How To Integrate Medical Devices



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Developing a Strategy for Integrating Medical Device Data with Clinical Information Systems

Developing a Strategy for Integrating Medical Device Data with Clinical Information Systems WHY NOW?

The Current Reality of Bedside Care

External Market Drivers for PCDI HITECH/ARRA incentives National healthcare reform & cost containment Patient safety focus Reimbursement pressures Patient acuity management in multiple settings Focus on mobile computing and all things wireless

External Market Drivers for PCDI IEC 80001 - voluntary standard focused on risk management of networked medical devices in hospitals Compliance requirements for hospitals, device manufacturers & IT infrastructure vendors IHE Patient Care Device Domain Use cases associated with patient care devices that communicate with another actor IHE & Continua announcement

Internal Hospital Drivers Adoption of sophisticated diagnostic and clinical care applications Deployment of technologically advanced medical diagnostic and treatment devices Drive to improve clinician productivity, quality and patient service Focus on next generation analytic and decision support systems Need to contain costs & improve ROI related to technology acquisitions

Benefits of PCDI Enhance quality of care & patient safety Documentation errors are significantly reduced or eliminated Nurses can review data collected when they are not present by the bedside Data is captured at increased frequency for a more accurate depiction of patient condition Rapid access to all data elements in EMR/CIS for clinicians across the enterprise Integrated systems can flag suspicious data (smart pumps & allergy alerts/ders)

Benefits of PCDI Improve productivity Reduces nursing time to manually enter high volumes of discreet data, particularly in high acuity intensive care units Nurses can validate rather than enter data Enhance staff satisfaction Automated data capture allows care givers to provide better patient care & support of family needs Nurse the patients, not the technology

Benefits of PCDI Integrated and interoperable devices will provide contextual awareness (www.mdpnp.org) Clinical decision support systems Smart clinical alarms Medical device safety interlocks Closed-loop control of medication delivery Remote healthcare delivery (home, battlefield, e-icu, etc.) Complete, accurate electronic medical records Hospital emergency preparedness Increased quality and completeness of national research databases

ROI & Field Studies MindGent Study: Addressing the Issues of Nursing Shortages and Patient Safety through Biomedical Device Integration Cost study extrapolated from a 150 bed hospital PCDI can save up to 2408 hours of nursing time annually (20 FTEs) Cost savings of up to $970,338 per year Rausch and Judd study: The Development of an Interoperable Roadmap for Medical Devices Projected savings of 50% of support staff charting time and 20% of practitioner charting time Associated with device-to-emr automatic charting and analysis of vital signs in the ED

ROI & Field Studies WellSpan Health (Pennsylvania) PCDI in ICU, ED & PACU Respiratory Therapy minutes saved per shift = 60 Registered Nurse minutes saved per shift = 30 (lower acuity ICU patients) UAB Health System RN minutes saved per shift = 175 225 (high acuity ICUs and PACUs) 20 seconds to verify data vs. 4 minutes to enter data (savings of 86,000 nursing hours per year) St. Johns MC (Wyoming) 60% time savings from importing rather than entering vital sign data More thorough documentation vital signs automatically charted every 5 minutes

Challenges Connectivity must be seen as in the service of tangible clinical benefits & productivity gains (e.g., connectivity is not plumbing ) Create a compelling vision for workflow automation to enable better patient care and safety, then translate that into implementation roadmaps for the organization This requires a lot of collaborative thinking and work across traditional departmental silos & with external partners From strategic vision to first implementation takes time about 2 years

Developing a Strategy for Integrating Medical Device Data with Clinical Information Systems One Provider s Experience

Overview Introduce Virtua Health Explain Motivation for Device Integration Review our Planning Process Create a Vision Assess Inventory and Database Define Data Needs and Clinical Workflow Prioritize Devices Evaluate Vendors Assess Network Assess Facility Create a Support Model

Located in Southern New Jersey Four Hospitals 975 licensed beds Specialized Programs of Excellence Long-Term Care Berlin 128 beds Mt. Holly 180 beds Ambulatory Ambulatory Centers (2) Satellite Emergency Room Surgical Centers (4) Health Fitness Centers (2) Home Health Physician Services 150 employed physicians Foundation Insurance Captive Nearly 8,000 employees Net revenue ~$1 billion

Coming Soon Ambulatory Services Center - Opens December 2009 Replacement Hospital 350 Beds - Opens Q1 2011

Virtua s STAR underpins everything we do. Excellent Service Clinical Quality & Patient Safety Outstanding Patient Experience Caring Culture Resource Stewardship Best People

Motivation for Device Integration Implementing an Enterprise Acute Care and Periop Clinical Information System Find ways to automate nursing workflow and get buy-in from nursing Device integration can save nursing time on documentation and ensure accurate, real-time patient data Received senior management and stakeholder support Considered a critical feature when evaluating CIS

Planning Process Create a Vision Assess Inventory and Database Define Data Needs and Clinical Workflow Prioritize Devices Evaluate Vendors Assess Network Assess Facility Create a Support Model

Create a Vision Determine the goals for device integration Enhance patient safety and quality of care - ensure accuracy of data, provide real-time patient data for clinical decisions, provide closed loop medication administration Increase nursing productivity Increase nursing satisfaction Facilitate alarm management Align strategic plan for device integration in Biomed, IT, Purchasing and Clinical

Assess Inventory and Database Start with a comprehensive biomedical database Make/model, serial #, biomed #, description End of life projection Firmware version IP address scheme Network diagrams Server information Communication/interface port Wireless capabilities Communication Protocol Data Output (type, frequency, elements, format) Technical Manuals Create a knowledge library Look for standardization opportunities

Define Data Needs and Clinical Workflow Assess current and future workflow with clinicians, HIM, biomed, IT and informaticists Define device data needs, storage, flow and validation approach Design CIS flowsheet and data display Map the patient identification and patientdevice association/disassociation process and perform risk assessment

Prioritize Devices A single hospital has thousands of medical devices Prioritize devices based on benefits you want to achieve Potential to improve productivity (amount and frequency of data gathering) Potential to improve quality of care (importance of realtime data for clinical decisions) Value of alarm notification (notification of medical device alarms to clinician devices)

Top Priority Devices Anesthesia machine BiPAP* BIS monitor Defibrillator** Fetal monitor Infant incubator Infusion pump Nitric Oxide delivery unit* PCA pump* Physiological monitor Specialty Bed* Spot Vital Signs Monitor Syringe pump* Telemetry** Ventilator *these devices have no connectivity ** these devices have limited connectivity

Nice to Haves 5 lead pneumogram Airway monitor Apnea monitor Arthroscopy pump Bladder Scanner Capnograph Cardiac Output monitor Continuous passive motion EEG monitor Electric bed Food pump Heated humidifier Holter monitor Hyperbaric chamber Hyperthermia Unit Hysteroscopy pump Insufflator Oxygen monitor Pulmonary Function Analyzer Pulse oximeter Scale Sequential compression unit Spirometer Thermometer Tourniquet Transcutaneous O2 monitor Wound vac * these devices have no connectivity

Device Integration Roll-out Plan Acute Care Periop ED Phase 1 (within 6 months) Phase 2 (within 1 year) Phase 3 (within 2 years) Phase 4 (within 3 years) - Physiological monitors and ventilators in critical care - Fetal monitors - Spot VS monitors in med surg - Infusion pumps - Incubators - Physiological monitors and ventilators in Periop - Anesthesia machines - BIS monitors - Pulse ox - Physiological monitors, spot VS monitors, and ventilators in ED

Evaluate Vendors Three types of device integration vendors Medical device manufacturer (often involve a gateway) Independent third party vendor Clinical Information System vendor Involve end users, biomed and IT to design evaluation criteria and testing

Vendor Selection Criteria Workflow requirements Backup and redundancy Barcode/RFID Security Capture 100% data output Management tools Frequency of data transmit Ease of maintenance (hardware, server, software) Wired/wireless solution Wireless roamability Driver development Device vendor-neutral Device manufacturer relationship Remote diagnostic capabilities Experience in healthcare IT and medical device industry Training Cost Robustness/reliability

Set up a Test Lab

Assess Network Work with IT and biomed to assess network infrastructure Identify all biomed and IT networks (either segregated or converged) Develop system-level network diagrams Assess bandwidth, capacity, wireless coverage, EMI, latency, redundancy, and scalability based on future state

Assess Facility Conduct a walkthrough with IT, biomed and facility Consider Data and power drops Environment for servers, network gear Physical space in patient care areas and closets to put device integration hardware Consolidation opportunities between biomed and IT closets

Create a Support Model Traditional Support Model Biomedical Device-related problems IT/Applications-related problems IT

Device data is not flowing into CIS... Who do you call? Fundamental integration point between Biomed and IT Santa Rosa Consulting 2008

Create a Support Model New Support Model Biomedical Clinical Systems Engineer IT Clearly define roles and responsibilities May need to create new processes Assess organizational structure Plan for cross training Form a partnership between IT and biomed

Summary Consider workflow throughout planning Create a strategic, multi-generational integration plan Need substantial planning effort, start as early as possible and get stakeholders involved Set up a test lab to effectively evaluate device integration solutions Prepare for collaboration and role changes in your IT and biomed departments

Questions? Marilyn Hailperin Associate Partner Santa Rosa Consulting marilynhailperin@santarosaconsulting.com Linda Chan IS Manager Virtua Health, Information Services lchan@virtua.org