Requirements for Infusion System - Final.pdf

VISN 12 Infusion System Minimum Requirements for Acquisition Planning

Specifications for Central Core Component

• System devices must run on an operating system supported by the Operating System

Manufacturer and be in accordance with VA Directive 6550

• Must be FDA approved (Reference: Federal Food Drug & Cosmetic Act (Fd&C Act), Title 21 Cfr Parts 800-1299)

• Must be FIPS 140-2 certified with plan to transition to FIPS 140-3 (Reference: FISMA Federal Information

Security Management Act, Federal Information Processing Standards Publications 140-2 And 140-3 (FIPS Pub), VA Directive 6550)

• Must have wireless communication - (Reference: VA Directive 6550, Industry Standard According to This Publication:

ECRI. Evaluation Background: Large-Volume Infusion Pumps. Device Evaluation 2022 Mar 3.)

• Required to have Cerner capability (Reference: VA DUSHOM Memo 10022017 -- Electronic Health Record Modernization -

Biomedical Devices Clinical Systems and Software Integration); Cerner CareAware Device List Q1 2022 pages 7,8,9; ECRI Institute.

Infusion pump integration: why is it needed, and what are the challenges? [guidance article]; Health Devices 2013 Jul;42(7):210-21; aami-infusion-anthology-10-8-20.pdf)

• Must have automatic switching to battery power upon line-power interruption (Reference: ANSI/AAMI ES60601- 1:2012 “Medical electrical equipment – Part I: General requirements for basic safety and essential performance.”)

• Must have ability to run multiple infusions concurrently with minimal control units

• Must send infusion data wirelessly from equipment to central repository for analysis (Reference:

Joint Commission Policy: NPSG.03.06.01 – MM.08.01.01, PI.01.01.01, EPs 12, 13, Industry standard according to publication: ECRI.

Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

• Must have primary and secondary infusion modes (Reference: Industry standard according to this publication:

ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

• Must have a minimum warranty of 1-year parts & labor (Reference: Industry standard according to this publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

• Contractor cannot propose a device that does not have anticipated parts support for the next 10 years.

• Must be portable – transportable with battery backup (Reference: 8 hours (standard battery) 4 hours (wireless module) FDA-2006-D-0300 Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff

• Must be mountable to an IV pole (Reference: Industry standard according to this publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

• Service & Maintenance – o Must be cleanable with hospital grade disinfectant o Must come with manuals (user, service, maintenance) o Must provide manufacturer training and service onsite o Must provide training for clinical end-users, BioMed and pharmacy staff prior to implementation o Must have company staff on site during implementation o Must provide 24/7 phone line for troubleshooting o Must have parts to support equipment repair at VAMC

Modules:

Large Volume Pump (LVP)

• Must be FDA Approved (Reference: Federal Food Drug & Cosmetic Act (Fd&C Act), Title 21 Cfr Parts 800-1299)

• Must have FIPS 140-2 wireless capability

• Must be able to download drug library updates wirelessly

• Must be validated with Cerner’s CareAware smart pump programming, infusion management, and event management workflows (Reference: VA DUSHOM Memo 10022017 -- Electronic Health Record Modernization - Biomedical Devices Clinical Systems and Software Integration); Cerner CareAware Device List Q1 2022 pages 7,8,9; ECRI Institute.

Infusion pump integration: why is it needed, and what are the challenges? [guidance article]; Health Devices 2013 Jul;42(7):210-21; aami-infusion-anthology-10-8-20.pdf)

• Must have automatic switching to battery power upon line-power interruption (Reference: ANSI/AAMI ES60601- 1:2012 “Medical electrical equipment – Part I: General requirements for basic safety and essential performance.”)

• Infusion data sent wirelessly from equipment to central repository for analysis (Reference: Joint Commission Policy: NPSG.03.06.01 – MM.08.01.01, PI.01.01.01, EPs 1, 5, Industry standard according to publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

• Must have bolus capability

• Must have fluid resistance ingress protection

• Device must have flow rate specifications capability to range from 0.1-999 mL/hr. and in incremental rate minimum of 0.001 mL/hr. (Reference: Infusion Nurses Society Third Edition page 442 & 437; ECRI comparison chart: https://www.ecri.org/Components/HPCS/Pages/Infusion-Pumps,-Large-Volume.aspx?tab=2 ; ECRI publication: ECRI Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3)

• Must default to the Dose Error Reduction System (DERS) upon startup

• Must have free flow prevention mechanism

• Must have the ability to set manual parameters within drug library

• Must have anesthesia mode

• Must have ability to change to different drug libraries

• Must have secondary infusion capability

• Must have automatic switching to battery power upon line-power interruption

• Must have patient tampering safety feature

• Must have loading dose capability

• Must have alarm volume control and alarm momentary silence

• Must be cleanable with hospital grade disinfectant

Syringe Pump

• Must be FDA Approved (Reference: Federal Food Drug & Cosmetic Act (Fd&C Act), Title 21 Cfr Parts 800-1299)

• Must have FIPS 140-2 wireless capability

• Must be able to download drug library updates wirelessly

• Must be validated with Cerner’s CareAware smart pump programming, infusion management, and event management workflows (Reference: VA DUSHOM Memo 10022017 -- Electronic Health Record Modernization - Biomedical Devices Clinical Systems and Software Integration); Cerner CareAware Device List Q1 2022 pages 7,8,9; ECRI Institute.

Infusion pump integration: why is it needed, and what are the challenges? [guidance article]; Health Devices 2013 Jul;42(7):210-21; aami-infusion-anthology-10-8-20.pdf)

• Must have automatic switching to battery power upon line-power interruption (Reference: ANSI/AAMI ES60601- 1:2012 “Medical electrical equipment – Part I: General requirements for basic safety and essential performance.”)

• Infusion data sent wirelessly from equipment to central repository for analysis (Reference: Joint Commission Policy: NPSG.03.06.01 – MM.08.01.01, PI.01.01.01, EPs 12, 13, Industry standard according to publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

• Must have fluid resistance ingress protection

• Device must have flow rate specifications capability to range from 0.1-99mL/hr. and in increments of 0.1 mL/hr. (Reference: Infusion Nurses Society Third Edition page 442 & 437; ECRI comparison chart:

https://www.ecri.org/Components/HPCS/Pages/Infusion-Pumps,-Large-Volume.aspx?tab=2 ; ECRI publication: ECRI Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3)

• Must default to the Dose Error Reduction System (DERS) upon startup

• Must have free flow prevention mechanism

• Must have the ability to set manual parameters within drug library

• Must have patient tampering safety feature

• Must have loading dose capability

• Must be cleanable with hospital grade disinfectant

• Must have alarm volume control and alarm momentary silence

• Must be able to accommodate various syringe volumes (minimum 10mL & maximum 60mL volumes)

End-tidal Carbon Dioxide (EtCO2) Monitoring (capnography monitory function)

• Must be FDA Approved (Reference: Federal Food Drug & Cosmetic Act (Fd&C Act), Title 21 Cfr Parts 800-1299)

• Must have FIPS 140-2 wireless capability

• Must have automatic switching to battery power upon line-power interruption

• Must have industry standard default alarms

• Must be able to configure alarm settings

• Must have ability to silence, override alarms (anesthesia mode)

• Must have alarm volume control and alarm momentary silence

• Must be cleanable with hospital grade disinfectant

• Must include list of consumables required and starter supplies

Patient Controlled Analgesia (PCA)

• Must be FDA Approved (Reference: Federal Food Drug & Cosmetic Act (Fd&C Act), Title 21 Cfr Parts 800-1299)

• Must have FIPS 140-2 wireless capability

• Must be able to download drug library updates wirelessly

• Must be validated with Cerner’s CareAware smart pump programming, infusion management, and event management workflows (Reference: VA DUSHOM Memo 10022017 -- Electronic Health Record Modernization - Biomedical Devices Clinical Systems and Software Integration); Cerner CareAware Device List Q1 2022 pages 7,8,9; ECRI Institute.

Infusion pump integration: why is it needed, and what are the challenges? [guidance article]; Health Devices 2013 Jul;42(7):210-21; aami-infusion-anthology-10-8-20.pdf)

• Must have automatic switching to battery power upon line-power interruption (Reference: ANSI/AAMI ES60601- 1:2012 “Medical electrical equipment – Part I: General requirements for basic safety and essential performance.”)

• Must have low battery, depleted battery alarms

• Infusion data sent wirelessly from equipment to central repository for analysis (Reference: Joint

Commission Policy: NPSG.03.06.01 – MM.08.01.01, PI.01.01.01, EPs 12, 13, Industry standard according to publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

• Must have fluid resistance ingress protection

• Device must have flow rate specifications capability to range from 0.1-99mL/hr. and in increments of 0.1 mL/hr. (Reference: Infusion Nurses Society Third Edition page 442 & 437; ECRI comparison chart:

https://www.ecri.org/Components/HPCS/Pages/Infusion-Pumps,-Large-Volume.aspx?tab=2 ; ECRI publication: ECRI Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3)

• Must default to the Dose Error Reduction System (DERS) upon startup

• Must have free flow prevention mechanism

• Must have multiple infusion capability

• Must have patient tampering safety feature

• Must be cleanable with hospital grade disinfectant

• Must have accumulated dose limit monitoring

• Must have patient pendant for PCA dose requests

• Must have bolus capability

• Must have loading dose capability

• Must have alarm volume control and alarm momentary silence

• Must be able to accommodate various syringe volumes

Dose Error Reduction System (DERS)

• Must be FDA Approved (Reference: Federal Food Drug & Cosmetic Act (Fd&C Act), Title 21 Cfr Parts 800-1299)

• Must be configurable with soft limits, hard limits, and/or soft limits nested within hard limits

• Must have capacity to download drug library updates wirelessly

• Must utilize Integrating the Healthcare Enterprise (IHE) Integration Profiles for standardized communication with hospital information systems

• Must be able to customize DERS and drug library o Drug library and health record need to match what is in drug library in pumps

• Must allow medication drug library catalog updates to be wirelessly pushed to devices

• Must have ability to program custom dilutions for critical/dangerous medications

• Must have anesthesia mode to run without EtCO2 monitoring

• Must be able to program DERS limits and infusion devices which actively use DERS for:

o Medication doses ….

o Define minimum # of meds/care areas that need to be programmed (ECRI greater than

10 care areas needed)

• Number of drug entries is greater than 400

• With options for different care therapies (same drug different limits)

• Medication concentration limits

• Infusion rate limits

• Titration limits

• Continuous infusion limits

• Intermittent and secondary infusion limits

• bolus dose and loading dose infusion limits

• Patient weight for weight-based dosing

• DERS Software must be common across all pumps o PCA o Large Volume o Syringe

• Configurable soft limits, hard limits, and/or soft limits nested within hard limits o Configurable alarm volume limits o Configurable infusion pauses duration limits and delayed start duration limits o Configurable clinical alerts to clinicians to be acknowledged during infusion device programming (example “requires central line”)

• Must provide the following data analytics/DERS compliance reports:

o Med specific compliance and alert reports o Total rates of alerts by med

• Reports of meds with low use frequency and high alert rate

• Rates of overrides by med

• Infusion parameter specific alerts reports (dose-rate, concentration, duration alerts)

• Facility compliance o Programming outside of DERS o Event logs - In the event of patient incident or near miss/close call event logs need to be available

• Downloadable and printable after download using

MS office or Adobe PDF

• Events stored o Key presses o Dose limit o Key presses, program settings, alarms, volume infused, dose limit warnings, o All timestamped

• Must have DERS safety features available on infusion devices during network downtime

• Must be validated with Cerner’s CareAware smart pump programming, infusion management, and event management workflows (Reference: VA DUSHOM Memo 10022017 -- Electronic Health Record Modernization - Biomedical Devices Clinical Systems and Software Integration); Cerner CareAware Device List Q1 2022 pages 7,8,9; ECRI Institute. Infusion pump integration: why is it needed, and what are the challenges? [guidance article]; Health Devices 2013 Jul;42(7):210-21; aami-infusion-anthology-10-8-20.pdf) o Must provide the following EHR integration data analytics:

• Integration compliance (rate of usage of smart pump workflows)

• Auto-documentation mismatch

• Failed auto-programming attempts

• Adhere to IHE model for EHR infusion Pump Integration

• Must provide network security documentation:

o Provide a list of Ports, Protocols, and Services required for network communications.

Alarms & Indicators for Overall System

• Fault condition alarms

• Vein and line blocked

• Clamped secondary line alarm

• Air is in the line for LV, PCA

• Infusion completed alert

• Infusion near end

• Empty reservoir

• Flow error

• Set loaded improperly

• Empty syringe

• Plunger disengaged

• Filter replacement

• Pressure Sensor (high pressure/occlusion)

• Occlusion upstream and downstream o Less than 15 psi for downstream o Detection mechanism

• Door/latch open sensor

• System Malfunction

• Low battery/ Depleted battery

• Volume control capability

• Momentary silence less than 2 minutes

Pre-Deployment Requirements

• Must provide all necessary documentation to meet VA Directive 6550 and Enterprise Risk Assessment requirements o MDS2 for each component

• Topology Diagram

• Hardware/Software Inventory

• Provide a list of Ports and Protocols the systems use to communicate on the network

• 6550 Appendix A for each component

• Must follow all required VA Handbook 6500 requirements to provide remote support of server components of the system including but not limited to background investigations, MOU/ISA, PIV badge issuance, check-in requirements.

• Must provide a listing of any required Government Furnished Equipment (GFE) and/or software if required including but not limited to server specifications, workstations specifications, software prerequisites that would be necessary for the infusion system and its associated information support systems.

• Must participate in pre-implementation meetings with VA information security professionals to review system operation to obtain an ERA. A current ERA is required for these systems to operate on the VA network

Training and Support:

• Must certify local Biomedical Engineering staff to perform maintenance and repairs on all equipment.

• Must provide phone technical support during normal business hours 7am-5pm CT, Mon-Fri.

• Must provide a list of approved sources to purchase necessary repair parts to ensure equipment operates to original manufacturer specifications. Parts availability should be generally available next-day shipment.

• Must comply with current FDA regulations pertaining to Recalls and Medical Device correction

• notices (Reference: site FDA regulation -- https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/overview-device-regulation)

• Must provide training for clinical users o Initial training for frontline users will be onsite and conducted by company representatives o Remote training must be available over digital platform, recorded and available for future reference o Must provide access to clinical user education/reference materials via online company site and physical user manual and instructions for use. o Must have 1:1 support available o Must provide notices for software, IFU, user manuals updates o Must provide education on updates via company online site and physical user manual and instructions for use