| This week sees the launch of a new strategy from the devices sector of
Medicines and Healthcare products Regulatory Agency, and the agency is
calling on pharmacists to help. The strategy aims to encourage patients
to report problems with medical devices and equipment direct to the MHRA,
and pharmacists can assist by having on view a pamphlet, produced by
the agency, setting out information for the general public about whom
to contact in the event of needing advice about a device, and how
to report adverse events (see PJ, 29 November, p733). Reporting adverse
events is of great importance if user issues are to be identified and
satisfactorily corrected.
Over the past few years there has been a huge increase in the number
of medical devices being used by patients at home. At the same time,
however, the MHRA has been aware that little support for this increasing
activity has been provided. This is why the MHRA will be making its pamphlet
available in all pharmacies across England.
The agency hopes that pharmacists will help by ensuring that people obtaining
medical devices are aware of the pamphlet.
Pharmacists may feel more encouraged to help if they know more about
the work of the MHRA devices sector and how it promotes and protects
public health.
The MHRA was created on 1 April 2003 through the merger of the Medicines
Control Agency and the Medical Devices Agency. Although most clinical
professionals are aware of the “medicines” side of the MHRA’s
work, the “devices” side of this new agency, and the functions
it carries out to promote and protect public health, are less well known.
Not everyone is sure of what is included in the definition of a “medical
device”. The term covers any products, other than medicines, that
are used in the health care environment for the diagnosis, treatment,
prevention or monitoring of illness or disease. It encompasses a huge
variety of products, ranging from the high-technology implantables such
as pacemakers, heart valves and joint replacements, to an increasing
number of home-use devices such as thermometers, wheelchairs, dressings
and over-the-counter test kits.
The MHRA (devices sector) is an executive agency of the Department of
Health entrusted with safeguarding public health by working with clinicians,
regulators and manufacturers to ensure that all medical devices used
in the health service meet appropriate standards of safety, quality and
performance and comply with the provisions of the European Medical Devices
Directives. It is also the primary source of United Kingdom information
and guidance on the safe use of medical devices.
The agency fulfils its roles in a number of ways, eg, operating an adverse
incident centre, acting as a European Competent Authority for devices,
and providing a medical device evaluation service.
Adverse incident centre The agency’s adverse incident centre currently
receives almost 9,000 device-related adverse incidents every year. Each
incident is investigated on a priority scale determined after discussion
with the reporter and any relevant clinical or technical staff involved.
Investigations may result in a number of actions being taken. Where necessary,
warnings and advice are issued by means of “Device Alerts”,
in order to alert users to real or potential problems. After an investigation,
the agency may also work with manufacturers to prevent recurrence of
a problem through modifications or recall of a device.
As a result of adverse incidents reported, last year some 56 device alerts
were issued to the health service and, in 1,033 cases, manufacturers
undertook to improve designs or manufacturing systems.
Although the MHRA receives a number of device-related adverse incident
reports directly from the manufacturer, these relate mainly to problems
arising from shortcomings in the device or its operating instructions.
Increasingly, we know that adverse incidents also occur as a result of
user practices, conditions of use, poor maintenance or difficulties with
cleaning, decontamination or sterilisation. If improvements are to be
made in design, function, materials, ergonomics and instructions for
use, therefore, it is vital that the agency continues to receive reports
from users who have experience of the device.
European competent authority The MHRA acts as the competent authority
(regulatory authority) for the negotiation, implementation and enforcement
of the European Devices Regulations, a body of legislation that has,
over the past few years, replaced the previously existing voluntary system
for the control of medical devices within the United Kingdom. Under the
provisions of these regulations, no device may be freely sold on the
EU market without a CE-mark, which denotes compliance with a number of
relevant essential requirements covering device safety and performance.
These regulations also allow strict controls to be applied to devices
that present the greatest risk to the health and safety of the patient
or user, including surgical implants, such as knees or hip prostheses,
or those that come into direct contact with the heart or the central
nervous system.
In order to be allowed to affix the CE-mark, manufacturers must go through
a conformity assessment procedure to confirm that the device complies
with the relevant requirements. With the exception of low-risk devices,
eg, tongue depressors, these assessment procedures must be checked by
a certification organisation known as a notified body, of which there
are more than 60 throughout Europe.
To demonstrate compliance, particularly with higher-risk devices, eg,
breast implants, clinical data may often be required. These data may
be obtained form previous clinical experience with the device, or from
a compilation of scientific literature relating to the device or a similar
device.
If this is not available, the required data will need to be generated
from a specifically designed clinical investigation. Such clinical investigations
must be notified by the manufacturer to the competent authority, which
then has 60 days in which to assess the safety of the device based on
the submitted information and inform the applicant of any grounds for
objection based on safety issues.
In making an assessment, the competent authority assessors will look
carefully at the risk analysis, taking into account the risk from such
factors as the design and materials used and the biological safety and
human tissue compatibility of the device in question. If objections are
raised, the clinical investigation may not proceed, even if it has local
research ethics committee approval, although the manufacturer may reapply
once the concerns raised have been satisfactorily addressed.
As a competent authority, the devices sector’s functions include
establishing systems for the designation of notified bodies, handling
clinical investigations and managing a statutory vigilance system through
which manufacturers are now required by law to report all serious device-related
incidents to a competent authority within a
given time.
Device evaluation service The agency’s third major role involves
managing an important programme of evaluation of certain medical devices,
intended to inform potential purchasers. The work is commissioned from
independent research specialists in the NHS or universities. Devices
are tested for performance and safety in both clinical and laboratory
settings, with the aim of providing a clear idea of the equipment’s
scope, ease of use and suitability for different environments.
Over 100 evaluation reports are published annually and made available
free of charge to the health service. These reports cover a wide range
of services, from diagnostic imaging and ultrasound equipment to “active” power-connected
equipment, including diathermy and defibrillators, and in vitro diagnostic
and disability equipment. |
