On 12th May, Professor Norman Williams, president of the Royal College of Surgeons of England, published the following letter in the Lancet in response to an editorial comment on the current controversy about regulation of surgically implantable devices (The Lancet, Volume 379, Issue 9828, Pages 1789 – 1790, 12 May 2012:
Richard Horton (Jan 21, p 204)1 is right that device regulation in the UK is insufficiently robust and does not guarantee patient safety.
I share the concern that, unlike the rigorous regulatory system in place for drugs, the assessment and regulation of medical devices is failing patients. Provided a device gains a CE mark from one of the 70 or more Notified Bodies (who do not necessarily require clinical trial data), it can be implanted in patients with no mandatory need by clinicians to keep an audit trail of device failures or complications. The barrier to entry is too low and independent surveillance too weak.
In the view of the Royal College of Surgeons, we should, as a minimum, have mandatory databases for all surgical implants and associated techniques which would provide ongoing patient safety data, while enabling trusts to make evidence-based procurement decisions. New surgical devices, and the techniques required to implant them, must be regulated so that they can be safely introduced into our health-care system, disseminated appropriately, and monitored in the long term.
However, regulation must be balanced with innovation. If we are to tighten regulation and surveillance then we must also enhance the surgical research infrastructure to teach and spread new techniques quickly—we would be letting down patients if the introduction of proven devices and techniques was to suffer delays as a result.
Peter McCulloch, Jeff Barkun and Art Sedrakyan responded on behalf of the IDEAL collaboration as follows:
We agree with Professor Williams about the unsatisfactory nature of the current regulatory framework for implantable devices in the UK (and EU) and are heartened to see the Royal College leading this debate.
It is hard to understand how a system so manifestly unfit for purpose has evolved, the commercially privileged relationship between manufacturer and evaluating Notified Body being the most obviously inappropriate aspect of a flawed structure.
We support the call for adequate mandatory clinical outcome databases for existing implants, and for regulatory evaluation for new ones which strikes a balance between fostering innovation and protecting patients.
The IDEAL framework and recommendations  deal with these issues amongst others relevant to this debate, and have recently been considered by the FDA in discussions about how the US system for device regulation might be strengthened .
Many of the challenging issues for the scientific evaluation of devices parallel those found in evaluating surgical operations, and similar solutions may apply. The meeting in Washington DC on 2nd and 3rd December concluded that a change was needed from a binary “approved/not approved” approach to one where evaluation and innovation continue throughout the product life cycle, using appropriate study design and reporting methods for the stage under consideration.
To provide access to innovative therapies whilst ensuring evidence is collected, healthcare funders will need to implement a “payment with evidence development” approach . The IDEAL framework provides a basis for such an approach, and merits consideration in discussions about how to reform the European system.
- McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009; 374(9695):1105-1112.
- FDA. Transcript for Public Workshop – Bridging the IDEAL and TPLC Approaches for Evidence Development for Surgical Medical Devices and Procedures, December 2, 2011; accessed 25/5/12.
- Centers for Medicare and Medicaid Services. MEDCAC Meeting, 5/16/2012; accessed 23/5/12.