Tag: ISB 0160
Home / ISB 0160
5 December 2016, by , in Blog, No comments
Working with manufacturers of health IT systems, it’s fascinating to watch organisations evolve and mature as they implement the SCCI 0129 safety management processes. I consistently see organisations pass through various stages of safety maturity. Proactive assurance and safe design is the ultimate goal. Yet so many organisations, without help, get lost along the way....
Safe hand - assuring healthcare technology
19 May 2016, by , in Blog, No comments
This week I’ve been developing a hazard log for an innovative health IT product. Constructing a hazard log from scratch can be a daunting experience and many see it as a labour-intensive tick-box exercise. But done properly, the activity really makes you examine the product – often you are the first person to look at...
Man using a computer
26 February 2016, by , in Blog, No comments
When health information systems exhibit faults the clinical impact ranges from inconvenient to dangerous, in some cases clinical safety can be compromised. But users are remarkably resourceful and when clinicians are reliant on systems to safely deliver care they are motivated to get the information they need. Complex applications often have more than one way of...
Safe hand - assuring healthcare technology
26 January 2015, by , in Blog, No comments
Health IT systems rarely cause harm in isolation; instead they form just one component of a complex ecosystem in which human operators co-exist and interoperate with technology. It is also naïve to conclude that any non-technical influential factor in contributing to risk exists exclusively in the domain of ‘user error’. Whilst it is the case...
13 January 2015, by , in Blog, No comments
We know that Health IT systems can introduce risk into the clinical environment. UK Safety Standards ISB 0129 and 0160 call for suppliers of Health IT systems and their implementing healthcare organisations to undertake Clinical Risk Management activities to manage that risk. In particular the Standards require organisations to nominate a Clinical Safety Officer (CSO),...
1 October 2014, by , in Blog, No comments
The industry has come to accept that Health IT (HIT) systems can both mitigate and introduce risk in healthcare delivery. Suppliers and healthcare organisations need to take proactive steps to manage risk in the deployment and maintenance of these systems. Both the FDA and UK’s HSCIC (under ISB 0160 and 0129) require us to formulate...
4 August 2014, by , in Blog, No comments
So you’ve identified a problem with your Health IT system and you know that it could contribute to clinical risk. What next? Often the most fruitful activity is to write it down ready for your risk assessment – carefully, unemotionally and objectively. Doing this brings together a clear understanding of the problem at that point...
ISB 0129
10 December 2013, by , in Blog, No comments
We often find ourselves trying to explain what we mean by terms like ‘risk’ and ‘clinical risk’. There are many definitions and it’s important for us to remain consistent, especially when we communicate across organisational boundaries. Ask the average person and they’ll probably say that risk is ‘the chance of something bad happening’ – or...
Dr showing patient information
13 November 2013, by , in Blog, No comments
We cover this topic in our ISB0160 Clinical Risk Management Course but here are some thoughts on the subject. Many of us who have worked on large projects are used to the idea of a risk log – arguably an essential component of any well-managed project.  However, safety standards such as ISB0129 and IS0160 require...
Medical Professional using an ipad
10 October 2013, by , in Blog, 5 comments
Are you confused by the different safety standards and regulations which apply to eHealth? Certainly the relationship between the Medical Device Directive (MDD) and eHealth Safety Standards ISB0129 and ISB0160 can, at times, be complex. The ISB Standards tell us that only one or the other can apply to a particular product so how do...