Internal Reference Number: FOI_9066
Date Request Received: 26/11/2025 00:00:00
Date Request Replied To: 12/12/2025 00:00:00
This response was sent via: By Email
Request Summary: Skin biocide use
Request Category: Health
| Question Number 1: Which product or products does your Trust use for pre-surgical skin antisepsis? | |
| Answer To Question 1: Betadine and ChloraPrep | |
| Question Number 2: Which product or products does your Trust use for skin antisepsis prior to peripheral vascular cannula insertion? | |
| Answer To Question 2: ChloraPrep | |
| Question Number 3: Which product or products does your Trust use for skin antisepsis prior to central venous line or peripherally inserted central venous line insertion? | |
| Answer To Question 3: ChloraPrep | |
| Question Number 4: If any of these products are categorised as biocides, for the relevant product/s: a. Has the supplier confirmed Great Britain Biocidal Products Regulation (GB BPR) authorisation? b. Has the Product Type been declared (PT1 Human Hygiene) ? c. Does the Product Type match its use in your Trust? d. If you use the product outside the GB BPR and Product Type authorisation, describe the governance processes that approved this use in your Trust. e. Do the label and marketing materials make medicinal claims that trigger Human Medicines Regulations? f. Is a current Safety Data Sheet provided with the product? g. Are Instructions for Use attached/provided with the product? h. Are concentration, contact time, and application methods relevant to your use of the product clearly stated and clinically appropriate? i. Is compatibility with skin confirmed? j. For biocidal products used for pre-surgical skin antisepsis, is compatibility with surgical materials confirmed? k. Is clinical evidence available for the specific formulation and your use of the product? l. Does use of the biocide align with NICE guidance? m. If used instead of an antiseptic that has MHRA Marketing Authorisation (MA), describe the governance processes that approved the biocide use in your Trust. n. If you use a biocide for pre-surgical skin antisepsis, do you declare this to patients and obtain their specific consent for this? o. Have your received supplier warranty that regulatory claims and labelling are accurate? p. Does your Trust have an established reporting pathway to report adverse events or incidents linked to the biocide to the Health and Safety Executive? q. Does your Trust have organisational indemnity / insurance cover for harm attributed to the biocide? | |
| Answer To Question 4: a. Has the supplier confirmed Great Britain Biocidal Products Regulation (GB BPR) authorisation? - Yes b. Has the Product Type been declared (PT1 Human Hygiene)? - Yes c. Does the Product Type match its use in your Trust? - Yes d. If you use the product outside the GB BPR and Product Type authorisation, describe the governance processes that approved this use in your Trust. _ N/A do not practice this e. Do the label and marketing materials make medicinal claims that trigger Human Medicines Regulations? - No f. Is a current Safety Data Sheet provided with the product?- Yes g. Are Instructions for Use attached/provided with the product? - Yes h. Are concentration, contact time, and application methods relevant to your use of the product clearly stated and clinically appropriate? 鈥� Yes i. Is compatibility with skin confirmed? - Yes j. For biocidal products used for pre-surgical skin antisepsis, is compatibility with surgical materials confirmed? - No k. Is clinical evidence available for the specific formulation and your use of the product? - Yes l. Does use of the biocide align with NICE guidance? - Yes m. If used instead of an antiseptic that has MHRA Marketing Authorisation (MA), describe the governance processes that approved the biocide use in your Trust. We only use product as an antiseptic. n. If you use a biocide for pre-surgical skin antisepsis, do you declare this to patients and obtain their specific consent for this? Do Not Use o. Have your received supplier warranty that regulatory claims and labelling are accurate?- Yes p. Does your Trust have an established reporting pathway to report adverse events or incidents linked to the biocide to the Health and Safety Executive? - Yes q. Does your Trust have organisational indemnity / insurance cover for harm attributed to the biocide? - Yes | |
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