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Compliance

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The most important medical advisor is your physician.
Corlife provides innovative cell-free allografts, such as cell-free heart valves, for the treatment of congenital and acquired cardiac and vascular defects. While we are fully convinced of the quality of our cell-free allografts, this type of allograft is not always the best therapy option for everyone. Only your treating physician can advise you adequately on the therapeutic approach most suitable for you. If a cell-free allograft is selected as the preferred option for valve replacement, your hospital will take all necessary steps to organise the allograft. This means that we are not in a position to discuss the provision of a cell-free allograft with you directly. There are several legal reasons for this:

No arrangements with patients

Corlife cannot discuss the provision of a cell-free allograft directly with you. There are good reasons for this:

  • We are not clinicians and, as such, cannot judge whether a cell-free allograft is the right treatment for you;
  • For the most part, the tissue banks providing the donated allograft decide on where the cell-free allograft is allocated.

Waiting times

At present, it is unfortunately not possible to meet the current demand for cell-free allografts, even where the treatment is deemed appropriate and necessary. Each cell-free allograft is dependent on a tissue donation. The timing of the tissue donation and geometry of the allograft must fit for the recipient. Other factors, including regulatory issues beyond our control, can also play a role. For this reason, we reserve the right to decide against providing a cell-free allograft where we consider this to be the right decision.

National Patient Organisations

We understand that you may be in a situation of great concern and uncertainty. For example, we are aware that cell-free allografts are not regularly reimbursed in some countries which can result in a case of hardship for individual patients. We fully understand patients’ need for support and take our responsibility seriously. However, assessing your situation and providing help in individual cases exceeds our competence, our authority, and our financial means. For this reason, we recommend that you contact your national patient organisations via ECHDO.eu (for further details, please visit www.echdo.eu/echdo-members).

Thank donors

After receiving a tissue donation, there is often a wish to thank the donor. This gratitude can be expressed in different ways and each of these ways has its dignity and justification.

In most cases, the donor will have passed away before the tissue is donated. In a few cases, the donors are still alive. They are people who have had a heart transplant themselves. The heart valves can be taken from the explan-ted heart as a tissue donation. We are not allowed to tell you which donation you have.

One way to say thank you is to write a letter of comfort and appreciation to the donor family. When you write this letter and what you write is up to you. There is no such thing as "too early" or "too late". For example, tell what tissue donation means to your daily life and how you feel when you think of the donor.

However, you should keep one very important rule in mind: This letter must be written in anonymous form. It is not allowed to reveal your identity. Therefore, avoid any information that allows you to draw direct conclusions about yourself. For example, the letter must not contain any information about your name (or your relatives), your address, your email connection, your presence in social media, the name of the treating clinic or the treating doctors. If the anonymity criteria are not met, your letter must not be forwarded.

The thank-you letter takes the reverse route of the tissue donation:

  • Give your thank-you letter in an open envelope to your attending doctor. Your letter must be accompanied by the "Consent form for forwarding an anonymous thank-you letter to the tissue retrieval organisation". We have also written a cover letter to support your intention. The thank-you letter will be addressed with the 40-digit SEC, the identification number of the tissue donation you received. This number can be found on the "Implant Identification Card" that was given to you after the surgery.
  • Your letter will then be forwarded to the tissue retrieval organisation by your attending physician. The tissue retrieval organisation will check whether your letter was written anonymously, whether your consent form is enclosed for forwarding and whether the donor family wishes to receive your letter. If these conditions are met, your thank-you letter can be sent to the donor family.

An anonymous response letter from the donor family can also be forwarded to you. Please do not interpret a lack of response as rejection or disinterest. It is sometimes very difficult for donor families to write a letter. Whether you want to receive a reply letter from the donor family is also your free decision. You can indicate on the consent form whether you would like to receive such a letter.

The procedure of saying thank you is not formally established and might be inhibited by laws at domestic and international level. There are therefore no guarantees that your thank-you letter will ever reach the donor's family. However, it is our experience that those involved are committed and will go out that extra mile to fulfil your wish.

Tissue Donations

Corlife is not directly involved in tissue donation. We receive tissue donations from donor institutions. Any cooperation with a donor institution must be approved by the German regulatory authorities. The donor institution reserves the right to decide which hospital will receive the cell-free allograft.

Tissue donations are a very personal gift which is directly linked to post-mortem personal rights and the dignity of the donor. We pay attention to respectful interaction and language.

Every tissue donation is a mission and deserves the best possible treatment to help a patient. In case of doubt, this goal takes precedence over the dictates of economic efficiency.

Tissue donation could also be used to transmit undetected diseases. We take a number of measures to protect patients, third parties (such as cleaning and transport personnel), medical staff and our own employees from the dangers that could be posed by the tissue, thus preventing the transmission of diseases.

Our employees are well qualified and are extensively trained in the processing of tissue donations. They handle each tissue donation with the necessary professionalism and respect the dignity of the donors.

Transparency

Remuneration

The German transplantation law allows in § 17 (1) an adequate remuneration for the processing of tissue donations. The amount of the fee is agreed with the hospitals and health insurance companies in a legally regulated procedure .

Corlife is not a non-profit organization. We need turnover and profit to shoulder salary payments, operating and material costs, services, investments and the entrepreneurial risks, while keeping a sense of proportion. An overview of our financial figures is available here.

Donations

Corlife supports initiatives for patients and further education in the healthcare sector. You can find an overview of our donations here.

Public participation

Corlife participates in the public, scientific and technical discussion on tissue medicine in Europe. We have deposited our interest profile in the European Transparency Register.

Traceability

An important safety element in transplantation medicine is traceability. Traceability and data protection are not contradictions:

  • Corlife is not involved in tissue donation, but receives tissue donations from independent donation establishments. These establishments know the identity of the donor, but forward to Corlife only a unique donation number. The unique donation number does not disclose the donor's identity.
  • Corlife processes the tissue donation into cell-free allografts. These are given to hospitals. The specific identity of the patient for whom the cell-free allograft is intended is not communicated to corlife.
  • Corlife informs the donor center about the delivery of the cell-free allograft to the hospital.