Top problems you face with medical device safety
Medical device and equipment service records should be traceable, verifiable and readily available. Instead, silos in your organisation and fragmentation across your ecosystem mean service histories are also siloed and fragmented. Meanwhile volume and complexity grow - as do the standards, guidelines and regulations for keeping your assets safe and in good order.
Barcodes, RFID tags and asset management databases can help, but still leave you sifting through a maddening mix of data, documents, workflows and systems.
You struggle to stay on top of recalls, field notices and safety alerts. You can’t respond quickly to software vulnerabilities or attacks.
You’re on your back foot when it comes to incident management or infection investigation and control.
You’re conducting high volume medical device reprocessing for surgical instruments, flexible endoscopes and other devices.
You need to evidence strong quality management systems and demonstrate adherence to governance, risk and compliance obligations defined by the FDA, MHRA, EU MDR or corresponding regulatory bodies in other jurisdictions.
Follow the line across the operating lives of medical devices and equipment.
All parties involved in medical device servicing record their actions on a secure registry to show appropriate actions have been taken timely.
Improve patient safety and clinical outcomes by ensuring medical devices and equipment are safe and in good order.
Canvass your inventory quickly, assess risks and take action on recalls, field notices and safety alerts.
Demonstrate adherence to policy, procedures and controls for quality management and governance, risk and compliance purposes.
The benefits of a new ‘middle ground’.
See the whole picture.
Spiritus’s permissioned, shared registry across parties provides service histories that are traceable, verifiable and auditable across an asset’s lifecycle.
Securely share key data.
Spiritus’s service records are verified, encrypted, tamper evident, and stored in a shared registry. This makes them highly resistant to fraud and attacks.
Take action quickly.
Our solution helps you target specific medical devices and equipment through timely alerts, geo-location services, data analytics, and robust visualisations.
Traceable, verifiable data and actionable insights.
Reduce risks by targeting recalls, faults, vulnerabilities or sources of infection.
Health technicians, clinical engineers, decontamination and sterilization managers and infection control specialists can:
Track and trace assets and issues more easily and accurately.
Take preventative and corrective action more quickly and efficiently.
Reduce costs and free up resource.
Reduce preventable injuries, complications and deaths.
Ensure and demonstrate compliance.
Records that are easier to cross reference against regulatory requirements, industry standards, recalls and other bulletins and guidance allow you to:
Quickly repair or upgrade vulnerable assets.
Prove to inspectors, auditors and regulators that proper checks have been carried out and controls are adequate and effective.