How to Inspect Medical Devices Before You Accept Them: A Quality Manager's 6-Point Checklist

I'm a quality and brand compliance manager at a medical device company. Every incoming shipment crosses my desk before it goes to the floor—roughly 200+ unique items each year. In 2024, I rejected about 12% of first deliveries because specs were off, documentation was incomplete, or hidden fees had changed the final scope. This checklist is the exact process I walk through. It's meant for CPAP machines (including the ResMed AirSense 11), anesthesia machines, ECG monitors, and MRI coils—basically any device where "good enough" isn't good enough.

Use it whenever you receive a new device, whether it's a $200 mask or a $200k imaging system. The logic is the same.

Step 1: Nail down every specification in writing

When I send out a request for quote, I write the exact model, software version, consumables, and accessories. No shortcuts. "CPAP machine" is not a spec—or rather, it's a starting point, but not a spec. I need "ResMed AirSense 11 with heated humidifier, X nasal pillow masks, and Y full-face masks." If you need different masks for a ResMed AirSense 10, list each mask type and count. Same for anesthesia machines—specify gas modes, ventilator options, and monitoring modules.

And here's the part I've learned the hard way: ask "what's NOT included?" before asking "what's the price?" Training, installation, calibration, even the power cord—we once had a vendor quote a nice price for 12 ECG machines, then add $180 each for "lead set extensions." That's the kind of hidden cost that makes transparency my #1 criterion. The vendor who lists all fees upfront—even if the total looks higher—usually costs less in the end.

Step 2: Inspect the shipment before you sign anything

Once the truck arrives, don't just count boxes. Opening every package takes time, but I've seen what happens when people skip it. A batch of MRI coils looked perfectly sealed from the outside, but once we unsealed them, the connectors were scratched—evidence they'd been dropped during transit. The packaging was pristine, but the internal foam had broken. From the outside it looked new. The reality was shipping damage.

So: photograph the exterior of every box, note any dents or discoloration, and check that the model numbers on the labels match the purchase order. For a ResMed AirSense 10, I check that the masks are actually the ones ordered—nasal pillows vs. full face—because masks are often substituted by accident. It's boring, but it prevents painful recalls later.

Step 3: Run a functional test on everything

It's tempting to trust that new equipment works. Don't. I've caught out-of-the-box failures on every category below:

• CPAP machines: power on and check for error codes. For example, a ResMed AirSense 11 might show error code 12. Before accepting, ask the vendor for the reset procedure. If they can't give you one in writing, that's a red flag. (And if you're curious, most CPAP error codes are in the service manual—you should have it.)
• Anesthesia machines: verify gas supply connections, leak rates, ventilator function, and the backup battery.
• ECG machines: run the self-test, check lead signal quality and paper if it uses paper.
• MRI coils: connect each coil to the scanner, confirm the correct detection, and verify the signal-to-noise ratio.

This is also the time to test the "user-facing" side. When I received a new anesthesia machine last year, the numbers all looked right—but my gut said something was off. The touchscreen lagged. Turned out it was running old firmware from a previous generation. The data said OK; my gut said keep digging. Always check the version.

Step 4: Verify documentation and compliance evidence

This is the step most people skip, and it's the one that usually gets my reject stamp. For any medical device, you should receive at minimum:

• User manual and technical service manual
• Software version release notes
• Declaration of Conformity or FDA clearance letter, as applicable
• Serial number registry and accessory list

Check that every error code mentioned in the manual is explained. For a ResMed AirSense 11, I want to know exactly what error code 12 means and how to reset it. If the manual is silent, send the device back or demand the updated manual before accepting.

Also confirm the labels on the device itself. The lot/batch numbers should match the packing slip. Under FDA quality system regulation (21 CFR Part 820), acceptance records must be kept—so this isn't just an internal preference. It's a regulatory requirement.

Step 5: Call the service line before you need it

Here's a counterintuitive step: before you accept the equipment, call the vendor's support number and ask a question about the device. Not after installation—before. Ask about warranty coverage for a specific accessory. Ask whether replacement parts are shipped separately or need a technician. Note how long it takes them to respond.

I once accepted a batch of ECG machines because the quote was 15% below the incumbent vendor. A week later, I learned their service line only operated during business hours, and replacement parts cost an extra $50 per module plus shipping. The upside was savings; the risk was downtime. I should have calculated the total cost of ownership—including a service plan—before switching. Transparency about post-sales support is as important as transparency about price.

Step 6: Don't pay until the full checklist passes

It sounds obvious, but I've been pressured to release payment because "the equipment was needed yesterday." Resist. Payment is your only leverage before acceptance. I've made it a rule that no PO gets closed until Step 1 through Step 5 are all done. If the vendor rushes you, that's an even bigger reason to slow down.

So glad I held firm on that rule last August. A hospital order for 40 ResMed AirSense 10 units arrived with a mix of different masks, and one unit showed a repeated pressure warning. If I had signed off early, the customer would have received a device that cycled off mid-sleep—and the replacement masks would have been our cost.

Notes and common mistakes

Lowest price is rarely the true cost. A supplier that hides fees behind a low quote costs more in the long run. I've learned to ask "what's not included" every single time.

Don't skip functional testing. Even new, certified equipment can be damaged in transit or fail software integration. Always turn it on and run the self-check.

Check for proper storage conditions. Devices like MRI coils are sensitive to temperature and humidity. If equipment sat on a hot loading dock for hours, it may be out of spec even though it looks fine.

This checklist isn't perfect, but it's saved us from several expensive mistakes. And honestly, once you make it a habit, it takes less than an hour per device type. Worth it.