Kurin Lock (Iskus Health Ltd) is a CE‑marked class IIa medical device, intended for use in collecting blood samples to check for the presence of infections. The Kurin Lock device consists of a needle, a flash chamber to collect, isolate and display the first 0.15 ml of blood drawn, and a tube to collect the remaining blood sample, which goes on to be cultured and analysed.
The company submission lists 14 different versions of the Kurin Lock device. The company stated that there is no impact on the generalisability of evidence across these various versions of the device. It advised that the different versions allow different methods of taking blood culture samples in clinical practice, such as variations in the bottles used to collect samples and taking blood samples from freshly inserted peripheral intravenous cannulas instead of through standard venepuncture.
People who are suspected to have a bloodstream infection or sepsis have a blood sample collected. The sample is sent to a laboratory for culturing to detect and potentially identify the infection. Current management involves cleaning the injection site with antiseptic, inserting the needle, and collecting blood directly into blood culture collection bottles. Measures such as appropriate skin and bottle preparation, taking cultures from peripheral venepuncture instead of catheters, and training, can minimise contamination risk. At least 40 ml of blood should be cultured for optimum detection of bloodstream infections. This requires at least 2 sets of blood culture samples to be taken within a few hours of each other. Kurin Lock could fit in to the pathway by replacing the standard blood culture collection device.
In clinical practice, once the infection-causing pathogen is identified, the initial antibiotic therapy may be changed to target the identified pathogen. This allows for more appropriate and tailored treatment. If the pathogen is considered to be a contaminant, then antibiotic treatment will be stopped.
The innovative aspect of Kurin Lock is the flash chamber, which passively diverts and contains the first 0.15 ml of blood that is drawn during blood sample collection. The intended purpose of this mechanism is to isolate the blood that could contain microbes from the skin at the site of venepuncture. This is to avoid contaminating the blood sample and reduce the rate of false positive bloodstream infection results.
Blood culture contamination or false-positive blood culture results complicate interpretation and can have detrimental effects on the patient and health service. People that have increased antibiotic exposure have increased risk of potential adverse events, including allergic reactions as well as the possibility of getting other infections. This may contribute to pressures faced by secondary caused by extended hospital stays, and unnecessary testing in hospital laboratories.
Kurin Lock is intended for use in secondary care, for people who have blood culture samples taken when bloodstream infections are suspected. This includes in emergency departments, intensive care units and other general inpatient wards. Specific subgroups who may benefit from Kurin Lock include populations in which taking blood samples may be more difficult, and so the risk of contamination is higher. For example, taking blood samples from children or from intravenous drug users. Other specific subgroups who may benefit from Kurin Lock include those in which organisms that would normally be considered contaminants may be a causative pathogen. For example, people with implanted cardiac devices or prosthetic valves.