Condom audits
6 September 2007
The Department of Health has been updated by the South African Bureau of
Standards on the ongoing audit relating to the evaluation of condoms that are
distributed by the Department of Health under a brand name "Choice."
These condoms are supplied by seven private companies that were awarded a
tender to support the free condom distribution programme in the country. This
programme is a crucial element of the Health Department's effort to prevent
sexually transmitted infections, including HIV and to reduce the number of
unwanted pregnancies.
As part of the tender specifications, the Department of Health requires that
all condoms be certified by SABS as being of adequate quality in terms of the
standards set by the World Health Organisation (WHO).
As you are aware, the Department of Health is recalling all condoms supplied
by one of the seven companies, Zalatex (and produced by Latex Surgical Products
[LSP]) as a precautionary measure. This follows charges that Zalatex bribed an
official of the SABS to approve condoms that were not conforming to the quality
standards.
Close to 5 million condoms supplied by Zalatex have been collected since the
recall and an additional 7,5 million condoms have been quarantined at the
company's warehouse. An urgent meeting of the Bid Adjudication Committee has
been called for next week to review the contract with Zalatex and the
recommendation from the Department of Health is that the contract should be
cancelled. The Department has ceased buying any stock from Zalatex.
We urge the public to continue to support the recall of these condoms by
returning to the nearest health facility all condoms with a lot number:
4308/ZLX*.
SABS has reported to the Department of Health that the organisation has
audited the remaining six suppliers. There were anomalies requiring further
investigation regarding some batches of condoms supplied by at least three
companies. The SABS has audited the quality assurance measures at these three
companies and is satisfied that the production processes at these companies
meet the necessary standard.
However, the SABS has recommended that the Department quarantines the most
recent batches of condoms supplied by these companies for retesting over the
next week. This is intended to verify the quality of these condoms and inform
the final conclusions of the audit process that is currently underway.
Information relating to the conclusion of this audit process will be made
available in due course.
In the meantime, it is important to continue to encourage the correct and
consistent use of condoms as an important barrier against unwanted pregnancies
and Sexually Transmitted Infections (STIs) including HIV infection. The
Department of Health will continue to work together with SABS to ensure that
all condoms distributed by government conform to the quality standard set by
the WHO.
Thami Mseleku
Director-General
Department of Health
Enquiries:
Sibani Mngadi
Spokesperson
Department of Health
Tel: 012 312 3196
Fax: 012 326 4395
Cell: 082 772 0161
Issued by: Department of Health
6 September 2007
