1. IPEM Conference - From MHRA Managing Medical Devices, April 2014
Instructions for Use
2.3 Device management policy
The medical devices management group should ensure that the
policy addresses:
 training and access to manufacturer’s instructions
This policy should be regularly reviewed to ensure that, whenever a
medical device is used, it is:
 used in line with the manufacturer’s instructions
6.5 Documentation
Evidence that suitable instructions and training were provided are
needed, should a legal case be brought
7.1 The importance of effective instructions
Clear responsibilities should exist for ensuring that the
manufacturer’s instructions are passed on to all users and, where
appropriate, carers
7.2 Instructions for the end user
A failure to pass on to the end user the manufacturer’s original
instructions may compromise the end user’s ability to use the device
safely, and may lay the healthcare organisation open to legal liability
under :
 The Consumer Protection Act 1987 [15] (in the case of a
medical device)
 The General Product Safety Regulations 2005 [16] (in the
case of a consumer product not covered by other specific
legislation)
 The Common Law of Negligence [17].
What we do :
Build and Manage Medical Equipment
User Manual Libraries:
 Directions for Use
 Instruction Manuals
 User Troubleshooting Guide
How do staff access them :
 Via the Hospital Intranet
 At the Point-of-Care
Key Benefits to your organisation :
 Standardised access to all
Manufactured Supplied
Equipment Information
 No increase in workload – we do
all the work
 Online support for Users
ospitals ( from 1 to
8.8 Routine maintenance by users
Users may need to be trained to carry out routine maintenance. For
example, they may require training on how to remove, change and
insert batteries correctly in line with the manufacturer’s instructions
info@bioclinicalservices.com.au

2. CLICK – from
your hospitals
intranet
CLICK 1
CLICK 2
CLICK 3
BAZINGA !
It should
be that
easy
Currently used by:
 Aintree University Hospital NHS ( 4yrs)
 The Walton Centre NHS ( 4yrs)
 Moorfields Eye Hospital NHS (3yrs)
 Royal Marsden Hospital NHS (1st yr)
And over 200 Australian Hospitals (6 to 1 yrs)
www.bioclinicalservices.com