{"product_id":"care-home-medical-devices-equipment-maintenance-puwer-compliance-sop-template-enterprise-uk-edition","title":"Care Home Medical Devices, Equipment Maintenance \u0026 PUWER Compliance SOP Template | Enterprise UK Edition","description":"\u003cdiv class=\"sopstream-product-description\"\u003e\n  \u003ch2\u003eEnterprise Care Home Medical Devices, Equipment Maintenance \u0026amp; PUWER Compliance Governance SOP\u003c\/h2\u003e\n  \u003cp\u003eProtect service users from equipment failures, barcode tag and catalog 100% of medical and care devices, enforce annual Portable Appliance Testing (PAT) and biomedical calibration schedules, triage MHRA National Patient Safety Alerts within 24 hours, govern red-tag defect quarantine procedures, and maintain 100% CQC inspection readiness across your care facility with this enterprise-grade Standard Operating Procedure (SOP). Specifically engineered for UK care home operators to satisfy the \u003cstrong\u003eProvision and Use of Work Equipment Regulations 1998 (PUWER)\u003c\/strong\u003e, the \u003cstrong\u003eMedical Devices Regulations 2002 (UK MDR)\u003c\/strong\u003e, \u003cstrong\u003eMHRA Managing Medical Devices Guidance (2021)\u003c\/strong\u003e, \u003cstrong\u003eCQC Regulation 12 (Safe care and treatment - Safe equipment)\u003c\/strong\u003e, \u003cstrong\u003eCQC Regulation 17 (Good Governance)\u003c\/strong\u003e, and \u003cstrong\u003eUK GDPR\u003c\/strong\u003e requirements.\u003c\/p\u003e\n\n  \u003chr\u003e\n\n  \u003ch3\u003eKey Regulatory \u0026amp; Medical Device Highlights\u003c\/h3\u003e\n  \u003cul\u003e\n    \u003cli\u003e\n\u003cstrong\u003eCQC Single Assessment Framework \u0026amp; PUWER 1998 Parity:\u003c\/strong\u003e Establishes auditable medical equipment engineering workflows ensuring all diagnostic, therapeutic, and care devices are suitable, properly maintained, and routinely tested.\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003e100% Inventory Barcode Tagging \u0026amp; Traceability:\u003c\/strong\u003e Standardizes asset intake protocols, serial number logging, and digital Master Equipment Register maintenance for complete device life-cycle control.\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eAnnual PAT Testing \u0026amp; Clinical Calibration Schedules:\u003c\/strong\u003e Enforces electrical safety testing and biomedical calibration for diagnostic equipment (blood pressure monitors, pulse oximeters, syringe drivers, glucose meters).\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003e24-Hour MHRA National Patient Safety Alert Action SLA:\u003c\/strong\u003e Governs Central Alerting System (CAS) monitoring, rapid inventory cross-checking, and recall execution within 24 hours of notice issuance.\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eRed-Tag Defect Quarantine \u0026amp; Decontamination SOPs:\u003c\/strong\u003e Mandates immediate physical isolation of faulty devices in locked quarantine rooms and requires infection control decontamination certificates prior to off-site repair.\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eData Protection \u0026amp; Confidentiality:\u003c\/strong\u003e Complete UK GDPR Article 9 compliance for secure, role-based encryption of building asset portals, maintenance logbooks, and biomedical engineering reports.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003chr\u003e\n\n  \u003ch3\u003eWhat's Included in the Download Package?\u003c\/h3\u003e\n  \u003cp\u003eDelivered as an editable Microsoft Word (\u003ccode\u003e.docx\u003c\/code\u003e) document formatted with Executive Midnight Navy styling and standalone control templates:\u003c\/p\u003e\n  \u003cul\u003e\n    \u003cli\u003e\n\u003cstrong\u003eAppendix A:\u003c\/strong\u003e Master Care Home Medical Device \u0026amp; Equipment Register Template\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eAppendix B:\u003c\/strong\u003e Annual PAT Testing \u0026amp; Clinical Calibration Schedule\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eAppendix C:\u003c\/strong\u003e MHRA Safety Alert Triage \u0026amp; National Recall Action Log\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eAppendix D:\u003c\/strong\u003e Defective Equipment Red-Tag Quarantine \u0026amp; Decontamination Sheet\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eAppendix E:\u003c\/strong\u003e Equipment Governance Non-Conformance \u0026amp; CAPA Tracker\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eAppendix F:\u003c\/strong\u003e Annual Care Home Medical Device \u0026amp; Equipment Governance Review Form\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eAppendix G:\u003c\/strong\u003e Internal Care Home Medical Device Audit Checklist\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003chr\u003e\n\n  \u003ch3\u003eVisual Operational Status Badges Included\u003c\/h3\u003e\n  \u003ctable style=\"width: 100%; border-collapse: collapse; margin-top: 10px;\"\u003e\n    \u003cthead\u003e\n      \u003ctr style=\"background-color: #0F172A; color: #FFFFFF;\"\u003e\n        \u003cth style=\"padding: 8px; border: 1px solid #CBD5E1;\"\u003eStatus Tier\u003c\/th\u003e\n        \u003cth style=\"padding: 8px; border: 1px solid #CBD5E1;\"\u003eVisual Badge\u003c\/th\u003e\n        \u003cth style=\"padding: 8px; border: 1px solid #CBD5E1;\"\u003eMedical Device Protocol\u003c\/th\u003e\n      \u003c\/tr\u003e\n    \u003c\/thead\u003e\n    \u003ctbody\u003e\n      \u003ctr\u003e\n        \u003ctd style=\"padding: 8px; border: 1px solid #E2E8F0;\"\u003e\u003cstrong\u003eTier 1\u003c\/strong\u003e\u003c\/td\u003e\n        \u003ctd style=\"padding: 8px; border: 1px solid #E2E8F0; text-align: center;\"\u003e\u003cspan style=\"background-color: #DCFCE7; color: #15803D; padding: 3px 8px; font-weight: bold; border: 1px solid #22C55E;\"\u003e[ EQUIPMENT \u0026amp; PUWER OPTIMAL ]\u003c\/span\u003e\u003c\/td\u003e\n        \u003ctd style=\"padding: 8px; border: 1px solid #E2E8F0;\"\u003ePAT test valid, calibration current, asset tag verified, decontaminated; cleared for resident use.\u003c\/td\u003e\n      \u003c\/tr\u003e\n      \u003ctr\u003e\n        \u003ctd style=\"padding: 8px; border: 1px solid #E2E8F0;\"\u003e\u003cstrong\u003eTier 2\u003c\/strong\u003e\u003c\/td\u003e\n        \u003ctd style=\"padding: 8px; border: 1px solid #E2E8F0; text-align: center;\"\u003e\u003cspan style=\"background-color: #F0F9FF; color: #0369A1; padding: 3px 8px; font-weight: bold; border: 1px solid #0284C7;\"\u003e[ MAINTENANCE DUE ]\u003c\/span\u003e\u003c\/td\u003e\n        \u003ctd style=\"padding: 8px; border: 1px solid #E2E8F0;\"\u003ePAT test or calibration due within 30 days; biomedical service visit scheduled (\u0026lt;14 days).\u003c\/td\u003e\n      \u003c\/tr\u003e\n      \u003ctr\u003e\n        \u003ctd style=\"padding: 8px; border: 1px solid #E2E8F0;\"\u003e\u003cstrong\u003eTier 3\u003c\/strong\u003e\u003c\/td\u003e\n        \u003ctd style=\"padding: 8px; border: 1px solid #FEF3C7; text-align: center;\"\u003e\u003cspan style=\"background-color: #FEF3C7; color: #B45309; padding: 3px 8px; font-weight: bold; border: 1px solid #F59E0B;\"\u003e[ DEFECT \/ EQUIPMENT ISOLATED ]\u003c\/span\u003e\u003c\/td\u003e\n        \u003ctd style=\"padding: 8px; border: 1px solid #E2E8F0;\"\u003eEquipment defect logged or calibration expired; red quarantine tag attached; stored in quarantine room.\u003c\/td\u003e\n      \u003c\/tr\u003e\n      \u003ctr\u003e\n        \u003ctd style=\"padding: 8px; border: 1px solid #E2E8F0;\"\u003e\u003cstrong\u003eTier 4\u003c\/strong\u003e\u003c\/td\u003e\n        \u003ctd style=\"padding: 8px; border: 1px solid #FEE2E2; text-align: center;\"\u003e\u003cspan style=\"background-color: #FEE2E2; color: #B91C1C; padding: 3px 8px; font-weight: bold; border: 1px solid #EF4444;\"\u003e[ CRITICAL DEVICE BREACH ]\u003c\/span\u003e\u003c\/td\u003e\n        \u003ctd style=\"padding: 8px; border: 1px solid #E2E8F0;\"\u003eMHRA National Recall Notice issued, device injury incident, or un-tested electrical gear deployed; Board alert.\u003c\/td\u003e\n      \u003c\/tr\u003e\n    \u003c\/tbody\u003e\n  \u003c\/table\u003e\n\n  \u003chr\u003e\n\n  \u003ch3\u003eDocument Technical Specifications\u003c\/h3\u003e\n  \u003cul\u003e\n    \u003cli\u003e\n\u003cstrong\u003eDocument Code:\u003c\/strong\u003e \u003ccode\u003eSOP-CARE-DEV-DIR-2026-043\u003c\/code\u003e\n\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eFormat:\u003c\/strong\u003e Microsoft Word (.docx) — Fully Editable\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eJurisdiction:\u003c\/strong\u003e United Kingdom (CQC Regulated Social Care — England \u0026amp; Wales)\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eTarget Audience:\u003c\/strong\u003e Registered Providers, Registered Managers, Medical Device Safety Officers (MDSOs), Maintenance Leads, and Clinical Nurses.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\u003c\/div\u003e","brand":"SOPStream","offers":[{"title":"Default Title","offer_id":58215999897932,"sku":null,"price":49.99,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1068\/2997\/1788\/files\/ce9e78f4-205a-4f03-ab11-70c8729e7b38.png?v=1785040727","url":"https:\/\/sopstream.co.uk\/products\/care-home-medical-devices-equipment-maintenance-puwer-compliance-sop-template-enterprise-uk-edition","provider":"SOPStream LTD","version":"1.0","type":"link"}