![CL-2022-000676 - [2025] EWHC 2486 (Comm)](https://backend.juristeca.com/files/emisores/logo_WAai98v.png){kind=logo}
The testing
The testing
Over the course of 2022, DHSC procured sterility testing on 120 gowns from Swann-Morton (Microbiological Laboratory Services) Limited (“Swann-Morton”) and 20 of the gowns from Synergy Health Ireland trading as Steris Laboratory Tullamore (“Steris”).
The Swann-Morton testing was carried out in two tranches of 60 gowns (30 being tested aerobically and 30 being tested anaerobically), with gowns of each size being tested:
The first tranche of 60 gowns was tested between April and June 2022. 26 out of 30 gowns failed the aerobic test; 29 out of 30 gowns failed the anaerobic test;
The second tranche of 60 gowns was tested between August and October 2022. 26 out of 30 gowns failed the aerobic test; 22 out of 30 gowns failed the anaerobic test.
Between November and December 2022, Steris also carried out (less detailed) microbiological identification. Of those 20 gowns, 19 were found to be not sterile.
- Heading
- This judgment was handed down by the court in person and by circulation to the parties’ representatives by email and released to The National Archives. The date and time for hand-down is deemed to be
- Sterility 101: An Introduction to sterility and Medical Device Law
- ISO 11137: Requirements of a Sterilisation Process
- Sterility level: EN 556
- Medical devices: MD Directive and MDR 2002
- Other relevant standards
- Summary
- Factual Background
- The PPE Cell
- The Recommendation
- The Essential Technical Requirements Document (“ETRD”)
- Precontractual Negotiations
- Closing
- Final Approval and Contract
- Manufacturing, delivery and inspection
- Rejection of the Gowns
- Testing of Gowns
- The Trial and issues
- The Contractual Claim
- The parties’ cases on construction
- The significance of the accepted obligation to deliver gowns with an SAL of 10 -6
- Was there breach of a requirement for a formally validated process in this case?
- Did the Contract require EN 556 or an Equivalent Technical Solution?
- Did the Contract require CE marking?
- The original case: Statistics, Physical Testing and Sterility
- Estoppel and related concepts
- Representation/assumption: clear?
- Approval of an ETS in place of EN 556
- Meeting the technical requirements/ No requirement to have a CE mark with an NB number
- Reliance
- Estoppel and validated process/SAL
- Non-Reliance and Entire Understanding Clauses
- Remedies
- Was the right to reject lost?
- Damages: The value of the Gowns and Mitigation
- Damages: The Claim for Storage Costs and Gown Disposal
- The Counterclaim
- Common mistake and rectification
- Negligent misstatement
- Conclusion
- Annex 1: Statistics, Physical testing and Sterility
- The testing
- Statistics
- The evidence and its implications
- The evidence gap
- Conclusion
- Annex 2: Relevant provisions of the Contract The Contract between DHSC and Medpro consists of a front page and several documents
- Order Form Section 5 of the Order Form “ The Supplier shall supply the deliverable described below on the terms set out in this Order Form and the Schedules and Annex A. Unless the Contract otherwise requires, c
- Section 7 of the Order Form is headed “Specification” and states: “The specification of the Deliverables is as set out in Annex A.1 – A.9 [26.06.2020]. Not as embedded/attached documents. Please confi
- Schedule 1
- Clause 2.2 of Schedule 1 states that the Order Form is to “ include, without limitation, the Authority’s requirements in the form of its specification and other statements and requirements, the Suppli
- Clause 3 of Schedule 1 is headed “ Quality assurance standards ” and states: “The following quality assurance standards shall apply, as appropriate, to the manufacture, supply, and/or installation of
- Conclusions