ISO 13485 in Hospital Central Sterilization and Clinical Engineering Services

R

Roland Cooke

#11
WARNING! - these checklists for HSDUs/CSSDs are VERY old, almost certainly obsolete in many sections.

A considerable number of hospitals within the UK NHS fell under the remit of the MDD because they offered commercial decontamination/sterilization services to organizations outside of their legal entity. Healthcare facilities are otherwise typically excluded from the MDD.

One checklist was developed by the MDA (the forerunner to the UK MHRA), the other was an unofficial draft developed by SGS.

Nonetheless, even though they are very antiquated the checklists provide some useful insight into the (previous) expectations for the QMS of hospital decontamination/sterilization departments, and could likely be updated without too much effort.
 

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xcanals_tecno-med.es

Involved In Discussions
#12
:agree1: Finally I found a Clinical Enginnering Dept certified:

http ://www .uhbristol.nhs.uk/memo/quality-assurance - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

MEMO Medical Equipment Management Organisation
MEMO is a NHS department registerd with the British Standards Institution (BSI) for meeting the Quality Assurance Standard BS ISO 13485 accreditation for the management of medical devices.

The services they offer are compliant with internationally recognised standards such as IEC60601 Medical Electrical Equipment Requirements for Safety. MEMO services also follow the Medicines & Healthcare products Regulatory Agency (MHRA) recommendations; “DB 2006(05) Managing Medical Devices - Guidance for healthcare and social services organisations”, in relation to the NHS Core Standards for better health.

Regards
 
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R

RA Princess

#14
Hi

Sorry I'm a little late in posting but I currently work with two UK hospital sterilization departments that are certified to ISO 13485, one of which has been for the past couple of years the second is currently going though the certification process.

I agree with Roland's comment in that they have done so because they fell under the remit of the MDD because they offered commercial decontamination/sterilization services to organizations outside of their legal entity.

Regards
 
B

Bill Marshall

#15
I'm also working with a number of sterile services departments in the UK.

My understanding is that all NHS departments now fall under the scope of the Directive, even if they don't put their product on the market.

The MHRA (who are responsible for implementing the Directive) say in their Medical devices Directive Bulletin 8 that all devices will have to be CE marked (ie comply with the requirements),

Regulation 12 of the 2009 Regulations (regulated by the Care Quality Commission) says that appropriate standards of cleanliness and hygiene must be maintained in relation to reusable devices.

I've always found 13485 an ideal reference document for the development of formal management systems in TSSUs and SSDs and most professionally run departments already comply with most of the requirements.
 
B

Bill Marshall

#17
I've never kept copies of my clients certificates, so this would take a few days to organise and I'm not sure how it would help. Is there something in particular you wanted to know about the certificates or the approach we've taken ?
Perhaps you can clarify.
 

xcanals_tecno-med.es

Involved In Discussions
#18
I've never kept copies of my clients certificates, so this would take a few days to organise and I'm not sure how it would help. Is there something in particular you wanted to know about the certificates or the approach we've taken ?
Perhaps you can clarify.
I'm promoting the certification for the Clinical Engineering and Central Esterilization Dept's and the example of success are even appreciated
Please see some examples of certificates in the facebook page:

http://www.facebook.com/#!/pages/ISO-13485/112554172095503

you may see distributors, hospitals, servicing, translators, ...

Regards

Xavier :thanx:
 
B

Bill Marshall

#19
Thanks for the link, I'll pass it on and let my clients decide whether to upload their certificates.

I'm curious about the translators with a 13485 registration, can't see how any of their processes would warrant it rather than 9001...
 
R

Roland Cooke

#20
Thanks for the link, I'll pass it on and let my clients decide whether to upload their certificates.

I'm curious about the translators with a 13485 registration, can't see how any of their processes would warrant it rather than 9001...
It's part of the manufacturing process for medical devices, and thus needs to be controlled, not least because there is often complex clinical and technical terminology involved.

Thus for medical device companies the translation process usually gets validated, or a competent translation agency is used. ISO13485 provides evidence of control and competency that your best friend's allegedly-bilingual cousin might not readily be able to provide. :)
 
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