Results of a WMDA survey
on HSC collection kits
shortage in Europe
In December 2022 the World Marrow Donor Association (WMDA) sent out a survey to its
members to understand the problems faced in regard to the haematopoietic stem cell (HSC)
collection kits shortage in Europe. A total of 21 responses from 17 different countries were
received, of which 10 are EU member states.* An analysis of the survey data leads to the
conclusion that there are still major issues surrounding HSC collection kit shortages and this
would require further action. The WMDA will continue to collaborate with all involved parties
until a solution is reached. Please find below a synopsis of the survey replies.
55% (n=11) of respondents indicated that
"[...] None of our centers have been able to
their registry has experienced capacity
make any purchase and the price of the kit
problems in the provision of bone marrow has doubled, even tripled and many centers
due to problems of availability of collection cannot pay those prices. It is not wise to let
a single company have a monopoly and we
bags. To solve these issues, many indicate
definitively need a European solution." - R4
that they are using inhouse solutions or are
exploring the options in doing so. Others opt
for collaboration with suppliers in support of In response to the question if assistance
their derogation procedures. from the WMDA or the EU would be
required to get the issue solved, 55% (n=11)
"[...] we initiated a derogation procedure,
indicated that no assistance from either
and our collection centres (CCs) are now party is needed, 40% (n= 8) would prefer
importing units from the US. Additionally, assistance from both the WMDA and the
the centers traded kits for a while and one
center validated their own procedure using EU, and 5% (n= 1) would require assistance
other components, not kits." - R21 from the EU only.
A total of 11 respondents (55%) shared that "We have some kits with expired date of use
they are aware of similar issues with bone which underwent risk analysis and are used
still, but this won't last long." - R15
marrow donation by related donors.
Respondents are largely facing the same
issues with related donors as with unrelated It is clear that the issues surrounding the
donors. shortages of HSC collection kits are not yet
solved. A European solution, where fair
"Some CCs stopped because of the prices, a regulated market and awareness of
shortage. CCs with collection kits had more the current issues are at the top of the
workload. Some CCs developed in-house-kit
to solve the problem." - R5 agenda, would be needed to offer a timely
solution to this pressing issue.
* Please note that this survey was shared during the December holiday period, and it is likely that some respondents filled out the
survey while on away on holiday. No question was included to indicate the country or region of their organisation. Data on respondent
origin may therefore not match the geographical location of their organisation.
Saatja: <
[email protected]>
Saadetud: 15.02.2023 12:34
Adressaat: <
[email protected]>
Koopia: <
[email protected]>; Laure DELIGNIVILLE
<
[email protected]>
Teema: Follow-up meeting of the National Competent Authorities for
Tissues and Cells on 07 February 2023
Dear colleagues, dear national authorities for tissues and cells,
It was our pleasure to have you all in our meeting on Tuesday last
week. As promised, we herewith provide you with a short list of follow-
up actions.
* We would like to inform you that the Council Working Party meeting to
discuss the SoHO proposal has taken place on 14th February and has
focussed on SoHO supervisory activities for Competent Authorities. The
next meeting will take place on 02nd March.
* Regarding the future EU SoHO digital platform you can provide us
until 28th February with your further views or comments on the mock-ups
and in general on the presentations (these files are available on ). We
will compile and forward them to the consultants working to draft the
technical specifications of the platform.
* The Microbiological Risk of Contamination Assessment (MiRCA) tool is
available via the following link: . For additional information or
questions, please contact EDQM directly at or Prof. Johan Guns at .
* We kindly remind you to inform us of any national derogations granted
for medical devices for non-CE marked bone marrow collection kits. We
attach (and copy on ) a summary received from the World Marrow Donors
Association regarding the situation in Europe for your
information. WMDA considers that the solutions found up to now are
somewhat fragmented and are temporary and they do not consider that the
availability situation is resolved. If you consider that the derogations
granted in DE, DK and EL needs to be extended to EU-wide, we would
suggest that you contact your medical device colleague that represents
your Member State in the Derogations subgroup of the MDCG as this option
will only be pursued if there is majority support from the Member States.
* We would also invite you to liaise with your colleagues from on the
if you consider that the extension of the deadline for compliance with
MDR for certain devices (including blood and bone marrow bags) should be
mirrored by a similar extension of the Sunset date for compliance with
Annex XIV of REACH (to allow more time for the industry and the blood
services to be ready for ban on the use of DEHP in blood and bone marrow
bags). This topic will be discussed at a meeting of the REACH committee
on March 1 where DG SANTE will make a presentation on this topic.
* ANSM would like to have some information from MS on ancillary
products and asked that we share the following request with you.
A few years ago, we defined a French status called PTA for "Produits
thérapeutiques annexes" leading to an ANSM authorization to be used
for the preparation of cells and tissues. This status has been abrogated
and according to the definition of the product, nowadays, we require a CE
label for these products as for example media for cornea or a marketed
authorization when possible as for example, human albumin used in
cryopreservation solution. Because of current difficulties for the
obtention of a CE label for the media which are used in cornea processes,
we were wondering how the other MS deal with this situation and have the
following questions for them:
* Are there requirements for materials/media coming into contact with
Tissues and Cells, in particular for corneas and notably in terms of
status (CE label or not) to authorize cornea preparations?
* If there is no specific requirement, are these media evaluated with
the tissue file during the process authorization?
* What is the number of references available on each national market
for corneal media ? What are they (name and supplier) ?
For information, as mentioned during the meeting, the main media used in
France is from Eurobio and it has not yet obtained a CE label. So that,
the deadline for entry into force of the MDR has no impact for these.
Please send your answers to Laure De Ligniville at Thank you for your
help.
* The next virtual meeting is planned on 24 May and will be a joint
meeting of the competent authorities for blood, tissues & cells and
organs.
Full minutes will be provided later.
With kind regards,