Tools of the trade

A medical device is a product that is used in healthcare for diagnosis, monitoring, prevention and treatment. In the UK this is regulated by the Medical Devices Regulations 2002, which incorporates the European directive 93/42/EEC (DH 2002).
    
A surgical instrument is a medical device and the principles of the regulations ensure that the surgical instrument is safe, performs the required task, causes no harm and, when used correctly, promotes effective patient care. A surgical instrument designated for single use must not be reused as reprocessing cannot guarantee effective decontamination, and the device may alter its characteristics so that it no longer complies with the original manufacturer’s specifications.

Selecting the right set/instrument
The scheduled operating list for that session, together with the surgeon’s preferences for the associated procedure, will give an indication of the sets/instruments required.
    
Sets and instruments should be stored in a clean, dry environment that is free of dust and protected from direct sunlight. The strategic placement of sets on shelving within the storage area must be in accordance with manual handling operating regulations with an appropriate risk assessment to identify and reduce the risk of injury to staff when moving and handling instrument sets. Heavier trays such as orthopaedic sets should be easily accessible and not placed on top of one another resulting in damage to those instruments below.
    
All sterile items have a shelf life. This is the length of time that a medical device can be considered sterile and is dependent on storage, handling and type of packaging. The item will remain sterile unless the packaging integrity is compromised.
    
Stock instruments and sets should be rotated and used in correct date order – nearest to end of shelf life first. This reduces the potential cost of reprocessing instruments whose shelf life has expired and also minimises the potential of sterility being compromised. Once the correct set/instruments have been located then the set/instrument itself must be checked. Medical Device Directive (MDD) 93/42 EEC states the information required to be shown on the label of each set/instrument.

Keeping track
In addition, for tracking of the instruments (sets and supplementary) through the sterilisation process an additional label will indicate date of sterilisation, identify autoclave number, and a unique batch code number. In the event of a problem or concern regarding sterility this enables sterile services departments to identify all instruments/sets within that autoclave cycle.
    
Practitioners also need to check the wrapping and packaging of sets/instruments for damage, evidence of fluid penetration or tampering with the sterile cable lock on the instrument casing (such as orthopaedic trays) as this is an indication that the instruments may not be sterile and the set/instruments should not be used but returned to the sterile services department. All wrapping materials (pouches, crepe and linen wraps) must conform to BS EN ISO 11607-1: 2006, Packaging for Terminally Sterilized Medical Devices: Requirements for Materials, Sterile Barrier Systems and Packaging Systems (BSI 2006). The correct packaging provides a barrier against bacteria and provides for the effective sterilisation and handling of instrument trays until they are used.
    
If there is any question that sterility has been compromised then the practitioner must return the set/instrument to the sterile services department immediately and select alternative sets/instruments. Having undertaken a manual handling risk assessment, practitioners must transport sets and instruments to the relevant operating theatre or preparation area appropriately to reduce the risk of injury.
    
Each healthcare organisation should have a policy outlining the roles and responsibilities of the circulating and scrubbed practitioner within the decontamination, tracking and traceability process for sterile sets/instruments. Perioperative practitioners are responsible for the correct handling and appropriate use of surgical instruments during the surgical procedure.

Role of circulating practitioner
The circulating practitioner is responsible for assisting the scrubbed practitioner to prepare for a surgical procedure but also to provide additional equipment/instruments throughout the procedure if required.
    
In preparing for a procedure each set will have an instrument tray list. This list is an accurate record of the instruments to be found in that tray. It will also say if items are missing or have been replaced. The instrument tray list includes the date of reprocessing and is countersigned by sterile services department staff. If the tray list is inaccurate then this should be recorded on the list and, dependent on the local reporting policy, additional documentation completed detailing the discrepancies.
    
The circulating practitioner completes the theatre section providing information on the date of use, case or patient number (patient confidentiality must be maintained), theatre and names of the scrubbed/circulating practitioner. The instrument tray list forms the basis of the instrument count, which must be performed by two members of staff, one of whom must be a registered practitioner. A minimum of two counts are performed: one prior to the commencement of the procedure and one as the procedure finishes (AfPP 2007).

Ensuring compliance
Checking the integrity and sterility of any wrapping or packaging for any instrument, checking the descriptive label on the set/instrument (as above) and reporting any lack of compliance is an essential part of the circulating practitioner’s roles and responsibilities prior to providing any additional sterile equipment.
    
Healthcare organisations should identify a protocol to be followed for the recording of supplementary instruments used during the procedure. This may be an additional sheet per patient that the circulating practitioner completes with the relevant details of case and number. It should list all the supplementary items used and this is then returned with the additional instruments in a separate tray at the end of the procedure to assist with tracking and traceability.

Role of scrubbed practitioner
The scrubbed practitioner must recognise and identify the instruments and their purpose within the set (AfPP 2007). The scrubbed practitioner is responsible for ensuring that all instruments are fit for purpose and able to perform the task required. If sterility is compromised (instruments found to be contaminated with blood or body tissue) then the set and instrument must be removed from theatre and reported to the sterile service department. If an instrument is damaged or its integrity compromised then the instrument and/or set must be removed and either sent for repair or discarded.
    
In 2000 the NHS Executive published Health Service Circular 2000/032, which stated that all NHS trusts should be putting systems in place to enable the tracing of instruments to patients on whom they were used by March 2002 (NHS Executive 2000). This was further enforced in 2006 with the publication of NICE interventional procedure guidance 196.
    
For an effective tracking system of instruments the scrubbed practitioner should ensure that the original designated instruments are returned to the right set. NICE guidance focused on high risk surgical procedures such as those involving the retina, optic nerve or within the dura for the reduction in risk of transmission of Creutzfeldt-Jakob Disease (CJD).
    
The scrubbed practitioner must ensure that all instruments are accounted for throughout a surgical procedure, and if an instrument was to break intraoperatively then all the pieces must be retrieved and discarded with the appropriate note made on the tray list if necessary. If an instrument from a set is damaged, broken or needing repair then, by adopting the NICE guidance, the set is removed from circulation until the instrument is repaired and returned. Each individual healthcare organisation must assess the risks to patients and implement appropriate policies and protocols to manage such situations.

The end of the procedure
At the end of the procedure all instruments must be counted and checked by the scrubbed and circulating practitioner. The scrubbed practitioner must ensure that all sharps and consumables are removed from the instrument tray to prevent injury to either sterile services staff or those who transport the instruments between theatres and the department. To assist with the tracking and traceability of instruments it is recommended that instruments are returned to their original set to prevent the set becoming incomplete (Spry 2007).
    
The instrument tray and relevant tray list included are wrapped in its original wrapping or all instruments returned within the case. Supplementary instruments should be kept and returned separately with the appropriate documentation. AORN (1997) recommends that initial decontamination of instruments begin immediately following every procedure to prevent transmission of pathogens. However, this is not always possible and so instrument trays and supplementary instruments must be wrapped securely for the safe transportation to the decontamination area and removed to that area as soon as is reasonably practicable (AfPP 2007).
    
Any instrument used during a surgical procedure is contaminated and personnel handling such products should be trained to collect and transport them and be provided with and wear protective clothing. The container used for transporting the instruments must be easily cleaned, able to be securely closed and labelled to identify user and contents (AfPP 2007).

Taking responsibility
Surgical instruments are the surgeon’s ‘tools of the trade’ and it is essential that each works every time. That responsibility is not just down to one person but many members of the interprofessional team as demonstrated in the instrument cycle: surgeons, perioperative practitioners, those who transport the instruments and those who reprocess them.
    
A defective, non-functioning instrument can compromise patient safety and potentially delay the procedure. The financial investment for any healthcare organisation in instrumentation alone is substantial and Spry (2007) identifies that the extra time taken to care for and ensure the correct functioning of an instrument is well worth the investment.

About the AfPP
The Association for Perioperative Practice (AfPP) was established as the National Association of Theatre Nurses, known as NATN, in 1964. It is a registered charity working to enhance skills and knowledge within operating departments, associated areas and sterile services departments. It aims to enhance the quality of care in the NHS and the independent sector throughout the UK.
   
AfPP also works to encourage the exchange of professional information between members and co-operation with other professional bodies. These include the Departments of Health, the Perioperative Care Collaborative, the Nursing, Midwifery and Health Visiting Advisory Committee (Scotland), the medical Royal Colleges, CNOs of all four member countries, Skills for Health and many of the British Safety Institution Committees and other groups set up to discuss specific issues. 

Diane Gilmour is a Trustee of AfPP and is the Association’s Decontamination Lead.