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New Childrens Standards EN 50637:2017 Q&A Bakare® Compliance

New Childrens Standards EN 50637:2017 Q&A Bakare® Compliance

Introduction

The existing adult bed standard EN 60601-2-52 that most medical beds are CE marked to for typical sized adults, does not cover requirements for children and adults with smaller anatomies. The EN 50637:2017 standard seeks to ensure safety for young patients and adults who, because of their smaller body measurements and anatomies, have higher risks of being entrapped in medical beds and cots.

Background

In November 2017, a European standard was published that addressed requirements for the basic safety and essential performance of medical beds for children and adults with atypical anatomy. The European standard seeks to ensure safety for young patients and adults who, because of their smaller body measurements and anatomies, have higher risks of being entrapped in ordinary medical beds and cots. The need to have a European Standard on this topic arose following incidents and casualties caused by medical beds with cot sides. The victims were children and adults with an atypical anatomy.

EN 50637:2017 focuses on medical beds with both non-adjustable and electrical/mechanical adjustable functions, with an internal length of up to 180 cm. In line with the requirement of the mandate, it modifies and completes the existing standard EN 60601-2-52 ‘Medical electrical equipment – Part 2-52: Particular requirements for the basic safety and essential performance of medical beds’.

Definition of a Child Patient
A CHILD is defined in this context as a PATIENT having a physical size equal to or less than 155 cm and a mass equal to or less than 70 kg. Please note that the standards also covers adult users with atypical anatomy within this range.

Key Highlights of  EN 50637:2017

When did the standard come into effect?
  • The new children’s standard EN 50637:2017 came into effect from 30/8/2018 with conformance for any new beds sold required by 31/8/2020
  • Any beds supplied / sold for use by children or adults with smaller anatomy after 31/8/2020 should comply with the new standard but it is not law. 
  • Any existing beds in circulation supplied before 31/8/2020 do not need to meet the regulation – it is only for beds supplied after 31/8/2020.
What is new or different about this standard?

The EN 50637:2017 standard contains updates to EN 60601-2-52, mainly:

  • lateral strength of side rails
  • secure storage & lockout of handset
  • extra precautions against strangulation & entrapment such as sizes of feed tube holes or loose cables that could get wrapped around a child’s neck. 
  • labelling
  • instructions & warnings
What or who does the EN 50637:2017 standard apply to?
  • The new children’s standard EN 50637:2017 applies to cots and junior beds with an internal length of up to 180 cm suitable to a body length of up to 155 cm & mass < 70kg. 
  • It is not age related, so can include elderly dementia patients with smaller body anatomy. 
  • The limitation of 180 cm lying surface length is to reduce parents sharing beds with the child or the bed being used by an adult. However, if a bed can be used by both a child and an adult, e.g. length of 180 cm or 200cm, then it will need to conform to both adult EN 60601-2-52 and the children’s EN 50637 standard.
  • Please bear in mind that this is a pan European standard, covering everything from small cribs in ICU to junior beds in the community so some of the regulations are a little over the top in places.

Bakare® Beds’ Paediatric Products Intended Application Environments

  • APPLICATION ENVIRONMENT 3 long-term care in a medical area where medical supervision is required and monitoring is provided if necessary and ME EQUIPMENT used in medical procedures may be provided to help maintain or improve the condition of the PATIENT. NOTE This includes use in ADULT & CHILDREN’S nursing homes and in rehabilitation facilities.
  • APPLICATION ENVIRONMENT 4 care provided in a domestic area where ME EQUIPMENT is used to alleviate or compensate for an injury, disability or disease. NOTE This excludes use in all other APPLICATION ENVIRONMENTs (e.g. CHILDREN’S nursing homes and rehabilitation facilities) when a MEDICAL BED is purely designed for APPLICATION ENVIRONMENT 4.

Bakare® Beds’ Paediatric Products Intended Patient Groups

The beds are intended for use to provide postural compensation, relief and reduced risk from falls & impacts to disabled adults & children.

Bakare® Beds’ Products’ Compliance

Slight modifications to Bakare® Beds’ paediatric range have been performed in order to achieve the stricter requirements of the new children’s standards. These included:

  • secure storage & lockout of handset
  • extra precautions against strangulation & entrapment such as sizes of feed tube holes or loose cables that could get wrapped around a child’s neck.
  • increased labelling for user orientation & updated instructions & warnings

Klearside®

The Klearside® was originally conceived as an adult bed, CE Marked to adult standard 60601-2-52 but has since become an important part of our paediatric range in both adult 200cm & junior 180cm lengths. The Klearside® in 180cm & 200cm sizes is now additionally CE marked to the new children’s standard EN 50637:2017.

  • If the Klearside®  is being purchased for use by a child or small adult (body length of up to 155 cm & mass < 70kg), then it needs specifying when quoting and will be supplied in modified form in order to comply.
  • A risk assessment by qualified professional is still critical
  • Adult sales are unaffected as the Klearside® still conforms to adult standard in unmodified form
Klearside Low - Rainbow
Klearside® shown in standard form

Savi Cots

Our Savi Cots are fully compliant with new children’s standard EN 50637:2017.

  • The obvious difference is the mounting of the wooden locking box for the handset that needs to be fitted to the outside of the cot in an accessible position. Consideration of the location of the lockable box must be discussed when a cot is being specified, as sometimes due to space it might not be possible to locate on the head or foot end.
  • The locking box is NOT required for any cot specified for a user not considered a child i.e. exceeds 155cm & 70kg
  • Risk assessment by qualified professional is still critical
Handset Locking Box which forms part of modifications to conform to EN 50637:2017
Handset Locking Box which forms part of modifications to conform to EN 50637:2017

Conclusion

The new children’s standard EN 50637:2017 are a welcome development to promote & improve the safety & wellbeing of children. Please bear in mind that they are “one size fits all” pan-European regulations designed for situations from cribs in ICU to junior beds in the community. However, please be reassured that Bakare® Beds’ pediatric products offer compliance for your peace of mind.

If you have any questions at all, please get in touch.

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