The PIP breast implant scandal has raised difficult questions for trusts and clinicians about the faith they place in the reliability of medical devices they use.
Higher pre-marketing thresholds and tighter surveillance of devices must follow if patients’ trust is to be restored. But this will be a lesson half learned if it is not matched by new structures which proactively disseminate new techniques across the NHS safely.
The regulatory system for medical devices is not as rigorous as that for pharmaceuticals. The Medicines and Healthcare products Regulatory Agency lays down detailed and direct mandates on pharmaceutical firms over the evidence needed to prove the efficacy, safety and manufacturing stability of their products. But for devices this is farmed out to what are termed “notified bodies”, of which there are more than 80 in the EU. Any of these can make a decision on whether the device warrants a CE mark.
The CE mark means that the product can be freely marketed anywhere in the EU without further control. The device can be implanted in patients and there is then no mandatory need for clinicians to report device failures or complications; this is an entirely voluntary process.
The scandal of the PIP breast implants seems to be that the manufacturer had started using non-medical grade silicon without authorisation. If proven, it is hard to imagine a licensed pharmaceutical company making a similar decision and hoping to get away with it. The adulteration of medicines does happen – but only through the outright criminal underworld of counterfeiting.
As a bare minimum we should have mandatory databases for medical devices. Not only would these provide patient safety data, they would help clinicians and trusts make evidence-based procurement decisions. With development they could also provide the outcome data that the government wants to see driving how quality is measured.
The National Joint Registry already monitors the crowded marketplace of hip and knee replacements. It has proved successful at identifying poor manufacturing batches and problems with whole types of implant.
Technology from other industries could be used to tag implants with microchips that provide details about when, where and who implanted the device. This would provide invaluable information in cases of clinics going out of business or surgeons no longer being available.
But if all we do is reach for regulation then we risk snuffing out innovation altogether. I would not wish to see the UK follow the US, whose Food and Drug Administration device regulations mean that American patients benefit from new devices years after Europeans. If we are to tighten regulation and surveillance then we also need to enhance the research infrastructure to quickly teach and spread new techniques safely.
During 2012, the Royal College of Surgeons, in partnership with a variety of organisations including the National Institute for Health Research, will develop research networks to support surgical trials and enable the quicker spread of good and proven ideas.
One example of why we need to get this right is the disorganised introduction of keyhole surgery in the early nineties. Without a structured training programme, individual surgeons acted alone out of enthusiasm or a sense of competitiveness and early results were poor. This led to widespread beliefs that the techniques were not valuable and the UK struggled to take up innovation that rapidly became common practice in France and beyond. Only now, nearly two decades on, are we catching up.
Many patients could have benefited from less scarring, infection risk and shorter recovery time in hospital, representing significant lost efficiency gains for trusts.
There is no doubt that surgical trials are much more technically challenging than pharmaceutical interventions – but I don’t see that as a reason for surgeons, industry, regulators and hospitals to let ourselves off the hook. The lessons of the past few weeks must surely be that this is a challenge we can afford to ignore no longer.