Alerts/Adverse Events

St.Jude must have issued a corporate sigh of relief when its investigators concluded that the recently reported incidence of Durata ICD lead failure was most likely caused by abrasion from another lead or indeed a calcified structure, rather than the inside-out abrasion which has characterised the company’s Riata family problems.

Sir Bruce Keogh, Medical Director of the UK’s NHS, has released his report on the PIP scandal, which reassuringly suggests the content of the implants, while being suitable for mattresses, is also non-toxic to humans. His advice to patients remains the same; If they’re troublesome, take them out.

The news that FDA’s MAUDE database of adverse events has reported an “externalisation” of St.Jude’s new and improved ICD lead is bad timing and bad news for the company.

UK competent authority the MHRA has taken the unusual step of using its medical device alert procedures to remind anaethestists and support staff that their machines and practices need to pass muster if they are to avoid serious patient incidents.

UK MHRA has issued a Medical Device Alert (MDA) pertaining to the GEMSTAR™ infusion pump manufactured by Hospira Inc. It seems the accessory Bolus Cord can become damaged and consequently fail to deliver requested medication to the patient.

UK Competent Authority on Medical Devices, the MHRA has issued a medical device alert relating to Nottingham-based Capatex Medical’s Endotracheal tube clamps which it says may result in a risk of airway loss due to slippage or airway obstruction, as a result of over-tightening of the clamp/holder.

An interesting read for anyone involved in medical devices. It’s perhaps unsurprising to see the data which after all only supports what we’ve seen… a series of high profile problems resulting in more than twice the number of recalls during Q1 than in the previous period.

Lord Howe’s report into the PIP breast implant scandal and specifically MHRA’s handling of it, suggests that the agency acted appropriately given the information available and the regulatory constraints existing at the time. A four year delay between first notification and ultimate action on the face of it looks like a long time, but Lord Howe seems satisfied enough.

St.Jude Medical’s Bi-Annual Product Performance Report highlights positive results for its Optim coated leads, while also accepting an ongoing problem with older Riata products.

More pacing leads from St.Jude are now at risk of externalisation according to a new MHRA medical device alert.

Not that breast implants set off any alarm bells or anything: Breast augmentation filler Macrolane may obfuscate the results of mammograms to the extent that its manufacturer has removed the indication and issued directions on how to treat patients with the filler in place. UK competent authority the MHRA has seen fit to issue an alert along the same lines to draw attention to it.

A US consumer protection website is urging regulators to move more quickly and decisively in dealing with the thorny subject of transvaginally inserted organ prolapse meshes.

As public spats go, this one is going to take some beating. St. Jude is not looking like its in the mood to give up as it comes right back at Medtronic, Dr Hauser and Heart Rhythm.

This week’s View From The Med is available for your perusal here. Like a cow chewing the cud, why not spend five minutes enjoying our sideways glance at the main events of the past week?

St Jude medical is taking the initiative over more of its leads in which so-called externalisation can result in problems, by issuing a physician advisory letter.

UK MHRA singles out specific combinations of hip/stem for attention, this alert proving the value of the data in England and Wales Joint Registry.