Human Tissue Authority

The regulator for human tissue and organs

Regulatory alert 002/2008

Issued 14 April 2008

Scope

This alert is being issued by the Human Tissue Authority (HTA) in its role as Competent Authority under the European Union Tissue and Cells Directives. The Directives have now been implemented into UK law via the Human Tissue (Quality and Safety for Human Application) Regulations 2007.

Issue

A Serious Adverse Event has been reported to the HTA regarding Femoral Head Storage Pots supplied by Medfor Products Ltd. The pots are supplied double wrapped in sterile packaging. On some units the seal on the outer packaging is defective/not sealed correctly, potentially rendering the external surface of the inner pack non-sterile.

This alert is to ensure that all establishments:

  • using Medfor products are aware of the affected lot numbers and if required take steps to identify potentially affected donors and quarantine affected tissue; 
  • are aware of their obligations to report Serious Adverse Events and Serious Adverse Reactions to the HTA;
  • are aware of their obligations to take steps to minimise the risk of bacterial contamination; and
  • are aware of their obligations to ensure appropriate third party agreements are in place with suppliers of goods and services that could affect the quality and safety of tissues and cells. 

Background

The HTA has received a Serious Adverse Event notification from a licensed establishment regarding femoral head storage pots supplied by Medfor. The affected product and lot numbers are:

Catalogue number Medfor lot number Dates issued Action taken
S400 111449 Sep 07 - Jan 08 RECALLED
S400 110407 Feb 07 - Jul 07 EXERCISE VIGILENCE
S400 112307 Jan 08 - Mar 08 EXERCISE VIGILENCE
S227 All  – EXERCISE VIGILENCE

It has been found that a number of units from lot number 111449 have a defective seal on the outer packaging. Sterility tests carried out by the manufacturer indicate that the outer surface of the inner packaging was not sterile in some affected units. Depending on the handling procedures of theatre staff this may mean a scrubbed nurse has handled a non-sterile surface.

Medfor has initiated a product recall on lot number 111449, and has issued guidance for extra vigilance in respect of two further lots, 110407 and 112307. Medfor has also issued guidance for extra vigilance on product S227, which uses the same type of packaging.

Action taken by the HTA

The HTA has contacted the reporting establishment, Medfor and the Medicines and Healthcare products Regulatory Agency (MHRA).

Actions for establishments licensed for human application

URGENT

  • Any establishment using Medfor products for procurement of tissue should check their current stock and historical procurement records for the affected product and lot numbers. 
  • If unused products from lot 111449 are found, they should be quarantined and the Medfor recall procedure initiated – please contact Medfor for details - Medfor website.
  • If unused products from lot 110407 and lot 112307 are found and have faulty packaging, they should be quarantined and returned to Medfor.  
  • If products from lot 111449 have been used for procurement of tissue and it is suspected that the packaging may have been faulty, then tissue should be traced and quarantined immediately pending investigation. Please notify the HTA via the HTA’s online Serious Adverse Event and Reaction reporting system.
  • Affected donors and any recipients should be identified and any subsequent adverse reactions reported to the HTA.
  • Establishments should carry out a risk assessment to determine the most suitable course of action with implicated tissue. Unless able to determine by further microbiological testing that irradiating tissue would be effective, or if testing and irradiating are likely to add further risk of contamination, then tissue should be disposed of.  Any disposal should be in line with HTA’s codes of practice.

ONGOING ADVICE AND GUIDANCE

All establishments are advised to refer to the manufacturer’s labeling and instructions for use which states that they should check the seal on the packaging before use.

Establishments are reminded that under HTA Directions 002/2018,

  • critical reagents and materials should meet documented requirements and specifications;
  • all relevant data relating to products and material coming into contact with tissues and / or cells should be traceable;
  • establishments must notify the HTA of any suspected serious adverse event and / or serious adverse reaction as soon as possible after the incident;
  • where a third party procures, processes, tests, distributes, imports or exports tissues and / or cells on behalf of the Licence Holder or Designated Individual the establishment shall put in place and maintain a written third party agreement;
  • where a third party supplies to the Licence Holder or Designated Individual any goods or services which may affect the quality or safety of tissues and / or cells the establishment shall put in place and maintain a written third party agreement.

Please contact the HTA if you would like any further advice on any of the above points or you are storing tissue which you think may be affected.

Further guidance in relation to your obligations under the European Union Tissues and Cells Directives as implemented by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) can be found by referring to HTA Directions 002/2018.

Audience: 
Last updated on: 29 Mar 2018