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Minimise Risk of Infections

 

Instrapac: Improved Infection Control – Minimised Risk

 

Reusable instruments have to be thoroughly decontaminated before being re-sterilised and used again. This has a potential for cross infection if the instrument is not efficiently cleaned.

 

Indeed diseases transmitted by prions, such as vCJD, may not be completely removed by cleaning. Cases have also been publicised where unclean instruments have interrupted procedures.

 

Single use instruments greatly minimise the risk of infection as each instrument is new and never been used before. Therefore there is no risk of contamination by blood, tissue, bacteria, viruses or prions. Every single instrument goes through the sterilisation process and is guaranteed sterile. This offers peace of mind to clinicians and patients. The NHS also makes savings - treatment of surgical site infections (SSI) is estimated to cost £758 million per annum (2). Minimising infection risk by using single use instruments can help to reduce this cost to the NHS and save lives.

 

Compliance with Legislation and Standards

 

It is a legal requirement for all medical devices to comply with the Medical Devices Directive (MDD) 93/42 EEC and carry the CE mark. Regulatory requirements differ according to the risk attached to the use of the product. The lower the risk, the easier it is to comply with the Directive.

 

Single use instruments are relatively high risk as many are surgically invasive and therefore classified as lla devices. They are therefore subject to greater levels of control than reusables, which are Class l devices except those used on central nervous tissue. Class l devices can be sold without any authorisation from an independent third party – a Notified Body. Class lla devices such as Instrapac require a Notified Body to assess the production of the device to Annex lV, V or Vl of the Directive and issue a certificate of conformance before a CE mark can be applied and the product legally sold.

 

Certification by the British Standards Institution (BSI) verifies that Instrapac products meet fully the requirements of the Directive. Robinson Healthcare also complies with the following standards and has current certification as part of the CE marking process:

 

 

  • BS EN ISO 13485:2003 Medical Devices Quality Management System
  • BS EN ISO 14644-1:1999 Cleanroom Validation & Operation
  • HTM 2010 Steam Sterilisation Validation
  • MDD Annex V Production Quality Assurance
    This is the most critical document and is issued by a Notified Body. It demonstrates that the facilities and systems necessary to secure and maintain the sterility of a product meet the required standards.

 

 

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Notes:

(2) University Hospitals of Leicester, Clinical Services Journal Sept 2010

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