Published: 14/07/2005, Volume II5, No. 115 Page 40

The NHS will have to raise its game if it is to meet forthcoming European requirements. Roger Evans looks at the options

As well as gracing tabloid horror stories and Conservative election slogans, improving decontamination has been identified as an important part of the Department of Health's strategy to combat healthcareacquired infections.

It was highlighted in the chief medical officer's report Winning Ways back in December 2003, which called for improved standards of decontamination and better protection of patients and staff.

Since then major improvements have been made and GP and dental services are part of the programme.

Standards are set nationally - but organised locally - and overseen by the Healthcare Commission.

Progress has been made in many areas. So far:

Every NHS trust central sterile supply department has been inspected on at least one occasion by a specialist team.

Over£130m has been spent on purchasing washer disinfectors, sterilisers and surgical instruments.

Some central sterile supply departments, which were not of an acceptable standard, have closed.

A 15-year strategy, embracing primary care and general practice, has been launched to the commercial sector at an industry conference.

All 28 strategic health authorities have designated a director to lead the decontamination programme and have drafted their plans for future sterilisation services.

The Healthcare Commission has included decontamination of surgical instruments in its audit and inspection programme.

Independent hospitals have embraced the need to ensure their services are acceptable - they are now working to the same timetable and standards as the NHS.

This is only a start to an exciting and challenging programme.

By April 2007, locations reprocessing surgical instruments will be expected to meet standards laid out in the European medical devices directive (93/42/EEC).

This will apply to those services delivered by commercial bodies as well as acute and primary care trusts.

Those that do not meet the standards will be expected to take any necessary action - or face closure.

The NHS will be able to demonstrate that instruments have been reprocessed properly, and also identify the patients those instruments have been used on.

The health service should also be capable of responding to changes in technology and technique. There must also be the capacity to carry out at least 20 per cent more work than now - in order to meet the increased demand.

By April 2007, GPs and dental practitioners will be expected to have modern facilities that ensure instruments used in surgeries are sterilised to a high standard. This will be monitored by PCTs. The British Dental Association has already addressed the issue with the publication of Infection Control in Dentistry.

Particular features of future decontamination and sterilisation services for GPs and dentists are:

Establishing the current state of decontamination services in medical and dental practices. This should include auditing sterilisers, premises and staff training.

Obtaining compliance with standards by 1 April 2007. The relevant standards are: BS EN ISO 9001: 2000 quality management system requests; and BS EN ISO 13485: 2003 medical devices - quality management system requests for regulating purposes.

Identifying the options to achieve this, including the costs. They are likely to include centralisation between several practices, upgrading the services in the practice, greater use of single-use devices, and enlisting an NHS decontamination and sterilisation service.

Putting in place a system for tracking and tracing patients who have been in contact with individual instruments or packs.

Challenges The NHS has four options for meeting this challenge for hospitals:

Local health systems agreeing joint venture arrangements with commercial interests. There will be approximately 30 contracts between NHS trusts and companies, which will be for at least 10 years. This presents exciting opportunities for commercial interests. Each will serve several hospitals and will be available for GPs. Substantial capital and management expertise are essential.

'Super centres' financed and managed by NHS trusts. These will have to comply with the national strategy and obtain medical devices directorate registration. They will cover several hospitals and the NHS will have to provide funding to build and run them.

The retention of existing central sterile supply departments. This will be the exception, not the rule. The likely locations are NHS trusts that are either geographically isolated or undertake specialist surgical work. A trust will be required to demonstrate it can meet key measures from the national strategy. This will include risk-management plans, confirming cover arrangements from another centre and providing resources to carry out an additional 20 per cent of reprocessing work.

A few trusts have contractual commitments for providing sterilisation services within publicprivate partnerships and private finance initiatives for major hospital developments.

Modern, reliable, systems are essential to track and trace which instruments have been in contact with specific patients in hospitals and general practice.

Ensuring good standard sterilisation services for general practice and hospitals must be a high priority for surgeons, GPs and dentists.

The DoH, with the Healthcare Commission, is committed to providing whatever reasonable support it can to achieve this. .

Roger Evans is decontamination programme director at the Department of Health.