APPENDIX 10
Memorandum by the Independent Healthcare
Association (B 18)
TABLE OF
CONTENTS
Table of Contents
1. Executive Summary
2. Independent Healthcare Association
3. Role of the Medical Devices Agency (MDA)
4. Regulation of independent Cosmetic Surgery
Clinics
5. The process whereby information relating
to risk is disseminated
6. The information provided by the Department
of Health directly to the public and action taken in response
to concerns raised
7. Guidance to healthcare professionals.
1. EXECUTIVE
SUMMARY
1. At present, certain shortcomings exist
in the system of communication from the Medical Devices Agency
(MDA) to independent sector health and social care providers.
Health Authorities have a statutory requirement to communicate
information received from the MDA to all independent sector hospitals
registered under the Registered Homes Act 1984. However, not all
Health Authorities fulfill their obligations to communicate to
independent sector providers.
2. In future, the Care Standards Act 2000
will regulate independent health and social care providers. The
Regulation of Independent Healthcare standards, currently being
developed for the Act, makes reference to the dissemination of
medical device information to the independent sector. However,
further consideration must be given as to how the MDA and the
National Care Standards Commission with independent sector providers
will manage the lines of communication.
3. Independent Healthcare Association welcomes
the introduction of the Care Standards Act 2000 as it will finally
regulate, to the same standards as mainstream hospitals, all independent
cosmetic surgery clinics, including those clinics not previously
regulated.
4. The Department of Health (England) and
The British Association of Aesthetic Plastic Surgeons have both
produced useful booklets for use by healthcare professionals performing
breast implant procedures.
5. The Independent Healthcare Association
has produced draft Standards for Cosmetic Surgery, which includes
breast implant procedures, for use in the independent sector.
The draft standards are currently out for formal consultation
and are attached as Appendix 1.[15]
2. INDEPENDENT
HEALTHCARE ASSOCIATION
6. The Independent Healthcare Association
(IHA) is the leading association for the United Kingdom's independent
health and social care providers. IHA's principal activities are
to promote and protect standards of health and social care in
the independent sector.
7. The independent sector has 211 acute
hospitals and delivers around one million surgical procedures
a year. It provides some 20 percent of all acute elective surgery
in the United Kingdom. [16]
8. All IHA acute member hospitals are required,
as a condition of membership, to be accredited with a recognised
quality accreditation scheme, such as Health Quality Service (HQS),
Hospital Accreditation Programme (HAP) or the ISO 9000 series.
IHA does not currently have in membership any purely Cosmetic
Surgery Clinics that perform breast implants. However, the IHA
Acute Board will be considering a proposal that IHA creates a
membership category for purely cosmetic surgery clinics. Acceptance
into IHA membership would be conditional on such clinics being
accredited with an IHA recognised quality accreditation scheme,
adhering to the IHA Code of Practice for Handling Patients Complaints,
and adhering to the finalised Standards for Cosmetic Surgery currently
being produced by IHA (see below).
3. ROLE OF
THE MEDICAL
DEVICES AGENCY
(MDA)
9. The IHA Executive has established good
individual relationships with the executive of the Medical Devices
Agency and IHA considers the supply of information from the Medical
Devices Agency to IHA itself to be good.
10. Independent sector hospitals and homes
are currently registered under the Registered Homes Act 1984.
Health Authorities have the responsibility to communicate information
received from the MDA to all independent sector hospitals registered
under that Act, unfortunately not all Health Authorities fulfill
this obligation.
11. For this reason, IHA provides a service
to members whereby it disseminates on a voluntary basis, via group
fax, notices and recalls received from the MDA, such as the recall
on TrilucentTM Breast Implants in March 1999. This is supplementary
service and IHA is not required to do so by statute. The IHA also
worked very closely with the Department of Health on that specific
recall.
12. Looking to the future, from April 2002
independent sector hospitals and homes will be regulated by the
National Care Standards Commission under the Care Standards Act
2000. An extract from the draft Regulation of Independent Healthcare
standards being developed for the Act reads as follows:
Policies and procedures must reflect a named
individual being responsible for the receipt of all information
received from the Medical Devices Agency or other cascade routes
and for the onward transmission of such information within the
specified time frames.
13. IHA has raised the issue of communication
to the independent sector in its responses to the various drafts
of the standards, making the point that: There needs to be further
in-depth discussion with the Medical Devices Agency (MDA) and
Medicines Control Agency (MCA) to ensure that the lines of communication
can be managed from both parties.
Additionally the role of the National Care Standards
Commission in disseminating such information needs further clarification.
4. REGULATION
OF INDEPENDENT
COSMETIC SURGERY
CLINICS
14. IHA welcomes the fact that the Care
Standards Act 2000 will finally regulate to the same standards
as mainstream hospitals, all cosmetic surgery clinics not previously
regulated. Such Independent Cosmetic Surgery Clinics perform,
inter alia, breast implants for purely aesthetic purposes.
5. THE PROCESS
WHEREBY INFORMATION
RELATING TO
RISK IS
DISSEMINATED
15. As mentioned above, IHA provides a supplementary
service to members whereby it disseminates, via group faxes, notices
and recalls received from the MDA. IHA also compiles a MDA News
Sheet which it includes in its monthly mailings to all IHA acute,
mental health and community care members.
6. THE INFORMATION
PROVIDED BY
THE DEPARTMENT
OF HEALTH
DIRECTLY TO
THE PUBLIC
AND ACTION
TAKEN IN
RESPONSE TO
CONCERNS RAISED
16. IHA member organisations contributed
to the Department of Health booklet Breast Implants: Information
for women considering breast implants. IHA believes that the
booklet provides sound advice for use by healthcare professionals
including IHA members.
17. The British Association of Aesthetic
Plastic Surgeons has also produced a set of booklets on varioius
cosmetic surgery procedures, including breast augmentation. [17][18]
The booklet covers such topics as "Expectations and Complications"
and "Safety of Silicone". IHA has advised the use thereof
for its member hospitals.
7. GUIDANCE TO
HEALTHCARE PROFESSIONALS
18. The Independent Healthcare Association
has established a member organisation Cosmetic Surgery Working
Group, in conjunction with Health Quality Service (HQS). The group
was established as a link to the General Medical Council Independent
Sector Group for Revalidation.
19. The working group's terms of reference
are as follows:
— To have a common set of standards
by which the sector can measure its compliance.
— To recommend proper professional
patient selection.
To adhere to advertising standards.
— To recommend that there are adequately
qualified and trained surgeons meeting GMC requirements who are
granted practising privileges for Cosmetic Surgery.
20. These standards are only one aspect
of a clinical governance framework for IHA member organisations.
The framework includes a comprehensive Code of Practice for Handling
Patient Complaints, the Private Practice Forum Principles for
Private Practice and a sector-accepted practising privileges template
for all clinicians to adhere to (not yeet agreed), including those
performing breast implants. Please see Appendix 1 for a copy of
the draft Standards for Cosmetic Surgery. As this is a
draft document, we would ask the Health Committee not to publish
the draft Standards for Cosmetic Surgery without written permission
from the IHA.)
15 Not printed. Back
16
Laing and Buisson, 2001. Back
17
British Association of Aesthetic Plastic Surgeons, Breast Augmentation
Fact Sheet. Available from the British Association of Aesthetic
Plastic Surgeons at the Royal College of Surgeons of England,
35-43 Lincoln's Inns Fields, London WC2A 3PN. Back
18
Not printed. Back
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