Recalls, FDA, and the Realities of Ongoing Hospital Activities

Abstract

Device recall notices are a challenge for hospitals. They have to be recognized for what they are when received, and then they must be routed and appropriately acted on—if the hospital actually has the item recalled. And this must be done in the context of the ongoing and busy hospital environment. Similar issues can arise with FDA Public Health Notifications and other safety advisories, including those not related to devices. Removing the device from service is not always an appropriate or even a possible response. Many recalls and FDA notices expressly allow for continued use (see Table 1 for examples), and/or provide information on steps that should be taken to mitigate the problem while continuing to use the device. Other recalls are for disposables that can be relatively easily replaced, such as a recent FDA recall for a single use, disposable catheter. The impact in this type of recall can be minimal, if alternative products are available or replacements easily obtained. More challenging is a recall or alert from FDA or other party that says that a device must be taken out of service immediately (see Table 2). On the surface the “discontinue use” scenario sounds simple enough. Confirm if the institution has the device, find it (or them, if there are multiple devices), and stop using it. From the manufacturer’s perspective, and from FDA’s, the issue of the use of the device is now resolved, i.e., use has been stopped. The manufacturer at this point can argue that it has ended any further risk associated with the allegedly faulty device, since hospitals have been directed to stop using it. If a hospital chooses to continue using the device, the associated risk is substantially borne by the user facility. Similarly, FDA can assert that it has fulfilled its responsibility to protect the public from faulty medical devices by directing that use be stopped, even if there is not a suitable answer to the “now what?” question.