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AAEP white paper offers guidance on approval process for medical devices
While this document does not address equipment such as syringes, needles and radiographic units, it does focus on devices marketed in the liquid form, for use exclusively within veterinary medicine.
The American Association of Equine Practitioners (AAEP) released a white paper developed by the Biological and Therapeutic Agents Committee to offer equine practitioners guidance regarding medical devices.
While the document does not address equipment such as syringes, needles and radiographic units, it does focus on devices marketed in the liquid form, for use exclusively within veterinary medicine. Why?
AAEP explains, "Understanding the appropriate use of medical devices is important for the treatment of horses in veterinary practices. This paper defines what constitutes a medical device and the associated approval/registration requirements and the use of these products by practitioners in relation to the product label."
Device advice: AAEP's white paper clarifies many aspects of medical devices in horses, which aren't as regulated as those in people.
This article explores some of the details that are documented within this white paper.
What is a medical device?
Although medical devices are commonly used in both human and veterinary medical practice, there is a distinction for those devices used exclusively within the field of veterinary medicine. That distinction relates to the regulatory oversight of these products.
Differences between human and veterinary medical devices:
- Device manufacturers who make or distribute devices used exclusively within veterinary medicine are not required to register their establishments or list their devices with the Food and Drug Administration (FDA)-Center for Veterinary Medicine (CVM). (Such registration is required for human devices.)
- There are no premarket notification requirements. (This notification is required for specific classifications of human devices.)
- There are no premarket approval requirements. (This approval is required for specific classifications of human devices.)
- There are no mandatory adverse event reporting requirements. (Adverse event reporting is required for human devices.)
- There are no registered or approved veterinary medical devices.
A medical device is defined by the FDA in the Food Drug and Cosmetic Act, Section 210 (h) "as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part or accessory, which is intended for use in the diagnosis, treatment or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or animals and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and it is not dependent upon being metabolized for the achievement of any of its principal intended purposes."
The most important aspect of understanding medical devices for equine practitioners is "an awareness on their part as to what they are using—is it a pharmaceutical or is it a medical device?" says Kenton Morgan, DVM, Dipl. ACT, chair of the AAEP's Biological and Therapeutic Agents Committee.
"First and foremost, whatever we do should be in the best interest and care of the horse. We want to use products that are formulated and developed for the indication of the equine patient. If we're not, we need to be aware of that and understand that we may be taking on some increased liability when we use these products in ways that are not consistent with what they were designed to be used for. And this is especially true if the product is not efficacious or if an unexpected outcome should occur. The primary concern is when we take a medical device and use it as a pharmaceutical."
Medical devices are designed for a specific use. These products may be useful tools to the equine practitioner for those intended purposes. Examples of specific medical device products include a number of hyaluronic acid-containing products and some combination products that have hyaluronic acid, glucosamine and chondroitin sulfate.
They are sold either as topical wound therapies or joint fluid lavage or replacement-type products.
"Concern arises because it is not uncommon for some of these types of medical device products to be used as pharmaceuticals," says Morgan. "They may have some benefits or they may not. We don't know, because most of them have not been evaluated in that way. The other issue is how they have been manufactured—in an environment that has paid attention to quality control or not. Those are significant issues."
Equine practitioners must understand what they are using and whether or not it has gone through FDA's review, Morgan says. "The labeling looks good, the verbiage may sound similar to that found with a pharmaceutical. Most veterinarians are not aware that there should be an NADA (New Animal Drug Application) or ANADA (Abbreviated New Animal Drug Application) number on the label." Those numbers would indicate that the product is an FDA-approved pioneer drug or an FDA-approved generic drug.
"It is our responsibility as practitioners to know exactly what we are using in our patients," Morgan says.
Safety and efficacy concerns
There is no true category for a veterinary medical device, per se, just medical devices. The general category of medical devices is regulated by the FDA's Center for Devices and Radiological Health (CDRH). There are well-defined processes or requirements to determine the safety, efficacy and registration of these products. However, the safety and efficacy of devices used exclusively within veterinary medicine is a gray area that the FDA-CVM does not currently have a formal review process for.
It all boils down to what is best for the horse. "If some of these devices, which are used as pharmaceuticals, are good and useful, let's get them approved by the FDA-CVM," Morgan says. "With approval comes the assurance that the drugs have been properly evaluated for safety and efficacy and that they are manufactured using very strict quality-control measures."
Will medical devices intended as pharmaceuticals be better-regulated in the future?
"We don't know what the future regulations will be," Morgan says.
"But just within the last 60 days, the FDA-CVM has requested public comment on how to address the prevalence of unapproved animal drug products here in the United States. Although this issue (unapproved animal drugs) is much bigger than just veterinary medical devices, it does apply to devices when they are used as pharmaceuticals. So I think this is very encouraging."
To review the white paper, go to aaep.org.
Kane is a researcher and consultant in animal nutrition. He is an author and educator on nutrition, physiology and veterinary medicine with a background in horses, pets and livestock. He is based in Seattle.