In part one, we explored the transformative impact of wearable technology. Healthcare workers can monitor their patients much more closely outside office visits and provide the option of home-use equipment.
But what happens when these same devices are subjected to a recall? How are patients receiving and understanding the safety notices that warn them of problems with the medical devices they are using?
The FDA guidance, 21 CFR Part 7 Subpart C, outlines that manufacturers clearly “define the level in the distribution chain to which a recall is extended” and provide instructions to the affected accounts (e.g. hospitals or distributors), so they can inform their impacted network. This downstream communication channel is not robust enough to ensure that patients affected by a recall are informed. Healthcare providers may not reach all their patient contacts, and device manufacturers have a reduced communication method to inform specific users due to HIPPA policies. Despite recommending having a “recall ready” communication plan, a public warning is usually reserved for urgent situations, as the recall strategy written by the manufacturer and reviewed by the FDA, will specify when a public warning is needed.
The ECRI listed “Gaps in Recalls for At-Home Medical Devices” as the top challenge for industry manufacturers to mitigate or eliminate. What areas of improvements do you suggest that could mitigate the confusion revolving around home-used medical device recalls, establishing an appropriate communication channel down to the patient level? Watch the Webcast below to hear professionals' thoughts on home-use equipment recalls.
More FDA Information: https://www.fda.gov/medical-devices/home-health-and-consumer-devices/home-use-devices