HSSU useful information
Frequently asked questions, useful links and quality assurance relating to our HSSU services.
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How frequent are deliveries and collections?
A schedule for delivery and collections can be designed to take in to account the required turnaround times and operational activity.
How do you ensure HSSU tools and equipment are handled and shipped correctly?
Delicate equipment is securely packed before being sterilised and transported in stainless steel, high strength, tamper-proof trolleys compliant with UN3291. This ensures negligible risk of damage to instruments, and reduced cost of instrument repair or replacement due to damage or loss.
How do you keep track of your tools?
All trays are bar coded and scanned in and out of customer premises where required, giving a full end-to-end audit trail and visible status monitoring of instrument inventory.
Will my instruments be treated separately?
Instruments are treated and segregated carefully, guaranteeing that customers get their own property returned, which helps maintains the integrity of your original instrumentation investment.
What if I require equipment at very short notice?
A generic pool of instruments is available for loan, which mitigates the need for fast track and/or reduces the requirement for new instrument purchases.
How will HSSU manage the transition from my existing provider?
We have a tried and tested mobilisation procedure. Providing a smooth transition from existing arrangements to the Nuffield Health HSSU Service. This enables you to maintain a 'business-as-usual' theatre scheduling during the transfer of the service.
- Institute of Decontamination Sciences (IDSc)
- The Association for Perioperative Practice (AfPP)
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- Association of British Healthcare Industries (ABHI)
Nuffield Health HSSUs are registered with the MHRA for the manufacture of sterile procedure packs.
• Compliance with all relevant legislation including EN 13485 (2003); ISO9001 (2008); Medical Devices Directive 93/42 EEC
• Bespoke specialised units
• Independently managed and financed
• A bespoke re-useable medical device (instruments) decontamination service from a purpose built unit at one of seven locations throughout England with access to fully supported and expert mobilisation and transition planning.
Our service is audited by the Notified Body SGS UK Ltd and identified as compliant with the following international standards and Directives:Medical Devices Directive 93/42/EEC (and amending Directive 2007/47/EC effective March 2010);
BE EN ISO 13485:2012 - Medical devices – Quality management systems – Requirements for regulatory purposes.
Nuffield Health HSSU risk management strategy is based on ISO 14971:2012 – Medical Devices – Application of Risk Management for Medical Devices
ISO 9001:2008 – Quality management systems – Requirements;
Audits are performed annually by the notified body SGS United Kingdom Ltd who are require to confirm our continued compliance with the MDD 93/42/EEC Article 12 Annex V.