Single Use / Reusable Surgical Instruments, Repair, Maintenance, and Recycling of Surgical Instruments

Concepts

• surgical instruments
• medical and surgical equipment
• repair and maintenance
• reusable surgical instruments lot
• single use / reusable surgical instruments
• single use instruments
• recycling of surgical instruments
• maintenance
• repair
• single use / reusable surgical instruments, repair, maintenance

Location

London

Description

The purpose of this notice is to draw attention to a procurement that NHS Supply Chain intends to commence during the subsequent 12 months for the Supply of Single Use / Reusable Surgical Instruments, Repair, Maintenance, and Recycling of Surgical Instruments. The scope of the intended framework covers Surgical Instruments including the following types of product ranges: Lot 1 – Single Use instruments & Packs Lot 2 – Reusable Surgical Instruments Lot 3 – Scalpel blades, Scalpel handles, and Disposable Scalpels Lot 4 – Repair, Maintenance Lot 5 – Metal Instrument recycling Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £16,600,000 to £21,500,000 in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement. The estimated value over the total Framework Agreement term (2+2 year term) is anticipated to be approximately £66,400,000 to £86,000,000 NHS Supply Chain expects to provide successful suppliers with the opportunity to offer additional savings to customers through the provision of discounted pricing, value added offerings and commitment/bulk buy initiatives. NHS Supply Chain intends to enter into arrangements under which it will be entitled to purchase supplies and/or services which it will make available for purchase by 1) any NHS Trust; 2) any other NHS entity; 3) any government department, agency or other statutory body and/or 4) any private sector entity active in the UK healthcare sector. Only NHS Supply Chain can order from the Framework Agreement and enter into contracts under it.

Lot Division

CPV Codes

• 33169000 - Surgical instruments
• 50420000 - Repair and maintenance services of medical and surgical equipment

Indicators

• Restrictions apply to the lot award allocation.

Other Information

The following certification will be a requirement of the upcoming tender exercise and Applicants may be required to include evidence of this within their tender submission: - ISO 9001: 2015 accredited by the United Kingdom Accreditation Service (or equivalent) to cover all segments of the Applicant’s and the product’s supply chain. This should include, but not be limited to, manufacturing, storage and distribution. If Quality Assurance Standard certificates are not in the name of the Applicant then the Applicant must supply a copy of agreements setting out the authority and responsibilities of all parties in the supply chain. - Declaration of Conformity and UKCA Certification to demonstrate compliance to UK Medical Device Regulations 2002 or Declaration of Conformity and CE Certification to d-Declaration of Conformity and UKCA Certification to demonstrate compliance to UK Medical Device Regulations 2002 or Declaration of Conformity and CE Certification to demonstrate compliance to Medical Devices Directive 93/42/EEC or Medical Device Regulation 2017/745 (where applicable). - MHRA registration of any medical devices, in compliance with the Medical Devices Regulations 2022 (SI 2022 No 618, as amended) (UK MDR 2022). - The Insurance set out below, acceptable evidence of which should be an Insurance Certificate or a signed Broker’s letter. > Employers liability Insurance cover of £5m per claim in the name of the Applicant > Public Liability Insurance cover of £5m per claim in the name of the Applicant > Product Liability Insurance cover of £5m in the name of the Applicant > Professional Indemnity Insurance cover of £5m in the name of the Applicant NHS Supply Chain will assess the Applicant’s economic and financial standing (or that of the entity or entities the Applicant is relying upon). Documentary evidence of this will be required at tender stage. All Applicants for this future tender must have a compliant Carbon Reduction Plan to be considered for the Framework Agreement (PPN 06/21). This future Framework Agreement will include some qualitative evaluation questions on Social Value with a minimum weighting of 10% towards the award (PPN 06/20). All Applicants bidding to be on any NHS Supply Chain Frameworks must submit an Evergreen Assessment as part of the tendering process. This must be completed annually, and the maturity score will be valid for 12 months. https://www.england.nhs.uk/nhs-commercial/central-commercial-function-ccf/evergr... As a minimum (and further requirements may be set out in the tender documents), Applicants are required to have 1) a Modern Slavery Assessment (MSAT) and 2) 3rd party modern slavery audits on your manufacturers assessing the International Labour Organisation's 11 indicators of forced labour, both completed within 12 months of the future tender close date (PPN 02/23).