Week 7, 2012
Fish, Burgers, Angry Birds, Angry Anaesthetists
To prepare this document we review all the news items we’ve covered during the past seven days and try to pick out some thread. Last week for instance it was clearly an “Orthopaedicfest” with AAOS being held in San Francisco. This week there is no enduring theme (other than perhaps the lack of a theme). You’ll see what I mean when I tell you our stories have covered everything from Zebrafish embryos being used to signal toxicity in medical device materials (by dying, presumably), to a poor chap who had a heart attack in a Los Angeles “restaurant” called the Heart Attack Grill, presumably himself being used as an indicator of some form of toxicity in what he was consuming.
See what I mean? It’s been a surreal mix of the sublime to the ridiculous. Take the brilliant concept of training people in remote places (ie space) to perform medical procedures using a smart and no doubt expensive piece of “augmented reality” kit. We’re actually quite excited about that article because it may just unearth one of those technologies designed for one thing that happens to be very useful for something else… we’re thinking training… watch one, do one (wearing a helmet and head-up display).
Finally (for the section entitled random news) it turns out that a significant proportion of European medics are using iPads in their jobs, if you believe a survey published this week. There’s no doubt in our minds that some docs are indeed doing this… if you can include Scrabble, Sudoku and Angry Birds in your list of things needed in your professional job as a medic (Anaesthetists?), but the authors of the report do recognise the potential skew in their survey… it was performed online… hmm.
So down to the nitty gritty. What’s new, what’s newly approved, what’s the big story, what’s happening Stateside, what’s occurring in regulatory world?
Newly approved: CE mark
Vital Access announced that its Venous Window implantable haemodialysis access device.
Custom Spine achieved CE mark status for its entire portfolio of spinal implants.
Edwards Lifesciences gained CE mark for its Invuity Valve, bringing rapid deployment to minimal access valve replacement.
Newly approved: FDA
Implantable programmable drug pump from Medasys Inc becomes the first such device to be FDA approved.
Smith & Nephew’s Polarcup Dual Mobility Hip System will now be available in USA, backed up by ten years of data from international markets.
Varicose veins made easy: Angiodynamics’ NeverTouch Direct™ Procedure Kit is claimed to no longer require a long guidewire or guiding sheath, reducing procedural complexity, bruising and pain compared with bare-tip fibres.
It’s important not to get too excitable when you read about a breakthrough like the one we reported this week in which a Lancet study has shown myocardial stem cells, reimplanted in post-infarct patients resulted in a significant increase in myocardium (and corresponding decrease in relative amount of scar tissue). Just imagine if that work could be replicated and the technology brought to market.
There continues to be a lot of twittering about patient access to data from their implantable cardiac defibrillators and we covered this again this week with the news that hackers have volunteered to help the main patient campaigner Hugo Campos in his efforts to see what’s going on inside him. We noted also by the way that another new word cropped up this week-”e-hypochondria”-which explains the concern of some that by giving patients access to the minutiae of their data we might risk inducing a new form of mental illness.
US Medical Devices Sales Tax: A survey by consultants Emergo Group suggested that over half the respondent companies would address the 2.3% sales tax levy by increasing prices. The interesting point here being that rather than surveying just the “big boys”, this survey addressed a mix of companies including a lot of SMEs. In that sense it’s perhaps not the most surprising news.
Regulatory news from around the World
The EU health commission has indicated that the recent PIP scandal needs to result in a tightening of Medical Device regulatory control.
In USA, implantable cardiac defibrillators are again in the news as campaigners call for Medtronic’s Sprint Fidelis guidance to be reviewed in light of new findings. Furthermore St Jude have published a robust defence of their practices following criticism of their post-marketing surveillance procedures. They have also been keen to ensure that none of the negativity surrounding Riata and Riata ST leads rubs off on the current Durata product.
Returning to another old favourite, there has been coverage this week in mainstream press of the ongoing saga of DePuy’s metal-on-metal hip. Apparently the company continued its activities in Europe after FDA had expressed concerns about the product. There might be a story there, but then again it looks more like a huge dose of hindsight than any whiff of wrongdoing. Until or unless FDA and European regulators act in unison, which they never will, what happens in one domain needn’t necessarily coincide with the other except to inform.
I’m looking for the big finish, and failing to find it, so have a great weekend and make sure, whether you’re scandalised by regulatory laxity or campaigning against NHS reforms, that you have a better plan.