SteriPath is a Class I device that is registered and listed with the FDA. The device is manufactured and sterilized in ISO 13485 and FDA registered facilities that are compliant with all GMPs, QSRs and other relevant regulations.
Yes, SteriPath is a commercially available medical device. For information on a distributor in your area, please contact us at email@example.com.
Yes – by a significant margin. Once integrated into your clinical process, the use of SteriPath represents simple and effective “forced compliance”. With built-in best practices that require minimal training to implement, SteriPath provides quality assurance “in-a-box”.
The sequestration of the initial sample (that is most likely to contain contaminants) is a compliant mechanical feature of the device and requires no special technique to perform correctly. SteriPath makes complex protocols previously necessary to reduce contamination rates, SteriPath replaces traditional and complex protocols with a simple, foolproof, all-in-one system.
Yes, SteriPath has been designed to prioritize the safety of both healthcare workers and patients. Each SteriPath system comes preassembled and sterilized in a sealed container that doubles as a portable sterile field. Simple operation and industry-standard venipuncture procedure means a minimal learning curve for healthcare workers and no safety impact on patients. The venipuncture needle is manufactured by Becton Dickinson (BD) and has a best-in-class, retractable safety feature. The safety transfer adapter and direct-to-media technique, facilitated by SteriPath, ensure best practice sharps safety is maintained throughout the procedure.
Yes. If your false positive rate is above 0%, patients may be at risk for receiving costly and unnecessary treatment. While 3% may seem like acceptable performance, if your hospital has an overall positive growth rate of approximately 10%, then 1 in 3 – or 33% – of all positive blood culture results represent inaccurate diagnoses.
SteriPath is designed to work with all BACTEC (BD) and BacT/ALERT (bioMerieux) blood culture bottles, as well as some VersaTrek bottles. The SteriPath safety transfer adapter is also configured to accommodate all standard blood collection tubes so that additional samples (e.g. “the rainbow”) can be collected after culture bottles are inoculated from the same venipuncture.
Because it is prepackaged and preassembled in a sterilized container, SteriPath can be used anywhere from the ICU to the ER to outpatient clinics.
SteriPath can be used by any individual who is trained, licensed (as required) and would normally collect blood culture samples. The venipuncture procedure is identical, and SteriPath is compatible with standard blood culture bottles and vacuum tubes.
Minimal incremental training is required for users of SteriPath. Virtually any healthcare professional that is trained and licensed (as required) to collect blood samples can learn to use SteriPath in less than 5 minutes. Magnolia Medical offers an online training module for use with your staff and can provide additional training services as needed.
According to independent, third party, peer-reviewed data, each and every abated false positive represents a direct savings of $3500 to the healthcare institution.
To estimate the potential savings at your hospital or healthcare system, you can enter specific culture volumes and current contamination rates in the ROI calculator.
The built-in best practices, portable sterile field, and simple operation of the SteriPath system can actually help healthcare professionals increase efficiency, especially in situations where SteriPath replaces complex manual protocols that are currently required to reduce false positive blood cultures.
Since most blood cultures are performed on inpatients that are reimbursed on a DRG basis, there is no specific incremental reimbursement for SteriPath. However, the direct cost savings and improved overall quality associated with reducing blood culture contamination will drive cost savings that provide significant economic benefit to your hospital.
Our distribution partners are ready and able to meet any specific supply chain and logistics requirements your hospital may have for SteriPath.
To learn more about SteriPath and our pilot program, call us at 888.617.3420 or email us at firstname.lastname@example.org.