Hospital Medical Devices

The Therapeutic Goods Act and the Decree on medical devices have resulted in
new responsibilities for hospitals. If the hospital does not enforce the new
regulations, there may be a risk of serious incidents with financial
consequences. The Swiss Agency for Therapeutic Products "Swissmedic" therefore
attaches particular importance to a wide information management and hospital
staff.

In recent months, various media have harshly criticized the fact that the new
Law on Therapeutic Products (LTP) and the Ordinance on Medical Devices (MepV)
result in extra costs for hospitals. The press has even made its headlines by
claiming that new legislation would cost $ 100 million more for hospitals.
Initially, the debate has mainly focused on the issue of re-sterilization and
maintenance of equipment, said Paul Dietschy, Member and Head of Sector 1
Swissmedic – this sector is responsible among other medical devices,
Inspections, trials and special permits. Add to this the fact that under the old
law now, many hospitals do not always respect the rules imposed in the context
of clinical trials of medical devices. The obligation to report adverse events
related to medical devices is not yet sufficiently followed. In this regard, we
can not exclude harm to patients. Hospitals are facing possible recourse
actions. Paul Dietschy underlines the fact that some reinsurance companies
therefore tend not to enter into contracts with hospitals that agree to comply
with all applicable laws. The acuteness of this problem has grown and H
Swissmedic to engage in discussions to resolve these problems jointly. This
interview with Paul Dietschy by jurisdiction is the first sign welcoming the
collaboration.

Competence: Paul Dietschy, what are the main changes affecting hospitals caused
by HMG and MepV?

Paul Dietschy: Ad mandatory serious incidents (materiovigilance) and the
obligation to guarantee the maintenance of medical devices are the two major
innovations to hospitals.

For equipment monitoring means the collection and processing of advertisements
relating to the endangerment of patients by medical devices imperfect. A
rigorous materio vigilance will allow the future to detect more quickly the
technical causes of such incidents and to eliminate all the hospitals concerned.
For example, Swissmedic can recall of a defective implant or inadequately
developed, or have improved the operating instructions from one device to the
announcements of vigilance. Since 1 January 2002, all professionals using
medical devices and all relevant agencies (including hospitals) employ such
persons are required to report serious incidents. Ads must be sent to Swissmedic.
Now, each hospital must designate a person responsible for equipment monitoring
to collect information on incidents and coordinate with Swissmedic. The
appointment of such persons is a managerial task or, where appropriate, the
college of surgeons. Whoever, in a hospital, says incidents, injuries or
potential risks associated with implants, devices, instruments, equipment or
consumer software errors, should immediately contact the person responsible for
equipment monitoring in- same hospital. Similarly, employees of the laboratories
will address this responsibility if they find problems with kits and diagnostic
equipment. The head of the materio vigilance sorts these listings and send, if
necessary in depersonalized form, important information Swissmedic.

Competence: What are the requirements for maintenance of equipment and
instruments?

Paul Dietschy: The proper maintenance is not a simple matter. Some medical
devices can be reused several times, some even hundreds or thousands of patients
(eg. Sphygmomanometers). The wear, deterioration or contamination of such
devices can cause considerable damage. In the same vein, we must be careful to
measurement error by failing calibration. Hospitals must remain in control
despite the huge number of medical devices and ensure orderly maintenance. This
question often leads to a conflict of interests between hospitals and providers
who offer maintenance contracts. This is a challenge for hospital services,
technical services and directions to hospitals.

The first priority is to properly organize the maintenance and servicing of
medical devices used to maintain or to save the life of the patient, diagnostic
equipment, therapeutic devices and measuring devices. In this area, any
malfunction could cause an accident, inducing a misdiagnosis or reduce the
chances of successful treatment.

Therefore, no hospital would admit a flawed organizational level of maintenance
of medical devices without which it is exposed to claims for damages by injured
patients. In this context, sterilization is obviously also an important quality
factor. Following the abolition of controls cantonal, some hospitals have
neglected this process for years. Now, it must be examined and, where
appropriate, to update the sterilization procedures. These procedures must be
put in writing and officials authorized to sign certificates of release should
be appointed. In this regard, Swissmedic has already produced information sheets
on maintenance issues. In addition, Swissmedic is preparing, in collaboration
with practitioners and hospital industry experts, publications dealing in detail
the practical aspects of the hospital sterilization and validation of large
sterilizers.

Competence: New rules have been introduced also for clinical trials of medical
devices. What exactly does it take into account?

Paul Dietschy: Doctors Hospital must comply with four rules:

First, physicians should check their insurance coverage is appropriate and
adequate prior to participating in a clinical trial. They consult with legal
counsel if necessary or administration of their hospitals.

Second, the device must be tested sufficiently developed to be applied to
humans. It’s the same for testing prototypes. For information, Swissmedic makes
available on its website a comprehensive guide also includes a list of technical
standards for medical devices (address: www.swissmedic.ch / md / files /
leitf-e.html).

Third, Ethics Commission appointed by the township for the testing of
therapeutic products must have given his approval.

Fourth, the tests must be reported to Swissmedic. It goes without saying that
clinical trials of medical devices must be conducted with the same care that
clinical trials of drugs. In both cases, tests are governed by the new ordinance
on clinical trials of therapeutic products for the purposes of the LTP, the
"therapeutic" includes both drugs and medical devices! This is to inform
physicians of hospitals so they are able to avoid any incident and to guard
against any action for damages.

Competence: What is the risk of liability? How to reduce it? What aspects to
take into account?

Paul Dietschy: Whether for medical devices or drugs, physicians should generally
stick to the instructions related to products (for use). In the case of a
clinical trial protocol approved by the Ethics Commission must be strictly
followed. Use by a method diverge must be scientifically justified and approved,
respectively, approved by the Ethics Commission as part of a clinical trial. It
is also essential to report adverse side effects and incidents. Under the law,
violation of the obligation to register is punishable to imprisonment or a fine
(art. 87 HMG).

Accountability in clinical trials is based primarily on the hospital for their
own studies. The case is not very simple test cases initiated by the industry.
Even if the developer meets industry first for injuries suffered by the subjects
of research, he can turn against the hospital or a hospital doctor cons. In
clinical trials in public hospitals, should be considered in addition to the
cantonal legislation governing state responsibility for acts of its agents.
According to a growing trend, large hospitals are therefore insurance covering
risks of research in their entirety. It is therefore necessary to check whether
the insurance coverage available to the hospital really covers its various
activities. Several hospitals have already put in place insurance models that
are both innovative and beneficial. In this regard, hospitals earn their
experiences. As zero risk does not exist: the doctors responsible must comply
with legal provisions (eg.’s Announcement of a clinical trial with medical
device Swissmedic or obtaining a special permit for use in Switzerland of
unapproved drugs) on pain of severe deterioration of the initial legal position
in case of damage. This applies even where a manufacturing defect is identified
without being announced and then, consequently, defective implants continue to
be used.

Competence: Is it true that the new ordinance on medical devices makes it almost
more than sterilize reusable devices? Who pays the extra costs that result?

Paul Dietschy: Reusable devices can still be retired. These medical devices are
specifically designed as such by the manufacturer and were verified so that it
can be reused several times in hospital. But it is also true that many feared
the possibility of possible transmission of prions (eg. New variant
Creutzfeld-Jakob disease). To face this new challenge, medical devices
surgically invasive should be retired through a sterilization cycle to ensure
treatment at 134 ° C for 18 minutes. Currently, it is not yet possible to
determine whether these measures will further strengthen in the future, eg. by
requiring the use of disposable instruments for certain procedures on critical
organs like the eye.

However, washing and re-sterilization devices intended by the manufacturer only
to be used once a problem. Many medical devices that do not lend themselves to a
reprocessing because they are difficult to reach places, hinges, delicate
surface coatings, synthetic materials, seals, etc.. It takes a microscopic
examination to detect cracks or traces of impurities that could undermine the
sterilization operations. In some cases, unfortunately, leads to material
fatigue rupture or tearing of some components.

In fact, just one tragic incident to annihilate all the financial benefits from
the reprocessing of invasive medical devices for single use.

The profitability of such reprocessing must be fundamentally questioned,
although so far the costs of the incidents were rarely recognized, registered or
supported by the hospital concerned. But in any event, it would be wrong to
conclude that the refurbishment is no longer possible for the equipment or
devices specifically designed for this purpose. This would surely result in
soaring costs so much criticism. If a hospital wants to practice
re-sterilization, he must submit to a process of quality assurance that could
guarantee its effectiveness, which presupposes in particular the appointment of
a person responsible for the release of medical devices retirees. In legal
terms, there are still other difficult issues that are debated among experts.
For example, the use of a potentially less secure it not only requires the
consent of the patient? According to the law on therapeutic products, medical
devices reprocessed single-use must meet the same requirements and the same
security as the new products. Logically, the costs of quality control and
certification increases as the potential risk to the device in question.

Competence: How the new rules it is checked, and what are the penalties for
non-compliance?

Dietschy Paul: The law on therapeutic products provides the opportunity to carry
out inspections with the assistance of the cantonal authorities and regional
inspectorates. Swissmedic gradually develops models of inspection and carry out
the implementation.

In this regard, Swissmedic working to develop guidelines and checklists into
account both the practical requirements and potential risks. In terms of care,
maintenance and sterilization, Swissmedic works closely with associations and
the relevant working groups, including various specialty medical societies, the
Swiss Association of Hospitals H, hospital associations of engineers and
technicians and hospital the Swiss medical sterilization.

Competence: What are currently the main expectations of Swissmedic against
hospitals to ensure patient safety?

Paul Dietschy: In the era of advanced medical technology, our main expectation
is to take greater account of medical technology in the system of quality
assurance and risk management implemented by hospitals. This presupposes, first,
a better management of medical devices both in terms of maintenance,
maintenance, reprocessing and sterilization, and secondly, the rules of good
practice in research and thirdly, the internal right announcements for Material
for serious incidents and, fourthly, the integration of hospital engineers and
officials of sterilization and hygiene in the system of quality assurance for
hospitals.

Finally, Swissmedic attaches great importance to the implementation of new
technical standards for medical gases. Hospitals must carefully plan the
transition to exclude any risk of confusion with fatal outcome, as would such an
interchange of oxygen and nitrous oxide. The technical adaptation of gas
networks should under no circumstances lead to incorrect connection may be
harmful to patients, because in this case, the hospital would be concerned not
only face a loss of image, but most likely also to heavy claims for damages.
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