FDA Testifies to Six Deaths and 44 Injuries Related to Health IT

Jeffrey Shuren, FDA: "...To date, FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices. Nevertheless, certain HIT vendors have voluntarily registered and listed their software devices with the FDA, and some have provided submissions for premarket review. Additionally, patients, clinicians, and user facilities have voluntarily reported HIT-related adverse events. In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm —including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist...."

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