The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert over VITEK ® 2 AST Test Cards after the discovery that when the cards are exposed to moisture, it can stop antibiotics from working.
Manufacturer BioMérieux published a Field Safety Notice to inform consumers of the issue at hand, and confirm the potential problems. The Notice explains that a defective test card may:
- Yield false resistance for antibiotics on the AST panel
- Cause a false negative ESBL test
- Result in a false positive urea reaction on ID cards
About the cards
The test cards are used for antimicrobial susceptibility testing to check bacteria and yeasts for susceptibility and resistance to antibiotics. Produced in a small pouch, the test cards are a fast and disposable detection method to help researchers and doctors find the right diagnosis, and therefore administer correct and effective treatment.
About the issue
The French biotechnology company who specialise in providing medical devices to identify disease and contamination looked into the issue and found that the incorrect stitch seal design combined with product shipping and handling may be the cause of the problem. Pictures of the defective pouch in which the test cards are held in show a small puncture or tear that looks like a small clamp has been pressed into it.
BioMérieux have since replaced the stitch seal wheels used in the manufacturing process, but continue to send out Field Safety Notices to consumers and call for directors of pathology, laboratory managers, and biomedical scientists in microbiology to follow the proposed action listed in the Medical Device Alert:
| All relevant staff to acknowledge receipt of the field safety notice after reading through it. |
| Do not use any pouches that are obviously defective through visual inspection. These are to be disposed of and relevant staff are requested to contact the manufacturer for replacements. |
| Anyone who uses a non-visually defective test card is encouraged to be vigilant in obtaining test results and repeat testing if results are inconsistent with expectations and other results. |
| If results continue to cause concern, use alternative methods or devices to test susceptibility and resistance. |
Worryingly, it’s believed the test cards have been distributed to U.S Military and government sites as well as over 100 locations across the globe.
First published by Admin on October 20, 2017
Posted in the following categories: Medical and tagged with mhra