Are there any pulse oximeters made in USA?

Current production and manufacturing options for pulse oximeters in USA

There are many different types of pulse oximetry monitoring devices available worldwide. They differ in cost, durability, accuracy, and the variety of information they are able to provide.

The main issue is the use of oximeters in home settings. As a general guide, pulse oximeters are divided into three distinct groups:

• Finger probe pulse oximeters intended for personal use.
• Hand-held units or stand-alone units which focus just on oxygen saturation and pulse.
• Stand-alone units which incorporate other parameters, or blood pressure monitoring.

When considering the benefits and drawbacks of these various units, the general specifications must be considered.

Pulse oximeters made in USA

• Fingertip pulse oximeters
• Handheld pulse oximeter
• Pulse oximeter medical grade

Fingertip pulse oximeters

Finger probe pulse oximetry units intended for personal use

While no single unit might have all features in a single probe, these units are able to measure SpO2 and pulse as a waveform and a numeric digital display.

They often have an adjustable alarm, are light, robust, and can withstand adverse climatic conditions for use and storage. They frequently run on rechargeable batteries.

Currently, units of this type are available from US$20 to US$50. Some are priced as low as US$10.

While such a unit would appear to meet the basic requirements, it is difficult to determine performance.

For example, how often will it give a false reading (either an unnecessary alarm or no alarm when the set parameters have been breached)?

• Is the monitor easily tested for validity in its measurement?
• As most finger units do not have the option of using other probes, how long will the unit operate before failing?
• If it does fail are spare parts easily obtained so it can be repaired locally?
• Does it need to be returned to a distant location for servicing?
• How often will the internal finger probes pick up the signal correctly and how often will they fail?

Part of the reliability comes from USA production standards

• Have the units been produced to ISO standards? and manufactured under Good Manufacturing Practices according to external assessment?
• Do the units meet electrical and other health product certifications?

Finally, the units must be easily adopted by clinicians in a range of health settings.

• Are the units easy to use?
• How much training might they require to use?
• Have the settings been designed to be easily adjustable?

Handheld pulse oximeter

In general, these units meet all of the monitoring specifications that the finger probe pulse oximeters include and have some additional features.

The screen tends to be larger, brighter, and easier to read. There are extra alarms, for example, for low battery power and poorly positioned probes. The addition of a cable running from the probe to the readout device means the screen can be positioned at a distance from the patient and a variety of probes can be attached depending on need (e.g. infants or adults).

Both disposable and reusable probes are available; however, the annual cost of disposable probes is likely to far exceed the cost of the instrument itself.

The internal memory may be an added feature and can be useful to record patient data. Some have ports to allow printing of recorded data or downloading of information onto a computer.

Currently, prices range from US$100 –US$250 but may vary depending on the features of the machine. As with the finger probe units, performance, reliability, and ease of use must all be considered.

Pulse oximeter medical grade

Stand-alone pulse oximetry units: Such units meet all of the general specifications, as the finger pulse oximeters and small hand-held oximeters did, and have some additional features.

The screen tends to be larger, brighter and easier to read than the other types of units. There are more alarms and indicators, both audio and visual. The software is more sophisticated, reducing false negative or positive signals; thus the accuracy tends to be improved.

There are more power source options, with longer autonomous service. A wide variety of probes are available for use with these types of units.

• There is a greater ability to store data for multiple patients over longer periods of time.
• Multiple modalities may be included, such as blood pressure and EKG monitoring.
• They are less portable than the other units and are less resistant to mishandling.
• Currently, prices range from US$250- US$1000; very sophisticated units may be priced well above this range, however.

Ultimately the choice of units will be a compromise between utility, reliability, and price.

Surgeons and anesthetists working in hospitals with strong financial support will likely want sophisticated units and will often be able to afford them.

On the other hand, those working in low-resource settings will likely accept less expensive units if they meet their needs and bring them into compliance with monitoring standards.

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