Guidance for purchasing Reusable Surgical Instruments in the NHS in Wales

Version: 1.0 - 9th Dec 2013

A PDF version of this document can be downloaded.

About this guidance

The document aims to provide appropriate information for the process of purchasing reusable surgical instruments for the NHS in Wales.

The aim of the document is to ensure that:

• clinically acceptable instruments are procured which are compatible with systems currently in use;

• instruments can be safely and effectively reprocessed and sterilised by the CSSD/HSDU;

• procurement regulations are adhered to and value for money is secured.

• relevant standards and guidance are used and adhered to;

• any change to existing suppliers does not compromise the quality and safety of care

Before an order is placed

The selection and procurement of surgical instruments should involve a range of disciplines as follows:

1. HSDU/CSSD “ who need to ensure that their reprocessing systems are appropriate for the device under consideration. This step is vital in ensuring that money is not wasted procuring devices which cannot be reprocessed locally.;

2. Infection control - the infection control team and HSDU/CSSD should be consulted in circumstances where the instructions provided by the manufacturer do not conform to recognised standards applicable in the UK or where the recommended agents or processes are not available or permissible within the UK.

3. End user “ usually a surgeon for surgical instruments “ to ensure that the devices are fit for their clinical purpose, and that appropriate training and support is available;

4. Procurement staff (including clinical procurement staff) “ to ensure the organization is achieving value for money and are complying with relevant legal requirements, including the procurement regulations and medical device directives;

5. All parties “ agree how many devices are necessary to cover turnaround time and service requirements (e.g., for example number of procedures using these devices each day)

Specific CSSD/HSDU advice

To ensure that the device can be reprocessed safely and effectively using the facility™s existing equipment (washer disinfectors and sterilisers), appropriate resources and conditions (equipment, detergent dosing regimes, water quality, pH, steriliser cycles), should be available in the department:

• Check whether suppliers conform with BS EN ISO 17664:2004, œSterilization of medical devices. Information to be provided by the manufacturer for the processing of re-sterilisable medical devices.. A paper in 2008 demonstrated that 90% of information provided was not compliant for cleaning processes, and 58% was not compliant for sterilisation processes¹

• If acceptable reprocessing instructions for decontamination and sterilisation, which are compatible with your equipment, are not available, then the devices should be rejected unless the manufacturer or Health Board/Trust have made a commitment to supply the appropriate systems.

• If there are questions about the appropriateness of the reprocessing instructions, manufacturers should be asked to provide written data/evidence to demonstrate that their Instructions for Use (IFU) has been validated for the instruments in question.

• All reprocessing instructions should be checked to ensure they are specifically written to meet the reprocessing parameters that are used in the UK.

• Manufacturers must be asked for sterilisation information which states that the items can satisfactorily withstand a cycle of between 134 and 137 degrees centigrade, which is the temperature range of all porous load autoclaves used in Wales.

• The temperature that all HSDU washer disinfectors in Wales operate to is now 90 “ 93 degrees. Reprocessing instructions should therefore state that the devices can be reprocessed at this temperature.

• Check the recommended detergent requirements (pH neutral/high pH/enzymatic) and ensure that these are available. Assess whether there are any issues which could place your equipment and/or other instruments at risk.

• CJD specific detergents “ the Advisory Committee on Dangerous Pathogens (ACDP) TSE Risk Management Subgroup has, in a meeting with IDSc (Institute of Decontamination Sciences) expressed caution against the use of untested or untried detergents due to concerns about their potential toxicity and the potential to provoke change in prions. Recommendations to use such detergents should therefore be considered in the light of evidence of their efficacy.

• Check to ensure that the stated water quality requirements are achievable, and that the supplier is not requiring unnecessarily stringent conditions.

• Check whether the supplier can undertake refurbishment of the instruments when aged/damaged (if necessary);

• Check whether the instruments meet appropriate standards (i.e., does the manufacturer claim compliance with instrument standards and stainless steel requirements - see below)

• Ensure that manufacturers of instrumentation have an obligation to provide proof of validation that detergents and temperatures have been tested using adequate certified testers.

• Evaluate instrument samples appropriately before placing orders (for example, as per Brophy²). This will usually include visual inspection by SSD staff for defects such as burrs, loose joints, poor quality insets.

• If the devices have a limited lifespan, such as Laryngeal Mask Airways (LMAs), ensure that advice is available on how this is to be determined and recorded (manually, electronically), and undertake an assessment of the practicability of recording the number of cycles the device has been subjected to, or whether visual inspection can be undertaken to ensure fitness for use.

• Maintain a list of approved suppliers who are known to meet the above requirements and therefore minimise disruption to the department's operations;

• Ensure that procurement and clinical staff are aware that without confirmation that the department can reprocess devices appropriately, there will probably be delays or cancellations.

• It is acknowledged that when the SSD and infection control have identified barriers to procurement, in the absence of anything else on the market, it may occasionally be decided to reprocess using processes /products outside of those recommended by the manufacturer. If a decision is made to consider reprocessing of instruments outside of the manufacturers recommendations (for example, because they require sterilisation cycles not available in the UK), then a Risk Assessment should be undertaken in conjunction with the Health Board/Trust risk and litigation departments. If a decision is made to proceed with such reprocessing, an entry should be made in the organisation's Risk Register and brought to the attention of the appropriate executive. If the process is to be undertaken by the HSDU, then this should be performed under concession and fully documented.

• Ensure that any traceability markings/systems used by the supplier are compatible with the system in use by the individual SSU.

Specific Procurement advice

• The Pre-Qualification Questionnaire (PQQ) and the supplier selection stage can be used in order to ensure that the suppliers that are selected have evidenced sufficient levels of certification and ability to service the contract/purchasing agreement.

• The following certification should be available:

  1. ISO 13485

  2. Instrument specific standards compliance certification (see œStandards section).

• Before the order is placed:

  1. Sign off from CSSD must be available acknowledging that the devices can be reprocessed by the organisation and that instrument quality is acceptable;

  2. Confirmation from the clinical team (for example, surgeon, theatre manager) should be available, acknowledging that the equipment is compatible with current theatre systems and procedures;

• Order specifications must, where appropriate, include the standards which the devices are expected to meet (see below).

• Ensure that the correct device can be sourced from an approved supplier, who can provide relevant documentation and certification (CE marking, quality management systems etc), and value for money.

• Ensure that clear instructions on disposal of equipment at end of life are available.

• Ensure that appropriate reprocessing baskets/trays/containers which are necessary for the devices are purchased at the same time.

Standards

There are a number of standards appropriate to stainless steel surgical instruments. A summary paper has been produced by Dr Gavin Hughes at SMTL, and is available from:

http://medidex.com/images/stories/SMTL-Stainless-Steel-Standards-Brief-Jan2012-Rev-1.1.pdf

The specific standards are:

• BS EN ISO 7153/BS 5194 “ Surgical Instruments;

• BS 7891- Surgical and Dental hand instruments;

Other standards which may be relevant to medical devices include:

• BS EN 60601 - Electrosurgical standards (parts of which are relevant to diathermy forceps for example);

Guidance

The decontamination guidance for Wales for these instruments, roles and responsibilities, plus instrument management is given in WHTM 01.01, parts A and B, which can be found at:

http://www.wales.nhs.uk/sites3/page.cfm?orgid=254&pid=64101

References