MC3 48145 alternatives: how to run a safe substitution

MC3 48145 alternatives: how to run a safe substitution

A substitution-workflow guide for perfusion and supply-chain teams, current as of September 2026. It publishes no equivalence table, gives no clinical guidance, and makes no claim about any product's availability or discontinuation. When a…

MC3 48145 alternatives: how to run a safe substitution
Posted on by White, John

A substitution-workflow guide for perfusion and supply-chain teams, current as of September 2026. It publishes no equivalence table, gives no clinical guidance, and makes no claim about any product’s availability or discontinuation.

When a specific oxygenator is hard to obtain, the instinct is to look for “the equivalent”. In perfusion, that instinct is worth resisting, because the equipment it substitutes into is a circuit whose components were validated together and a care process governed by hospital change control. The useful deliverable is not a cross-reference table but a substitution workflow: how to establish what is genuinely interchangeable in your setting, and who has to approve it.

When an oxygenator substitute is a clinical change

Two oxygenators can share a design intent and still differ in ways that matter to a specific program: priming volume, surface area, coating, connection geometry, and the documented conditions under which they may be used. Because those differences can change how the circuit behaves, substituting one model for another is not a warehousing decision. It is a change to the circuit, and in most hospitals it engages the same process that governs any change to a clinical system.

That framing is what protects the buyer. It also explains why sellers who offer “equivalents” without documentation are not providing the thing the buyer needs.

Finding legitimate cross-references

Legitimate cross-referencing starts with the manufacturer, not the marketplace. The sources that can support a substitution decision are the ones that describe the products themselves:

  • The instructions for use for the product you currently use, which state its intended use and specifications.
  • The instructions for use for the proposed alternative, read against the same criteria.
  • The manufacturer’s own cross-reference or compatibility documentation, where one exists.
  • Your hospital’s clinical and technical change-control record for the circuit.
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A supplier’s claim that two products are equivalent is a prompt to look for the documentation, not a substitute for it. Where the documentation cannot be obtained, the honest position is that the substitution is unverified ¡ª regardless of how many sellers describe it as compatible.

Running hospital change control

Change control is where a substitution decision becomes a documented, approved change rather than an improvised one. The process varies between hospitals, but the inputs are consistent: what is being changed and why, what evidence supports the change, who has assessed the clinical and technical implications, what training or documentation follows, and what the fallback is if the alternative does not perform as expected.

Stage What to complete Who is normally involved
Establish the need Why the current product cannot be supplied, and over what period Supply chain with perfusion leadership
Assess the alternative IFU comparison against the criteria that matter for the circuit Perfusion with technical review
Approve the change Documented decision with the evidence attached Clinical governance or the hospital’s change-control body
Implement Documentation updates, staff briefing, and supply arrangements Perfusion and supply chain
Review Whether the change should be kept after the shortage The same group that approved it

Comparing availability and price in the secondary market

Once a substitution is approved, the commercial comparison can proceed ¡ª and it should be made on the same terms for every option: what is included, what documentation accompanies it, what the expiry position is, and what the lead time has actually been rather than what it is advertised as today. For single-use items, the lot and expiry information belongs in the comparison, because a cheaper carton with a short remaining shelf life is not cheaper.

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Where a purchase is being made to cover a shortage, price the continuity as well as the product: how much is needed to cover the period of uncertainty, and what the plan is if supply tightens further.

What to ask a seller instead

When a seller offers an alternative to a product that is hard to obtain, the useful questions are documentary rather than commercial: which product is being offered, by its full part number; what documentation accompanies it; which manufacturer’s cross-reference, if any, connects it to the product it is replacing; and what the expiry and lot position is for the stock on offer. A seller who can answer those four questions is giving you something a buyer can act on. One who cannot is offering a description.

It is also worth asking what the alternative was used for previously, and whether it is being offered as a one-off or as a continuing supply. A single carton that closes this month’s gap is a different proposition from a supply route that will be relied on for the next year, and the due diligence should match the duration of the commitment.

Red flags in substitute claims

  • “Direct replacement” with no documentation from either manufacturer.
  • A cross-reference table that lists part numbers without stating its source.
  • Claims that a product is discontinued or unavailable, presented without evidence.
  • Pressure to approve a substitution quickly because stock is limited.
  • No lot or expiry information offered for sterile single-use items.

Questions buyers ask

Can we use a different oxygenator while the usual one is unavailable?

Only through your hospital’s change-control process, supported by the documentation for both products. Shortages create pressure to move quickly, and that is exactly when an undocumented substitution is most likely to be proposed.

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Do we need to tell anyone after the shortage ends?

Yes. A temporary change should be reviewed when the pressure passes, so that the circuit configuration is a deliberate decision rather than a residue of the last shortage.

What should we do if a seller cannot provide documentation?

Treat the substitution as unverified and keep looking, or make the purchase contingent on the documentation arriving before the item is used.

Treat a substitution as a change to the circuit, document it, and review it afterwards. If you are sourcing perfusion components and want the records that travel with them, ask HHG for the documentation on a specific item, or browse the current perfusion listings. Related reading: how priming volume shapes oxygenator choice and the cardiac and perfusion sourcing guide.

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