Sarah Hiom, Pamela Ashman, John Rhodes, Alison Jones, Andrew Sully, Mark Temple (CAVUHB) and Ian Samuel (Merck Millipore)
Cardiff and Vale University Health Board and industry partner, Merck Millipore
This Bevan Exemplar project facilitated the introduction of rapid micro-technologies to improve the manufactured IV feeds. quality and safety of NHS manufactured IV feeds.
Background
Intravenous (IV) products are high risk, particularly IV feeds which are susceptible to contamination during the manufacturing process. This is evidenced by numerous global incidents of administered contaminated products including one in London in 2014 resulting in three neonatal fatalities.
Microbial quality assurance of these products currently relies on traditional microbiological tests [End-of-session media fills] which require growth until the organisms is visible, giving results after 7-14 days. IV feeds, however, are often administered to patients within 24-48 hours of manufacture.
Aims
We proposed to introduce near “real-time” rapid micro technologies to be used instead of the retrospective media fills, therefore aiming to provide microbial quality assurance (QA) data before the product is administered to the patient These rapid technologies are not based on traditional microbiology but on novel rapid detection methods such as fluorescent staining. Being able to provide prospective microbial QA data will improve the quality and safety of NHS prepared IV feeds.
Challenges
Traditional microbiological methods have been in use for over 100 years and are still advocated by UK Pharmaceutical Regulators [MHRA]. Although the food and beverage industry have largely accepted rapid micro methods in QA activities there are only a few Pharmaceutical Industries (and no NHS pharmacy manufacturing units) who have gained regulatory approval to do so, as yet. Regulatory approval for new methods require statistically robust non-inferiority equivalence studies which are complex, time consuming and costly and therefore unachievable for the majority of NHS manufacturing units. This precedence setting piece of work will establish “proof of concept” and “spread” of these novel rapid microbial technologies.
Outcomes
This Bevan Commission programme has facilitated the coming together of an effective team who have met the challenges of understanding the evidence required, articulating an action plan, facilitating specific engagement with the MHRA and finally performing these data collection activities.
Next steps
Continue gathering the planned evidence and engage with MHRA on approval of these novel rapid “real-time” microbial tests.
“My experience as a Bevan Health-Technology Exemplar has been superb. I believe passionately in the aims of this project and after some years of hitting brick walls, the Bevan Commission has empowered me to make it happen.”
Sarah Hiom
