Veterinary Medical Devices

The key difference between an animal drug and an animal device is how the product works. If it relies on a chemical action occurring in or on the animal’s body to achieve its primary intended effects, the product is a drug, not a device. If it needs to be broken down (metabolized) by the animal’s body to work, the product is a drug, not a device. Antibiotics, anesthetics, and insulin are examples of drugs. Needles, syringes, surgical instruments, X-ray equipment, certain diagnostic test kits, and dental appliances are examples of devices.

The Center for Veterinary Medicine is sharing the following announcements from the FDA’s Center for Devices and Radiological Health about human medical device recalls that may potentially present significant risks to consumers or users of the product. CVM is sharing these recall announcements because these devices may be used in veterinary settings.

Description

Veterinary Medical Devices (VMDs) regulations in the European Union (EU) in the Member States and Economic European Space (EES) including Norway, Iceland and Liechtenstein currently are not harmonized. Most of these countries do not have any regulation, while some Member States have strict regulations that proceeded the accession to the EU. VMDs are being adopted more frequently, which is driven by the same factors influencing the adoption of technologically advanced Medical Devices (MD) in human medicine.

Geriatric companion animals suffering from chronic disease requiring continued therapy and the need to decrease antibiotic use have contributed to the need and development of new and innovative medical devices. These new veterinary borderline products are derived in part from MD for human medicine and are completely new with particular reference to In Vitro Diagnostic (IVD) tests and VMDs incorporating an ancillary medicinal substance.

Features of Veterinary Medical Devices

An animal device that is also a radiation emitting electronic product, such as an MRI device intended for animal use, must comply with all requirements for animal devices in addition to applicable requirements for radiation-emitting electronic products in 21 CFR 1000 – 1050. FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating radiation-emitting electronic products

Functions

Standard parameters: ECG, RESP, SpO2, PR, NIBP, dual-channel TEMP
1)ECG   Heart rate (HR)
      ECG waveform
      Arrhythmia and ST-segment analysis
2)RESP   Respiration rate(RR)
      Respiration waveform
3)SpO2   Oxygen saturation(SpO2)
      Plethysmogram(PLETH) waveform
      Pulse rate(PR)
      Bar graph
4)NIBP   Systolic pressure(SYS), Diastolic pressure(DIA), Mean pressure(MEAN)
5)TEMP   T1, T2, TD
It has abundant functions, such as audible and visual alarm, trend data storage and output, NIBP measurement, alarm event marking and drug concentration calculation, etc

Prices of Veterinary Medical Devices

$280.00-$1,500.00/ Unit

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