Controversy over instrument cleaning

A request by the Association for Perioperative Practice (AfPP) to its members for information on outsourced decontamination of instruments has highlighted concerns. More than threequarters of those who responded are said to have reported negative experiences.

Problems highlighted included surgery being cancelled as instrumentation had been wrongly labelled while off-site, instruments being returned with visible blood and bone contamination, as well as delays in instruments being returned. Diane Gilmour, decontamination lead for the AfPP, commented: “If we can’t rely on the very tools of our trade to be back, complete and clean in order for operations to go ahead patient safety is bound to be compromised. In some instances an operating list may be determined by which instruments are available rather than by clinical need and the fast-tracking procedures are simply too slow.”

The AfPP said that the findings echo those within a report from the NHS Decontamination Programme, which revealed that 1,765 operations had been called off at the last minute in 2005-06 because of instrument problems. The programme’s latest bulletin admitted there had been “teething problems”.

Diane Gilmour continued: “When lost or broken instruments and mixed up trays become more and more frequent then patient safety is a serious risk and one which cannot be ignored. It is easy to dismiss these incidents at teething troubles but practitioners and patients need to be assured that realistic deadlines are now being set to ensure that these problems will be reduced to acceptable levels within a short space of time. Healthcare organisations intending to outsource their decontamination of surgical instruments need to learn from these lessons.”

Martin Williams, chairman of the Institute of Decontamination Sciences (IDSc) responded: “The Institute recognises that the provision of decontamination services has changed significantly since the Department of Health National Review of the late 1990s and early 2000s, including the means by which services are provided, but also the significant improvements in the standards to which these services are expected to operate.”

The IDSc commented that the National Decontamination Programme was devised to promote public sector partnerships, (joint ventures) to provide state-of-the-art facilities offering an alternative to the significant investment that would have been required to replace poorer standard departments within the NHS.

It also pointed out that the statement regarding cancelled operations related to instrument problems quoted figures from 2005-2006 which is “somewhat out of date and came before the first ‘super centre’ had been built” and as such is “somewhat confusing”. Furthermore, the AfPP did not disclose the number of members or hospital sites that were represented in the survey, nor did it say if those with “in house” on-site services were asked if they had similar concerns.

It added that mechanisms are being put in place to prevent services transferring to off-site facilities until such time as checks have been undertaken on the readiness of both parties to move services to a different service provider. The IDSc advised that checks should be made to ensure the inventory of instrument sets match the proposed workload. “This will ensure that agreed turnaround times for standard and fast track requirements can be safely met – instrument shortages are historical within the NHS,” the institute stated.

Instruments should also be checked to ensure they are “fit for purpose” and can be safely decontaminated. In addition, tray contents should be checked to ensure they match check sheets, so that an audit trail can be maintained between the decontamination processes to the patients on whom they have been used. Historically this is often not the case, the IDSc claimed.

Service providers have a legal obligation to comply with the requirements of the Medical Device Directive and operate a quality management system to BS EN ISO 13485.

The IDSc pointed out that many of the NHS sterile service departments were not able to apply these standards. Many of the off-site services are run by staff who had previously worked in the NHS and have moved over to private sector partners under TUPE, providing continuity of staff between locations which “should not in itself alter the basis of the service being provided.”

The institute concluded: “Irrespective of the location of decontamination services, the standards to which equipment needs to be reprocessed remain the same, and both the user and the service provider need to work together to achieve these and ultimately safeguard the patient interests.”

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