Originally Published EMDM November/December 2001
A NOTE FROM THE EDITOR
The New World of Risk Management
Risk,
it has been noted, means different things to different people. Manufacturers
in the medical sector have a special relationship with the word. They live and
breathe risk management.
To begin with, risk analysis is an integral part of the CE marking process. The essential requirements of the Medical Devices Directives (93/42/EEC) state that “devices must be designed and manufactured in such a way that . . . they will not compromise . . . the safety of patients . . . or users.”
This is a worthy
goal indeed, but also a lofty one. The obsession with risk has always set the
medical industry apart from other business sectors, a fact that will be painfully
clear to any manufacturer who has been frustrated by a supplier’s failure
to meet the quality requirements of a demanding project.
In a strange way,
the horrifying series of anthrax attacks recently unleashed through the US postal
system has brought not only general industry, but also the general public, into
a rare alignment with the medical sector.
What I’m talking
about is subtler than the recent discovery of anthrax spores at the offices
of US FDA, or the overnight transformation of Cipro into the world’s most
famous pharmaceutical. Rather, it is a frame of mind that seems to be spreading
through the world more quickly than a computer virus: safety and security first.
Failproof solutions. Zero tolerance for error. In effect, the kind of rigid
quality assurance and strict adherence to standards that are so familiar to
the medical industry may soon become ubiquitous in a world where our security
is constantly called into question.
People all over
the world have seen evidence of this new attitude at airports, where they undergo
increased screening and face severe luggage restrictions. And they have felt
it in their homes and offices, where every letter and package they receive must
be considered as a potential terrorist weapon until proven otherwise.
In this new atmosphere
of vigilance, some readers may have noticed that their medical suppliers are
getting a lot more press—outside of EMDM. In particular, IBA Sterilization
& Ionization (Louvain-la-Neuve, Belgium) recently made the welcome announcement
that its sterilization technologies can be used to kill anthrax spores in contaminated
mail. “The anthrax spore is like any other bacteria we treat today,”
says Yves Jongen, the company’s chief research officer. “It’s
a question of determining the right dose to ensure elimination of the deadly
spore—whether the technology used be EtO, gamma, e-beam, or x-ray.”
According to Jongen, the company’s electron accelerators can sterilize
anywhere from 240 kg to 20 t of mail in one hour.
And in the United
States, SureBeam Corp. (San Diego, CA, USA) has already received a US$26 million
order from the US Postal Service to supply e-beam and x-ray sterilization systems
that will ensure the safety of mail.
It should come
as no surprise that the suppliers who are taking on the daunting task of sterilizing
the mail hail from the medical sector. After all, what industry is better equipped
to meet the highest standards under the most challenging conditions?
In addition to
sterilizers, manufacturers of diagnostic equipment are being called on to speed
the development of technology that can offer reliable early warnings of chemical
and biological attacks. And this is only the beginning. As time goes on, it
seems certain that the medical industry will play an increasingly vital role
in civil defence, not only in dealing with the aftermath of terrorist attacks,
but also in leading R&D efforts that will keep us one step ahead of those
who would destroy us.
At press time, with the announcement of an attack against the offices of a Pakistani newspaper, there is evidence to suggest that anthrax terrorism is spreading beyond US borders. As it becomes clear that the world is full of new risks, we can take some comfort in knowing that we will be defended, in part, by those for whom risk management is a mantra.
Copyright ©2001 European Medical Device Manufacturer
