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Surgical Instruments

The SMTL have been evaluating the quality of both reusable and single use surgical instruments for the Welsh NHS for several years.

These studies have usually arisen from adverse incidents within hospitals, however the SMTL have now developed a series of test methods using a team of highly trained laboratory staff, metallurgists, Welsh NHS consultants and UKAS accredited consultants. This now enables the laboratory to offer these services as a both as a preventative measure to monitor the current quality and to aid in the assessment of instruments when changes have been made by either the manufacturer or supplier. The laboratory offers the following services to the NHS and the medical device industry to test their products for specific sections of several standards:

 

BS 5194 – Surgical Instruments

BS 5194 are a suite of standards that specifies requirements for various surgical instruments. It is divided into multiple parts, each focusing on different types of instruments:

  • Part 2: Specification for instruments with pivot joints, excluding cutting instruments
  • Part 3: Specification for dissecting forceps
  • Part 4: Specification for scissors, shears, and other jointed cutting instruments

 

There is commonality between each standard part and several features of the surgical instruments are assessed including:

  • Materials - Component parts, rivets and screws
  • Hardness and heat treatment - Rockwell/ Vickers hardness
  • Corrosion resistance - Resistance to Copper Sulphate and resistance to boiling water
  • Design and workmanship – Assessment of key instrument features such as screw joints, box joints, jaws and needle holders
  • Surface condition - Surface finish and passivation final treatment
  • Packaging
  • Marking

 

BS EN ISO 7153-1 – Surgical Instruments – Materials – Metals

This standard specifies the metals commonly used to manufacture various types of standard surgical instruments. This standard is crucial for ensuring the quality and safety of surgical instruments used in general surgery, orthopaedics, and dentistry.

 

BS EN ISO 13402 – Surgical and dental hand instruments

This standard specifies test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion, and thermal exposure. Compliance to this standard demonstrates that surgical and dental instruments can withstand the rigorous conditions they are subjected to during sterilisation and include the following tests:

  • Autoclave test simulates the service environment and assesses resistance to corrosion
  • Boiling water test for corrosion resistance
  • Copper sulphate test to detect improper heat treatment
  • Thermal test to assess resistance to thermal exposure

In addition to testing to the above standards, the SMTL have worked closely with clinicians to devise instrument specific functionality tests which give our clients a more rounded view of their instrument’s operational quality.

If you would like further information or would like to discuss a tailored testing programme, then contact the SMTL smtl.info@wales.nhs.uk

 

Relevant Standards

  • BS-EN-ISO-7153-1, BS-5194-1 – Surgical Instruments - Stainless steel - Assessment of chemical composition
  • BS 5194-2 Surgical Instruments – Specification for instrument with pivot joints (excluding cutting instruments)
  • BS 5194-3 Surgical Instruments – Specification for dissecting forceps
  • BS 5194-4 Surgical Instruments – Specification for scissors, shears and other jointed cutting instruments
  • BS EN ISO 13402 / BS 7891 – Surgical and dental hand instruments – Determination of resistance against autoclaving, corrosion and thermal exposure