SafeMesh for Clinical Safety
Clinical safety that runs in production, not in documents. Safety cases that cover boundary crossings. Compliance maintained continuously, not compiled for audit.
The Challenge
Clinical safety in healthcare is a document-based discipline. Hazard logs are spreadsheets. Clinical safety cases are PDFs. Compliance is demonstrated annually. Between audits, clinical safety is an assertion, not an observation.
DCB 0129 covers the manufacturer. DCB 0160 covers the deploying organisation. Nobody covers the space between them. When a clinical pathway crosses an organisational boundary, the clinical safety case has a gap exactly where risk is highest.
A 2025 study found low compliance rates with DCB 0129/0160 even within organisations that consider themselves compliant. Across organisational boundaries, compliance is effectively unmeasured.
What SafeMesh Does Here
Living hazard management
Hazard logs are maintained as living systems, not static documents. Hazards are linked to specific pathways, procedures, and boundary crossings. Risk assessments update as pathways change. Mitigations are tracked against real operational performance. When a new procedure is introduced or a boundary is modified, the hazard assessment updates before the change goes live.
Boundary safety cases
SafeMesh extends clinical safety cases to cover the crossings between organisations. For each material boundary, hazards are identified at the crossing point: what can go wrong when responsibility transfers, when clinical context moves between systems, when consent must be re-evaluated. Mitigations are defined as engineering controls where possible. The safety case for the boundary is always current.
Continuous DCB 0129/0160 compliance
SafeMesh maintains compliance across the full lifecycle: development, test, and production. Evidence is generated continuously as a by-product of normal operation. There is no annual compliance exercise because compliance is maintained as a running state. Manufacturer obligations (DCB 0129) and deploying organisation obligations (DCB 0160) are both addressed, including at the boundary between manufacturer and deployer.
LFPSE integration
Patient safety events are detected, classified, and reported as part of normal SafeMesh operation. Integration with the Learn from Patient Safety Events service (which replaced NRLS in June 2024) is built into the platform. Safety events at organisational boundaries — the most underreported category — are surfaced and reported with full governance context.
Post-market surveillance
SafeMesh supports continuous post-market surveillance. When a governed boundary is operating in production, safety performance is monitored continuously: adverse events, near misses, hazard mitigation effectiveness. This supports MHRA post-market surveillance requirements and provides evidence for DTAC compliance.
ALCOA+ compliance
All clinical safety evidence in SafeMesh meets ALCOA+ standards: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available. This is the MHRA GxP data integrity standard, applied to clinical safety records as a structural property.
For Clinical Safety Officers
CSOs are often asked to sign off on risks mitigated purely by training and procedural controls. "The clinician will be trained to check." "The user will be alerted." "The policy requires verification." This places an unfair burden on the CSO.
SafeMesh provides engineering controls that the CSO can point to: structural constraints that prevent harm regardless of human behaviour. The safety case is stronger. The CSO's exposure is reduced. The evidence is always current.
"The system prevents wrong-patient referral through bilateral identity verification at the boundary."
Not: "Clinicians are trained to check patient identity."
For CQC Inspections
When CQC asks about clinical governance, the evidence is already structured, traceable, and current. Hazard logs. Risk assessments. Mitigation tracking. Incident reports. Boundary governance performance. All linked, all auditable, all generated continuously.
No week-long evidence compilation exercise. No scramble to reconstruct the safety case. The evidence exists because SafeMesh generates it as part of normal operation.
The Clearing Metric
Clinical safety at organisational boundaries requires continuous evidence, not periodic review. The Clearing Metric provides the operational measure of whether governed transfers are actually completing.
Clearing Volume
Across all governed boundaries, how many responsibility transfers are currently unresolved? How many are generating open items in the boundary hazard log?
Clearing Age
How long has each unresolved transfer been waiting? Which have exceeded the threshold defined in the clinical safety case - triggering an active hazard?
Clearing Rate
What is the Clearing Rate across all governed boundaries? Where are the tail events - the transfers that exceeded their clinical threshold and require investigation under DCB 0160?
A Clinical Safety Case built on administrative controls cannot demonstrate continuous compliance. The Clearing Metric provides the engineering evidence that the governance is working.