Reducing cost of IEC 60601 3rd edition testing

[Peter Selvey]

There are some devices where usability issues could plausibly relate to employee injury, but that is the exception rather than the rule.

An example could be X-ray machine where the operator is exposed to risks of radiation exposure or mechanical injury. In such a case, the NRTL would be required to use IEC 60601-1-6, but only with respect to operator safety.

The NRTL could argue that it makes no sense to selectively apply IEC 60601-1-6 to just the operator, the responsible approach would be to cover both patient and operator.

But it is a perfect example because for patient safety, usability for such a device would be a extremely critical area, but the NRTL would be woefully out of it's depth, ending up rubber stamping the manufacturer's report (for a sizeable fee).

The claim that it would be irresponsible to exclude patient aspects is only plausible if the NRTL can take responsibility for the assessment. It would be irresponsible to write a report (and charge money for it) if the NRTL is not competent for the task.

 

[Mark Meer]

The NRTL could argue that it makes no sense to selectively apply IEC 60601-1-6 to just the operator, the responsible approach would be to cover both patient and operator.

Especially if they are considering operator safety from risk of liability suits!

The claim that it would be irresponsible to exclude patient aspects is only plausible if the NRTL can take responsibility for the assessment. It would be irresponsible to write a report (and charge money for it) if the NRTL is not competent for the task.

So how has it come to this? ...that NRTLs are peddling services for which they are not ultimately responsible and questionably competent? Is it really just an opportunistic money-grab by test-labs?

 

[Peter Selvey]

I think to be clear, for X-ray there are already a lot of protections in place for the operator according to collateral and particular standards, and in the context of usability, there is not going to be a lot of critical issues for operator safety related to usability.

However, in the context of patient safety there is a lot of stuff like making sure the user enters the correct setting, patient data, correctly stores the recording, correct timing of release of radiation etc. Even if user messes up the image/record so that the X-ray has to be done again it exposes the patient to unnecessary dose.

It is a huge difference between usability for operator safety and usability for patient safety, and I have absolutely no doubt the test lab would feel no sense of responsibility for the patient related usability aspects.

 

[Peter Selvey]

I should disclose here that I am stuck in the system and occasionally forced to write reports for these management system based standard like PEMS, usability etc (so far not in the NRTL context). I hate it, and would rather stick to concrete test standards with objective test methods and criteria. I am sure that my fellow test engineers feel the same.

From the point of view of the test engineer, the project often gets thrown at them as a package with the management system parts being more of an afterthought. There is little guidance from upper management how to handle or where the responsibilities lie. Everyone is fumbling through. On top of this, there has been a long standing practice of test labs rubber stamping manufacturer reports for areas outside of their competence, the justification being that it is necessary to make a complete report, everybody else does it, and everybody knows the test lab is just rubber stamping so it's OK.

So don't blame the test engineers

To some extent, there is a degree of complicity from manufacturers, and in that context it feels a bit like money laundering: they get the test labs to "wash" their in-house documents to make a nice looking test report to give to the regulatory agencies. That would be no problem, except that the in-house documents are usually surface level and rarely tackle the "pinch points" every medical device has.

It is not unlike the financial crisis, where financial auditors and credit ratings agencies were making huge amounts of money writing positive reports for stuff they don't understand.

The difference is that in medical, we are unlikely to see big crunch where the problems suddenly rise up. But I am confident that regulators will eventually clamp down on the practice ... it is only a matter of time.

 

[Mark Meer]

Good discussion. Nice to know others feel the same towards these management standards...

So don't blame the test engineers
To some extent, there is a degree of complicity from manufacturers

Yes, except that they are the ones making tons of $$ for reviewing documents and filling out checklists. ...Though I suppose if it weren't for companies being convinced the service is necessary, this wouldn't be the case... so ya, maybe fault is with manufacturers not knowing what is and what is not providing value.

But I am confident that regulators will eventually clamp down on the practice ... it is only a matter of time.

I'm skeptical. It seems that the general trend seems to always be towards more regulation, and consequently more involved testing requirements.

My feeling is that these management-based standards - such a usability - will (unfortunatey) become more-or-less de-facto required. In otherwords, like many other harmonized/consensus standards, although they are not strictly required, they have become so much a part of regulatory submissions that omitting them is sure to raise eyebrows of regulatory bodies, and just make the approval process more burdensome. Therefore, more and more manufacturers will just opt to get the rubber-stamp, and it will become a standard part of 60601 testing.