Image courtesy of Porex
Measles, mumps, and tuberculosis—these are all diseases the general public has long disregarded as active threats. Yet, these highly infectious and potentially life-threatening diseases once considered eradicated have been resurfacing across the United States. Measles, for example, was declared eliminated in 2000 by the CDC, yet this year alone more than 1,200 individual cases have been confirmed in 30 states. This outbreak represents the greatest number of reported cases for the disease in the United States since 1992.1
While the ongoing anti-vaccination movement may not be the cause of these reappearances, it does open windows of opportunity for these diseases to reemerge. It also poses threats to healthcare workers collecting samples for diagnosis, potentially exposing them to airborne viruses, and places donated blood and its recipients at risk throughout the transfusion process.
As the blood supply continues to reach dangerously low levels—so much so that the Red Cross recently issued a public plea for donations2—it is crucial that the remaining supply is protected during the testing and transfusion process, starting with the healthcare worker who is drawing blood from a patient. Specially engineered porous polymer materials used in devices for clinical, analytical, and blood transfusion testing can help enhance the level of protection and safeguard the nation’s critical blood supply.
RISKS TO PATIENTS AND HEALTHCARE WORKERS
Eighty percent of all healthcare decisions affecting diagnosis or treatment involve pathology investigations3, and all blood donations are screened in laboratory environments to protect transfusion recipients from infection. Carefully designed equipment and instrumentation can play a critical role in these settings, helping to reaffirm the integrity of donated blood and its components. Ultimately, these devices ensure that blood screenings are accurate and safe for healthcare workers and patients at various stages of the collection and transfusion process and help to reduce the likelihood of diseases spreading and becoming more critical threats to public health.
After a patient is exposed to a disease like measles, it can take 10 to 12 days for the first symptoms to emerge—usually a fever. That being said, while infected individuals may not experience any symptoms, they can still transmit the disease to healthcare workers and possibly contaminate the blood supply by donating blood or receiving a routine blood exam. In the case of measles, which can be confirmed with a blood test, healthcare workers can become infected if they are not properly vaccinated. When drawing blood in any environment, healthcare workers are potentially at risk to bloodborne pathogens if their eyes, noses, mouths, or skin meet any exposed pathogenic microorganisms.
When collecting or initially analyzing samples, healthcare and laboratory workers may not be aware of the pathogens that blood samples contain, especially in blood transfusion pooling procedures where multiples of 6 or 16 different samples are pooled and tested as one sample. As such, a particular sample carrying a pathogen could contaminate workers, as well as other viable samples, without their knowledge if their devices aren’t properly equipped.
Above: Image of infusion set courtesy of Porex
For patients, IV catheter insertion, which is commonly used during blood withdrawal and transfusion, can introduce infection into the bloodstream. When inserted, the catheter’s surfaces are coated with plasma proteins enabling bacteria on the skin to travel to the exterior and interior of the catheter track. This creates biofilm, a structure formed by bacteria that have attached to an artificial surface or dead tissue and contributes to potential infection in the bloodstream.
A catheter lock, which is used to fill the catheter when not in use to prevent clotting primarily, can reduce the risk of infection by preventing contamination in the device and reducing biofilm formation. Still, they are not used continuously or globally, leaving many products improperly equipped. For test diagnosis, these devices can yield unreliable samples, and in the case of donations, can compromise the safety of blood desperately needed by millions globally.
Above: Image of an IV safety catheter courtesy of Porex
Risks of infection from bloodborne pathogens can occur easily—with a simple needle stick or just a splash of body fluid that touches healthcare workers. Blood flashback, which is the appearance of blood in the hub of an IV catheter as it is positioned, can occur within any procedure. The presence of blood flashback enables medical professionals to verify proper placement of catheter assembly when withdrawing blood, a crucial step in the process when retrieving samples. However, inadequate components for IV and safety catheters can lead to potential contamination with every injection.
There are a range of materials that can provide a solution for medical device manufacturers, but porous polymers are unique in their durability, flexibility, and suitability for diverse applications and have become the standard of performance in many applications. When fused or bonded, porous polymers create a network of cells in which filtering, absorption, or other relevant functions are accomplished. Depending on the application, pore size, thickness, and flexibility can be tailored for a desired result, allowing specific rates of filtration, flow, etc. One such porous polymer is sintered PTFE, which can act as a membrane.
Above: Image of the surface of ePTFE courtesy of Porex
In IVs, porous polymers can act as a safety catheter plug, porous flash plug, integrated flash chamber plug, or flash plug membrane. This allows air or gases to freely pass through the porous media, but when wet, the material blocks liquids by forming an immediate viscous solution, thus shutting off air flow.
Sintered PTFE can act as a flash plug in IV catheter devices. Featuring an open-celled, omnidirectional 3D pore structure that is design-flexible, the porous material functions as a vent that allows air or gases to freely pass through the media. Simultaneously, the sintered PTFE actively blocks liquids by forming an immediate viscous solution that shuts off air flow when wet.
Porous polymers can also be used in arterial syringe vents when samples of blood collected under arterial pressures require high air flow and protection against contamination from blood and blood-borne pathogens. Porex arterial syringe vents made from specialty polymers including PTFE maximize air flow at arterial pressures and eliminate blood bypass through use of specially designed porous vents that help prevent aqueous liquid contamination.
Proper venting facilitates gas and air passage, helping to block blood bypass that could contaminate samples or units during collection. This reduces blood-borne pathogen exposure and protects healthcare workers from exposure to infectious substances. Porex Virtek sintered PTFE venting solutions, engineered to eliminate blood bypass in arterial syringes and other devices, are design optimized to stop bypass and reduce blood pathogen exposure and transmission.
Above: Image of the surface of Virtek courtesy of Porex
In a laboratory environment, porous polymers can act as a pipette tip filter to ensure that results collected from scientific samples help eliminate aerosol bypass, sample carryover, and the passage of aqueous-based liquid to equipment and instrumentation. In such an environment, it is important that healthcare professionals are equipped with the proper components to enable efficient, accurate results. Delicate in nature, collected samples are often impacted by aerosols, which can not only contaminate the samples intended to be tested, but can also expose personnel to dangerous microorganisms that can reach the bloodstream. This becomes a primary concern when a worker is handling a wide variety of routine and infectious samples. Cross-contamination can occur between different samples and create an inaccurate diagnosis for a patient. In addition, a donated unit of blood can be incorrectly deemed as safe or unsafe to use for transfusion either putting transfusion recipients at risk or wasting valuable blood.
The Fortress Pipette Tip Filter offers a liquid-sealing barrier devoid of any contaminates or additives that can cause PCR, molecular, or analytical methodology and protocol issues. During sample retrieval, pipettes are typically subject to easy interference as a result of over-pipetting or using filter pipette tips with non-pure filters or other materials. During viral tests, even one drop of blood or sample can cause contamination of the entire lab and equipment, making the integrity of the pipette extremely critical to operations and outcomes.
The Fortress pipette tip filter incorporates inert and hydrophobic filters that function as a barrier to seal out unwanted fluids and aerosols, keeping them from infiltrating the pipette shaft or instrument sampling head or system and tampering with the sample. Through an extensive qualification program conducted by independent third-party laboratory analysis, the Fortress technology, which is part of the Certified-Pure Porex media family, has been verified to be free of materials additives, contaminates, or heavy metals that can cause interference in clinical, analytical, and blood transfusion testing. This protection also extends to the lab as a whole, which must be guarded from the spread of any viral infections when conducting analysis.
The filter protects samples from aerosols that could be preexisting in the pipette from previous procedures, as well as those that are created when the sample liquids are aspirated, providing the highest bacterial filtration efficiency available. The technology provides this protection while simultaneously optimizing airflow and allowing for sample recovery, thus helping to preserve the accuracy of the result.
Manufactured with a proprietary PE matrix, the Fortress pipette tip filter can be used to cleanly and precisely collect and dispense tip samples and reagents for blood transfusion medicine. The technology also provides a solution for other applications such as analytical testing and molecular diagnostics. Additionally, the filter offers all laboratory professionals an advanced component that prevents cross-contamination and sample carryover without using additives. Its construction avoids the use of carboxymethyl cellulose (CMC) or cellulose gum and other additives that can leach into samples and affect test results.
As infectious disease outbreaks continue to pose a threat to public health, it is imperative that healthcare providers are equipped with the right tools to thwart any chances of contamination. Carefully designed components can protect viable blood from contamination—an occurrence that can undermine the limited blood supply. And specially engineered components play an integral role in preserving the purity of each sample collected for a more accurate diagnosis, especially in a laboratory environment, where a contaminated sample could mean the difference between saving a life or not.
- "Measles Cases and Outbreaks," The Centers forDisease Control and Prevention, https://www.cdc.gov/measles/cases-outbreaks.html.
- "American Red Cross Issues Emergency Need for Blood Donors," American Red Cross, https://www.redcross.org/about-us/news-and-events/press-release/2019/american-red-cross-issues-emergency-need-for-blood-donors.html.
- "In Vitro Diagnostics Quality Control Market Size, Share & Trends Analysis Report By Application, By Type (Quality Control, Quality Assurance Services), By End Use (Lab, Home-care, Hospital), And Segment Forecasts, 2019 - 2026," Grand View Research, https://www.grandviewresearch.com/industry-analysis/in-vitro-diagnostics-ivd-quality-control-market.