DECONTAMINATION
minimise instrument handling, the performance can easily be monitored, and there are no toxic residues. “However, there are certain disadvantages, as the equipment is expensive, requires maintenance, and it’s not suitable for delicate or electrical items which are sensitive to heat, water or high pressure.”
When choosing a chemical disinfectant, Karren described a number of considerations, such as the range of activity and efficacy; the rate of kill at use in-dilution; the toxicity; stability; and, ultimately, cost.
When decontamination goes wrong
Wayne Spencer, authorising engineer decontamination at Spencer Nickson, shared his thoughts on the need for a validated decontamination process. He started by describing the basic purpose of decontamination and went on to explain the importance of ISO 17664:2017. “There are a number of reasons we use decontamination,” he said. “Firstly, to protect the patient from disease and death; secondly, to protect staff from disease; thirdly to protect staff from litigation or dismissal; next, to protect the organisation’s reputation – and to prevent financial liquidation; and finally, to protect the organisation from litigation. “The new edition of ISO 17664:2017 explains the importance of processing healthcare products, and advises that information should be provided by the medical device manufacturer for the processing of medical devices. “Section 3.8 states that at least one validated method should be specified for each applicable stage of processing of a medical device, and that the method should be relevant to the market in which the medical device is to be supplied. “It continues by advising that if a medical device is intended to be disinfected, at least one validated automated disinfection method should be specified - unless the medical device cannot withstand any such process. In that case, it advises that a statement should be provided which alerts the user to this issue.” Validation is the documented procedure
Glenn Jefferson, field operations manager and Dan Oakes, sales and support, South West and South Wales demonstrated how trophon works during the study day breaks.
Liz Collins, clinical lead infection prevention, University Hospitals of Leicester NHS Trust.
for obtaining, recording and interpreting the results needed to show that a process will consistently yield a product complying with a pre-determined specification. Validation, testing and maintenance of probe decontamination systems is the responsibility of the unit manager, and Wayne listed what to expect from a validation process: “Validation will include visual inspection of the system and components; a test of alarm systems; automatic control type test; dosing system checks and/or calibration; and temperature calibration (if temperature control used or temperature limits are applicable). “When checking the validation report, you should ask a few questions. Do you know who undertook the testing? Is it stated in the report? Was the person qualified to do so? Is there a certificate of competency or training in the report? What instrumentation was used? “The best reports have a list of the tests carried out, either in the beginning or back of the report, so make a checklist of expected tests if you are unsure which tests should be included. If there are test failures, check if retests were undertaken during the testing period, and whether further retests are needed. If repairs were needed during the testing period, check if those repairs invalidate previous tests. “We live in an increasingly litigious society, so people realise that they can make a claim if there’s an incident. Bad press coverage compounds this negative message, and this results in fewer patients – as they refuse to go to that hospital – then lower funding and care, and ends in yet more press coverage, describing the hospital’s ‘spiral of decline’! “In terms of validation and legislation, it’s vital that you keep a record of everything.”
A clinical user’s viewpoint
A delegate from the Study Day asks the expert panel a question.
Dr Peter Cantin, consultant sonographer at University Hospitals Plymouth NHS Trust began his talk by alerting delegates that the ultrasound service delivery is under enormous pressure nationwide. This, he asserted, was a critical issue as the knowledge base was so specialised. He said: “Sonographers need to know
Panel experts: Claire Jones-Manning, Wayne Spencer, authorising engineer decontamination, Spencer Nickson Ltd; Karren Staniforth, clinical scientist, infection prevention & control, Nottingham University Hospitals; Liz Collins, clinical lead infection prevention, University Hospitals of Leicester NHS Trust; and Dr Peter Cantin, consultant sonographer, University Hospitals Plymouth NHS Trust.
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everything, from infection control and decontamination, current recommendations, and their own roles and responsibilities, to professional regulatory obligations, methods of decontamination and work flow, and manufacturer recommendations. “The roles and responsibilities of a decontamination lead, include supporting organisational strategies in decontamination, guidance in implementing best practice, supporting the responsible person in implementing acceptable decontamination practices, and supporting the responsible person in monitoring decontamination policy. “So, what about the responsible person? They are responsible for the safe decontamination of ultrasound probes, following manufacturers and HSE guidance from acquisition to disposal, and have links with the decontamination lead. The
SEPTEMBER 2019
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