The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a medical device alert over the test disc for the antibiotic ‘Ceftazidime’, warning that storing the test discs at the wrong temperature can increase the chances of false resistance results.
The antibiotic is used to treat all sorts of bacterial infections including joint infections, sepsis, pneumonia, urinary tract infections and more. In cases where the Ceftazidime test disc was not frozen between the temperatures of +2o and -20o, notably at +8o, the antibiotic’s shelf-life may have been degraded.
The antimicrobial susceptibility disc uses a ‘disc diffusion method’ to check for microorganism sensitivity to Ceftazidime; i.e. check that the antibiotic works correctly. If the disc has degraded because of incorrect storage, it can give a false resistance result.
Manufacturer ThermoFisher Scientific has issued a Field Safety Notice for the warning and provides the following instructions:
- Check Ceftazidime stocks and how long old they are
- If the product has been stored for less than 24 months then its performance is unaffected, regardless of the storage temperature
- If the product has been stated between -20o and +2o then the product is unaffected for its entire shelf life of 36 months
- If the product has been stored at over +2o for over 24 months then the affected lots need to be destroyed
- Once the affected lots have been destroyed, relevant staff members will need to contact the manufacturer or their distributor for a replacement
If stocks are not affected but concerns remain, repeat testing should be carried out; including alternative methods of checking for Ceftazidime susceptibility.
Manufacturers of medical drugs and medical devices must ensure they do all that they can to provide doctors with the equipment and medicine they need so that they can treat patients safely and effectively. When things go wrong or not as expected, they need to take measures to correct the issues or provide comprehensive instructions and advice on how to deal with the issues, or sort alternates.
Hospitals and healthcare clinics with the microbial discs in stock are therefore being sent a copy of the field safety notice.
At a time where experts are warning that the use of antibiotics needs to be reduced to prevent over-reliance and prevent diseases building resistances to weaker medicines, this recall is a serious one.
First published by Admin on January 31, 2018
Posted in the following categories: Medical and tagged with antibiotics | mhra