FDA Registration For Hospital 04/06

  

" I would like to start this month with a question that was recently raised concerning registration with the FDA. "

Bacterial and viral contamination of tissue grafts from cadaveric donors has been a cause of morbidity and mortality in tissue recipients. Most of these infections have been caused by tissue products such as tendons, articular cartilage, fresh bone grafts, heart valves and other tissues that cannot be treated harshly with chemicals or radiation to remove or diminish the risks of contamination. There have been cases of contamination arising from infected donors as well as all steps in the recovery and processing of tissue. Physicians are often unaware of the risks of infection that each type of tissue presents and the choice of which vendor of tissue to utilize often fails to include this major factor.

 

The risks of tissue transplant have led to increased regulation through the Food and Drug Administration, some state regulatory agencies and stricter standards created by the American Association of Tissue Banks and Joint Commission. Complications from tissue transplantation have resulted in a number of lawsuits directed against tissue suppliers, processors, hospitals and physicians.
 

Does your hospital need to register with the FDA for its tissue activities?

The FDA regulates human cells, tissues, and cellular and tissue based products (HCT/P) under 21 CFR 1270 and 1271. HCT/P is defined as articles containing or consisting of human cells or tissue that are intended for implantation, transplantation, infusion or transfer into a human recipient. In addition to musculoskeletal grafts, heart valves, skin and blood vessels, the regulations now include stem cells and reproductive cells as well, but not blood, organs or marrow. Any institution that is involved in the recovery, processing, storage, labeling, packaging or distribution of tissue or tests cell or tissue donors for communicable diseases must register.

Questions to determine requirement for registration with FDA

  1. Does your institution produce HCT/P including stem cells, reproductive cells or tissue or surgical bone?

 

  1. Does your institution store purchased tissues and ship to another institution not part of your organization, for example does your institution supply a VA hospital or other hospitals in the community?

 

  1. Does your institution store tissue from a patient in case the surgeon needs it for another patient, for example during organ transplant does is vascular conduits stored and occasionally used for transplant into another patient? (Note this does not include chemical or microbiological testing for donor tissue)

 

  1. Does your institution perform additional processing on incoming tissue, for example gas sterilize bone for further use?

 

  1. Does your institution’s testing lab perform tissue donor testing for communicable diseases? Does your lab test specimens for organ donors and the results are used to determine eligibility for tissue donors?

 

For further information concerning FDA registration go to: http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfr1271_05.html