Cardiac Rhythm Management Special Interest Section
The Cardiac Rhythm Management Special Interest Section comprises
members from all six companies who operate within this highly
specialized segment of the cardiology and cardiac care
market.
Issues affecting the industry often require a dialogue with the
appropriate government department or agency. In these
situations, individual commercial interests need to be set aside in
favour of delivering consistent messages through an organised
forum such as the industry association.
Cardiac Rhythm Management
Cardiac Rhythm Management (CRM) relates to the treatment of
disorders of the conduction system within the heart, which controls
heart rate and rhythm. This includes treatment for
quality-of-life-limiting bradicardia (a slow heart rate) and
tachycardia (a fast and irregular heart rate) as well as
debilitating or life-threatening conditions such heart failure and
sudden cardiac arrhythmia.
Devices produced to treat these conditions are active
implantable products of a highly complex and specialized nature.
Consequently their sale to the healthcare community requires
significant company-provided education and guidance for clinicians
and patients. In the UK these products and services are
primarily sold into the NHS as a government regulated
consumer.
CRM SIS
There are many issues within the NHS, as well as much legislation
implemented by the DH, that have direct consequences on the
way in which medical device companies operate within the UK health
sector. Often European and UK legislation and other health
service initiatives are complex in nature and open to
interpretation in different ways by different
communities.
In recent months the CRM SIS has influenced organisations and
policies such as: -
- NICE - on issues of evidence provision by manufacturers to
support HTA and guidance on therapies;
- HITF - to establish a framework to raise visibility of the
UK medical device industry as a provider of services to patients, a
developer of IP, an employer and a wealth generator for UKPLC;
- Payment by Results - to evaluate the positioning of
specialized therapies;
- Services within the national tariff structure, BPEG and
HRUK - in their reorganization and transition as the
professional body for arrhythmia clinicians and clinically related
staff, the DH and DE regarding issues on WEEE and safe device
removal and disposal;
- PaSA - relative to the formation and use of framework
agreements.
All of these issues are of central concern to all businesses
within the CRM SIS. Through this group's work with high level
contacts developed with the Government, the DH and the NHS by ABHI
staff, it has been possible to increase patients' access to complex
cardiac therapies and improve quality of care standards in the
treatment of cardiac arrhythmias.
The group meets approximately four times a year or more
frequently as issues dictate.