Trust’s validation underlines quality of long-term endoscope storage and transportation
Nothing exemplifies confidence in a device more than buying a second one. That’s just what Great Western Hospital, in Swindon, has done, adding a second SureStore Endoscope Storage and Transportation system from Cantel (UK).
Not only that, with the innovative device being introduced since the current HTM, the trust’s team devised and carried out its own machine validation process with outstanding results.
“Our decontamination covers both sterile services and endoscope reprocessing, but the machines there are owned by endoscopy,” Stuart Colquhoun, supervisor/super user with a specific responsibility for IT support for sterile services and endoscopy, at Great Western Hospital NHS Foundation, tells Hospital Times. “We saw the original article on Cantel’s SureStore in Inside Hospitals (now incorporated within Hospital Times) and discussed the possibility of such a machine and the benefits it would deliver.
“We arranged for Kenny Ader, Cantel’s regional sales manager, to do a demo of the machine to myself, Traci Parfect, head of service for sterile services, and Carol Davies, production and instrument manager across both departments.
“Just from that demo, between the three of us, we saw enough to realise the benefits. The cost savings that would be achieved by removing some of the drying cabinets – saving on running costs and service contract. The time-saving, cost of not having to reprocess the scope after 72-hours, which we would have to do if the scopes hadn’t been used by then.
“The SureStore flushes N-Sure, a low-level hydrogen peroxide solution, through each of the channels of the endoscope. In addition, the packing process maintains the high-level disinfection status. The system gives 100-days’ storage, while maintaining high-level disinfection. This allowed us to look for business outside the trust, as we would not be limited to use within 72-hours, and the system packs the scopes in an easily transportable format.”
Business case goes to capital group
Stuart explains: “Cantel supplied a report from leading French laboratory Biotech Germande, which substantiated the performance standards for the machine. This gave us the reassurance we needed. Our AE(D) is Tom Hall. His view was that he would support the business case as the evidence was there.
“We wrote the business case and presented it to the capital group, who rubber stamped the proposal. The order went in on the 31 December 2015 and the machine was delivered in February 2016.”
Stuart says: “The SureStore’s such an easy machine to use. There are only four connectors at most, depending on the type of scope being processed, and just two buttons to press. A sterile pad is placed around the distal end and you press ‘Start’. It’s that simple. The longest cycle is 242 seconds for a duodenoscope.
“The training was straightforward. As we alternate staff through both sterile services and endoscopy, the training was delivered to all the decontamination staff. To help the technicians, I created connection charts for all the different scope types we use.
“We bedded the first machine in and after six-months got rid of one of the endoscope drying and storage cabinets. That gave us extra space, which is at a premium in the department.
“From an IT point of view, the SureStore is not an issue. It just runs. Adding new scopes on it is a 30-second job. We can track all the scopes through it to maintain full traceability.”
BS EN 16442 does not apply to the SureStore device. However, Stuart explains: “In HTM 01-06 Decontamination of Flexible Endoscopes there are requirements for annual tests. As the HTMs obviously cannot keep up with new technology that might be adopted, such as the SureStore, we decided to do the enzyme and protein test that we would normally use on the AERs.
“HTM 01-06 Part D, section 4.29 gives guidance on how to build a surrogate device. We started testing in November 2016. We attach the surrogate to the AER, process it through a standard cycle, attach it to the SureStore and package in the normal way. Rather than do a straight 100 days, we decided to test three surrogates after different storage periods. This would enable us to pick up any issues earlier.
“We processed and packaged three surrogate scopes and labelled them 30, 60 and 100 days,” adds Stuart. “At the end of the respective period we carried out the standard lumen test from the HTM in Part D under aseptic conditions. The samples were sent to Serve Medical, which we use for all our water testing.
Tests validate Cantel work
“The results said that there was absolutely nothing there. It was literally zero. We were very happy. It validated everything Cantel had said. It gave us the assurance that we were reprocessing everything correctly and gave endoscopy reassurance for their patients.
“We have our own, in-house engineers for sterile services and endoscopy. They look after all our equipment and carry out the surrogate testing. Cantel engineers undertake the annual service and maintenance. Our test is additional to the work they do.
“We shared the information with Cantel. They were pleased to receive the information and asked if they could share it, which we were happy to agree.”
Stuart explains: “Shortly after taking delivery of the SureStore we undertook some contingency work for the nearby Nuffield hospital. Having one machine – a single point failure – we would not have been able to fulfil the contract if there had been any issues.
“We started to look at taking on a second SureStore machine and considered how it could be funded.
We used some of the money we had made from the external contract and savings made within the department. This enabled us to buy the second machine.
“We had no room to put the second one in until we removed a second drying and storage cabinet. So, it was a quick turnaround. This meant we saved on the service contract for the second drying cabinet and its running costs.
“The second SureStore arrived in the first week of August 2017 – an ideal time as another trust had issues in its endoscope reprocessing department. We helped them by reprocessing some of their scopes. With our own busy workload, we wouldn’t have been able to do that with just one machine.”
Both machines perform well
Stuart explains: “Both machines are performing well. They’re very easy to use. We’re now about to start the annual surrogate device testing, which we’re hoping will go as well as last year’s.”
Echoing Stuart’s comments, Traci Parfect, head of service for sterile services, says: “Cantel has said that the results of our surrogate validation confirm the validation carried out at Biotech Germande. We’ve fed back all our experiences to Cantel and they have taken them on board.
“I like the SureStore. It’s a neat unit and it does a good job. It does what it says on the tin. It’s safe too. The hydrogen peroxide is only 1.5 per cent in the SureStore’s N-Sure, the same as proprietary mouthwash. It reverts to its constituents – hydrogen and water. It’s completely non-toxic.
“SureStore delivers a truly packaged product, with no need to dry the scope prior to packing. From a logistics point of view, we’ve reduced the number of drying and storage cabinets, which can take up a lot of space. It’s easy to learn to use the machine. Cantel trained all the staff and we cascade the training down to new staff.”
Traci explains: “The results of the surrogate testing were very reassuring
It’s always nice when our results are as good as the manufacturer’s. I’m a member of the Endoscope Users Group, which meets once a month. I report on behalf of decontamination and reassured them on the performance of the SureStore. I explained that the tests were all fully documented. They were happy.
“They were also impressed as the scopes were being used less frequently, as we were not having to reprocess scopes that had reached 72-hours, which would have been the case with the drying cabinets.”
Rebecca Moss Sutton, sister endoscopy, explains: “I’ve got absolute confidence in the SureStore. It’s improved our efficiency. Often, when you get improved efficiency it impacts on quality. We have rigorous standards to adhere to and we demonstrably know we do so with SureStore.”
With a final comment on the success of the surrogate testing, Stuart adds: It’s not within the HTM but with us it’s all about ensuring that all we do is safe for patient use.”
For more information, call Cantel (UK) on 01702 291 878 or visit www.cantelmedical.co.uk