Contaminated Hydrogels Danger To Humans

When water comprises ~80% of a hydrogel’s weight, any water-borne contamination can have disastrous consequences.

In late 2020, a topical cream product underwent voluntary nationwide recall due to suspected contamination by bacteria. Regenecare HA Hydrogel is a gel suspension for soothing skin irritations. However, a few consumers reported visible discolorations in the product. Later, it was discovered after testing to be contaminated with the bacteria Burkholderia cepecia (BC). No adverse health effects were reported during the recall period.

However, BC is potent against the immunocompromised patients. Four years before, severe BC infections happened in children who were on mechanical ventilators. The manufacturer responsible faced criminal charges.

BC is a bacteria group comprising 20 bacterial strands that thrive in water environments. It is most often propagated in factories that have poor water quality control, leading to contaminated aqueous content in the final hydrogel products.

In response, the FDA issued several guidelines for manufacturers of non-sterile hydrogel products. The USP also created a compendial test for BC.

While there have been few serious cases among the healthy users, friends of immunocompromised patients should crosscheck the FDA announcement to stay updated with any product recalls. We hope that the industry can upkeep the required water quality control standards and continue to provide the community with innovative hydrogel products.