Draft:RightBio Metrics

From WikiProjectMed
Jump to navigation Jump to search


RightBio Metrics

RightBio Metrics is a medical device company that provides technology that is used in medical practices for the accurate placement of nasogastric and orogastric tubes. The company has indicated that its primary goal is to reduce harm caused by misplaced NG/OG tubes through biofluid measurement solutions.[1]

History and Development

RightBio Metrics was founded in 2005 by Paul Gilbert, MD and Robert Gilbert, MD. The company is primarily known for the development of the RightSpotpH® Indicator, which was launched in 2011. The device introduced a new method for verifying nasogastric and orogastric tube placement via pH.[2]

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. The device aims to reduce risks imposed by traditional tube confirmation methods such as auscultation.[3] In a study published by the National Library of Medicine, it was found that "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."[2]

Applications in Medical Practice

Indicated for neonates, pediatrics, and adults, the RightSpotpH® Indicator's use is intended 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.[4][5] Correct placement helps prevent procedural risks resulting from improper tube placement, such as aspiration pneumonia.[6]

Research and Clinical Studies Regarding The RightSpotpH® Indicator & pH Testing

Research published in the National Library of Medicine suggests the effectiveness of the RightSpotpH® Indicator in neonatal settings, describing its potential role in clinical outcomes.[7] 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.[8] An NCBI study on feeding tube placement supports the importance of precise placement techniques, providing support for pH-based verification methods.[9]

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.[10] The NHS has issued guidelines and safety alerts on nasogastric tube placement, stressing the need for verification technologies.[11] Perspectives from the AACN on critical care nursing have addressed the challenges in feeding tube placement.[12]

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.[13] 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[14] and is CLIA-waived[15].

Industry Recognition

RightBio Metrics received the Patient Safety Innovation Award given by the Patient Safety Movement Foundation [16] during the 6th Annual World Patient Safety, Science & Technology Summit held in London, England in 2015. Recognition has been given to RightBio Metrics by the Florida Hospital Tampa Pepin Heart Institute, now known as AdventHealth Tampa, and the University of Florida College of Medicine.[17]

References

  1. ^ "About RightBio Metrics | Accurate NG/OG Tube Placement Confirmation". RightBio Metrics RightSpotpH Indicators. Retrieved 2024-06-18.
  2. ^ a b Lambert, Charles R; Varlotta, David; Posey, Marjorie; Heberlein, Jadie L; Shirley, Janice M (2013-07-17). "Validation of the RightSpot™ device for determination of gastric pH during nasogastric tube placement". International Journal of Emergency Medicine. 6 (1): 28. doi:10.1186/1865-1380-6-28. ISSN 1865-1380. PMC 3726362. PMID 24499632.
  3. ^ "Confirming Feeding Tube Placement: Old Habits Die Hard". PA Patient Safety Authority. Dec 3, 2006.
  4. ^ "U.S., European Regulators OK Devices to Measure Gastric pH Levels". Medical Product Outsourcing. Retrieved 2024-06-21.
  5. ^ "Nasogastric/Orogastric Tube Insertion, Verification, and Removal (Pediatric and Neonatal)" (PDF). Children's Minnesota.
  6. ^ "Misplaced Nasogastric Tube Resulting in Aspiration". 2009-08-01. {{cite journal}}: Cite journal requires |journal= (help)
  7. ^ 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.
  8. ^ Clifford, Patricia; Heimall, Lauren; Brittingham, Lori; Davis, Katherine Finn (2015). "Following the evidence: enteral tube placement and verification in neonates and young children". The Journal of Perinatal & Neonatal Nursing. 29 (2): 149–161, quiz E2. doi:10.1097/JPN.0000000000000104. ISSN 1550-5073. PMID 25919605.
  9. ^ Dias, Flávia de Souza Barbosa; Emidio, Suellen Cristina Dias; Lopes, Maria Helena Baena de Moraes; Shimo, Antonieta Keiko Kakuda; Beck, Ana Raquel Medeiros; Carmona, Elenice Valentim (2017-07-10). "Procedures for measuring and verifying gastric tube placement in newborns: an integrative review". Revista Latino-Americana de Enfermagem. 25: e2908. doi:10.1590/1518-8345.1841.2908. ISSN 0104-1169. PMC 5511002. PMID 28699995.
  10. ^ 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".
  11. ^ 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".
  12. ^ American Association of Critical-Care Nurses (April 2016). "Initial and Ongoing Verification of Feeding Tube Placement in Adults".
  13. ^ Child Health Patient Safety Organization (August 2012). "A Patient Experienced a SERIOUS SAFETY EVENT - Take Action to Reduce Risk of Similar Harm" (PDF).
  14. ^ U.S. Food & Drug Association. "CLIA - Clinical Laboratory Improvement Amendments".
  15. ^ "TESTS GRANTED WAIVED STATUS UNDER CLIA" (PDF). Centers for Disease Control and Prevention.
  16. ^ "RightBio Metrics Wins A First Place Patient Safety Innovation Award for the RightSpot®". BioSpace. Retrieved 2024-06-18.
  17. ^ hheadmin (2015-05-13). "Safety in nasogastric tube placement through POCT". Hospital Healthcare Europe. Retrieved 2024-06-21.
Retrieved from "https://mdwiki.org/wiki/Draft:RightBio_Metrics"