Thursday 2 July 2015

Pharmig and NHS hold joint sporicide disinfection transfer meeting (report)

On 1st July 2015 in Birmingham, Pharmig and the NHS held a joint meeting examining the use of sporicides for aseptic transfer in pharmacy units. The meeting was convened in response to recent MHRA guidance, at the initiative of Rachel Blount. The object of the meeting was to share best practice and to outline a strategy for the implementation of sporicidal disinfectants.

The meeting titled “Sporicides – As Part Of Your Transfer Process”, was chaired by Tim Sizer (Regional Pharmaceutical Quality Assurance Officer South West).

The opening presentation was delivered by Tim Sandle (Pharmig committee member) on the subject of spores. Tim introduced bacterial and fungal spores and explained therisk factors associated with both (bacterial spores having a three layered structure that confers resistance and limits chemical diffusion; and fungal spores, which can secrete enzymes). Tim placed a strong emphasis on the need for a sound biocontamination control strategy to reduce the presence of spores in the first place.

The second presentation was delivered by Tim Sizer. Here some of the recent contamination incidences involving fungal and bacteria spores were outlined. This included the infamous New England Compounding Centre fungal meningitis issue, where a number of failures to adhere to Good Manufacturing Practice led to a mutli-state outbreak of infections. The other topical issue was the contamination of intravenous bags with Bacillus cereus, which led to several deaths of babies in NHS hospitals during 2014.

Mark Oldcorne (All Wales Quality Assurance Specialist Pharmacist) delivered the third presentation of the day. Here Mark focused on an interpretation of the MHRA guidelines and the key requirements of effective use of sporicides in aseptic transfer (including the need to standardise wiping steps).

Rachel Blount (Pharmig committee member) presented the fourth lecture on disinfectant efficacy standards. This included the new standard for pre-saturated disinfectant wipes (ISO 16615). Rachel outlined key aspects such as contact time, challenge populations, clean and dirty conditions (through simulated soiling). Rachel emphasised that the surface test provided more meaningful information than the suspension test.

The fifth presentation was delivered by Tim Sandle. With this Tim outlined many of the sporicidal disinfectants available and narrowed the list down to those that could readily be used in practice. Tim urged delegates to challenge the information provided by manufacturers and that the only ‘true’ test was how a product behaved in practice; here data from environmental monitoring is important.

This was followed by a second presentation from Mark Oldcorne. Mark outlined the important criteria for the selection of a sporicidal product. The important criteria were contact time; residue breakdown products; concerns with corrosiveness; stability; and quality.

The day finished with a best practice session presented by Tim Sizer and Mark Oldcorne, looking a schematics relating to the best practices for implementing a risk-based sporicidal transfer process. The key steps involved were outlined.

The event was supported by Pharmig members who supply disinfectant products and related tests for environmental control. The 130 delegates gave positive feedback, and found the opportunity to discuss matters with experts throughout the day very useful.

The one-day event was both educational and practically based. Importantly, many delegates left with a clearer understanding of what needs to be done for the implementation of a sporicidal product into a pharmacy unit.  Pharmig and the NHS are planning to hold a second event in the near future.

Posted by Tim Sandle

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