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Instrument integrity and sterility: the perioperative practitioner's responsibilities.

Introduction

A medical device is a product which is used in healthcare for diagnosis, monitoring, prevention and treatment, and is regulated in the United Kingdom (UK) by the Medical Devices Regulations 2002 which incorporated 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 (Fulbrook 2007). 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. The performance may be compromised (MHRA 2006).

As registered practitioners, patients enter the perioperative environment relying on us for their safety and protection. We have a legal duty of care and are personally accountable for our practice (HPC 2003, NMC 2008). We must ensure that all surgical instruments meet the required standards before, during and after use. If there are faults or problems identified then these must be dealt with efficiently and appropriately to reduce the risk of harm to that and subsequent patients, scrubbed staff or any other member of the interprofessional team (AfPP 2007, Spry 2007).

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 free of dust and protected from direct sunlight (AfPP 2007). The strategic placement of sets on shelving within the storage area must be in accordance with manual handling operating regulations (HMSO 1992) 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 (Hurrell 2005, AfPP 2007).

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 (MDD 1993) (see Table 1).

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 standard identifies the general requirements and test methods for all packaging of medical devices that are to be terminally sterilised in the package (Letovouri 2003). The correct packaging provides a barrier against bacteria and provides for the effective sterilisation and handling of instrument trays until they are used.

The convenient choice for most healthcare organisations for supplementary instruments is one that is a heat sealed see through package, allowing for quick identification of the instrument, but is water resistant and provides a protective barrier against bacteria. For individually wrapped instruments the wrapping should be intact, dry and the appropriate tape on the outside wrapping of sets should have dark brown stripes as an indication of steam sterilisation (Lehtovuori 2003).

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 (AORN 1997).

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 tray list and, dependent on the local reporting policy, additional documentation completed detailing the discrepancies (AfPP 2007).

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).

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. The 'tear-off' strip from the reprocessing label and smaller batch label are removed from all the relevant sets or instrument packaging utilised throughout the procedure and attached to the appropriate documentation within the patient's care plan or notes (depending on healthcare organisation policy).

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 which 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.

Practitioners need to be aware of limited-life devices such as laryngeal mask airways, diathermy leads and forceps. Participating within an effective tracking and traceability system is essential to ensuring that manufacturer's instructions are followed and that the instrument is discarded after maximum uses to prevent the risk of failure in use (Hurrell 2005).

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 evidence presented identified that the probability of at least one instrument being swapped from the main set with a supplementary--and vice versa--either during the procedure or the decontamination process was 50%. If that was to occur during an identified high risk procedure then there was a 10% chance that potentially 700 new cases of fatal CJD would occur every year in England and Wales, resulting if continued in an epidemic within five years (NICE 2006). While not every procedure is on high risk tissues, the argument for ensuring that instruments do not migrate is essential for patient safety and allows healthcare organisations to identify patients who, at the time of the procedure, may have been exposed to an infectious agent such as tuberculosis (NICE 2006).

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).

The decontamination process

The 2006 Health Act in England and Wales placed a duty of care on acute and primary care trusts to put systems in place supported by evidence-based protocols to protect patients, staff and visitors. One of the requirements is that each NHS organisation must have a lead manager for decontamination and that the decontamination programme demonstrates that decontamination of reusable devices is carried out within dedicated facilities (Gilmour 2007). The Healthcare Commission (HCC) Core Standard C4c (HCC 2006) reinforces the Health Act requirements but is also applicable to the independent sector. It also states that the risks associated with decontamination facilities and processes are well managed (HCC 2006). The MDD 93/42/EEC was originally designed for medical device manufacturers but as hospital-acquired infections increased the directive was then seen to be relevant for the reprocessing of medical devices within healthcare organisations. If an organisation is compliant with MDD then they must have a quality system in place related to the reprocessing of medical devices which measures all aspects of decontamination work including processes. Decontamination is a combination of processes including cleaning, inspection and sterilisation.

Cleaning is the removal of visible contaminates from an instrument's surface, and mechanical cleaning with automated washers is preferable. When considering the purchase of new instrumentation practitioners, in consultation with the sterile services department, must ensure that manufacturers' reprocessing instructions are included and that the instrument can be appropriately reprocessed within current facilities (Spry 2007).

Washer/disinfectors are automated, with failure lockouts if the machine has no detergent or does not reach the correct temperature (Meredith & Sjorgen 2008). The process is monitored and validated quarterly. Instruments, particularly those with lumens and removable parts, may initially require manual cleaning. Cleaning manually is not consistent and, although prescriptive on the amount of detergent used, the technique and method of hand washing cannot be easily controlled and should not be the method of choice. Staff should wear adequate personal protective clothing at all times during this phase to prevent accidental exposure to contaminants, blood or body tissue (AORN 1997, AfPP 2007, Meredith & Sjorgen 2008). Ultrasonic washers may also be used in the initial cleaning process for delicate instruments and those with serrations where debris may collect. Obstetric instruments in particular are difficult to clean and using an ultrasonic washer enhances the washer/disinfector process.

[FIGURE 1 OMITTED]

Instruments are opened, ideally lighter weight instruments on top, and arranged in mesh bottomed trays and placed within the washer/disinfector. Additional attachments within the machine can accommodate the mechanical cleaning of, for example, laryngeal masks. Powered tools are now machine washable and can be accommodated through the mechanical cleaning process. Washer/disinfectors must comply with HTM 01-01 (formerly HTM 2030) (DH 2007) and consist of pre-wash, wash, rinse and reverse osmosis (RO) cycles. The RO improves the efficacy of the disinfection process by stripping the instrument of contaminates.

The instruments are then dried--either electrically or by steam. Drying prevents rust formation thus ensuring further integrity of the instrument (AORN 1997). The instruments pass through the washer/disinfector and into a clean controlled environment where they are inspected, packaged and prepared for sterilisation (Gibson 2008).

Inspection of instruments must be done individually for cleanliness, function, defects, sharpness and alignment before being prepared for packaging and sterilisation (AORN 1997, AfPP 2007). Insulated instruments are examined closely to ensure that that the insulation layer is intact. Instruments are tested for free movement, that jaws do not stick, that teeth mesh together, scissor edges meet at the tips and that screws on jointed instruments are tight.

Debate continues regarding the benefit of lubricating instruments, particularly those with moving parts. The process of RO may remove any instrument lubrication resulting in a reduction in the instrument's natural defence against corrosion. This may lead to instrument stiffness and a reduction in its being fit for purpose. A non-water based lubrication to reduce the contamination risk can restore instrument function (Storr 2008).

Sterilisation of the instruments, once they have been inspected and are packaged, is the next step of the decontamination process. The correct packaging of sets and instruments has already been discussed earlier within the article. Moist heat sterilisation using steam under pressure is the sterilisation method of choice. If the instrument is known to be damaged by heat or moisture (such as flexible endoscopes) then ethylene oxide sterilisation may be preferred. Sterilisers must comply with HTM 01-01 (formerly HTM 2030) (DH 2007) and are validated and monitored regularly. Daily tests include a steam penetration test and an automatic control test. Until these tests have been carried out and passed, the sterilisers cannot be used.

Once sterilised, the instrument tray/supplementary is transported and returned to the theatre storage area where the instrument cycle starts again.

Conclusion

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 inter-professional team as demonstrated in the instrument cycle: surgeons, perioperative practitioners, those who transport the instruments and those who reprocess them. This article has focused on the role and responsibilities of perioperative practitioners in that cycle. 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.

Acknowledgements

My thanks to Karen Crouch, Assistant HSDU Manager, Crawley Hospital for her time and guidance.

References

Association for Perioperative Practice 2007 Standards and Recommendations for Safe Perioperative Practice Harrogate, AfPP

Association of Perioperative Registered Nurses 1997 Recommended practices for the care and cleaning of surgical instruments and powered equipment AORN Journal 65 (1) 124-128

British Standards Institute (BSI) 2006 BS EN ISO 11607-1: 2006 Packaging for Terminally Sterilized Medical Devices: Requirements for Materials, Sterile Barrier Systems and Packaging Systems Available from: www.bsi-global.com

CancerWEB 1998 Online Medical Dictionary Available from: www.cancerweb.ncl.ac.uk [Accessed 16 May 2008]

Department of Health 2002 The Medical Devices Regulations 2002 London, DH

Department of Health 2007 HTM 01-01 Decontamination of reusable medical devices London, DH

Department of Health 2008 NHS Decontamination Programme Available from: www.dh.gov.uk/en/ Managingyourorganisation/Leadershipandmanageme nt/Healthcareenvironment/NHSDecontaminationProgr amme/index.htm [Accessed 16 May 2008]

Fulbrook S 2007 Infection control legislation for medical devices Nursing Standard 22 (13) 51-54

Gibson D 2008 Decontamination in the dental setting Journal of Perioperative Practice 18 (7) 289-290

Gilmour D 2007 HCAIs: a statutory code of practice in England and Wales Journal of Perioperative Practice 17 (6) 266-271

Health and Safety Executive 1992 Manual Handling Operations Regulations Norwich, HMSO

Health Professions Council 2003 Standards of Conduct: Performance and Ethics London, HPC

Healthcare Commission 2006 Criteria for assessing Core Standards in 2006/07 London, HCC

Hurrell D 2005 Decontamination of Reusable Medical Devices In: Woodhead K, Wicker P (Eds) A Textbook of Perioperative Care Edinburgh, Churchill Livingstone

Lehtovuori A 2003 Specialised Packaging for Hospital Sterilisation Business Briefing: Global Healthcare

Medicines and Healthcare products Regulatory Agency 2006 Single-use Medical Devices: Implications and Consequences of Re-use London, MHRA

Meredith S, Sjorgen G 2008 Decontamination: back to basics Journal of Perioperative Practice 18 (7) 285-288

National Institute for Health and Clinical Excellence 2006 Patient safety and reduction of risk of transmission of Creutzfeldt-Jakob disease (CJD) via interventional procedures--IPG 196 London, NICE

NHS Executive 2000 Health Service Circular 2000/032 London, DH

Nursing and Midwifery Council 2008 The NMC Code of Professional Conduct: Standards for Conduct, Performacne and Ethics London, NMC

Spry C 2007 Care and Handling of Basic Surgical Instruments AORN Journal 86 (Suppl 1) S77-S81

Storr M 2008 Instrument lubrication risk investigated Clinical Services Journal 7 (3) 66-68

Correspondence address: diane.gilmour@afpp.org.uk

Diane Gilmour

RGN, PGCEA, BN, DANS, Dip Infection Control

Clinical Team Leader Crawley Day Surgery Unit, Crawley Hospital; Trustee, AfPP
Table 1 Instrument label indicating reprocessing information

* Date of sterilisation

* Expiry date

* Bar code identification

* Sterile indicator

* Destination

* Description of instrument/set and specific number

* ID number

* Location of sterilising unit and contact phone number

* Statement to say that 'this pack has been manufactured in
accordance with article 12 of council directive 93/42/EEC
concerning medical devices'

* Tear-off identification label including bar code to place in
patient's notes (additional tracking of instruments)

* Some facilities may also record the weight of sets for health and
safety guidance (manual handling operating regulations)
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Title Annotation:CLINICAL FEATURE
Author:Gilmour, Diane
Publication:Journal of Perioperative Practice
Date:Jul 1, 2008
Words:3328
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