips, Azizi said contained blood, bone, tissue, even rust. Azizi further stated, “I don’t know who approved this or
who made this item reusable, but this is not a reusable or cleanable item,” about a particular suction tip. Azizi said he
chose suction tips because they are included in almost every tray of instruments surgeons use, but that the lesson is far
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reaching. He also said that there are a lot of them that are difficult or impossible to clean . As a single-use closed-loop
device, the AQUALINE SID™ does not have these issues.
Reoperation costs. Patel et al. stated that the pooled average surgical site infection (SSI)-associated re-admission
rate was 67.1%. According to two studies reporting direct costs, spine surgical patients incur approximately double the
health care costs when they develop an SSI. They documented that among patients undergoing revision instrumented
lumbar fusion, the mean two-year direct costs were reported as $57,513 ±$8,253 for those with SSIs compared with
$32,067 ±$6,959 for the control group .
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Cannula clogs. With AQUALINE SID™ the ability to suction and irrigate simultaneously, controlled by the
surgeon, provides improved capability to clear bone, debris and blood. With tip clog clearing, surgeon and OR staff
frustration may be significantly reduced and allow the surgeon and assistants to tend to other critical matters.
Surgery duration and the cost of delays. In additional to adding complication, clogged suction devices can
delay surgeries. James Stiehl, M.D. summarized tests that show yankauers and super suckers plugged in 47% and 71% of
orthopedic joint arthroplasty cases respectively, with the average number of minutes to unplug at 3.9 and 2.8 minutes
respectively . In addition, Alex Macario MD, in a 2005 study of 100 U.S. hospitals, found that OR per-minute-charges
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averaged $62/min with a range from $22 to $133/min., not including surgeon and anesthesia provider fees . Surgical
duration times are a factor in the cost of some surgeries.
Damaged suction distal tips. Quite often frequent surgical drilling and tool operation next to the suction distal
tips cause sharp burrs and jagged edges, which may lead to unintended anatomical tears and complications. A single-use
suction device would limit this potential risk.
Surgical complications and outcomes. As stated by Victor Chang et al., given the scrutiny of spine surgery by
policy makers, spine surgeons are motivated to demonstrate and improve outcomes . The repercussions of SSIs include
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prolonged hospitalization, increased morbidity, worse long-term patient outcomes, and greater direct costs. The mounting
pressure to manage health care resource utilization and rising health care costs has resulted in the downsizing of
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reimbursement for treatment of preventable complications such as SSIs . Preventing SSIs is a national priority. Bacteria
are becoming increasingly resistant to antibiotics, making SSI prevention even more important today .
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Conclusion:
Spinal and other orthopedic surgery outcomes are sensitive to infections, surgeon concentration, surgery
disruptions, and operating durations, amongst other factors. Based on the above information and cited
sources, having an all-in-one sterile suction and closed-loop irrigation device which can remove clogs
appears to have many benefits.
References:
1. Salassa T, Swiontkowski MF, Surgical Attire and the Operating Room: Role in Infection Prevention. The Journal of Bone and Joint Surgery, Inc.
2014;96:p1485-1492, p1485, p1490
2. Stiehl JB, Mechanical Performance of a Self-Unplugging Surgical Suction Instrument: A randomized Controlled Trial. Joint Implant Surgery &
Research Foundation. Reconstructive Review. Vol 4, Num 1, Mar 2014, p18-22, p18
3. Eaton J, Filthy Surgical Instruments: The Hidden Threat in America’s Operating Rooms. Center for Public Integrity. (Published on Center for Public
Integrity, https://www.publicintegrity.org), Feb 22, 2012, p1-8, p3
4. Chang V, Schwalb JM, Pietrantoni L, Jones S, Jankowski M, Oje-Tebbe N, Bartol S, Abdulhak M, The Michigan Spine Surgery Improvement
Collaborative: a statewide Collaborative Quality Initiative, Nurosurgical Focus Vol 39(6):E7,Dec 2015, p1-11, p1
5. Patel H., Khoury H., Girgenti D., Welner S., Yu H., Burden of Surgical Site Infections Associated with Select Spine Operations and Involvement of
Staphylococcus aureus. Surgical Infections. May 1, 2017, p1-23, p1, p2, p10
6. ECRI Institute PSO, If it’s Not Clean, It’s Not Sterile: Reprocessing Contaminated Instruments. ECRI Institute, Event Reporting & Analysis-Alerts,
Apr 11, 2017, p1-2, p1
7. Kainer M, Keshavarz H, Jensen B, Arduino M, Brandt M, Padhye A, Jarvis W, Archibald L, Saline-Filled Breast Implant Contamination with
Curvularia Species among Women Who Underwent Cosmetic Breast Augmentation. The Journal of Infectious Diseases. July 1, 2005:192, p170-177,
p170, p174, p176
8. Macario A, What does one minute of operating room time cost?, Journal of Clinical Anesthesia, 2010; 22, p233-236, p234
9. Spruce L, Back to Basics: Preventing Surgical Site Infections. AORN Journal, May 2014, Vol 99, No5, p600-6011, p601
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