FOI release

FOI Request – Basis and timing of MHRA assessment (“not the same foam”) – Löwenstein WM090TD

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/00488

Received 4 May 2026

Published 6 July 2026

Request

I request information under the Freedom of Information Act 2000 relating to MHRA’s assessment of the Löwenstein prisma SMART max (WM090TD), specifically the statement communicated to me that the foam/material is “not the same” as that implicated in the Philips PE-PUR recall. This request is limited to recorded information held by MHRA at the date of search. 1) Basis and timing of MHRA’s “not the same foam” position Please provide any recorded information that states or explains: * the basis for MHRA’s conclusion that the foam/material in WM090TD is not the same as the Philips PE-PUR foam; and * the date(s) when this position was formed, reviewed, or communicated internally. This may include internal notes, summaries, emails, or correspondence referring to that conclusion. 2) Evidence relied upon Please provide any recorded information identifying the type of evidence MHRA relied upon to reach that conclusion, for example: * manufacturer statements or declarations; * notified body statements; * material descriptions or datasheets; * test evidence identifiers (e.g., ISO 18562 reports), if referenced. (Where documents are exempt in full, please provide titles/identifiers and dates, with redactions as appropriate.) 3) Assessment scope (device-specific vs model-level) Please confirm whether MHRA holds any recorded information showing that: * the assessment was device-specific (e.g., linked to a serial/lot/UDI-PI), or * the assessment was conducted at model/family level only. If held, please provide the recorded confirmation. 4) Foam/material change timing and implementation In light of information indicating a material/foam change (e.g. Polyester-polyurethane to Polytethylene-polyurethane) around late September 2024, please confirm whether MHRA holds any recorded information on: * change-control initiation/approval date(s); * implementation/effective date(s); * affected serial/lot/UDI-PI ranges; * any statement of from which point in 2024 devices would contain the new material. If held, please provide the recorded information (redacted as necessary). 5) Inter-regulator communications Please confirm whether MHRA holds any recorded correspondence or notes of communication with other regulators (including the Therapeutic Goods Administration) relating to: * the foam/material used in WM090TD; or * the assessment that it is “not the same” as Philips PE-PUR. If held, please provide such records (with appropriate redactions). 6) Market actions relating to earlier material configuration Please confirm whether MHRA holds any recorded information indicating: * whether devices with any earlier foam material configuration (prior to the 2024 change), that had the same foam or similar from the same or similar manufacturer of the foam, as a result of Philips CPAP medical devices recall due to PE-PUR Foams were withdrawn, restricted, or subject to corrective action in the UK; and * if not, any recorded rationale for no withdrawal/restriction in the context of industry concerns about foam degradation. 7) Breathing gas pathway / ISO 18562 evidence (identifiers only) Please confirm whether MHRA holds recorded identifiers for any ISO 18562 (or equivalent) evidence relied upon for this device family, including: * report title/identifier and date/version; * whether the evidence related to WM090TD specifically or a representative model; * whether the test boundary was device-only or system-level (device + tubing/mask/interface). (I am not requesting full confidential reports, only identifiers/scope information where held.)

Response

See attached

Documents

• Email correspondence (1) (redacted).pdf (149.5 KB)
• Email correspondence (2) (redacted).pdf (3.0 MB)
• FOI2026_00488 (redacted).pdf (2.5 MB)
• TGA email (redacted).pdf (451.4 KB)

This is Medicines and Healthcare products Regulatory Agency's response to a freedom of information (FOI) or environmental information regulations (EIR) request.

You can browse our other responses or make a new FOI request.