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Select Committee on Health Appendices to the Minutes of Evidence


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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