Unique Methodology for Medical Device asset management with UDI coding

2. Device Management
Many Heath Care Facilities do not track Instruments and
other devices. Some devices only through a paper-based
method or work with Excel. Time-consuming process logging
of manual Entries.
Data becomes easily contaminated by uncontrolled logs.
Unable to accurately account for which devices were used for
a procedure, when or where an Device is misplaced.

3. Key Findings In Hospitals - Devices
• Poor conditions, past expiry date.
• Low quality parts that cause unexpected failures.
• Incidents go unseen without accountability.
• Devices used often uncalibrated.
• Second hand use of implants. (Actual found)
• Cases of deleted entries after adverse events.
• Devices disappear from Premises.
• Inefficiencies due to time consuming reporting of faults. Instrument and equipment checklist in Staff washroom

4. Key Findings
OT staff unable to register faulty equipment, due to no PPM planning
Services stopped or bypassed due to faulty equipment
Staff regularly reuse devices, no calibration found prior return in service
Emails – calls-hard copy repair requests, frequent fail to meet required time frame
Engineers and purchasing, spend large amount of time due to unplanned required work
Parts supply delay issues due to unplanned maintenance
Compromised procedure
outcomes
Patient Risk, Malpractice
Patient Risk -procedure
accountability
Patient Risk-procedure
accountability
High Cost HCF, budgets
Patient risk, High costs

5. Current Practice of Device Registration
• Our survey in 14 hospitals resulted with, zero (0)
availability of any Electrical Safety Tests or
Commissioning Test Reports.
• Predictive, Preventive Maintenance (PPM) planned via
Excel sheets.
• 2 facilities had a program--> However there was no
device history kept.
• Repairs and Maintenance record are hardly
traceable.
• 1 facility kept track of the devices through
their Biomed Engineer.

6. Currently the DME EQ-Manager is a unique new development
that is not available anywhere else in the world.
In order to manage a Device properly and meet International
Standards, a large amount of information is captured:
• Device Name & Picture
• Manufacturer & Primary Use
• Product attributes & Recommended Maintenance cycle
• Import & Origin paperwork
• Catalogues & Unique Barcode
• Supplier & Service Provider
• Repair & Test Reports
• Location of the device
• Risk Class & UMDNS
Solution: Digital Asset Management
All information is required to ensure there are no similar
looking items mixed up and all devices can be tracked for
re-calls or maintenance purposes.

7. Device Status
• Consistent control of status for
your devices.
• Color code status:
Green = OK
Blue = Upcoming PPM
Red = PPM or Repair Overdue

8. Device Work Order Repairs
• Work Orders per device
• Quick View Search
• Search Device
Repair History

9. Search Devices
• Search Filter : Device
Parts
Users
Work Orders
PPM’s
• Filter by date for Work order issued
and completed

10. Reports
• Devices added
• Work order issues and completed
• Adverse events

11. Manage Users
• Manage your users by user type to ensure
access of information is controlled
• Prevent user names and password
exchanges between staff
• Unlimited Users

12. Instrument Management Solution
Service &
Repair
New Device
Cleaning
assigning
Patient
connected
Patient
logging
Cleaning
assigning
Patient
disconnected
Inspected
Inventory
Inspected
Bar code
Registered
Supplier to
End user
Warehouse
End user
asset

13. Process Cycle
Vendor:
• Ensures Regulator verifies the device.
Enter database
with approval No.
Vendor
Healthcare Facility:
• Healthcare facility receives, adds to database,
commission device and take in use.
Healthcare Facility
Health Care Workers (HCW):
• Requests necessary Repairs
• Verifies repair upon return
• Biomed, plans required PPM
• Control Device status and repair flowHCW
Disposal/
Donate Ministry:
• Ensures proper disposal is guidedLife Cycler
PPM

14. The Results
High Control -
• Desired quality (patient safety, long lifecycle, lower costs)
• Tagged, traced, accountability (more cautious staff, fewer lost items)
• Maintaining inspection program (maintenance prevents patient injuries, long
lifecycle of devices)
• Disposed of properly (Patient safety, safe environment)
Healthcare
Safety
Best Practices Guaranty:
• No RSB are left behind (patient safety, prevent malpractice claims)
• Minimal incidence of hospital-acquired infection (HAI) due to defective or poor
quality instrumentation (patient safety, infection and malpractice prevention)
• Prevent adverse events
Best Financial Results:
• Cost efficient services, Optimal cost/quality ratio
• Guaranteed Accreditation of Device asset management

15. Thank you for your
kind attention.