Hi folks,

Another qustion raise here!!! Wondering that whether orthopeadic products (bone screw, plates, bolts, washer, etc.) are sterilized at the factory before deliver to hospital for use? Or it need to be sterlized in hospital but not the manufacturer???

Thanks

Tiffy....

Most of these items are intended to be used multiple times, thus must be designed to withstand the hospital's in-house decontamination and sterilisation processes.

As such they are typically supplied non-sterile, but should be issued with appropriate (validated) instructions for decontamination, sterilisation, and information on re-use limitations.

Most of these items are intended to be used multiple times, thus must be designed to withstand the hospital's in-house decontamination and sterilisation processes.

As such they are typically supplied non-sterile, but should be issued with appropriate (validated) instructions for decontamination, sterilisation, and information on re-use limitations.Do I understand you correctly that bone screws and other orthopedic hardware would be used more than once? That seems odd to me as once they are implanted, I thought, they remain in place. I think they are not reusable and would be supplied in sterile condition.

I'm not 100% sure on this, I'll check with my tech specialists in due course. There may also be country differences.

But it really wouldn't surprise me if these things are re-used where they are not patient-customised components - a major orthopaedic surgery equipment set doesn't look too different to what you would find in a car service centre.

Decontamination/re-use of (principally metal) surgery equipment is an integral part of any hospital as these surgical sets can be hugely expensive. It might be economical to throw some bits away, but if you are decontaminating the rest of the set anyway (and it would be uneconomical not to do so), you might as well do the nuts and bolts as well if they are still usable.


Of course, most of the public don't realise this, and might be shocked to learn about it, especially when they see pretty pictures of cleanrooms....

The entire Bone Fixation system to include bone plates, screws etc are usually supplied Non Sterile and have to be sterilised in the hospitals.

These are also single use devices and NOT to be re-used.

I am attaching product inserts from 2 suppliers for Bone Screws and Bone Fixation system, which illustrate this point. Refer to the sections on handling, sterilization etc.

Well it turns out we are both right. Or wrong. Or something. :D

Once used on a patient, these nuts, bolts, plates and screws etc are indeed discarded.

The obvious question is - if these are supplied for single-use, why are they not supplied sterile, in appropriate packaging....?

The answer is that they are (at least in the UK), unpacked and added to the rest of the surgical orthopaedic equipment tray. The equipment tray is subjected to continuous decontamination and sterilisation cycles for the reasons I described above.

The nuts and bolts are used as required, if not all used immediately, they go round the cycle again and again until they are.



The problems are that:
a) traceability of the nuts and bolts is usually immediately lost when they are "thrown into the mix".

b) there is a risk of cross-contamination. Thus whilst the nuts and bolts might arrive non-sterile, they may actually get more dirty, and biohazardous to boot.
(Yes, of course everything should be wonderfully clean and sterile, but the reality is sometimes different.)