FDA issues Safety Communication on cybersecurity vulnerabilities in Medtronic cardiac devices
Editor's Note The Food & Drug Administration on March 21 issued a Safety Communication on cybersecurity vulnerabilities identified in wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors. Medtronic (Dublin, Ireland) is working on updates to address the vulnerabilities and recommends that healthcare…
Disruptive innovation in supply chain: Impact of Amazon Business and technology, Part 2
Supply chain is ripe for innovation, as Amazon Business and technology manufacturers have discovered. In part 1 of this two-part series, we focused on the company’s role in the supply chain (OR Manager, February 2019, 1, 9-12). In part 2, we look at technology-related trends and innovations that can improve…
Disruptive innovation in supply chain: Impact of Amazon Business and technology, Part 1
Supply chain is the lifeblood of the OR, so any disruption in the flow of that lifeblood can lead to outcomes ranging from dissatisfaction with backorders to chaos if a new implant doesn’t arrive on time. But disruption also can be a positive force, especially if it supports flow. When…
Top 10 health technology hazards for 2019 named
The devices and systems we use when diagnosing and treating patients are invaluable to patient care—but they are not perfect. Patients and staff can be harmed if design flaws or system faults aren’t identified and rectified, equipment isn’t adequately maintained or prepared for use, or proper procedures aren’t followed. Preventing…
HHS opens Health Sector Cybersecurity Coordination Center
Editor's Note The Department of Health and Human Services (HHS) on October 29 opened the Health Sector Cybersecurity Coordination Center (HC3) at its headquarters in Washington DC. HC3 will play a vital role in early detection of cybersecurity attacks and coordination of information between the healthcare sector and the Department…
FDA announces public workshop on management of cybersecurity in medical devices
Editor's Note The Food & Drug Administration (FDA) on October 17 announced a public workshop to discuss the newly released draft guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The need for effective cybersecurity to ensure medical device function and safety has become more important with…
FDA, DHS increase coordination for medical device cybersecurity
Editor's Note The Food and Drug Administration (FDA) on October 16 announced that as part of the Administration’s efforts to strengthen cybersecurity in healthcare, the FDA and Department of Homeland Security (DHS) have agreed to greater coordination and cooperation for addressing cybersecurity in medical devices. Under the agreement, DHS will…
FDA announces framework for strengthening medical device cybersecurity
Editor's Note The Food & Drug Administration (FDA) on October 1 released a “Playbook,” developed by the Medical Device Cybersecurity Regional Incident Preparedness and Response (MITRE) Corp, to assist hospitals and other healthcare providers respond to cybersecurity incidents involving medical devices, the American Hospital Association reports. The MITRE Playbook outlines…
ECRI Institute releases 2019 Top 10 Health Technology Hazards
Editor's Note The ECRI Institute on October 1 released its 2019 Top 10 Health Technology Hazards. Among the hazards: First is cybersecurity attacks Second is blood and body fluids on mattresses after cleaning Third is retained sponges Fifth is mishandling flexible endoscopes after disinfection Ninth is cleaning fluid seeping into…
FDA takes steps to address cybersecurity concerns of medical devices
Editor's Note The Food and Drug Administration (FDA) has taken steps to ensure that medical device manufacturers do as much as possible to defend against hacking and other threats to their devices, according to a new report from the Department of Health & Human Services Office of Inspector General. The…