MDR Equivalence Rules Reinforce Deltex’s Unique Evidence Base
Deltex Medical’s Oesophageal Doppler Monitoring system (ODM+) stands out from the crowd in important ways that are highly relevant when it comes to MDR assessment. Not least in the way it derives information about a patient’s haemodynamic status. ODM+ is the only system to use ultrasound to monitor blood flow velocity directly from the descending aorta. Alternative systems that deliver data using other modalities, such as blood pressure, are fundamentally different. Yet Deltex’s competitors have historically, repeatedly (and incorrectly) referenced Deltex clinical data to support their claims.
New Medical Device Regulations (MDR) clearly state that for a company to base its regulatory submission on a claim of equivalence to another product, the device “must be of similar design; is used under similar conditions of use; has similar specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment methods, where relevant; has similar principles of operation and critical performance requirements’.
Oesophageal Doppler Monitoring is supported by a hard-earned body of clinical studies. Deltex can point to over twenty Randomised Controlled Trials including the landmark FEDORA study.
Deltex Medical CEO Andy Mears states: “This has been a constant source of frustration. Some of our competitors have for years chosen to piggyback on Deltex’s clinical evidence base. The unfairness and implied deceit of so-doing is wrong on many levels. Indeed if the practice were to continue its existence would undermine the intention of the new MDR regulations. Leaving commercial considerations aside, the clinical implication is more serious for healthcare professionals and their patients. We sincerely hope that strict enforcement of the new MDR rules will put an end to the practice. Plagiarising or passing off data as being applicable when it clearly is not is clearly not allowed under the welcome new regulations.”
