We are a pioneer in the introduction of single-use instruments, continuing the company’s long tradition of innovation.
Launched in 2002 under the name of Instrapac®, the range has developed to become the brand of choice for numerous healthcare professionals throughout the UK, delivering high quality, reliability and value for money.
Until relatively recent time, reusable instruments were generally the only option for healthcare professionals. Following concerns on the potential risks of cross infection, plus a growing need for cost reduction, single-use instruments were introduced. They are now commonly used throughout the NHS, mainly for frequently performed or minor procedures. Single-use instruments now deliver real and tangible benefits to healthcare organisations and patients in three ways:
- Save money - reveal the hidden costs
- Save time and improve efficiencies
- Improve infection control - minimise risk
UK Production Facility
Almost all of our products are produced at a large UK manufacturing facility in Worksop, Nottinghamshire. Single-use instruments, which are classed as medical devices, are AQL inspected and hygienically packaged in a large Class 7 cleanroom, then sterilised in by Ethylene Oxide gas to meet rigorous quality standards.
Products comply with the relevant British Standards for surgical instruments and the quality control team ensure that products meet specification before being released for packing. All metal products are manufactured using medical grade stainless steel and plastic products are manufactured using biocompatible certified polymers. The Instrapac® range is packaged in high quality, easy to peel packs which feature indicators to verify that the contents are sterile. All procedure packs are presented wrapped in a sterile field for convenience.
We fully understand that a consistent and reliable supply of quality products is critical to the smooth and efficient running of healthcare services at the point of delivery.
Compliance with Legislation & 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, which make up a large proportion of the Instrapac® range, 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 Regulation.
Want to know more about Instrapac®?
Come and talk to us.
Instrapac® has been tried and tested over many years to become first choice for many clinicians, and our team of specialists will be able to help you with any enquiries you may have.