For HTM teams, parts sourcing decisions depend on far more than price or availability.

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By Alyx Arnett

Choosing between original equipment manufacturer (OEM) and aftermarket parts is rarely a simple purchase decision. For healthcare technology management (HTM) teams, it’s a judgment call that weighs patient risk, system performance, contracts, and whether the choice will stand up under scrutiny.

At Carle Foundation Hospital, Tim Seitzinger, CBET, a biomed tech III who works primarily in the operating room (OR), says parts decisions are more conservative in his department. “OR is pretty specific on parts,” he says. “That’s the high-acuity type of equipment.” He notes that vendors often require the use of their own components.

Still, OEM parts aren’t automatic. Seitzinger says cost, availability, and contract terms all factor into the decision. For lower-risk items—such as patient-room ECG leads or Doppler probes—third-party parts are used more freely.

Parts sourcing decisions, says Pujitha Gourabathini, manager of quality assurance and risk management at Becton, Dickinson and Company (BD), should start with understanding impact. “HTM teams should start by asking, ‘What does this part contribute to the system’s essential performance, and what is the downstream impact if it fails?’” she says. “Price is secondary to understanding the part’s risk profile and the consequences of failure.”

Risk-Appropriate Sourcing

Gourabathini notes that updates to the US Food and Drug Administration (FDA)’s Quality Management System Regulation place greater emphasis on risk-based controls and procurement. That shift, she says, means regulators are less concerned with whether a part is OEM or aftermarket than with whether a hospital can explain how the decision was made and demonstrate that safety and performance were evaluated.

“Regulators don’t prescribe which parts a hospital must use, but they absolutely expect organizations to be able to defend their sourcing decisions,” she says.

Against that backdrop, Gourabathini says HTM teams should take a “risk-appropriate sourcing” approach—matching a part to the level of risk it introduces into a device. Some components require tighter controls because even small deviations can affect performance.

Electronic components tied to essential performance—such as sensors, printed circuit boards, and power-related parts—often require OEM sourcing or suppliers that can demonstrate equivalent testing, controls, and traceability, she says. She also points to fluid-path components, including valves or tubing interfaces on devices like infusion pumps or dialysis systems, where failures can affect therapy delivery. Calibration- and measurement-critical components, such as pressure transducers and optical sensors, are another category where small differences can carry clinical consequences.

Other categories present lower risk. Cosmetic or nonfunctional plastics, such as housings or battery doors, typically do not affect device performance, making aftermarket parts “typically appropriate,” she says.

Compatibility Inside Complex Systems

Even when a part appears appropriate based on risk, compatibility within a specific system still has to be verified. Seitzinger recalls a case involving a HemoSphere cardiac output monitor. The facility tried a third-party cable intended to connect invasive blood pressure output to a GE monitor. “It did not work,” he says. The connection produced interference and artifacts, and the team ultimately ordered the OEM cable.

He does not generalize the experience to all aftermarket options, but says parts that seem interchangeable can behave differently once installed within a particular configuration. In an OR setting, where clinicians rely on clean waveforms and rapid troubleshooting, even minor signal issues can affect workflow.

Manufacturers describe similar considerations around system integration. Joe Matijow, vice president of product management and strategy at Siemens Healthineers North America, says quality variation can appear as “compatibility issues, a drift in image quality, the need for repeat scans, and unplanned downtime.”

Aaron Goryl, vice president of strategic service solutions at GE HealthCare, says the question is not only whether a replacement part fits mechanically, but whether the system returns to validated performance after installation. “Concerns could include performance variability, uncertain provenance, incomplete validation, and limited traceability. These could increase troubleshooting time and impact clinical disruption,” he says.

When the Paperwork Decides For You

In some cases, service agreements and warranty terms can limit what parts are allowed. Seitzinger says some of Carle’s agreements follow a “first look” model, allowing biomed to attempt repairs—but requiring the use of manufacturer parts.

On certain equipment, including some Alaris infusion pumps, that requirement is spelled out in the documentation. “We can’t send something in to get repaired if we have put a third-party part on it,” he says. “It actually says in the manual that if they can see a non-OEM part, they won’t return it,” he says.

Manufacturers say those requirements are tied to how their systems are validated and supported. Service programs, documentation, and performance guarantees are built around equipment being maintained with approved components, says Siemens Healthineers’ Matijow. He notes that service programs and documentation assume systems are maintained with “OEM-approved components and certified procedures” to meet safety, quality, and compliance expectations. He adds that full coverage contracts include OEM parts and delivery commitments built around validated system configurations.

GE HealthCare’s Goryl says mixing third-party accessories with certain systems “may void a warranty or create challenges in finding technical support.” He recommends aligning internal parts policies with contract terms and defining an exception process when non-OEM parts are considered.

What HTM Teams Can Test Themselves

When deciding whether to purchase a third-party option, Seitzinger will weigh lead time and price. “If we see the lead time is much shorter, the price is much better, we might get a couple of them and actually do testing prior to putting it in use,” he says.

The team will perform a full-function test whenever possible. For monitor cabling, they connect a patient simulator, let the system run, and intentionally create conditions that should trigger alarms or waveform changes, says Seitzinger. For internal components, the team may run a device at maximum load for a typical use period and then complete a full checkout to confirm the part works within their setup.

Seitzinger says evaluation also includes researching reported issues, reviewing industry coverage or user feedback, and checking with colleagues who have used the supplier. He reviews FDA recalls weekly. “If I see [a part] that has been on the FDA recall, I try to stay away from that one,” he says, adding that recall notices do not always reach the right people internally.

At Carle, that approach has led to ongoing use of some third-party components. For example, the team uses third-party filters on Philips V60 ventilators.

And What They Need From Suppliers

Even with internal testing, HTM teams often depend on supplier quality systems for assurance. Glenn Schneider, chief service officer at Elite Biomedical Solutions, says most departments cannot replicate manufacturer-level validation, making the supplier conversation critical.

He says HTM teams should ask how parts are tested, controlled, and tracked over time and look for certifications such as ISO 13485:2016 or ISO 9001:2015 and FDA registration. He says suppliers should also be able to explain their quality processes, including product controls, change management, and traceability from raw materials through shipment.

BD’s Gourabathini says hospitals should closely review the documentation that accompanies non-OEM parts. “Safety documentation is a core risk control,” she says. For higher-risk parts, teams should expect evidence of equivalent safety and performance testing, material compatibility documentation for components exposed to heat, fluids, or sterilization, and clear traceability such as lot numbers and change-control records.

“If a supplier can’t provide even basic testing data or traceability, that’s a strong signal that the part may only be appropriate for cosmetic or non-critical use,” Gourabathini says.

From the OEM perspective, GE HealthCare’s Goryl says teams often evaluate aftermarket parts against the three “Fs”: form, fit, and function. “The aftermarket part must look like the part being replaced, fit like the OEM part, and function exactly like the OEM part,” he says. He adds that teams should also consider factors such as recall history, return processes, and whether suppliers maintain credible quality systems and responsive support.

Bruce Yokley, senior vice president at Ozark Biomedical, says ISOs “should absolutely test everything they touch.” He describes his company’s process as including multiple quality-control steps and unit testing under load before parts are shipped. Ozark tracks failure rates and shares that documentation with customers, Yokley says, while acknowledging that it is “virtually impossible to eliminate all failures.”

Software, Firmware, and Cybersecurity

Parts decisions become more complicated when hardware interacts with software or affects how a system is validated and serviced. Siemens Healthineers’ Matijow says HTM teams should treat hardware and software as one configuration. “Parts selection should consider firmware versions, safety interlocks, calibration routines, and remote service capabilities that depend on OEM components,” he says. 

Goryl says teams should treat parts selection as “a system integration decision, not a component swap,” as many parts now include embedded logic, calibration data, or firmware dependencies. “The question becomes, ‘Is this part compatible with the system’s version of software? Will the part disrupt any proactive or predictive capabilities?’ And for some parts, the system will reject the part as non-compatible and could, potentially, impact system performance,” he says. 

The safest approach, he says, “is to verify that the part is approved for the specific configuration, that it supports the required software features, and it preserves any embedded monitoring or analytics functions that the facility relies on.”

Gourabathini says these considerations also extend to cybersecurity. For networked or software-driven devices, parts sourcing has “a cybersecurity dimension.” Components that store, transmit, or interact with data—such as network interface cards, communication modules, wireless transceivers, RFID-enabled components, and storage media—can introduce vulnerabilities if they are not properly vetted, she says.

“It needs to be assured that replacement parts maintain the device’s cybersecurity posture and don’t introduce untested software or firmware interactions,” she says.

Beyond OEM vs ISO

Mature sourcing programs don’t treat each parts decision as a one-off, stakeholders say. Instead, they establish clear rules for how parts are evaluated, approved, and documented. “The decision framework should begin with patient safety, then uptime impact, then cost,” says GE HealthCare’s Goryl.

Gourabathini emphasizes a risk-based framework. “Parts sourcing is not a procurement exercise; rather it’s a risk-based decision,” she says. That means tiering components by their impact on safety and performance and documenting why a particular choice was made.

“When HTM teams adopt that mindset, the conversation shifts from ‘OEM vs ISO’ to ‘What level of assurance does this part require based on the risk it introduces?’” she says. “That’s where organizations start to build sourcing strategies that are safe, compliant, and sustainable.” 

For Seitzinger, the framework ultimately comes down to something simpler. “My teacher told me to work on each piece of equipment like it’s going to be put on your family member—if you’d trust it for them,” he says.

Alyx Arnett is chief editor of 24×7 Magazine. Questions or comments? Email [email protected].

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