Baxter-Syndeo

Medical Devices Today has a good post on potential safety and effectiveness issues surrounding medical devices where home use by patients is outside the scope if intended use. “Although manufacturers need FDA approval to market a device
over-the-counter directly to a patient or specifically for home use,
there are few restrictions on whether a physician can send a patient
home with a device that is not specifically labeled for use in the home.”

One of the biggest issues revolves around older devices that have been replaced and become hand-me-downs for home health. Concerns include:

  • Neither devices or directions for use not designed for patient use
  • Hand-me-down devices frequently missing directions for use
  • Patient purchased devices, e.g., after the reimbursed rental period, end up getting “recycled” through eBay – with no safeguards for proper maintenance, operation or directions for use
  • Proper distribution channel safeguards to ensure safety and effectiveness when sold retail or through other resellers

Besides contemplating new regulations or legislation, the FDA is making the following responses:

Meanwhile, in the next six months FDA hopes to invite manufacturers
to participate in its new online labeling repository for home-use
devices. The voluntary repository, which will initially focus on
infusion pumps, will give consumers access to the most up-to-date
instructions for specific models.

The agency is also preparing to launch a sub-network of its MedSun
adverse event reporting program called HomeNet. Participating home
health agencies will be encouraged to report to FDA adverse events,
including close-calls, related to devices used in the home setting.

Be sure to read the whole thing. Pictured right is a Baxter Syndeo pump – perhaps something that might be used in the home?