In a press release issued last friday the French Medical Devices Industry Association (SNITEM) was quick to dispel the fear that the PIP scandal was anything more than an isolated incident. The organisation is obviously keen to avoid stigmatising the French medtech industry as being unduly lax or that it somehow allows “unsafe” devices to reach the market.
The Notified Body “Paradox”
While we may point fingers at Eu medical devices regulations compared with FDA’s seemingly tighter controls, we do so only in order to stimulate debate about a framework which must aspire to perfection. In fact most of the time we find ourselves struggling to define what the perfect system should look like in terms of the pace or ease with which new technologies can provide ever better treatments for patients. There’s little doubt that a system that relies on a degree of self-policing as the current medical devices directive does, is always open to rule bending and relies on companies and personnel being genuine, honest, intelligent and “human” if it is going to work well.
When it gets difficult is not the times when judgment is called for about a specific issue and the expertise doesn’t exist in house to make the decision. In these cases a regulatory consultant or the notified body is frequently the first port of call. No, when it gets sticky is when the company either deliberately sets out to bend the rules by hiding information from its notified body, or when it makes a judgment call on its own without recourse to any outside agency. In the latter case they’ll soon be found wanting if the auditor is doing his or her job. Most companies will use external consultants/auditors to provide essential expertise and checks and balances to ensure that notified body audits are based on independently assessed findings, but again this depends on a high degree of openness and disclosure of all relevant information and/or a tough minded approach by the auditor. The paradox of course is that auditors and notified bodies get paid by the company, both need the business of the company in question, so will balance for themselves the risk of being bad cop with the need to retain the account. As with all things companies are at liberty to go elsewhere.
So where do we end up? Notified bodies such as TUV have a reputation to maintain and are probably the best known NB in the world, for the reason that they walk the line very well. They do this by erring on the conservative, (ie tough) side and adopting the stance that companies will gain a reputation for integrity and credibility by putting themselves under the microscope that is a tough NB. In a sense the NB needs to behave like a paid-for dominatrix and the company has to really embrace the pain of subjugation if they’re to pass muster. Indeed the smart medtech company will use its NB as a management tool, embracing tough rules and picky audits to control its relevant activities.
But as SNITEM points out, if an individual wants to cheat there is the opportunity to do so and only so much the regulators can do about it. Having said which, it would take a particular kind of person in a particular kind of company for any such behaviour to endure for long. Maybe PIP is that situation, and while we shouldn’t be complacent, neither should we tar the entire industry with the same brush.
Source: medlatest staff