Draft:RightBio Metrics

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RightBio Metrics

RightBio Metrics is a medical technology company primarily known for the RightSpotpH® Indicator product line. This technology is used in medical practices for the accurate placement of nasogastric and orogastric tubes. The RightSpotpH® Indicator is noted for its role in patient safety and clinical efficiency.[1]

History and Development

RightBio Metrics was founded in 2005 by Paul Gilbert, MD and Robert Gilbert, MD. The company has stated its primary goal as “...eradicating harm caused by misplaced NG/OG tubes through innovative and accurate biofluid measurement solutions, ensuring the highest standards of patient safety and care in healthcare settings.”[2] The development of the RightSpotpH® Indicator, which was launched in 2011, could be considered one of the company's significant milestones, introducing a new method for verifying nasogastric and orogastric tube placement via pH.

RightSpotpH® Indicator

The RightSpotpH® Indicator is a medical device designed for verifying the correct placement of nasogastric and orogastric tubes. It functions based on pH measurement, providing an enclosed system for healthcare professionals to determine that a tube has been placed into the patient’s stomach successfully. Traditional tube placement confirmation methods, such as auscultation, have been noted for the danger they pose to patients due to their unreliable nature.[3] In contrast, "The RightSpotpH™ indicator is sensitive and specific for determination of intragastric pH determination as less than or greater than 4.5 as commonly used for nasogastric tube placement."[4] Correct placement helps prevent procedural risks resulting from improper tube placement, such as aspiration pneumonia.[5]

Applications in Medical Practice

Indicated for neonates, pediatrics, and adults, the RightSpotpH® Indicator is used to ensure the safety and accuracy of nasogastric and orogastric tube placement, a common procedure in hospital settings and an important aspect of intensive care situations.[6][7]

Research and Clinical Studies Regarding The RightSpot® Indicator & PH Testing

Research published in the National Library of Medicine highlights the effectiveness of the RightSpotpH® Indicator in neonatal settings, describing its role in clinical outcomes.[8] A clinical study published in The Journal of Perinatal & Neonatal Nursing on enteral tube placement discusses the significance of accurate tube placement and the role of pH measurement.[9] An NCBI study on feeding tube placement supports the importance of precise placement techniques, providing support for pH-based verification methods.[10]

Guidelines and Safety Standards

The National Patient Safety Agency (NPSA) in the UK has set guidelines on tube placement that have informed the development and application of the RightSpotpH® Indicator.[11] The NHS has issued guidelines and safety alerts on nasogastric tube placement, stressing the need for verification technologies.[12] Perspectives from the AACN on critical care nursing address the challenges in feeding tube placement[13], an area where RightBio Metrics' technology is applied.

Patient Safety and Clinical Impact

Assessments of patient safety risks in tube placement from the Children's Hospital Association highlight the necessity of reliable verification methods.[14] The article presents pH testing as a reliable method for testing the accuracy of NG tube placement.

Regulatory Approvals and Compliance

RightBio Metrics' RightSpotpH® Indicator has received FDA approval[15] and is CLIA-waived[16].

Industry Recognition and Outreach

RightBio Metrics has received industry recognition for its technology. One such award presented to the company was the Patient Safety Innovation Award given by the Patient Safety Movement Foundation to RightBio Metrics during the 6th Annual World Patient Safety, Science & Technology Summit held in London, England in 2015.[17] Other recognition has been given to RightBio Metrics by healthcare industry professionals such as the Florida Hospital Tampa Pepin Heart Institute and University of Florida College of Medicine.[18]

References

  1. PMID 24499632
    .
  2. ^ "About RightBio Metrics | Accurate NG/OG Tube Placement Confirmation". RightBio Metrics RightSpotpH Indicators. Retrieved 2024-06-18.
  3. ^ "Confirming Feeding Tube Placement: Old Habits Die Hard". PA Patient Safety Authority. Dec 3, 2006.
  4. PMID 24499632
    .
  5. ^ "Misplaced Nasogastric Tube Resulting in Aspiration". 2009-08-01. {{cite journal}}: Cite journal requires |journal= (help)
  6. ^ "U.S., European Regulators OK Devices to Measure Gastric pH Levels". Medical Product Outsourcing. Retrieved 2024-06-21.
  7. ^ "Nasogastric/Orogastric Tube Insertion, Verification, and Removal (Pediatric and Neonatal)" (PDF). Children's Minnesota.
  8. ^ RightBio Metrics (2014-10-28). Product Validation Study of RightSpot Infant pH Indicator for Rapid Bedside Verification of Proper Nasogastric (NG) Tube Placement in Newborn Intensive Care (NICU) Patients (Report). clinicaltrials.gov.
  9. PMID 25919605
    .
  10. PMID 28699995
    .
  11. ^ National Patient Safety Agency (March 2011). "Patient Safety Alert NPSA/2011/PSA002: Reducing the harm caused by misplaced nasogastric feeding tubes in adults, children and infants".
  12. ^ National Patient Safety Agency (March 10, 2011). "Reducing the harm caused by misplaced naso and orogastric feeding tubes in babies under the care of neonatal units".
  13. ^ American Association of Critical-Care Nurses (April 2016). "Initial and Ongoing Verification of Feeding Tube Placement in Adults".
  14. ^ Child Health Patient Safety Organization (August 2012). "A Patient Experienced a SERIOUS SAFETY EVENT - Take Action to Reduce Risk of Similar Harm" (PDF).
  15. ^ U.S. Food & Drug Association. "CLIA - Clinical Laboratory Improvement Amendments".
  16. ^ "TESTS GRANTED WAIVED STATUS UNDER CLIA" (PDF). Centers for Disease Control and Prevention.
  17. ^ "RightBio Metrics Wins A First Place Patient Safety Innovation Award for the RightSpot®". BioSpace. Retrieved 2024-06-18.
  18. ^ hheadmin (2015-05-13). "Safety in nasogastric tube placement through POCT". Hospital Healthcare Europe. Retrieved 2024-06-21.
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