Ben Pardoe Heater Cooler Units (HCU) – Where are we now? Presentation of the results of a national survey Ben Pardoe

Aims History FSA & revised IFU RBH strategy Presentation of survey results Latest considerations Are we better off now?

History 14th July 2014 SwissMedic Press Release Public Health Switzerland reported about patients with Mycobacterium Chimaera who had previously undergone open-chest heart surgery with exposure to contaminated heater cooler units (HCUs)

History 3rd June 2015 Sorin release FSA to heads of units LivaNova (Sorin) released a field safety notice advising voluntary corrective action for their 1T and 3T HCUs

History 9th June 2015 PHE release advice 12 Page document :- FAQ Background Risk assessment PHE released a report to raise awareness of mycobactrerial infections.

History 9th June 2015 PHE release sampling protocol 10 Page document :- Air Sampling Water Sampling (Updated 22nd July 2016 And released recommendations for sampling.

History 11th June 2015 NHS England Letter to Chief Executives and Medical Directors

History 5th November 2015 PHE update document 17 Page “comprehensive guidance document” Public Health England released report providing comprehensive guidance on heater cooler maintenance and monitoring.

History 30th November 2015 Maquet release FSA Mycobacteria in Water Maquet later released an FSA following concerns of mycobacteria in their systems.

History 28th April 2016 Contamination at source paper published Eurosurveillance report was published suggesting contamination of LivaNova HCUs during the manufacturing process. LivaNova stated the HCUs tested were manufactured before the implementation of their extra disinfection process.

History 21st June 2016 LivaNova (Sorin) release FSA – Hydrogen Peroxide However this confilcts with Maquet’s oxygenator instructions which says water only in the heat exchanger

History 22nd August 2016 Maquet release FSA Revised decontamination “Potential” for aerosol Maquet also release a revised decontamination protocol.

RBH Strategy 4 Sorin 3T (DOM – July 12, April 13, August 15, March 16) 2 Sorin Flextherm (DOM – September 15, September 15) Tubing replaced annually including all connectors (Drinking water standard) Weekly disinfection (Puristeril) – No Hydrogen Peroxide Bi-Monthly water sampling (Environmental Scientific Solutions) Bi-Monthly air sampling (AirisQ) £75,000 to date So from all this information and different recommendations, what do we do at the Brompton?..... Reason for no H2O2 is due to a recommendation from Maquet in their IFU for their oxygenators and heat exchangers. Costs >£75,000 to date for sampling So we conducted a survey to identify what other centres were doing, whether they differed from our strategy and whether there is much variation between our approaches in the UK.

Survey - Decontamination Fairly varied with the majority of centres disinfecting weekly “Other” responses are between every 1-3 months. With those centres using Maquet HCUs following their bi-monthly guidelines.

Survey - Decontamination Shows the majority of centres use hydrogen peroxide. Don’t have breakdown. 6 nos may be due to centres using the Maquet oxygenators which have instructed water only when running the heater coolers.

Survey - Decontamination “Other” field use Chlorina

Survey – Water Sampling Majoriy of centres carry out water sampling

Survey – Water Sampling “Other” field is every 2-6 months, so this shows great variation across centres.

Survey – Water Sampling Shows that most centres carry out their water sampling internally

Survey – Water Sampling Mixed results between perfusion team and microbiology

Survey – Air Sampling So while the majority of centres carry out water sampling, most centres do not carry out air sampling

Survey – Air Sampling Of those that do, there is lots of variation with the frequency of air sampling. “Other” field either carried out as a one off or as directed from the microbiology team.

Survey – Air Sampling Of those that do air sampling, the majority sample internally

Survey – Air Sampling All but one centre have air samples reviewed by a microbiologist.

Latest Considerations Unsatisfactory review of results From our experience, one of our main issues is getting regular Microbiology Review. We are still waiting for results from beginning of sept. Machines have been disinfected multiple times since the samples taken.

Latest Considerations Drinking Water Standard PHE advise that where not specified by the manufacturer, microbiological drinking water quality standards should be derived from the EU Drinking Water Directive (98/83/C) standards for water in containers, with maximum counts being: E. coli: 0/250 ml Pseudomonas aeruginosa: 0/250 ml Colony count 22C: 100/ml Colony count 37C: 20/ml As well as this, PHE advise water drinking quality. LivaNova recommend consulting a microbiologist upon positive water samples but we currently have no set procedures or actions to be taken for positive results. What we ideally want to implement is for each set of water results to be reviewed by Microbiology & limits set with “real” actions ie. Extra disinfection, additional change of lines, double disinfection, Quarantine & clean, contact sorin etc

Latest Considerations Is Air Sampling useful? PHE & multiple FSA’s – HCU’s aerolise Expensive Mandated in FSA We know the devices aerosolise. Multiple FSA and PHE advice say as much. Does air sampling improve anything. Again delayed results - >6 weeks and multiple decontamination cycles between results. Cost for water & Air to date >£75,000 – But our process hasn’t changed since the FSA in June last year

Latest Consideration Multiple “Guidance” documents PHE FSA (Sorin, Maquet) IFU (Sorin HCU, Maquet Oxygenator) Information is at best “confusing” So far we’ve had multiple guidance documents with the information at best confusing.

Latest Consideration 13th October 2016 FDA safety communication: So after all these various and sometimes conflicting recommendations from different companies, where does this leave us. LivaNova have released an FSA in response to the FDA communication, still recommending water quality monitoring as per LivaNova’s June 2015 FSA.

Are we better off now? Are we better off now?