Press Release: Withdrawal for products distributed as condoms
Across 7 and 8 August 2024, Sexual Health and Family Planning ACT (SHFPACT) issued a product withdrawal for products distributed as condoms by SHFPACT.
We took this step after becoming aware that instead of condoms, lubricated probe covers for medical ultrasound were inadvertently distributed to community health organisations and members of the public at events in the ACT. The products have similar packaging and the appearance of condoms but do not provide the same level of protection against pregnancy and sexually transmitted infections.
SHFPACT is grateful for the way that the Canberra health, education, and community sectors responded to this issue. Our priority is the health and well-being of Canberrans, and we are aware of the additional burden this issue placed on our partners.
As we talked with our partners and the Canberra community to issue the withdrawal and provide advice to impacted organisations and individuals, I committed to resolving this issue with transparency and diligence. As part of that commitment, SHFPACT engaged PKF Integrity Services (PKF) to undertake an independent critical event analysis to determine the cause and extent of the issue and to provide recommendations to prevent such occurrences in the future.
I write to share with you the review's outcomes and an overview of SHFPACT’s commitments as a result.
The probe covers were distributed through various community outreach events conducted by SHFPACT between 19 January and 7 August 2024. SHFPACT’s stocktake identified approximately 4,200 probe covers that may have been distributed to the community.
- PKF’s analysis identified the following as key contributing factors:
- The absence of a formalised or documented procurement and purchasing procedure within SHFPACT.
- There was no mechanism in place to verify the accuracy of orders upon submission to the supplier, post-placement or once received at SHFPACT upon delivery.
- A contributing risk factor was the vendor listing probe covers under the product category of “condoms” on their website.
- Stock items were not recorded in a central matrix/register, which would have facilitated and supported the re-ordering of like goods when needed, ensuring consistency in the products that were purchased.
- The probe covers were accepted by SHFPACT as being condoms upon delivery and no additional validation or verification was undertaken to ensure that the product was appropriate for the intended purpose.
- Regular inventory counts or stocktakes for items that were not sold (condoms) to the public by SHFPACT were not undertaken. Stocktake control measures may have identified probe covers were added to the condom inventory.
PKF made a number of recommendations to improve SHFPACT’s procurement and inventory controls. These include:
- The development of an ordering catalogue/central matrix for regular products inclusive of the product number. Products should only be ordered using the available product number and avoid ordering products by key word searchers such as “condoms”, “lube” and “needles”. This matrix should be compiled with a comprehensive list of essential and regular items including contraceptives, medication and personal protection equipment. Low risk items (e.g. stationery) may be purchased outside of this catalogue and deviation for high-risk items (defined as items that may be distributed to the public) should require the order be reviewed and approved by the CEO or their delegate. Implementing a comprehensive ordering catalogue will standardise item selection and mitigate the risk of errors. Further, regular stocktakes of particular items, such as condoms, will enhance inventory accuracy and act as a safeguard against future discrepancies.
- Allocating a specific individual to oversee a procurement portfolio, ensuring they have the authority and accountability to oversee procurement activities, coupled with the introduction of two-factor authorisation for all purchases to ensure that all procurement decisions undergo assurance.
- Establishing training for staff involved in procurement outlining roles and responsibilities regarding new procedures.
SHFPACT is committed to fully implementing the recommendations made by PKF and have formed an internal working group to imbed these suggestions into our procurement process. Strategic oversight will be provided by the Governance subcommittee of the SHFPACT Board.
SHFPACT staff and board are grateful for the professional advice provided by PKF to improve our procurement and inventory processes. We remain committed to providing sexual and reproductive health education and clinical services to the Canberra community, and these enhanced processes will support our ability to continue to distribute condoms to prevent sexually transmissible infections and as a contraceptive method to prevent pregnancy as part of our approach.
We know that your trust and confidence are prerequisites for the successful delivery of our health promotion, workforce development, and clinical services. If you require any further information, please contact SHFPACT directly on 02 6247 3077.