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  • 1.  Electric Homecare and Hospital Bed Standards for US, - Follow-up Voluntary versus Required

    Posted 11-Jan-2021 12:15

    Here is my follow-up question-

    My team and I were having a lively discussion regarding  FDA required versus voluntary  consensus standards for medical devices. In particular, we were reviewing the IEC electric standard requirement for homecare beds.  The general belief of the cross functional team was that these are voluntary and not currently implemented by the industry here or worldwide.

    I was wondering what the Regulatory community's thoughts were regarding the implementation of these voluntary IEC 60601 standards for medical devices, specifically homecare beds. 

    Thanks!



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    Patty Beja
    Manager, Regulatory Affairs
    Oceanside NY
    United States[
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  • 2.  RE: Electric Homecare and Hospital Bed Standards for US, - Follow-up Voluntary versus Required

    Posted 12-Jan-2021 01:53
    Yes, you will want to consider these voluntary standards as the FDA considers them important.  I can think of several reasons.  Risk reduction, the FDA has a guidance Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment you will want to consider, the 2 standards Edwin Bill's mentioned (both Edwin & myself are on the US standards committee) are something the FDA will want to consider as these are state of the art standards so these will help your cause and would be easier to support your case than not using them.  Would be harder to support your case without using the appropriate standards as not state of the art.

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    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
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    Original Message


  • 3.  RE: Electric Homecare and Hospital Bed Standards for US, - Follow-up Voluntary versus Required

    Posted 12-Jan-2021 09:27
    There are other reasons for applying a standard than regulatory mandates. Two of these reasons:
    • If you end up in court because your bed hurt somebody, you can point to your compliance with state-of-the-art safety standards as due diligence.
    • Prescribing physicians and healthcare organizations may require them. Your product may not be prescribed, or may not be compensated because of lack of compliance.


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    Fred Wittekind
    Advanced Codes and Standards Engineer
    Dubai
    United Arab Emirates
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    Original Message


  • 4.  RE: Electric Homecare and Hospital Bed Standards for US, - Follow-up Voluntary versus Required

    Posted 12-Jan-2021 09:34

    Most bed manufacturers are implementing the standards and monitoring or participating in the development of the new version of IEC 60601-1-52, which will be released as IEC 80601-2-52 as a joint IEC and ISO standard applicable to both manual and electric beds.  The new children's bed standard, will be released as IEC 80601-2-89 for the same application. The side rail entrapment requirements of the standards are applicable in any case. Earlier FDA had developed and implemented a guidance (2006) on siderail entrapment which were then implemented in the bed standard IEC 60601-2-38 current at that time which was replaced by IEC 60601-2-52. FDA shows 2-52 as the recognized bed standard on the product code database for FNL as one example. FDA expects this standard be used as one way to implement FDA's regulations for medical beds. 


    From a product liability perspective, implementing the standard is a good way to reduce awards in a case involving hospital bed safety. I need to reveal that I have been an expert witness in a number of these cases, and compliance with the standard is one of the first places the lawyers go. The awards in these cases often exceed any implementation costs. BUT the most important aspect is to make sure we are protecting patients and users from injury or death, and the standards provide many, if not all, of the safeguards needed. 



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    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
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    Original Message


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