Effect of Kurin on blood culture contamination rates and cost savings

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Patricia Le, Anita Smith, Joyce Pazhayattil, Ryan Walters, and Stephen Cavalieri from CHI Health – Creighton University Medical Center, Bergan Mercy, Omaha, NE

Background
Blood cultures are susceptible to contamination with skin commensal organisms. Contaminated blood cultures cost hospitals $4,000 to $10,000 per patient and extend hospital stay by 1 to 8.4 days. Initial specimen diversion devices (ISDDs) function by diverting a small volume of initial blood into culture bottles. Our study assesses blood culture contamination rates and associated cost savings of multiple Catholic Health Initiatives (CHI) sites using Kurin®, which diverts 0.15 mL of initial blood drawn, compared to the standard blood collection method, which uses a butterfly needle and chlorhexidine without any blood diversion.

Design
We performed a retrospective study between October 2022 and September 2023 across Creighton University Medical Center, Lakeside, Immanuel, Midlands, and Mercy Council Bluffs Hospital. Contamination rates were stratified by Kurin® use and presented as percent alongside an Agresti-Coull confidence interval. Contamination rates were compared between Kurin® and standard method sets both overall across all facilities and within each individual facility using the log binomial regression model. All analyses were conducted using SAS v. 9.4 with two-tailed p < .05 used for statistical significance. The cost savings and reduction in contamination rates after Kurin® implementation were calculated. The cost of supplies was $17.50 compared to its standard method counterparts of $1.95. We estimated the cost of contaminated blood culture per patient as $4,538 (from a 2022 study by Marcelino et al.).

Results
There was a total of 13,801 blood draws from the standard method and 15,011 blood draws from Kurin®. Kurin® averaged 47% lower risk of contamination compared to the standard method (95%, CI: 38.8-54.0%, p < 0.001). The average blood culture contamination reduction rate was 1.9% for the sites that showed statistically significant reduction (see Table). When projected over 12 months, the estimated total cost savings was $1,063,967.

Conclusions
This study is the first to evaluate blood culture contamination rates before and after Kurin® use across multiple departments while previous studies studied only the emergency department. A 2023 review paper by Mohajer and Lasco found that four of nine studies found reduction in contamination rate to less than or equal to 1% after Kurin® implementation. Future studies could stratify contamination rates between staff such as nurses and phlebotomists and departments such as the emergency department and intensive care unit.

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Do blood contamination reduction devices work? A single institution comparison

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Maria E Navas, Salman Siddiq, Laurie Bauer, Jose A Rivera, Anita J White, Stella Ache, Mark Osborne, Nataliya Kachaluba, Brian Klonowski, Christine Robbins, and Curtis Donskey from VA Medical Center, VA Northeast Ohio Healthcare System

Abstract
We compare two initial specimen diversion devices evaluated over 3 months to investigate their utility in lowering blood culture contamination rates at or below 1%. Overall contamination rates during trial periods were 2.46% and 2.60% but usage was low, whereas device-specific contamination rates were 0.68% and 0.8%, respectively.

Results
During the first phase (Kurin) 441 of 1,626 (27.12%) BC sets returned with a completed device slip versus 254 of 1,126 (22.55%) during the second phase (Steripath). During the trial periods, the contamination rate was 2.46% for the Kurin and 2.60% for the Steripath, which was lower than the same months the prior year (3%), but higher than the desired 50% reduction from the prior year, and higher than the new 1% benchmark. The device-specific contamination rates were 0.68% (3/441) for the Kurin device and 0.8% (2/254) for the Steripath device. Twenty-six surveys were analyzed from Steripath and 20 from Kurin users. The device was rated worse than the standard of care by 73% of users for Steripath and 30% for Kurin. The need for the phlebotomist to activate the Steripath by squeezing the device created complications for some users. No device failures were reported with Kurin.

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Prospective trial of a passive diversion device to reduce blood culture contamination

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Sami Arnaout, Shannon Stock, Julia M Clifford, Thomas C Greenough, Azalea Wedig, Michael J Mitchell, and Richard T Ellison. UMass Memorial Medical Center

Background
Blood culture contaminants can lead to inappropriate antibiotic use, prolonged length of stay, and additional hospital costs. Several devices have been developed to reduce the risk of blood culture contamination by diverting a portion of the initial blood sample from the blood culture bottle. We assessed the effectiveness of 1 blood diversion device (BDD) in a prospective trial performed at the 2 separate emergency departments (EDs) of an academic medical center.

Methods
A multiphase prospective crossover trial was performed with the BDD in use at 1 ED and standard equipment at the other ED for 10 weeks, and a second 10-week study phase was conducted with the use of the BDD and standard equipment in the EDs reversed. Contaminants were identified both by standard clinical microbiology lab criteria and by independent retrospective review by 3 infectious disease (ID) physicians. The primary analysis was performed based on intention-to-use data using the physician review of positive blood cultures.

Results
A total of 5637 blood samples were obtained, with 5625 samples analyzed after 12 blood culture results were deemed inconclusive by the ID physician review. The University ED had a higher blood culture contamination rate of 2.9% compared with the Memorial ED at 1.4%. In an intention-to-use analysis, the overall contamination rates were 2.0% and 2.9% in the BDD and standard equipment periods, respectively (P =.03), and in an actual-use analysis the contamination rates were 1.2% and 3.0% for the BDD and standard equipment, respectively (P < .001).

Conclusion
The BDD was associated with significantly lower blood culture contamination rates at the institution’s 2 EDs, with a stronger effect noted at the campus caring for higher acuity patients.

Implementation of an initial specimen blood culture diversion device to reduce blood culture contamination: lessons learned

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Francine Touzard Romo, Dianne Auld2, Alison de Abreu, Kimberly Roberts, Gail Jackson, Valerie Whitehead, Emerald O’Rourke, Phinnara Has, Leonard A Mermel. Lifespan Health System, Providence, RI

Background
Lifespan healthcare system implemented the Kurin Lock® ISDD in three acute care hospitals (Rhode Island Hospital [RIH]—a 714-bed tertiary care teaching hospital, The Miriam Hospital [TMH]—a 247-bed community teaching hospital, and Newport Hospital [NH]—a 129-bed community hospital) beginning October 2022 and assessed the impact on Blood culture contamination BCxC and vancomycin utilization in adult EDs, intensive care unit, and step-down units (ICU/SDUs). Blood cultures were obtained by nurses (all 3 hospitals) and phlebotomists (NH) after training by the manufacturer. Blood culture technique was followed per protocol, and growth was monitored using the BioMérieux VIRTUO system. No changes in phlebotomy, laboratory practices, or antimicrobial stewardship interventions were implemented during the study period.

Methods
BCxC rates were calculated dividing the number of contaminated cultures (per CDC NHSN commensal list) over the total number of blood cultures/month. The pre-implementation period was defined as the 6 months prior, and the post-implementation period were the months following implementation through December 2023, excluding the month of implementation. Mean BCxC rates prior to Kurin Lock® implementation and after implementation were compared using the Wilcoxon rank sum test. An interrupted time-series analysis was performed using binomial regression models; implementation dates were standardized as “Day 0.” Vancomycin days of therapy (DOT) by order entry indication of “bacteremia” was analyzed using a generalized linear model (Stata/MP 18.0; College Station, TX).

Results
The mean (SD) BCxC rate for all three hospitals and locations declined by 37% [from 3.0% (2.1) to 1.9% (1.4) after the ISDD implementation (P = 0.009)]). The mean number of blood cultures per month was similar during the pre- and post-Kurin period. In time-series analysis, we observed an abrupt 65% decline in BCxC following education and implementation of the Kurin Lock® ISDD at all three hospitals and locations (P = 0.04). Post-Kurin BCxC rates remained lower than pre-Kurin rates at 400 days after implementation; however, increasing BCxC rates were observed post-implementation, particularly in the Eds. TMH and NPH ED BCxC rates were already declining pre-Kurin Lock® implementation. Nonetheless, rates of contamination only reached 1% or less after the ISDD was implemented. The authors did not observe any significant change in mean vancomycin DOT for bacteremia up to 200 days after Kurin implementation in ICU/SDUs.

Conclusion
Although lower BCxC rates were sustained with time, the abrupt decline in rates and intermittent spikes resulting in an upward trend highlights the critical value of continuous quality improvement efforts focusing on best practices paired with the device implementation. An independent review of blood culture collection practices by the manufacturer noted: (1) occasional blood draws from existing intravascular catheters; (2) inconsistent skin preparation; (3) placement of blood culture bottles on patient’s beds; (4) inconsistent stocking of supplies; and (5) new staff unawareness of allowing lock side channel blood flow to stop before accessing the blood culture bottles. In addition, ED staff were not utilizing peripheral IV sets with an attached extension (PV-18) designed to reduce contamination from touch points. Based on our findings, some action items we suggest are critical when implementing an ISDD include: hands-on education when onboarding new staff, emphasizing the importance of drawing blood from fresh venipuncture and not from previously inserted peripheral IVs, establishing PAR levels for all blood culture collection items, stocking enough supplies in IV carts, and provide targeted feedback to individual staff associated with high levels of blood culture contamination.

Implementation of the Kurin Lock® ISDD lowered BCxC in large academic and community hospital settings. Continuous quality improvement efforts regarding best practices for blood collection through skill development and staff accountability are important to assure the efficacy and cost-effectiveness of this intervention.

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Kurin Works with The Ohio State University Wexner Medical Center on Patient Safety and Increased Access to High Quality Healthcare

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Kurin, Inc., a certified Minority Business Enterprise, and The Ohio State University Wexner Medical Center are working together to reduce contaminated blood cultures and improve high quality healthcare at Ohio State patient care centers.

“We are pleased to engage with this prestigious organization,” said Tom Thompson, Kurin Executive VP of Sales. “We are always impressed when hospitals demonstrate an unwavering commitment to their patients. We are similarly driven to improving patient outcomes and helping those who are providing care to these patients.”

This agreement:

  • Provides FDA 510(k)-cleared approaches to address contaminated blood culture problems.
  • Brings clinicians elegantly simple, intuitive technologies that help simplify clinical workflow, specimen stewardship, and prevention of sepsis misdiagnosis.

Contaminated blood cultures are a significant problem, as roughly one-third of the positive results are wrong, exposing these patients to unnecessary antibiotics, extending hospital stays and impacting larger community health issues, such as antimicrobial resistance and life-threatening C. diff. infections. Kurin Lock® and Kurin Jet™ provide clinicians the tools they need to address these problems.

About Kurin, Inc.

Kurin Inc., a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.

Final Judgment Entered in Kurin’s Favor over Magnolia Medical

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Kurin, Inc., the inventor and manufacturer of the Kurin® blood culture collection sets, announced that Chief Judge Connolly of the U.S. District Court for the District of Delaware entered Final Judgment that Kurin does not infringe Magnolia Medical, Inc.’s patent. The district court proceedings in the patent infringement lawsuit brought by Magnolia in 2019 are now closed.

“We are pleased that the Court has ruled in our favor,” said Bob Rogers, CEO of Kurin, Inc. “This case took five years and during that time Magnolia has loudly proclaimed that they would put Kurin out of business, creating confusion in the marketplace. We took the high road with our customers and, although it took years, we stayed true to our values and prevailed in the end.”

“Previously, on Dec. 1, 2023, the US Patent and Trademark Office issued a final rejection of the key patent claims that were the cornerstone of this litigation. This is a complete victory for our team, confirming both that the Kurin Lock does not infringe any Magnolia patent and that the asserted patent is invalid. We are pleased to have this distraction behind us and can now continue on our mission of partnering with clinicians to improve clinical and financial outcomes regarding blood culture contaminations.”

Kurin’s revolutionary approach to the contaminated blood culture problem is an elegantly simple, intuitive design that requires no additional user steps. Kurin passively sidelines potential contaminants during blood culture collection. Kurin is a simply better and more sustainable approach over conventional mechanical diversion. Contaminated blood cultures are a significant problem, as roughly one-third of the positive results are wrong, exposing these patients to unnecessary antibiotics, extending hospital stays and impacting larger community health issues, such as antimicrobial resistance and life-threatening C. diff. infections. Kurin Lock and Kurin Jet give clinicians the tools they need to address these problems.

About Kurin, Inc.

Kurin Inc., a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.

Kurin Announces Appointment of Chief Commercial Officer

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Kurin, Inc., the inventor and manufacturer of the Kurin® blood culture collection sets, announced Christine Arme as their Chief Commercial Officer. Christine has been in the healthcare industry for 35 years, working in both start-up and scaled-growth stage healthcare organizations in both a domestic and international capacity. Most recently, Christine served as the Vice President of Healthcare Systems at Solventum (formerly 3M Healthcare), where she has been since 2015. She led the Key Account organization for the Medical Surgical business unit, which is the largest business group within Solventum.

“I am pleased to announce Christine’s arrival to Kurin,” said Bob Rogers, CEO of Kurin, Inc. “She has had a storied career, including being one of the key reasons for our success at Ivera Medical, the creators of the market-leading Curos Port Protector, which was acquired by 3M in 2015.”

“Her continuing success and evolving leadership roles have been a pleasure to watch and we are excited to have her return to our group. Kurin has had a very successful stretch, mirroring the performance of Ivera Medical. We are in a great position to accelerate this growth and Christine’s skill, leadership, and energy are exactly what we need to take Kurin to the next level.”

Christine is thrilled to be re-united with Ivera Medical leadership team and others and commented, “It’s like coming home to a familiar family that exudes a strong culture and a mission to improve healthcare, reduce costs, and help clinicians and patients – all of which I am very passionate about.”

Kurin’s revolutionary approach to the contaminated blood culture problem is an elegantly simple, intuitive design that requires no additional user steps. Kurin passively sidelines potential contaminants during blood culture collection. Kurin is a simply better and more sustainable approach over conventional mechanical diversion. Contaminated blood cultures are a significant problem, as roughly one-third of the positive results are wrong, exposing these patients to unnecessary antibiotics, extending hospital stays and impacting larger community health issues, such as antimicrobial resistance and life-threatening C. diff. infections. Kurin Lock and Kurin Jet give clinicians the tools they need to address these problems.

About Kurin, Inc.

Kurin Inc., a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.

Court Determines that Kurin Does Not Infringe Magnolia Medical Patent

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Kurin, Inc., the inventor and manufacturer of the Kurin® blood culture collection sets, announced that Chief Judge Connolly of the U.S. District Court in Delaware issued an opinion in the patent litigation brought by Magnolia Medical, Inc. finding that “Kurin is entitled to a judgment of noninfringement of claims 1 and 24 of the #483 patent as a matter of law.”

“It is rewarding to receive the Court’s determination that Kurin does not infringe the ‘483 patent and I appreciate the efforts of our team over the last few years,” said Bob Rogers, CEO of Kurin, Inc. “From the beginning of this case, we felt confident that we would prevail and that the lawsuit was a desperate move by a competitor who could not compete in the marketplace.”

“Previously, on Dec. 1, 2023, the US Patent and Trademark Office issued a final rejection of these same two patent claims. This opinion by the Court confirms that even if these patent claims were valid, Kurin does not infringe them. With Magnolia’s case now largely behind us, we can continue to focus on helping hospitals improve clinical outcomes and address the financial challenges posed by blood culture contamination.”

Kurin’s revolutionary approach to the contaminated blood culture problem is an elegantly simple, intuitive design that requires no additional user steps. Kurin passively sidelines potential contaminants during blood culture collection. Kurin is a simply better and more sustainable approach over conventional mechanical diversion. Contaminated blood cultures are a significant problem, as roughly one-third of the positive results are wrong, exposing these patients to unnecessary antibiotics, extending hospital stays and impacting larger community health issues, such as antimicrobial resistance and life-threatening C. diff. infections. Kurin Lock and Kurin Jet give clinicians the tools they need to address these problems.

About Kurin, Inc.

Kurin Inc., a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.

Children’s Hospital Achieves Zero Contaminations with Kurin Lock

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Oishei Children’s Hospital, Buffalo, NY.

Key Takeaways

  • This was the first published clinical study in a pediatric hospital demonstrating the impact of Kurin’s PIV product.
  • During the two phases of the trial, the ED staff collected almost 1200 cultures with ZERO contaminations when using Kurin. The overall rate during the trial was ~0.5%. (0% with, 8.4% without).
  • Clinical results showed ~80% decrease overall in the BCC rate compared to their historical average.

The Situation

Oishei Children’s wanted to reduce blood culture contaminations (BCC) and improve on historical rates that were closer to 3%. With Kurin, they collected almost 1200 cultures without a single contamination. This data was presented at APIC in 2021.

Baseline & Interventions

As in most facilities, false positive blood cultures (FPBCs) were an ongoing problem. Rates were generally near 3% but occasionally reached 5% or more. Blood cultures were obtained by trained RNs. Leadership provided additional education to nurses who drew FPBCs but 1:1 education yielded only temporary results.

Kurin Implementation & Process

Kurin was used in the first phase of the trial during the summer of 2018. After comparing data to historical averages, a second trial period was completed during the summer of 2019 with similar results. Hospital policy was to collect cultures from a freshly placed IV, so Kurin’s low-volume PIV was the appropriate product to accommodate this policy.

Summary

Rates dropped ~80%, down to ~0.5% during the Kurin trial periods. When measuring rates when Kurin was used, the children’s hospital reported a 0.0% rate. The authors reported this result as clinically significant with a p-value of 0.00001.

Download a PDF of this study.

Kurin, Inc. Reports Record Revenue for Q1 2024

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Kurin, Inc., the inventor and manufacturer of Kurin® blood culture collection sets announced record revenues for the first quarter of 2024, following a record 2023. Despite a challenging healthcare environment, revenue in Q1 was ~30% higher than Q1 2023 and ~8% higher than Q4 2023, which was also a record quarter for Kurin.

“We are pleased with Kurin’s continued success and rate of market adoption, and I am grateful for the professionalism and dedication of our team,” said Bob Rogers, CEO of Kurin, Inc. “We continue our expansion of the sales, clinical and manufacturing teams to meet future growth requirements, leaving us well positioned for the changes CMS is forecasting in the blood culture contamination market.”

“We remain the market leader due to our small, simple device, and our continual quest to develop improvements to the Kurin Lock family,” said Rogers. “Hospitals are facing critical financial pressures and Kurin helps those facilities improve their quality of care, and reduce costs at the same time.”

Kurin’s revolutionary approach to the contaminated blood culture problem is an elegantly simple, intuitive design that requires no additional user steps. Kurin passively sidelines potential contaminants during blood culture collection. Kurin is a simply better and more sustainable approach over conventional mechanical diversion. Contaminated blood cultures are a significant problem, as roughly one-third of the positive results are wrong, exposing these patients to unnecessary antibiotics, extending hospital stays and impacting larger community health issues, such as antimicrobial resistance and life-threatening C. diff. infections. Kurin Lock and Kurin Jet give clinicians the tools they need to address these problems.

About Kurin, Inc.

Kurin Inc., a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.