Important announcement: Coroner’s recommendation regarding the risks of bed levers and side rail supports

Following the deaths of three elderly people over a three year period, coronial findings have recommended that no patients should be provided with a “metal hoop bed that carries a risk of head entrapment”, and has advised both ACC and DHBs to replace existing metal hoop bands with a “less risky model.”

In a report released in mid-February, Coroner Michael Robb recommended that “risky models” should be replaced with “three-bar bed levers with cord and cleat and a gap between the vertical bars of the lever handles between 60mm and 85mm.”

These findings are not consistent with current international standards
Coroner Robb’s ruling is not consistent with current international standards (refer below), which state that the recommended minimum gap between the vertical bars of the lever handles should be less than 120mm to prevent an adult head entrapment.*

As such, we are currently awaiting further clarification and advice from the Ministry of Health, ACC and NZ Standards to ascertain if Coroner Robb’s ruling will result in changes to existing standards.

Our side support rail equipment meets current NZ/AU and international standards
At Cubro we always put the safety and wellbeing of our clients and those using our equipment, first. That’s why we invest in robust Quality Management procedures which ensure our equipment adheres to all relevant NZ/AU and international standards.

We would like to assure our customers that our both our bed and side support rail equipment, meet the following standards:

  1. IEC 60601-2-52:2009 – Medical electrical equipment – Particular requirements for the basic safety and essential performance of medical beds
  2. ASTM F3186-7 Standard Specification for Adult Portable Bed Rails and Related Products. (This standard is acknowledged by the FDA as a Recognised Consensus Standard in regards to Plastic Surgery/General Hospital).

We will continue to provide equipment which adheres to these standards until we receive further advice from the Ministry of Health and/or Standards NZ. We will advise our customers if this ruling results in a change to current standards.

*Relevant international standards
We encourage everyone working in the health industry to familiarise themselves with relevant NZ/AU and international medical equipment standards.

For those interested in learning more, the International Standards relating to medical beds that Cubro comply with are as follows:

  • IEC 60601-2-52:2009 – Medical electrical equipment – Particular requirements for the basic safety and essential performance of medical beds
  • IEC 60601-2-52:2009 Amd 1 2015 – Amendment 1 – Medical electrical equipment – Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
  • IEC 60601-2-52:2009 Cor 1 2010 – Corrigendum 1 – Medical electrical equipment – Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
  • ASTM F3186-7 Standard Specification for Adult Portable Bed Rails and Related Products. It is on the FDA website as a Recognised Consensus Standard in regards to Plastic Surgery/General Hospital.

Seek qualified medical advice
We wish to express our deepest sympathies to all those impacted by these cases. They unfortunately highlight the importance of ensuring that a resident in a care facility, or a client in their own home has the correct bed rail support systems installed on their bed.

If you are providing care and are unsure about the correct installation of bed support systems or if your equipment meets required standards, we strongly encourage you to seek qualified medical advice. Raise any concerns immediately with your Occupational Therapist or Facility/Clinical Manager who can refer to the standards and the Ministry for guidance.

Occupational Therapists and Physiotherapists should complete a thorough risk assessment before prescribing equipment.

 

Get in touch

If you would like to further discuss this matter or have any safety concerns about your equipment, please feel free to contact us at any time on 0800 656 527 or email hello@cubro.co.nz