Decontamination supercentres

For practitioners and the medical device industry, decontamination of surgical instruments looks set to be the hot story of 2008. With new outsourcing arrangements – the so called decontamination “supercentres” – coming on board, the experiences of the first outsourced arrangements are important barometers of how the new systems will work and what teething problems may be encountered.
    
Healthcare organisations were required to meet the Medical Devices Directive (MDD) for the reprocessing of medical devices – substantially raising standards for decontamination of surgical instruments – by March 2007. The financial burden for an organisation to meet this directive with onsite provision could be substantial, making the outsourcing of the decontamination of surgical instruments a viable and potentially preferred option. Many onsite decontamination centres required large investment in buildings, services and training. Furthermore, the move to a centralised service would reduce procurement costs and improve quality standards.

Mixed views
The drive towards the centralised cleaning of surgical instruments in decontamination “super-centres” has provoked much comment, discussion and debate within the healthcare world – amongst users, medical device companies and those working in sterile services.

AfPP requested confidential feedback from its members on the outsourcing of decontamination services such as “supercentres” and responses from across the UK.

• 50 per cent were not yet outsourced
• 23 per cent are due to be outsourced. Many respondents had misgivings.
• 21 per cent used outsourced facilities and found the experiences negative.
• One per cent were outsourced and found there were positives and negatives.
• Five per cent were outsourced and had positive experiences.

Those who responded positively to the new outsourcing experiences identified that staff had been involved from the start of the proposed changes and continue to meet with sterile services staff regularly. Others have a well-established service, which meets their needs, and for some there were reservations but, with robust processes and service level agreements, the concerns have not materialised.
    
Of those respondents whose services had been outsourced, 76 per cent expressed dissatisfaction with the service. There appear to be three main areas where users raised concerns and questioned the decision to change decontamination service arrangements:

• Timeliness of supply – instruments are not always available when requested and so practitioners rely on the “fast tracking” service to ensure delivery.
• Availability of instruments - practitioners reported that there were usually instruments missing and not reported, wrongly labelled instruments and instruments returned damaged and unusable.
• Responsibility – staff communications with outsourced centres, whilst in some areas was excellent, in others was inconsistent. Incidents discussed with colleagues from sterile services focussed on missing instruments, unclean sets and instrument quality.

Clear responsibilities
The law is clear on responsibility for defective products – among which poorly decontaminated instruments are included. The responsibility lies with the manufacturers but under Consumer Protection laws, processors are also viewed as manufacturers. In centralising decontamination away from the area of use the responsibility for the cleanliness of the instruments has been moved from the organisation where they are to be used to processors entirely unconnected with that organisation. In a litigious age users and processors need to be aware of their liabilities for surgical site infections caused by the use of poorly sterilised instrumentation. The level of responsibility between the user’s organisation and the processor’s organisation needs to be determined to quantify the risk for each of those organisations.
    
Practitioners identified both positive and negative experiences with outsourcing of instruments and their expectations of the service. Those on the ground processing the instruments and those in the operating area need to be confident that they are using sterilised instruments. Not least, the patient needs to have confidence that their interests are more important than reducing costs and standardising decontamination quality. Such concerns were also identified and explored within a document released by the National Decontamination Team on the lessons learned from wave one projects. Tray lists, instrument quality, staff training, fast tracking of instruments and mislabelled sets were just some of the issues raised resulting in some changes being made to the services provision.
    
Changes to services
Changes to any service will be accompanied by “teething problems”. What is crucial is that lessons learned and the resultant actions are instigated immediately building the confidence between users and providers of the service. In so doing and fostering greater collaboration between all parties, the risk to patients of delayed or postponed surgery due to lack of instruments or incorrectly decontaminated equipment is further diminished and the risk of surgical infection minimised.