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Cr2-6

Extended Use Microbial Challenge and
Disinfection Study of the CLAVE® Connector
Introduction
ICU Medical, Inc. of San Clemente, California has been funnel unit, and the filter membrane was then incubated in manufacturing and marketing the CLAVE Connector since SCDB for seven days or 168 hours at 32-35°C. Any microbial 1993. New standards in IV therapy are being directed towards contaminates were identified and characterized. The positive longer use life for connecting devices such as the CLAVE control was flushed with 10mL of a nominal 1.0 x 102 /mL Connector. In order to reduce costs yet maintain quality medical volume of challenge suspension. The negative control was care, products proven to be effective in the hospital as well as processed by eliminating the inoculation procedure.
alternate site for longer than the recommended usage, willbetter suit the needs of some health care agencies. In the interest Results
of safety and efficacy, ICU Medical has microbially challengedthe CLAVE Connector in this study for a period of six days The study indicated no microbial contamination of the CLAVE using multiple activations in order to validate its ability to Connector for six days or 144 hours. Initial contamination of maintain a physical microbiological barrier. The CLAVE the CLAVE was verified to be at least 870 CFUs per sample on Connector is a swabable system, as well as a physical barrier to average. The ability of the CLAVE Connector to maintain its bacteria under normal clinical settings. integrity as a "stressed" system when microbially challengedunder a worst case clinical simulation is demonstrated in the In this study the CLAVE Connector is microbially challenged to a rigorous use model in order to demonstrate its integritywhen subjected to what would be considered a worst caseclinical scenario. Samples of the CLAVE were artificiallycontaminated with Pseudomonas aeruginosa in order todetermine if it can thereafter be effectively decontaminated witha standard disinfection protocol. Pseudomonas aeruginosain a 8.9 x 103 population was selected as the challenge organismfor its aggressive characteristics in a clinical environment. TheCLAVE is designed to maintain a physical barrier with repeatedexposure to microorganisms. The samples were accessed usingtwenty four (24) bolus pushes of sterile saline every twenty four(24) hours for a period of six (6) days to demonstrate the worst Conclusion
case clinical model. The multiple activations and the durationof the study were chosen to show the integrity of the product as In all cases the CLAVE Connector was able to maintain a physical barrier for 144 hours (six days) while administering 24repeat activations per day for a total of 144 activations. The Protocol
study results indicate that the CLAVE Connector when using astandard disinfection protocol did not increase infection rates To validate the ability of the CLAVE Connector to prevent microbial contamination, Laboratory Services, Inc. ofMonrovia, California was contracted to perform the Recommendations
independent study. Twenty samples of the CLAVE wereselected as required by the United States Pharmacopoeia (USP) • Use aseptic technique and accepted IV practice.
for sterility testing. The test also included a positive control,negative control, and four population verification samples. The twenty test samples and the controls were challenged againstthe simulated use model. The test units were assembled onto disinfectant in accordance with facility protocol.
individual sterile filter funnel units. Each of the twenty samplesand the positive control were inoculated with an average of • Flush CLAVE Connector after each use in more than 870 colony forming units (CFUs) as confirmed by the population verification samples. To simulate the worst caseclinical model, the samples were then disinfected with a 70%sterile alcohol swab and accessed with a 10mL bolus push of • Change the CLAVE Connector according to CDC sterile saline. The saline wash was passed through the filter into Guidelines or validated facility protocol.
The CLAVE® Connector
Performance with High Risk Infusates
Introduction
It has come to the attention of ICU Medical, Inc. that some infusates, used in high risk clinical applications, can
cause a plastic device such as the CLAVE Connector to degrade and not function as intended. The CLAVE Connector
is designed to be a universal connector, capable of withstanding such infusates in order to qualify it for most clinical
applications. This study is used to demonstrate the functional integrity of the CLAVE Connector when used with
certain infusates that are known to be incompatible with plastics. The CLAVE Connector is manufactured using
polycarbonate, polyester and silicone components. Five different drugs were used to conduct this study as follows:
Taxol, Cisplastin, Adriamycin, Oncovin and Lasix.
Procedure
Sixty samples of the CLAVE Connector were assembled together as one test setup. The test infusate was prepared per the manufacturer’s instructions and available in a 5cc luer lock syringe. Water available in a 5cc syringe was used as the study control. The syringe containing the test infusate was attached to the proximal end, or the silicone seal of the test setup, by fully activating the CLAVE Connector and securing the luer lock connection. The contents of the syringe was infused through the entire string of connectors until an excess of the drug was captured in a secondary syringe. The capture syringe was attached using a double female connector at the distal end or male luer of the CLAVE Connector test setup. The entire setup was a closed system and was monitored for leakage at any of the connection points. At one hour intervals the samples were tested for patency by pushing at the proximal syringe, and then reversing the action by pushing at the distal syringe. This action was repeated twenty four (24) times per day, for seventy two (72) hours or three days. At all times each of the CLAVE Connectors was exposed to the test infusate and the patency test. Following the three days of exposure the test infusate was disposed of per the manufacturer's instructions and the samples were generously flushed to remove any drug residue. The samples then underwent functional and visual evaluation according to the CLAVE Connector’s performancespecifications. Flow testing was used to identify any degradation of the internal polycarbonate spike component.
Backpressure testing to 60 psig was used to identify any degradation of the silicone seal and polyester housing. All samples were visually inspected for degradation. The results of the study are reported in the following table: Results
Test Infusate
Flow Rate:
Backpressure:
Overall Failure Rate
number of failures
number of failures
for Test Infusate
per 60 samples
per 60 samples
Conclusions
The CLAVE Connector met its functional specifications following exposure to the test infusate. According to this study the CLAVE Connector should not suffer from any degradation when used with Taxol, Cisplastin, Adriamycin,Oncovin and Lasix.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
1999 ICU Medical, Inc. San Clemente CA U.S. Patent Nos: 5,685,866; 5,694,686; Other Patents Pending

Source: http://www.hospira.ae/english/_docs/CR2-6CLAVEICUMedical.pdf

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