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- Medical
Devices Agency (MDA) advice
regarding “third party” repairers.
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- Recently, the
issue of “authority” to carry out repairs to scopes has re-emerged.
Thanks largely to “scare” tactics employed by the large
manufacturers who often incorrectly quote MDA guidelines as saying that
endoscopes should always be returned to the original manufacturer for
repair. This is not the case.
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- The MDA
guidelines, as published in June 2000. Ref: -
MDA DB2000(02) Medical Devices and Equipment: Repair and Maintenance
Provision.
- This
is a fairly lengthy and broad based document covering many
aspects of repair and maintenance of many differing types of equipment,
not just endoscopes. To quote the entire document here would not be
beneficial as it covers areas in which we are not involved. We would of
course, be happy to discuss the contents of the whole document with any
interested body or send you the relevant section for your own appraisal.
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- What follows
are edited extracts which we consider to be the main points from the MDA
document, in relation to the repair and maintenance of rigid endoscopes.
We have quoted directly from the document with Custom Optics comments /
interpretation in italics and bold.
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- 1.2
Introduction.
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- The main
objective of the MDA is to take all reasonable
steps to ensure that medical devices and equipment in the UK are of safe
design, of appropriate quality, perform as intended and are properly
used. The repair and maintenance of a medical device or item of
equipment has an influence on its safety, quality and performance. It is
therefore important that any work is carried out correctly such that the
device will continue to meet these criteria….
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- The MDA
document goes on to say..
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- Users (Hospitals)
should ensure that they carry out both a risk-benefit as well as a
cost-benefit analysis in selecting a service organisation for the repair
and maintenance of a specific device.
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- Our
interpretation of this is that the MDA recognise that with respect to
the cost-benefit analysis, using a “third party” repairer such as
Custom Optics may have a cost-benefit in saving you money. In so far as
the risk-benefit analysis, Custom Optics can answer affirmatively to the
following requirements of the MDA.
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- User
organisations (i.e. the hospital), should only adopt repair and
maintenance organisations which:
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- Can
demonstrate appropriate training, knowledge and experience of the repair
or maintenance of the device;
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- Have access
to appropriate equipment to undertake repair and maintenance;
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- Have a system
in place to notify the user organisation of any deviation to the
maintenance repair or maintenance method;
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- Take
responsibility for the repair or maintenance.
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- Custom
Optics can fully meet these criteria.
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- Section 2.
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Repairers and Service Providers.
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- 2.1 Types Of
Organisation.
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- A medical
device service provider may be:
Manufacturer
service organisation.
Authorised
service agents.
Managed
service providers.
In-house
service providers.
Multi-vendor
service providers;
A Manufacturer who repairs and maintains
devices manufactured by another manufacturer in addition to his own.
Third
party service providers;
A specialist organisation operating
primarily in the field of repair and maintenance. These
organisations may also specialise in the repair and maintenance of
one particular type of device or equipment, e.g. endoscopes. The
organisation may draw on the knowledge and experiences of
ex-employees of a manufacturer of this type of device. The
organisation may be an intermediate or a small-scale operation…
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- Custom
Optics falls into two of the above categories being both a
“Multi-vendor” service, (as we manufacture and service our own brand
of endoscope), as well as being a “Third party” service provider.
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- If any
organisation or individuals other than the manufacturer undertake repair
or maintenance work, they should ensure that it is done in accordance
with the manufacturer’s instructions. The user organisation should
ensure that its chosen service provider has the capability to carry out
the work. It is the responsibility of the user organisation to ensure,
as far as possible, that equipment continues to operate in accordance
with its original specification after repair.
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- So, far from
advising against using third party repairers, the MDA recognise that
there may be cost benefits in doing so.
- The MDA do suggest a number of
criteria that staff should consider before using a third party repairer.
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Custom Optics can meet and exceed all of these criteria.
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