U.S., European Regulators OK Devices to Measure Gastric pH Levels

RightBio Metrics has scored a double victory. The Scottsdale, Ariz., company received both U.S. Food and Drug Administration (FDA) and CE Mark approvals, and is launching three new products for safe placement of nasogastric tubes and measurement of gastric pH levels. The products include the RightSpot pH Indicator, RightSpot Infant pH Indicator, and RightLevel pH Detector, all three of which are designed to increase safety and improve reading accuracy in a cleaner fashion.

The RightSpot pH and RightSpot Infant pH Indicators are non-invasive devices for verifying gastric acidity in order to avoid improper positioning of nasogastric and percutaneous endoscopic gastrostomy tubes. The RightLevel pH Detector is indicated for measuring pH levels in the stomachs of critically ill patients.

The technologies accurately measure bio fluids at the bedside to enhance the speed and quality of medical treatment. They are safer, cleaner and more accurate than pH paper test strips used today, giving clinicians additional confidence in nasogastric intubation (NG) tube placement, and treatment decisions, without incurring substantial costs to verify placement using X-rays or fumbling with messy manual paper tests, the company noted in a news release.

The third device, the RightLevel pH Detector, quickly measures stomach pH levels of critically ill patients to aid in proper medication dosage for treating gastric ulcers and bleeding. All three products have received CLIA Waived status, which means the FDA has classified them as simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, which makes it easier for hospitals to perform onsite and maintain per competency assessment program regulations.

“As an emergency room physician, I experienced firsthand the devastating effects of improper NG tube placement and uncertainty about treatment-critical metrics due to antiquated technology. Seeing patients put at unnecessary risk ignited my passion to make much needed fluid measurement technology improvements,” said Paul Gilbert, M.D., co-founder and president of RightBio Metrics.

Roughly 12.6 million NG tubes were placed in 2012 in the U.S. alone and studies show between two and four percent were misplaced. Misplaced tubes are typically misguided into the lungs causing significant morbidity and mortality and costing medical providers millions of dollars, RightBio bigwigs contend. In fact, from 2001 to 2011, medical providers in the Chicago, Ill., area paid more than $10 million to resolve lawsuits filed for injuries and deaths caused by misplaced NG feeding and suction tubes.

“Care providers are continuously looking for solutions that combine quality improvement with financial responsibility. RightpH devices help clinicians put science into decision-making and increase certainty about tube placement and treatment decisions without losing critical time,” Gilbert said. “RightpH indicators also help hospitals save important resources by lowering the risk of readmission and malpractice claims, which position themselves as leaders in patient safety and clinician practice conditions. In medicine, quick decisions have to be made in treatment environments that often do not permit the use of expensive equipment. While pH measurement has become standard practice to ensure better treatment, RightpH offers a technology for easy pH measurement.”