Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Dear RAPS members,

Our organization is looking for standards and regulations for medical beds connected to an application that allows display of bed/patient status including nurse call and patient data (name, weight). I am also looking at confirming that bed remains Class I device. Any help and input will be greatly appreciated.

Thank you in advance!

Hi there,

Health Canada has a risk-based classification scheme, so your extra features may bump you up from Class 1. There's an old keyword index (2006) that shows hospital beds have been assigned to all 3 classes, depending on their claims. 

Health Canada also has a guidance document on Adult Hospital Beds: Patient Entrapment Hazards, Side Rail Latching Reliability and other Hazards that outlines some testing you should perform to comply with regulatory requirements. It is based on the US FDA guidance "Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment". 

I hope that helps. Your product sounds cool!
Karen

------------------------------
Karen Long RAC
Vancouver BC
Canada
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Original Message:
Sent: 21-Feb-2019 18:05
From: Anonymous Member
Subject: Patient data transfert and Nurse Call Sys. in Brazil/Canada

This message was posted by a user wishing to remain anonymous

​Dear RAPS members,

Our organization is looking for standards and regulations for medical beds connected to an application that allows display of bed/patient status including nurse call and patient data (name, weight). I am also looking at confirming that bed remains Class I device. Any help and input will be greatly appreciated.

Thank you in advance!

This message was posted by a user wishing to remain anonymous

It does help! Thank you very much Karen!​
Original Message:
Sent: 22-Feb-2019 14:50
From: Karen Long
Subject: Patient data transfert and Nurse Call Sys. in Brazil/Canada

Hi there,

Health Canada has a risk-based classification scheme, so your extra features may bump you up from Class 1. There's an old keyword index (2006) that shows hospital beds have been assigned to all 3 classes, depending on their claims.

Health Canada also has a guidance document on Adult Hospital Beds: Patient Entrapment Hazards, Side Rail Latching Reliability and other Hazards that outlines some testing you should perform to comply with regulatory requirements. It is based on the US FDA guidance "Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment".

I hope that helps. Your product sounds cool!
Karen

------------------------------
Karen Long RAC
Vancouver BC
Canada

Original Message:
Sent: 21-Feb-2019 18:05
From: Anonymous Member
Subject: Patient data transfert and Nurse Call Sys. in Brazil/Canada

This message was posted by a user wishing to remain anonymous

​Dear RAPS members,

Our organization is looking for standards and regulations for medical beds connected to an application that allows display of bed/patient status including nurse call and patient data (name, weight). I am also looking at confirming that bed remains Class I device. Any help and input will be greatly appreciated.

Thank you in advance!