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?
There are many challenges that face the FDA when it comes to the monitoring of medical devices used at the home. You did a antastic job of mentioning just a few of them here!