! DOBS Is Not a Medical Device
DOBS is a documentation and record-keeping tool for care homes. It is not a registered medical device under the UK Medical Devices Regulations 2002 or the EU Medical Device Regulation (MDR 2017/745). It does not provide medical advice, clinical diagnosis, or treatment recommendations.
NEWS2 and GCS Calculations
DOBS calculates National Early Warning Score 2 (NEWS2) and Glasgow Coma Scale (GCS) totals based on the values entered by staff. These calculated scores are provided for reference and documentation purposes only.
- Scores must be verified by a qualified healthcare professional before any clinical action is taken
- DOBS does not validate whether the input observations are clinically accurate
- Incorrect data entry will produce incorrect scores
Escalation Alerts and Suggestions
DOBS may generate escalation alerts, safeguarding notifications, and observation level suggestions based on configurable rules and thresholds. These are advisory suggestions, not clinical directives.
- Alerts are triggers for staff to review and apply professional judgement
- No alert or suggestion from DOBS should override clinical assessment by qualified staff
- The absence of an alert does not mean there is no clinical concern
Clinical Decision-Making
All clinical decisions -- including but not limited to escalation to emergency services, changes in care plans, medication administration, and safeguarding referrals -- must be made by qualified healthcare professionals in accordance with:
- The care home's own policies and protocols
- Local NHS and integrated care system guidelines
- Professional body standards (NMC, HCPC, etc.)
- CQC fundamental standards of care
- The Mental Capacity Act 2005 where applicable
Data Accuracy
DOBS records data exactly as entered by staff. It does not independently verify the clinical accuracy of observations. The care home is responsible for:
- Ensuring staff are appropriately trained to record clinical observations
- Reviewing and auditing records for accuracy
- Correcting any errors identified through clinical governance processes
Intended Use
DOBS is intended to support care homes by providing a digital system for:
- Recording and storing body map observations for injury tracking and safeguarding documentation
- Logging clinical observations (vital signs, neurological checks, food and fluid intake) for continuity of care and handover purposes
- Generating structured records suitable for CQC inspections, local authority safeguarding reviews, and internal audits
- Facilitating read-only information sharing with designated family members
DOBS is not intended to replace clinical assessment tools, electronic patient record (EPR) systems, or clinical decision support systems used in acute healthcare settings.
Regulatory Position
DOBS has not been assessed or certified under DCB0129 (Clinical Risk Management for Health IT Systems) or DCB0160. Care homes should conduct their own clinical risk assessment in line with their governance framework before deploying DOBS in a clinical environment.
