Blood Salvage Compatible Suction Canister University of Pittsburgh Senior Design – BioE 1160/1161 Blood Salvage Compatible Suction Canister Andres Correa Adam Iddriss Brandon Williams April 18, 2006 Mentors: Jonathan Waters, MD Marina Kameneva, PhD Good Afternoon distinguished ladies and gentleman, professor gartner, and my fellow classmates. My name is Brandon Williams and my partners are Andres Correa and Adam Iddriss. Our senior design project focused on the redesign of a blood salvage compatible suction canister. Our mentors were Dr Jonathan Waters , Chief of Anesthesiology at Magee womens hospital and Dr. Marina Kameneva from McGowen institute of regenerative medicine.

Unexpected Blood Loss Unexpected blood loss occurs in approximately 1/70 surgeries (Magee Hospital) Challenges of blood transfusions 5% of eligible donors making donations costs of blood typing and screening ($300/unit) Risk of disease transmission: 1/10,000 for Hepatitis C 1/676,000 for HIV This has led to the development of alternatives in blood management I would know like to briefly introduce you to some of the complications that occur associated with surgeries and typical blood transfusions. At Magee Womens hospital unexpected blood loss occurs in approximately 1 in every 70 surgeries. This unexpected blood loss calls for blood to be transfused to the patient from donor blood under current methods. However, the use of donor blood has its drawbacks. Firstly, only 5% of eligible donors are making donations in the United States and also the cost of blood typing and screening is approximately $300/unit. Where as a unit of blood is 450ml. There is also an inherent risk for the infection of disease. Currently 1 in every 10,000 transfusions infects the patient with hepatitis C and 1 in every 676,000 infect the patient with HIV. The combination of these facts has lead to the development of alternative in blood management.

Cell Salvage Allogeneic and autologous blood transfusions generate $1.3 billion in US Allogeneic transfusions involve the infusion of blood from a donor Autologous transfusions involve the re-infusion of the patient’s own erythrocytes Autologous transfusions have emerged as a viable alternative to allogeneic transfusions decrease immunomodulation prevent transmission of viral diseases decrease transfusion reactions associated with the more traditional technique religious beliefs Currently there are two main methods of blood transfusions practiced in the united states. They are allogeneic and autologous transfusions. The combination of both allogeneic and autologous transfusions generated a 1.3 billion dollar industry in the US. Allogeneic transfusions refer to those transfusions in which donor blood is given to the patients, contrasting this method is autologous transfusions where the patient is reinfused with their own erythrocytes Autologous transfusions have emerged as a viable alternative to allogeneic transfusions for several reasons. They decrease immunomodulation, the body’s immune response to a foreign substance. They prevent the transmission of viral diseases. Decrease transfusions reactions associated with allogeneic transfusions, and due to religious beliefs. Jehovia Witness’s do not believe in receiving donor blood and will refuse it during surgery.

Cell Salvage Continued Blood typically discarded as waste http://www.haemonetics.com/site/flash/cell_saver.html

Cell Salvage Continued Blood salvaged http://www.haemonetics.com/site/flash/cell_saver.html

Suction Canisters Suction canisters are plastic containers used during irrigation to remove excess fluids from patients and provide a clear surgical site for operations US market = $94 million Annual growth rate of 0.4% Unit cost $1.22 Market distribution: Allegiance 58% Abbott 20% Bemis 15% Frost & Sullivan, 2003

Problem Statement Current methods of blood management do not adequately meet transfusion needs 12-14 million blood transfusions annually in the US Increased need for blood (38,000 units /day) Lack of donations High cost of blood management Risks of transfusion

Our Project Redesign suction canister liner to incorporate the use of a cell salvage system Decrease the dependency on donated blood Increase patient confidence Improve safety Provide a cost-effective means of transfusing patients in emergency situations

Design Requirements Perform as a typical suction canister Leak-proof Transparent for visual blood inspection Viable under closed suction system Collection, retention, and disposal standards Easy connection to cell salvage system Injection port for heparin delivery Sterile Economical ($4.00)

Redesigned Suction Canister Proposed Solution Redesigned Suction Canister Must have membrane capable of withstanding vacuum pressure of at least 200 mmHg Membrane must be penetrable by a simple device Puncture device must be able to connect to cell salvage vacuum tubing Must be able to have heparin introduced to the blood volume

Prototype Development Complicated design due to the need for a membrane valve Re-modification of vacuum canister housing Decreased blood volume due to reduction in size of canister

Prototype Development Better design than Prototype 1.1 due to stopcock valve to prevent flow Re-modification of vacuum canister housing Decrease collected blood volume due to reduction in size of canister

Prototype Development Polyethylene membrane capable of withstanding vacuum pressure of 200 mmHg Membrane penetrable by puncture apparatus Best design due to no need for vacuum canister housing modification and original canister volume is maintained

Prototype Fabrication + + Poly(ethylene) sheet Drill pressed liner Stainless steel washer + + Adhesive SLA Puncture Apparatus Prototype

Rubber stopper for disposal Modified liner with membrane Finalized Prototype + + Rubber stopper for disposal Puncture Apparatus Modified liner with membrane

Experimental Methods Testing of two cell salvage compatible suction canisters for: Membrane Strength Membrane Penetrability Leakage of fluid from the closed system During our testing phase we decided to focus on the functionality of our device rather than the viability of blood collected by the device, which is to be determined by the anestiologist. We concentrated on the membrane strength, membrane penetrability, and leakage of fluid form the closed system

Experimental Methods Testing: Canister was connected to Cobe Brat II and vacuum pressure was placed at maximum pressure (200 mmHg) Membrane was observed to make sure it withstood pressure 1000cc of saline was suctioned into the cell salvage compatible canister at vacuum pressure of 200 mmHg Canister was removed from its housing (membrane withheld) Membrane was penetrated by puncture apparatus and no observed leaking of saline occurred The saline was then vacuumed to the cell salvage filter During our testing we were unable to obtain pictures and could not set up another testing date in the OR. So I will briefly demonstrate each step of the testing to you.

Experimental Methods Complications During Testing: A residual volume of saline was observed in the cell salvage canister upon extraction This problem led us to consider a device to seal the canister upon extraction of fluid: Model a device similar to our puncture apparatus that does not have a hollow tube and ends at the circular washer 6 mm rubber stopper plug During our testing we encountered one minor complication. A residual volume of saline was observed in the canister upon extraction. This problem led us to consider a device to seal the canister upon the extraction of fluid. We originally considered 2 different methods.

Discussion Our testing showed: The polyethylene membrane withstood 200 mmHg No leaks were present during the suction of the saline Need for a device to prevent leakage of residual volume Our testing showed us several things. Which included:

Economic Considerations Cost analysis: 1 unit of blood = $300 Average suction canister = $1.22 Modified suction canister = $4.00 Drainage hole and polyethylene covering membrane ~$2,500 for membrane and hole tooling ~$.15 for membrane incorporation Puncturing device ~$10,000 for injection molding mold ~$0.10 per puncturing device Sterilization Plasma sterilization ~ $2 per canister Proportion of unexpected blood loss = 1/70 surgeries (Magee Womens’ Hospital)

Economic Feasibility Price spent on current canisters: $1.22/canister x 70 canisters/day x 365 days/year = $31,171/year on canisters Price spent on re-designed canisters: $4.00/canister x 70 canisters/day x 365 days/year = $102,200/year on canisters Assume a minimum of 1 unit of blood is lost per 70 surgeries $300/unit of blood * 365 days/year = $109,500/year on blood $70/ cell salvage * 365 days/year = $25,550/ year on cell salvage Summation of canister cost and blood cost $109,500/year + $31,171/year – ($102,200/year + $25,550/ year) = $12,921 saved per year assuming only 1 unit of blood is salvaged every 70 surgeries Data from Magee Hospital extrapolated to national level $12,921/year x 5,794 hospitals in the US ~ $75 million annually

Competitive Analysis Strengths Weakness Compatible with the cell salvage system The potential to save the hospital money Reduces complications associated with allogeneic blood transfusions Weakness The modified canister is more expensive There is a chance for blood leakage and contamination of the OR environment due to the blood transfer to the cell salvage system

Constraints Limiting Phase I Testing Economic $500 budget from the bioengineering department Cost of sterilization Biocompatibility testing Cytotoxicity Thrombi formation analysis Regulatory Institutional Review Board (IRB) for human clinical testing Blood-borne pathogens regulations

FDA Regulation TITLE 21--FOOD AND DRUGS CHAPTER I—FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES Subpart G--General Hospital and Personal Use Miscellaneous Devices Sec. 880.6740 Vacuum-powered body fluid suction apparatus. . (a) Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge). (b) Classification. Class II (performance standards). US Food and Drug Administration: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=870.2700

Initial Hazard Analysis Product manufacturing Human Factors Analysis Project Distribution Andres Adam Brandon Fault Tree Initial Hazard Analysis FMEA PDS Ordering Materials SolidWorks Model Contacting companies Product manufacturing Product Testing Competition Entry Human Factors Analysis

Acknowledgements Dr. Jonathan Waters Dr. Marina Kameneva Mark Gartner Department of Bioengineering Department of Chemistry Pittsburgh Life Sciences Greenhouse Drs. Hal Wrigley & Linda Baker

Questions?

Blood Viability Collection Type Storage Temperature Expiration Special Conditions Acute nomovolemic hemodilution (whole blood) Room temperature 8 hours from start of collection None 1-6 C 24 hours from start of collection Storage at 1-6 C shall begin within 8 hours of start of collection Intraopeerative blood recovered with processing 4 hours from completion of processing Storage at 1-6 C shall begin within 8 hours of start of collection American Association of Blood Banks Annual Report (2005)