April 04, 2023
The manufacturer of the eye drops linked to a recent outbreak of bacterial infections has been cited by the U.S. Food and Drug Administration for failing to follow proper protocols to prevent contamination.
FDA investigators discovered dirty equipment and dozens of other sanitation concerns at a Global Pharma Healthcare facility in India during an inspection from Feb. 20 to March 2, a few weeks after the company issued a recall of its EzriCare Artificial Tears.
The recall initially only involved EzriCare Artificial Tears, but was later expanded to include another eye product manufactured by Global Pharma, Delsam Pharma's Artificial Eye Ointment.
The bacteria responsible for the infections, Pseudomonas aeruginosa, is resistant to most antibiotics. As of March 21, the latest update, the outbreak had caused 68 infections in health care and long-term care facilities in 16 states, including Pennsylvania and New Jersey. Three people had died and eight had experienced vision loss. Four of them had to have an eye surgically removed.
Inspectors found that the manufacturing process – particularly for eye drop batches made between December 2020 and April 2022 – "lacked assurance of product sterility," according to the FDA report.
Citations were given for poor cleaning procedures and discrepancies in the facility's records detailing when equipment was sterilized. Inspectors also found gaps in written procedures and training for employees, according to CBS News. Important checks to ensure that products had been sterilized were not always being performed.
People infected with Pseudomonas aeruginosa don't always have symptoms, which makes stopping its spread more challenging, the U.S. Centers for Disease Control and Prevention says. In the current outbreak, health officials identified several people who carried the bacteria without showing any signs of infection. They were discovered through screenings at inpatient health care facilities where infections had been reported.
"The bacteria can spread when one patient carrying the bacteria exposes another patient, or when patients touch common items or when healthcare workers transmit the germs which is why infection control, like hand hygiene, is so important," the CDC told CNN.
The particular strain of the bacteria involved in the outbreak previously has not been seen in the U.S. Though the people involved in the outbreak reported using different brands of eyedrops, most reported using preservative-free EzriCare Artificial Tears prior to the start of their illnesses. Health officials at the FDA and CDC are continuing to monitor the outbreak.
People are urged to stop using the recalled eye drops immediately and get evaluated by a health care provider if they start to feel ill. Signs of an eye infection include pain, swelling, discharge, redness, blurry vision, sensitivity to light and the sensation of a foreign object stuck in the eye. The bacteria also can cause respiratory and urinary tract infections. It can be fatal if it enters the bloodstream.