Editing Apheresis (section)

==== Donor safety ====
* Single use kits – Apheresis is done using single-use kits, so there is no risk of infection from blood-contaminated tubing or centrifuge. Blood does not contact the device and during the separation, blood does not exit the kit.<ref name=Vrielink23/>
* Reinfusion – At the end of the procedure, the remaining blood in the kit is given back to the donor with a process called 'reinfusion'.
* Immune system effects – "the immediate decreases in blood lymphocyte counts and serum immunoglobulin concentrations are of slight to moderate degree and are without known adverse effects. Less information is available regarding long-term alterations of the immune system".<ref>{{cite journal |doi=10.1002/jca.2920020112 |title=Apheresis donor safety – changes in humoral and cellular immunity |year=1984 |last1=Strauss |first1=Ronald G. |journal=Journal of Clinical Apheresis |volume=2 |pages=68–80 |pmid=6536660 |issue=1|s2cid=25890912 }}</ref>

===== Kit problems =====

Two apheresis kit recalls were:
* Baxter Healthcare Corporation (2005), in which "pinhole leaks were observed at the two-omega end of the umbilicus (multilumen tubing), causing a blood leak."<ref>{{cite web|url=https://www.fda.gov/CbER/recalls/baxaphe013105.htm |title=Recall of Amicus Apheresis Kits, Baxter Healthcare Corporation |website=[[Food and Drug Administration]] |access-date=2008-12-20 |url-status=dead |archive-url=https://web.archive.org/web/20090117033956/https://www.fda.gov/cber/recalls/baxaphe013105.htm |archive-date=2009-01-17 }} "Recall of Amicus Apheresis Kits, Baxter Healthcare Corporation", US FDA, Jan 31 2005</ref>
* Fenwal Incorporated (2007), in which there were "two instances where the [[acid-citrate-dextrose|anticoagulant citrate dextrose]] (ACD) and saline lines were reversed in the assembly process. The reversed line connections may not be visually apparent in the monitor box, and could result in excessive ACD infusion and severe injury, including death, to the donor."<ref>{{Cite web|url=https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm053390.htm|archive-url=https://web.archive.org/web/20090709195045/http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm053390.htm|url-status=dead|archive-date=July 9, 2009|title=Recall of CS3000 Apheresis Kits|date=June 21, 2007|website=[[Food and Drug Administration]]}}</ref>
<!--* Sri lanka expired kits – " top Health Ministry officials accompanied UNP parliamentarian Jayalath Jayawardena to the Centre, on his request, and found 44 expired apheresis kits, allegedly damaged, in two rooms close to its director's office."<ref>[http://sundaytimes.lk/080817/News/sundaytimesnews_12.html  More bluffs and blunders in bloody mess, By Kumudini Hettarachchi, August 17, 2008, ''The Sunday Times'']</ref> -->

===== Donor selection =====

People who do not use a drug that may prevent blood donation, who do not have the risk of the carrier of a disease, and who have suitable vascular structure may be apheresis donors. For apheresis platelet donation the donor's pre platelet count should be above 150 x 10^9/L. For apheresis plasma donation, the donor's total protein level should be greater than 60 g/L. For double red cell apheresis, donors of either gender require a minimum hemoglobin level of 14.0 g/dl.<ref>{{cite journal |vauthors=Boulton F |title=The 13% rule. Comments |journal=Transfusion Today |date=2007 |volume=71 |pages=7–9}}</ref>

===== Plasticizer exposure =====

Apheresis uses plastics and tubing, which come into contact with the blood. The plastics are made of [[PVC]] in addition to additives such as a [[plasticizer]], often [[DEHP]]. DEHP leaches from the plastic into the blood, and people have begun to study the possible effects of this leached DEHP on donors as well as transfusion recipients.<ref>{{cite journal |vauthors=Larsson L, Sandgren P, Ohlsson S, Derving J, Friis-Christensen T, Daggert F, Frizi N, Reichenberg S, Chatellier S, Diedrich B, Antovic J, Larsson S, Uhlin M |title=Non-phthalate plasticizer DEHT preserves adequate blood component quality during storage in PVC blood bags |journal=Vox Sang |volume=116 |issue=1 |pages=60–70 |date=January 2021 |pmid=32918773 |doi=10.1111/vox.12982 |doi-access=free }}</ref>
* "current risk or preventive limit values for DEHP such as the RfD of the US EPA (20 μg/kg/day) and the TDI of the European Union (20–48 μg/kg/day) can be exceeded on the day of the plateletpheresis. ... Especially women in their reproductive age need to be protected from DEHP exposures exceeding the above mentioned preventive limit values."<ref>{{cite journal |doi=10.1007/s00204-005-0004-x |title=Intravenous exposure to di(2-ethylhexyl)phthalate (DEHP): Metabolites of DEHP in urine after a voluntary platelet donation |year=2005 |last1=Koch |first1=Holger M. |last2=Bolt |first2=Hermann M. |last3=Preuss |first3=Ralf |last4=Eckstein |first4=Reinhold |last5=Weisbach |first5=Volker |last6=Angerer |first6=Jürgen |journal=Archives of Toxicology |volume=79 |issue=12 |pages=689–93 |pmid=16059725|s2cid=743051 }}</ref>
* "Commercial plateletpheresis disposables release considerable amounts of DEHP during the apheresis procedure, but the total dose of DEHP retained by the donor is within the normal range of DEHP exposure of the general population."<ref>{{cite journal |doi=10.1046/j.1537-2995.2003.00479.x |title=Donor exposure to the plasticizer di(2-ethylhexyl)phthalate during plateletpheresis |year=2003 |last1=Buchta |first1=Christoph |last2=Bittner |first2=Claudia |last3=Höcker |first3=Paul |last4=Macher |first4=Maria |last5=Schmid |first5=Rainer |last6=Seger |first6=Christoph |last7=Dettke |first7=Markus |s2cid=34539126 |journal=Transfusion |volume=43 |issue=8 |pages=1115–20 |pmid=12869118}}</ref>
* The Baxter company manufactured blood bags without [[DEHP]], but there was little demand for the product in the marketplace
<!-- * Some apheresis products are now manufactured in China. <ref>http://nigale.en.alibaba.com/offerdetail/203354126/Sell_Single_use_Apheresis_Plasma_Separating_Kit.html {{Bare URL inline|date=May 2022}}</ref> -->
* "Mean DEHP doses for both plateletpheresis techniques (18.1 and 32.3 μg/kg/day) were close to or exceeded the reference dose (RfD) of the US EPA and tolerable daily intake (TDI) value of the EU on the day of the apheresis. Therefore, margins of safety might be insufficient to protect especially young men and women in their reproductive age from effects on reproductivity. At present, discontinuous-flow devices should be preferred to avert conceivable health risks from plateletpheresis donors. Strategies to avoid DEHP exposure of donors during apheresis need to be developed."<ref>{{cite journal |doi=10.1016/j.ijheh.2005.07.001 |title=Di(2-ethylhexyl)phthalate (DEHP) exposure of voluntary plasma and platelet donors |year=2005 |last1=Koch |first1=Holger M. |last2=Angerer |first2=Jürgen |last3=Drexler |first3=Hans |last4=Eckstein |first4=Reinhold |last5=Weisbach |first5=Volker |journal=International Journal of Hygiene and Environmental Health |volume=208 |issue=6 |pages=489–98 |pmid=16325559}}</ref>