Swissmedic Annual Report 2018

12
Is medical device safety
guaranteed in Switzerland?
Can patients be confident that implants have been adequately
tested before they are used? This was the question
at the heart of the “Implant Files”, a large-scale investigation
by an international network of journalists that started
to make headlines in November 2018. The global investigation
focuses on defective medical devices. Publication of
the first results was preceded by several years of research by
more than 250 journalists from 36 countries, including representatives
of Swiss media outlets.
oversight of CABs has been stepped up in recent years, and
there will be an overall shift towards proactive market surveillance
by regulatory authorities. Surveillance and coordination
will be improved across Europe. Systematic implementation
of the new requirements will be key. This will
involve giving the authorities responsible for implementation
adequate resources with which to enforce the requirements.
Swissmedic too will have to substantially augment
its competencies and resources.
In contrast to the USA, medical devices are not subject to
official authorisation either in Switzerland or the European
Union (EU). Medical devices undergo a conformity assessment
by notified bodies. Switzerland is in the European
system. Swissmedic’s primary goal with reference to medical
devices is to ensure effective market surveillance.
Weaknesses identified
One of the examples used by the Implant Files to illustrate
the weaknesses within the system is the Cadisc-L, a spinal
disc implant manufactured by a British company. The case
caused considerable consternation, particularly in Switzerland
and Germany. Some time after implantation, several
patients’ implants disintegrated. This had serious consequences:
the fragments caused the affected patients severe
health problems and had to be removed in painstaking
surgery.
It transpired that a European conformity assessment body
(CAB) had CE-certified the implant, even though it had not
undergone adequate clinical trials. As a result, it was
launched throughout Europe and implanted into a large
number of patients. A small number of these patients were
in Switzerland.
It is indisputable that the current regulatory system has
weaknesses. However, a new, stricter EU Regulation, which
will also be adopted in Switzerland, should close many of
the gaps in the system identified by the Implant Files.
Under the new Regulation, the basic system that is currently
in place will be retained. Furthermore, medical devices
will continue to be certified by a CAB rather than approved
by a regulatory authority like medicinal products. Official
New Regulation brings stricter control
The new Regulation will subject high-risk products such as
implants to stricter controls in terms of clinical evaluation
and clinical trials. Until now, manufacturers have often
been able to rely on clinical data for existing products, and
have not had to submit their own trials in order to obtain
certification. In the future, however, companies will have to
better demonstrate the benefits and safety of their products
by means of clinical data. Products will also have to
be labelled with a Unique Device Identification (UDI) to
make it easier to trace them.
CABs will also be subject to stricter requirements so that
they can review clinical evaluations appropriately during the
certification procedure. To enable them to examine the
dossiers in the necessary depth, they will therefore have to
provide the relevant competencies. Furthermore, the experts
they consult will have to satisfy tougher neutrality
criteria. The responsible authorities will also inspect dossiers
at random as part of their supervisory role, and attend
CABs’ manufacturer inspections.
While doubtlessly tragic for the patients affected, the cases
described in the Implant Files are no longer current, since
some of the products in question were placed on the market
over ten years ago.
Supervision has already been improved in the years following
the PIP breast implant scandal in 2012, and surveillance
has been intensified. CABs have had to satisfy substantially
more stringent requirements since 2013, and they are audited
by international inspection teams, as well as national
authorities, before they are accredited.