What’s the appropriate course of action when a sealed vascular graft is found on several occasions to suffer uncontrolled bleeding and the manufacturer doesn’t know the cause?
Alerts/Adverse Events
Human Face Of Riata Lead Problem
St Jude’s Riata problems have been covered by Minneapolis’ Star Tribune with a report on the recent summit and the tale of a re-do patient.
UK MHRA Responds To Media Criticism
MHRA fights back against media claims that it needs to “recover its grip” over medical device regulation in light of the metal-on-metal hip situation.
UK MHRA Issues Detailed Guidance On All-Metal Hips
MHRA provides advice on follow-up systems for all-metal hips to include testing of all patients with large diameter femoral component and all ASR hips.
Medical Device Alert: Smiths Medical Level 1® Normothermic IV Fluid Administration Sets And Hotline® Blood And IV Fluid Warming Sets
MHRA has followed up last November’s Field Safety Notices from Smiths Medical, with its own Medical Device Alert pertaining to the company’s Fluid warming and Administration sets.
UK MHRA Finally Issues Alert On Covidien Duet One Month After The Company Contraindicates It
It’s only a month, but when people have died because of a medical device technology being found wanting, shouldn’t the UK’s competent authority have acted sooner?
Vascutek Anaconda Field Safety Notice
Vascutek Field Safety Notice issued to ensure safe removal of the bifurcate delivery system when inserting Anaconda and Anaconda ONE-LOK™ AAA grafts.
Internal Emails Cast Doubt On DePuy Claims About Reasons For Halting PMA
Will we ever see through the fog in the DePuy ASR case? Internal emails now suggest product performance was a consideration in stopping the PMA and ultimate product withdrawal.
Externalised Defibrillator Leads: State Of Play
Nice piece updating us on the Riata/Sprint Fidelis ICD lead situation.
PIP Cross-Selling! Just How Commercial Is This Business?
The Amazonification of Boob Jobs…Patients who have their PIPs replaced might also like…
PIP: MHRA Raises Questions About Responsibility Of “Member States”
MHRA counters Financial Times article and “raises questions” about the responsibility of “member states”.
PIP Scandal: EU Scientific Committee Adds Its Voice
European report says we don’t have enough data to conclude PIPs have a greater risk, but the data we do have raises concerns to the extent that health effects can’t be ruled out.
Now UK NHS Issues Its Own Statement On All Metal Hips.
Following another media flare-up in the ongoing metal-on-metal discussion, NHS has followed UK competent authority the MHRA into releasing a positioning document of its own.
UK MHRA Updates All-Metal Hip Status
UK MHRA updates all-metal hip guidance with statement that most patients are at low risk of developing any serious problems.
PIP Boss Charged
Apparently ailing 72 year old boss of PIP has now been charged with causing involuntary injury.
Just A Reminder: SJM Riata Is Subject To Alert In UK Too
Details of UK MHRA’s alert relating to St Jude’s Riata defibrillator leads.