Re: But how to know if someone has an implant?
As someone who works in the medical device industry - this story does perhaps need a bit more in depth information than it offers now...
The NHS is stamping barcodes on breast implants, replacement hips and surgical tools in a bid to improve patient safety.
It is hoped to avoid future scandals such as the faulty Poly Implant Prothèse (PIP) silicone breast implants scare in 2010, in which fraudulently manufactured silicone gel implants affected 50,000 British women.
By using barcodes, anything that might develop a fault years later, for example a screw used in a knee operation or breast implant, can be traced, said the Department of Health in a press release.
Sorry to say this, but this statement is absolute rubbish. The bar codes on itself would have solved nothing. The issue with the PIP implants in short was the fact that the French producer used industrial, in stead of medical grade silicone in its manufacturing process. Surprisingly, they hadn't done this when they offered the implants for registration (Medical Directive 93/42/ECC). However, the Notified Body, the regulatory (commercial) organisation that inspects and approves these registrations (in the PIP case TÜV) should have done their "regulatory-checks-of-manufacturing-facilities-after-approving-implant" quality inspecting job right. Without going into too much detail here, QA is a very large, if not an all determining factor in the regulatory process and subsequential approval (CE mark approval). In the end, TÜV didn't, thus PIP could produce dodgy boob implants. Nothing that bar codes could have changed there.
Furthermore, the bar codes on implants might improve safety, although one could argue that the bar/ QR codes on the packages currently also (can) do that. One should perhaps also consider the fact that an alternative (main) reason might be, not the safety of the patient, but the (financial) risk management of the NHS itself. This becomes perhaps most clear if one considers the MoH statement more carefully. First, bar codes have nothing to do with keeping a good record of who received what when. Practice however shows that this at present day is rubbish to none existent. Second, one might wonder why the MoH is so concerned about this. Concerns about the health of the population in general? Documentation helpful for later claim cases?
Perhaps also helpful in this discussion (and appealing to techies): several medical device manufacturers have tried to get approval for devices (e.g. syringes, surgical equipment) with RFID chips in them. Regulators have long, continuously and consistently, refused approval for these. Some reason quoted: competition legislation, customer lock-in, preventing use other than pre-programmed (e.g. no reuse of syringes because injection equipment refuses already used ones, documenting reuse of surgical materials registered as disposable originally), and thus price increase. Although honesty forces me to agree at some level, it is also surprising that these initiatives were always killed immediately and completely. After all, exploring solutions should consider all options.
It also also expected to provide a more effective means of managing medical stocks and saving staff time searching for items.
The government claims the project could save £1bn across the NHS over seven years.
But... but... it is all about patient safety!
And... if you could save £ 1bn, I can stop wondering how you go about your affairs now. Like I already mentioned, packaging of medical devices is a separate item in the medical device regulatory approval process. Change the package, and you have to resubmit your approval/ Technical File for the regulatory authorities to agree on your changes. So OR the NHS stores everything in sheds and bottom drawers, OR this (again) is more about financial risk avoidance, OR this number appeared magically out of a body orifice.
Tim Wells, consultant cardiologist at Salisbury NHS Foundation Trust, said: "Knowledge is power - not only does this provide us with a level of data and insight that can be used to better challenge clinical practice and variation, helping us to reduce inefficiencies and improve patient experience and outcomes - more importantly it ultimately helps to safeguard our patients from avoidable harm.
"In the event of a product recall, we can now easily and quickly track an affected product to the right patient."
Knowledge is power... Hummm... Ignorance is Strength
Again, this has nothing to do with bar codes on products, and is already, with no limitation, possible in the current situation. I can't shake the feeling that these kind of statements show striking similarities with the “more-cameras-more-safety” discussion. Although more cameras can indeed help in solving crime, their efficacy in preventing crime is questionable. So, how do bar codes “ improve patient experience and outcomes […] safeguard our patients from avoidable harm.” First, if havoc has already happened, it can only help in fixing and finger-pointing. And perhaps more importantly, as mentioned before, this is all already possible, but does perhaps have more to do with how things are now done in the NHS.
Without sliding off into a complete, vein-popping rant (and at the risk of sounding unreasonably silly) I can only say that, if somebody is interested in some examples of the excellent record-keeping skills of physicians (including cardiologists) I'm more than happy to share.
Err... Did we change coffee brands...?