Hi,

I have a couple of questions relating to "compatible" pulse oximeter probes supplied by 3rd parties:

1). Can anyone tell me if there are any significant savings to be made by purchasing compatible probes for pulse oximeters (Nellcor, Datex-Ohmeda, Masimo, BCI, etc), or those used on multi-parameter monitors, from 3rd parties these days?

2). Do the probes from these 3rd parties meet the essential requirements of BS EN ISO 9919:2005 (Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use)?

Specifically:

Quote:


102 * Pulse oximeter probes and probe cable extenders

102.1 General

All pulse oximeter probes and probe cable extenders shall comply with the requirements of this International Standard, whether they are produced by the manufacturer of the pulse oximeter monitor or by another entity (“third party manufacturer” or healthcare provider) or are reprocessed.

Manufacturers of reprocessed pulse oximeter probes and probe cable extenders shall conduct tests to ensure that all pulse oximeter equipment specifications are met with each model of pulse oximeter monitor with which the pulse oximeter probe or probe cable extender is intended to be used.

In the accompanying documents, the manufacturer shall list all pulse oximeter monitors with which compatibility is claimed.

It is the responsibility of the manufacturer to validate their processes to ensure that any new or reprocessed product complies with the requirements of this International Standard.

Check the compliance by the tests of this International Standard.


102.2 Labelling

The model or type reference of at least one pulse oximeter monitor shall be supplied with each pulse oximeter probe, compliant with 102.1.

Statements shall be included with each pulse oximeter probe or cable to the effect that

 probes are designed for use with specific monitors,
 the operator is responsible for checking the compatibility of the monitor, probe and cable before use, and
 incompatible components can result in degraded performance.

See also 102.1.

Check the compliance by inspection of the accompanying documents.
EN ISO 9919:2005


I notice there are still companies offering "compatible" probes but I've never been able to get proof that these have met the required standard(s), e.g. required markings, documentation and validation of performance.

Irrespective of the fact that it's the manufacturer who's obliged to demonstrate compliance and give statements, to the effect that compatibility checks, i.e. validation, has been carried with specific devices, in the documentation supplied.

This standard does state that the operator is considered responsible for ensuring the compatibility of probes and interface cables with the oximeter. The "buck stops" with the operator who buys the "compatible" probe or extender cable it seems.

However it appears that any negligence on the part of the manufacturer in providing the required information, RE: full compliance with BS EN ISO 9919:2005, could leave purchasers of "compatible probes" or cables in an awkward situation.

Particularly if these probes and accessories do not come with the necessary documentation, or the manufacturer/supplier cannot subsequently give evidence that their clinical use has been validated, and there's a clinical or warranty issue.


Quote:

AA.102 Pulse oximeter probes and probe cable extenders

Pulse oximeter probes and probe cable extenders are as important in establishing the safety and accuracy of the complete pulse oximeter equipment as is the pulse oximeter monitor itself.

Clause 102 establishes that the manufacturer of the pulse oximeter probe or probe cable extender (including a manufacturer of a reprocessed pulse oximeter probe or probe cable extender) is responsible not only for the separately testable properties (such as biocompatibility) of the pulse oximeter probe or probe cable extender itself, but also for the affected combined properties (such as accuracy, electromagnetic compatibility, electrical safety, and protection against excessive temperature at the pulse oximeter probetissue interface) of the pulse oximeter equipment that the manufacturer specifies that the pulse oximeter probe or probe cable extender can be used with.

As an example of a possible effect of reprocessing on biocompatibility, glutaraldehyde sterilization of silicone rubber materials can result in impregnation of the material with solvent, which if not sufficiently removed by subsequent processing can cause a chemical burn when that process is not described (and therefore validated) in the accompanying documents.