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Why Stricter Standards Are Needed for Medical Devices

Written by Ankin Law Office

Medical devices service an integral role in the health and well-being of many individuals. Unfortunately, like all products, medical devices are subject to manufacturing defects and/or design flaws, resulting in more harm than good for the patient. For instance, Medtronic Inc.’s SynchroMed infusion pumps were recently found to have four flaws that resulted in the deaths of 14 patients, prompting U.S. regulators to issue their most serious recall on the implantable device. According to Bloomberg, 11 patients died as a result the inadvertent injection of a drug into the patient’s subcutaneous tissue, rather than into the pump; two patients died from a blockage; and another from an electrical short.

Like all manufacturers, medical device manufacturers have an obligation to provide consumers with safe and effective products. If a medical device is found to be dangerous or defective, the manufacturer may be liable for any resulting injuries. Moreover, medical device manufacturers are subject to a number of laws and regulations designed to ensure product safety. As technology changes and information grows, the laws and regulations regarding medical device safety need to be reevaluated.

For instance, the Food and Drug Administration (FDA) has recently tightened safety standards for a wide range of medical devices, including fetal monitors and pacemakers, due to increasing concerns that certain medical devices are susceptible to cybersecurity breaches that could harm patients.

FDA officials say that computer viruses and other malware are infecting equipment, such as hospital computers used to view X-rays and CT scans and devices in cardiac catheterization labs, more frequently. These security breaches cause the equipment to slow down or turn off completely, which can put a patient’s health at risk.

In an effort to reduce these risks, the FDA now requires medical device manufacturers to explicitly state how they will address cybersecurity, and the FDA is authorized to block approval of medical devices if manufacturers fail to provide adequate cybersecurity plans.

Although there have been no known cases in which a patient has been injured because of a medical device compromised by a computer virus, government officials and patient safety advocates say that hospitals and device manufacturers need to use multiple defenses to protect against cybersecurity threats.

The Chicago defective medical device law firm of Ankin Law Offices, LLC is committed to protecting the victims of substandard medical care and unsafe medical devices. If you have suffered injuries as a result of a medical device, such as a hip implant, transvaginal mesh implant, injection pump, or a pacemaker, do not hesitate to contact the skilled Chicago product liability attorneys at Ankin Law Offices at (312) 600-0000 to schedule a free consultation to discuss a possible medical malpractice or product liability claim.

Categories: Medical Devices