News
Vernacare takes preemptive measures to assist Pseudomonas investigation
As part of an ongoing investigation due to an outbreak of Pseudomonas Aeruginosa in several hospitals across Norway, Vernacare are working closely with the Norwegian officials and infection control authorities.
On Friday 18th March, Vernacare were alerted that one of its products – Oasis Bedbath unperfumed 5 pack, product code BB05UP – was potentially linked to an outbreak of Pseudomonas Aeruginosa in several hospitals across the country by our distributor, Kvinto.
Since this time, Vernacare have been working closely in full cooperation and collaboration with the Food Safety Agency and Norwegian Institution for Public Health (FHI) and Dr Egil Linglaas from Oslo University Hospital, to provide any documentation required to support in the investigation.
Key representatives at Vernacare are in direct communication with Dr. Egil Lingaas to support the mapping of all potential risk factors, including any potential for contamination from the Oasis Waterless Bathing Products supplied into Norway during the outbreak.
Based on the information shared by Dr. Egil Lingaas, to date, the alleged contamination is associated with one production LOT of product code BB05UP– LOT no 107537 (produced in September 2021).
It is understood that seven separate LOTs of the Oasis Bedbath BB05UP have been tested by Oslo University Hospital. Pseudomonas Aeruginosa was confirmed to be absent from 6 of these LOTs.
We are able to confirm that this batch (1494 cases) was sent in full to Kvinto, Vernacare’s appointed distributor of this product to public hospitals in Norway – LOT no 107537 was not distributed to any other market or customer.
Vernacare are working with Kvinto to trace the journey of this batch to establish which hospitals each case of product was sent to. A hold on the use of this LOT and, as a precaution, other Oasis products has been put in place in Norway until such time as investigations are satisfactorily concluded.
The Oasis range is produced in a facility accredited to ISO 22716: 2007 (Good Manufacturing Practice) and the range of products is notified to the Cosmetic Products Notification Portal (CPNP) under Regulation (EC) No 1223/2009 on cosmetic products. Under this regulation, all products produced are tested in accordance to ISO 17516 (Cosmetics – Microbiology – Microbial Limits). Only if products meet the criteria detailed in this standard will they be released for sale, at which time a Certificate of Analysis is generated.
Business Unit Director Rachel Downham said, "Investigations are still very much ongoing with no final conclusions drawn at this stage. Vernacare will continue to work closely with the authorities until the root cause is identified."
Vernacare will be conducting further testing on retained samples from the LOT detailed above and subsequent LOTs produced at its facility in Lancashire, England as well as coordinating further testing in conjunction with the Norwegian authorities.