The FDA will enforce stricter guidelines for reusable medical instruments in an attempt to reduce the spread of hospital-acquired infections, the AP reports. Federal health officials hope to prevent more hospital-based outbreaks like those that occurred recently at the Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center in LA.
Although the FDA began working on the new guidelines in 2011, it has accelerated its pace due to the recent outbreaks in these LA hospitals. In both cases, the instrument suspected to have caused the hospital-acquired infections was a contaminated duodenoscope, a device used to diagnose and treat patients with cancer and gallstones. Health officials claim that these duodenoscopes were harboring a highly antibiotic-resistant and potentially deadly strain of bacteria known as Carbapenem-resistant enterobacteriaceae (CRE). These bacteria were able to survive in the contaminated duodenoscopes due to the instrument’s design which makes it difficult to reliably disinfect them. As a result, the FDA is now requesting that manufacturers like Olympus, Pentax Medical, and Fujifilm — all three of which have experienced problems with contaminated medical instruments — provide scientific evidence that their products can be safely disinfected.
The FDA’s announcement comes after much criticism of the agency’s handling of the contaminated duodenoscopes. While many agree that these new and more stringent guidelines are a step in the right direction, there is still much debate about how well the federal government is protecting the health of hospital patients. Hospital-acquired infections like those found at the two LA hospitals are hardly uncommon. According to a 2011 estimate from the federal Centers for Disease Control and Prevention, 1 in 25 hospitalized patients acquire an infection, and roughly 722,000 hospital-acquired infections result in or contribute to 75,000 deaths each year.
Hospital-acquired infections can be caused by numerous factors, including defectively designed medical devices, poor sterilization procedures, and lax hospital policy implementation. If you believe you or a loved one acquired a hospital-related infection during an uncontrolled outbreak, contact the attorneys at Lopez McHugh. You may qualify for compensation through a medical malpractice or product liability lawsuit.