Blog Articles

The healthcare industry has long overlooked cybersecurity in medical devices, but recent legislative and regulatory changes are starting to address these concerns. With cyberattacks becoming more sophisticated and posing serious threats to patient safety and hospital operations, the FDA has introduced stricter requirements for device manufacturers. In 2023, new FDA regulations and guidance were implemented to enhance oversight of cybersecurity risks in medical devices.

The letter outlines concerns regarding the marketing of convenience kits containing piston syringes without proper FDA approval. These devices are deemed adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act. Furthermore, the FDA highlighted quality system regulation violations, particularly in the establishment of procedures to ensure product conformity and manufacturing controls. Cardinal Health’s failure to adequately address these violations may result in regulatory action, including seizure and injunction.

Smith’s Medical is recalling over 2,900 emergency ventilators in the U.S. due to a fault linked to eight serious injuries, announced the Food and Drug Administration. This fault can lead to patients receiving incorrect ventilation levels or insufficient oxygen, and even partial or complete airway blockages.

The FDA has issued a recall for two heart pumps, the HeartMate II and HeartMate 3, due to their association with hundreds of injuries and at least 14 deaths. Manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories, these devices are used in patients with end-stage heart failure either as a bridge to transplantation or as a permanent solution.

At least nine people have been hospitalized in nine states after receiving injections of counterfeit or mishandled botulinum toxin primarily for cosmetic purposes. All affected individuals were women aged 25 to 59 and received injections in non-healthcare settings or from unlicensed individuals. Symptoms reported include vision changes, drooping eyelids, difficulty swallowing, dry mouth, slurred speech, difficulty breathing, fatigue, and weakness, similar to botulism.

The New England Journal of Medicine (NEJM) has announced changes to its embargoed access policy, limiting advanced access to certain news organizations. Publications targeting physicians will no longer qualify for embargoed access, according to Dawn Peters, director of strategic communications & media relations at NEJM Group. This decision comes amid shifts in medical publishing and the growth of NEJM Group’s journal portfolio.

The FDA has issued a warning to consumers against using certain topical pain relief products marketed for use before, during, or after cosmetic procedures due to potential health risks. These products contain high concentrations of lidocaine, which can lead to serious side effects including irregular heartbeat, seizures, and breathing difficulties. Despite previous warnings, these products are still available online and in stores.

Vyaire Medical, Inc. has issued a Class I recall, the most severe type, for several models of AirLife Manual Resuscitators due to a critical manufacturing flaw. The recall affects devices manufactured before 2017 or those lacking a clear production date, with over 6.6 million units recalled in the U.S. alone. These manual resuscitators, crucial for respiratory support in emergency situations, may fail to provide adequate ventilation due to the defect.

The FDA has recently authorized a new antibody drug, Pemgarda, developed by biotech company Invivyd, to protect immunocompromised individuals from Covid-19. This approval comes after the withdrawal of AstraZeneca’s Evusheld due to its ineffectiveness against Omicron variants. Immunocompromised individuals, such as certain cancer patients, organ transplant recipients, and those with autoimmune disorders, often have weakened immune systems and may not receive sufficient protection from vaccines alone.

This decision, only the second of its kind, comes after determining that these devices pose an unreasonable risk of harm. ESDs deliver electrical shocks to individuals through attached electrodes, attempting to mitigate harmful behaviors. However, these devices have been found to present various psychological and physical risks, particularly for those with intellectual or developmental disabilities.