Human Tissue Authority

The regulator for human tissue and organs

Regulatory alert 001/2012

Issued 30 March 2012

Scope

This alert is being issued by the Human Tissue Authority (HTA) as designated Competent Authority for the purposes of the European Union Tissue and Cells Directives (2004/23/EC, 2006/17/EC and 2006/86/EC), brought into law by The Human Tissue (Quality and Safety for Human Application) Regulations 2007.

Issue

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that Bristol Myers-Squibb has initiated a precautionary recall of all batches of Viaspan, a solution used in organ transplant operations. For further details please refer to the information published on the MHRA website.

Viaspan solution is manufactured at Fresenius Kabi, Austria, and distributed in the European Union, including the UK, by Bristol Myers-Squibb which has advised that all batches manufactured since 4 July 2011 may be affected by this issue.

Bristol Myers-Squibb was informed on 19 March 2011 of a failure in a routine media fill procedure on the dedicated production line of Viaspan at Fresenius Kabi Austria. The manufacturer believes the issue is related to a faulty pressure gauge on the filling line that was found to have a small leak. All batches since the last successful media fill have passed all testing, including sterility testing.  At the present time, there is no evidence of contamination of the Viaspan that has been released to the marketplace. However, Bristol Myers-Squibb believes that it cannot completely assure that batches manufactured since the last successful media fill are free from contamination.

Bristol Myers-Squibb has initiated a precautionary recall of all batches manufactured since 4 July 2011.  This recall is likely to result in an out of stock situation. New batches will not be available until June 2012 at the earliest.

The current advice from the Chief Medical Officer to transplant centres which use Viaspan solution is to continue to use any material in stock until an alternative solution can be obtained.  Bristol Myers-Squibb has advised that any patients who recently underwent or will undergo an organ transplantation in which Viaspan had been used or will be used as an organ preservation solution should be monitored closely for signs and symptoms of systemic as well as local infections.  The organism identified in the routine media fill procedure is Bacillus cereus, which is widely distributed in the environment and is most typically associated with food poisoning. It can cause a number of systemic and local, non-gastrointestinal-tract infections in susceptible patients, such as in transplant recipients.  Antimicrobials noted to be effective in the empirical management of a Bacillus cereus infection include ciprofloxacin and vancomycin. Antimicrobial treatment of Bacillus cereus infections should take into account local infectious disease knowledge and practices.

This alert is to ensure that all establishments using Viaspan solution, distributed by Bristol Myers-Squibb, are aware of the alert and the required actions.

Action taken by the HTA

The HTA has been in contact with the Department of Health, NHS Blood and Transplant and the MHRA, and has issued this alert.

Actions for establishments

Establishments which use Viaspan during the processing of tissues and cells should consider the clinical risks and benefits of continuing to use the solution.  The advice from the Chief Medical Officer to transplant centres is to continue to use any material in stock until an alternative solution can be obtained.  A risk analysis of the release for end use of tissues and cells which have been in contact with Viaspan should include the potential clinical use of prophylactic antibiotic treatment for the recipient of the tissues and cells.

Establishments must notify the HTA of any suspected serious adverse event and / or serious adverse reaction relating to Viaspan solution within 24 hours of the discovery of any incident.  This includes any effect on processing which results from the proposed recall and consequent shortage of stocks of the solution.

Please contact the HTA on 020 7269 1900 or email enquiries@hta.gov.uk if you would like any further advice on any of the above points or you are processing tissues and cells which you think may be affected.

Audience: 
Last updated on: 2 Nov 2014