Clinical Literature

Quantification of urine capture by a novel external female catheter for accurate urine output measurement

Elena Lagunilla, Kevin Klocek, Thomas Hallowell

Clinical White Paper published by Boehringer Laboratories, January 2025

Indwelling catheters effectively track urine output but increase the risk of catheter-associated urinary tract infections (CAUTIs). Reducing their use, especially in female patients, is a primary clinical goal. External urinary management systems offer an alternative, but many lack the necessary accuracy for critically ill patients requiring precise urine output measurement. This study evaluates the performance of a novel external female catheter in a clinical setting. Results show the device captured an average of 97.2% of total urine output, demonstrating high accuracy. The novel external catheter system provides an effective solution for urine output measurement, reducing reliance on indwelling catheters and mitigating the risk of CAUTIs.

Staple Usage Comparison Between Suction Calibration System and Rubber Bougie in LSG

Elizabeth Dovec, MD, Medical Director, GBMC Comprehensive Obesity Management Program

Data suggests a savings of 0.33 staple load per laparoscopic sleeve gastrectomy (LSG) procedure after switching to a suction calibration system (SCS). That translates to saving a staple approximately every third case. With bariatric staple loads costing upwards of over $400 per staple, this could mean significant savings for institutions that implement a SCS in their LSG procedures.

Evaluation of Safety and Effectiveness of a Novel Suction Calibration System vs. Bougie in LSG

Leonardo Claros, MD, FACS, FASMBS, El Chaar, MD, FACS, FASMBS, Rose Huang, MSBME, George Ezeji, MD, Jill Stoltzfus, Ph.D., St. Luke’s University Health Network

ViSiGi 3D® is a safe and effective tool for LSG. SCS was shown to reduce each step of a sleeve gastrectomy during LSG, decrease the chance of cross-contamination in a hospital, reduce the likelihood of accidental tube stapling, and decrease the risk of esophageal perforation.

OG Tube/Bougie vs. Suction Calibration System During Laparoscopic Sleeve Gastrectomy

Rose Huang, MSBME, Michel Gagner, MD, FRCSC, FACS, FASMBS

Presented at: 19th World Congress of the International Federation for the Surgery of Obesity and metabolic disorders (IFSO2014)

ViSiGi 3D® was shown to clearly delineate and indicate the proper
staple placement, significantly decreases the time needed to complete each step of sleeve gastrectomy, reduces corkscrewing, and may reduce esophageal damage and accidental tube stapling.

Use of Filters on Medical Gas System Outlets and Vacuum System Inlets

User Experience Network™ [Health Devices Dec 1994;23(12):494-5]

Recommendations include routinely inspect and maintain medical gas and vacuum systems, use filters on medical gas outlets only as a temporary measure to protect patients and devices against particles, bacteria, or liquid water found in the system, use suction canisters for any suctioning procedure, and use smoke evacuators instead of the central vacuum system for smoke evacuation during most procedures. Note that filters will not remove water vapor or other gases, which can damage some medical devices.

Veterans Administration Directive on Reusable Medical Equipment (RME)

Department of Veterans Affairs Veterans Health Administration Washington, DC 20420; VHA DIRECTIVE 2009-004; February 9, 2009

This Veterans Health Administration (VHA) Directive provides procedures for the design and implementation of a systematic approach for the setup, proper use, reprocessing, and maintenance of all reusable medical equipment (RME) used in VHA facilities.

The Efficacy of Backflushing Suction Regulators as a Method of Internal Disinfection

John J. Hill, BA, RRT-NPS, Director Respiratory Care Services; Michael J. Neary, MD, Director MICU/SICU, Associate Medical Director Respiratory Care Services; Caroline Panichello, CRT/RPFT, Respiratory Care Staff; Deborah Heart and Lung Center, Browns Mills, NJ, USA

Presented at the 55th Annual International Respiratory Conference (AARC 2009).

This study demonstrated that manufacturer-recommended backflushing does not adequately disinfect internal suction regulator passages. The novel approach to device sterilization offered by the Boehringer Regulator, wherein traditional, well-accepted autoclave techniques are employed to optimize device disinfection, would appear to offer a substantial clinical advantage in the prevention of nosocomial infections.

Clinical Importance of Unrestricted Flow in Hospital Suction Systems

Michael J. Neary, MD;  John J. Hill, BA, RRT-NPS; Bonita Weyrauch, RN, CWS, DNC, CCT; Kevin Klocek, EMT, BSBME, MBA; Randolph Cremer, CBET

Clinical White Paper published by Boehringer Laboratories August 2008

Hospital suction outlets need to provide a minimum of 85 liters per minute of unrestricted airflow to be compliant with established standards. Suction regulators attached to the wall outlets restrict the flow available from these outlets. Only Boehringer suction regulators minimally affect the available flow and deliver maximum suction power, ensuring the most significant ability to remove patient secretions at any suction setting.

Intraoperative Whole Blood Autotransfusion

John Karpowicz, Chris Radl, Kevin Klocek

Clinical White Paper published by Boehringer Laboratories, May 2010

An examination of the process of autologous blood transfusion using the Boehringer Laboratories AUTOVAC® Intraoperative Autotransfusion System (Model 7904R). Presentation of a review of clinical applications on the use of shed whole blood across a spectrum of surgical procedures and actual clinical results obtained with the Boehringer AUTOVAC® system. When used in appropriate clinical settings, whole blood autotransfusion has shown to be an effective method to reduce allogeneic exposure with minimal complications. The AUTOVAC® system provides whole blood that is appropriate for vascular and trauma procedures.

An Evidence Based Approach to Determining Hospital Suction Canister Change Protocols

Keith S. Kaye, MD, MPH; Dror Marchaim, MD; Lauren Bentley, MS

Presented at the 37th Annual Meeting of the Association for Professionals in Infection Control and Epidemiology (APIC 2010).

The contemporary literature review does not substantiate the Q24hr recommendation. In vitro work performed shows that a significant risk to the patient exists at 24hrs. Survey results showed that although 93% of facilities have a canister change protocol, only 53% of them change the canister on a Q24hr basis. We suggest that more evidence needs to be obtained for generating canister change protocols. Also, facilities should study their suction circuits to identify any associated risk.

Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff

Document issued on: March 17, 2015. This document supersedes: “Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance” issued April 1996.

This guidance provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable medical devices. This guidance document also provides recommendations for the content and review of premarket notification submissions [510(k)], premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests and investigational device exemption (IDE) applications, concerning the labeling instructions for reprocessing reusable medical devices.

Healthcare Product Comparison System Report on Suction Regulators

(Note the HPCS report is not an evaluation. The information it contains is not the result of testing by ECRI Institute’s clinical and engineering personnel. Although this information is obtained from reliable sources, ECRI Institute cannot guarantee its accuracy.)

This Product Comparison covers low-volume, surgical, thoracic, and tracheal suction regulators that dynamically control the selected vacuum level, responding to changes in flow conditions that may be introduced during suctioning procedures. Adapters that convert continuous regulators to intermittent regulators are also covered. Other regulators, such as those controlled with a bleeder valve that does not dynamically control vacuum levels, are omitted. In addition, any accessories associated with suction regulators are excluded; however, compatible inlet and outlet fittings are listed in the chart.

Reduction of Waste Anesthetic Gases attributable to Membrane Oxygenation during Cardiopulmonary Bypass

Bradley Thompson, MS, CCP, Appleton Medical Center – Appleton, WI

Presented at CREF 2013 – 33rd Annual Cardiothoracic Surgery Symposium

Purpose: To quantitatively evaluate a convenient, commercially available waste anesthetic gas removal system for membrane oxygenation that does not impart excessive suction across the membrane oxygenator or allow for the accumulation of positive pressure in the system. Results: Subsequent badge test resulting in the perfusion work area indicated <0.42ppm residual anesthetic with the scavenger setup in place and operational.

Suction Regulators: A Potential Vector for Hospital-Acquired Pathogens

Keith S. Kaye, MD, MPH; Dror Marchaim, MD; Chester Smialowicz, MD; Lauren Bentley, MSBME

Infection Control and Hospital Epidemiology 2010, 31(7), 772-774.

The role of suction regulators in nosocomial infections has, to our knowledge, not been studied. A sampling of devices used in hospitals was conducted. Many regulators (173 [37%] of 470) were found to be colonized. A suction circuit model revealed that pathogens can disseminate throughout the circuit (retrograde and antegrade), colonizing an experimental patient’s stomach.

Reducing the HAI Risk Attributable to Hospital Suction Canisters: An Evidence Based Approach

Michael J. Scala, RN, BSN, EMT-P

Clinical White Paper Published in 2011 

Suction collection canisters are used in almost every patient care area. They form a reservoir where solid and liquid components are separated from air and aerosols. Once these collection vessels have been employed clinically, they become an environmental reservoir of pathogens in that patient care area. Ventilator-Associated Pneumonia (VAP) bundles commonly include the recommendation that collection canisters be changed at a minimum of Q24hrs. This literature review will attempt to demonstrate an evidence-based canister change protocol supportive of the reduction of this potential HAI vector. This evidence-based protocol recommendation could represent over $1000 worth of savings per ICU bed per year.