Infusion pumps on hospital networks

Why this exists

A hospital does not buy one infusion pump. It buys hundreds, sometimes thousands, and they all light up on the same network in the same few weeks. Almost every hard problem in this domain comes from that fact, and almost nothing in a vendor evaluation addresses it.

There is no standard for this, and there is no notified body to ask. The one international technical report specifically on wireless medical device networks, IEC/TR 80001-2-3:2012, was withdrawn on 5 March 2024 and nothing replaced it. The governing FDA guidance on RF wireless technology in medical devices was issued in August 2013 and is still current. NIST, ECRI and AAMI publish excellent material on infrastructure and on cybersecurity. None of it operates at this level.

So these criteria are one practitioner's, built from forty years of doing it. They are not a standard and they are not a substitute for one. What they are is a list of questions that turn out to matter, most of which are buried in a specification nobody reads until the deployment is already unhappy. Ask them before the purchase order rather than after.

How to score

Rate each criterion 0 to 5 using the scale below. Each criterion also carries a weight from 1 to 5 reflecting how much it matters, shown as a small number beside it. Score = rating × weight, so a mediocre answer on something important still outranks a perfect answer on something trivial.

Sections A, B, C, D and F are claims, answered from a datasheet. Section E is measurement, answered by running a test. Where a measurement contradicts a claim, the measurement wins and the claim scores zero. Read Section E first when comparing two vendors. A device scoring high on claims and low on measurement is the worse choice, and it will give the better demonstration.

What to require from the vendor before scoring

A rating of 1 only means something if you defined what documentation you expected. Request all of the following in writing, at the RFP stage, before any of it becomes a negotiation.

• Network and security architecture document. Every port, protocol and direction for device, server and gateway. Data flow diagram. Where the trust boundaries are.
• Wireless radio specification. Chipset and module, supported standards and bands, transmit power, antenna gain and pattern, minimum RSSI and SNR for reliable operation, supported 802.11k/v/r, OFDMA, TWT, and the exact roam behavior.
• Manufacturer Disclosure Statement for Medical Device Security (MDS²), current version, for the actual model and software release you are buying.
• Software Bill of Materials (SBOM) for device and server, and the vulnerability disclosure and patch commitment that goes with it.
• IHE Integration Statement naming profiles, transactions, options and the Technical Framework revision. A profile list without those three is not a conformance claim.
• Cryptographic module validation certificates. Note that all FIPS 140-2 certificates move to the Historical List on 22 September 2026. Ask for 140-3.
• Deployment diagram naming every component that runs inside your perimeter. Ask for it by that name. For anything sold as cloud, this single document settles the architecture faster than an hour with the sales engineer.
• Attestation covering any vendor-hosted component. SOC 2 Type II or HITRUST, with the report date and the scope statement naming the service. A certification claimed without a scope is not an attestation. Ask in the same breath for data residency, the business associate agreement, and whether device and cloud logs can be forwarded to your own SIEM.
• Bandwidth and traffic characterization. Steady state per device, peak during a library push, and aggregate at your planned fleet size. If the vendor has never measured this, that is your answer to several criteria at once.
• Battery specification measured with the radio associated and reporting, not idle.
• Certificate and credential lifecycle procedure for a fleet, including what happens at expiry and how many devices need a human.
• Server sizing, failover design and measured failover time.
• Reference sites at comparable scale, with your EHR, that you may contact directly.
• Installation and validation plan, including what the vendor will measure at go-live and what they hand over as evidence.

Put the list in the RFP. The response to it is itself a measurement, and it arrives before you have spent anything.

Test equipment for Section E

The test schema in Section E is adapted from a 2008 methodology that used a laptop and an AirMagnet card. That entire product architecture is gone. AirMagnet WiFi Analyzer PRO and Spectrum XT were discontinued and left support on 31 December 2025. The line passed from AirMagnet to Fluke Networks in 2009, to NETSCOUT in 2015, to NetAlly in 2019. Ekahau went from Ookla to Accenture, closing 17 June 2026. Both major survey vendors have been through roll-ups, which is worth knowing before a hospital standardizes on either.

The methodology survived. The equipment did not. Current equivalents:

Devices under evaluation