Home Articles Downloads Forum Products Services EBME Expo Contact
Previous Thread
Next Thread
Print Thread
Rate Thread
Joined: Jul 2000
Posts: 1,889
Likes: 21
Hero
OP Offline
Hero
Joined: Jul 2000
Posts: 1,889
Likes: 21
Did you know...,In MHRA DB 2015: Managing Medical Devices, it states:

Section 2.1 Management Responsibility
• Healthcare organisations should appoint a director or board member with overall responsibility for medical device management.
• The management structure for medical devices should have clear lines of accountability up to board level.
• Healthcare organisations should set out a long-term approach and objectives for the management of their medical devices.

Section 2.6 Monitoring and Audit
• An Audit Report should be submitted to the board examining policies and procedures for the safe acquisition, use, maintenance and repair, decontamination and disposal of medical devices.
• External monitoring and audit by the Care Quality Commission (CQC).
• The CQC will inspect against their ‘Essential standards’ of quality and safety.
• Healthcare organisations need to review their policies and systems for managing the use of medical devices regularly.

I think there are many NHS and Private Healthcare organisations who are unaware there is a regulatory responsibility for a designated director to be responsible for devices, even though this has now been around for over 5 years.

Anyone out there have a director interested and active in medical devices management?


Be Proactive and reactive.
1 member likes this: Damola
Joined: Feb 2009
Posts: 1,871
Likes: 7
Hero
Online Happy
Hero
Joined: Feb 2009
Posts: 1,871
Likes: 7
Hi john

we started this years ago in the Desert Kingdom, and from what I have seen in the past few months in the UK, hospital and healthcare centres here in the UK are light years behind.

Neil


If you think hiring professionals is expensive, try hiring amateurs!
Joined: Feb 2004
Posts: 14,341
Likes: 23
Super Hero
Offline
Super Hero
Joined: Feb 2004
Posts: 14,341
Likes: 23
... and a light-year is 5.88 trillion miles (give or take a few yards)!

As I have suggested many times on here before - there should be a Technical Services Director, responsible for all aspects of engineering throughout the hospital.

Yes, Neil, we had such an appointment in Jeddah as far back as 1982! The guy was a Brit (ex-NHS Hospital Engineer) - a good (competent) chap who delegated biomed matters to the Biomed Manager. One can only wonder how that 500-bed hospital fairs these days.

@John:- as a matter of interest, how often can hospitals expect to be descended upon by the Care Quality Commission?


If you don't inspect ... don't expect.

Moderated by  DaveC in Oz, RoJo 

Link Copied to Clipboard
Who's Online Now
1 members (Neil Porter), 89 guests, and 21 robots.
Key: Admin, Global Mod, Mod
Newest Members
Kemalin, Mendonça, StevenR, enesorin, Mirza
9,850 Registered Users
Forum Statistics
Forums25
Topics10,755
Posts72,469
Members9,850
Most Online5,980
Jan 29th, 2020
Powered by UBB.threads™ PHP Forum Software 7.7.5