Surgeons Object to New CDC Organ-Screening Guidelines

[Guest guest]

http://blogs.wsj.com/health/2011/09/22/surgeons-object-to-new-cdc-organ-screenin\

g-guidelines/

September 22, 2011, 1:58 PM ET

Surgeons Object to New CDC Organ-Screening Guidelines

By Landro

New guidelines for stricter testing of organ donors are raising concerns among

transplant surgeons, who fear they may limit availability of organs.

The Centers for Disease Control and Prevention yesterday issued new guidelines

recommending that all organ donors be checked for HIV and hepatitis B and C with

the most sensitive screening method, known as nucleic acid testing, the Wall

Street Journal reports today.

Henry, president of the American Society of Transplant Surgeons, and

chief of the transplant center at Ohio State University, tells the Health Blog

the guidelines go too far in the pursuit of safety, and don’t take into

consideration the realities of organ transplantation — which is often performed

in life-and-death situations with little time to spare.

“We support guidelines which help to decrease disease transmission, but we want

them to be evidence-based and balanced by the risks of dying without an organ

transplant,” says Henry.

Guidelines were last updated in 1994, when the more sensitive tests weren’t yet

in use, and covered only HIV.

Nucleic-acid testing, or NAT, can detect an infection acquired seven days before

testing. Standard blood tests, known as serologic testing, measure antibodies to

an infection that may take months to appear. Only about half of procurement labs

in the country voluntary use the newer test, but it can double screening costs.

Moreover, Henry says NAT isn’t always feasible — for example, if an organ has to

be flown to a transplant center from a remote location where no labs are

available.

The proposed guidelines also broaden the types of donors considered to be at

increased risk of spreading an infection. Henry says his group believes they now

classify too many segments of the population as riskier donors even though they

might be good candidates, such as anyone who has had sex with two or more

different partners in the last year. “That could cover three quarters of college

kids in America,” Henry notes.

Kuehnert, who oversees blood and organ safety for the CDC, stresses that

the guidelines are meant to give potential recipients and their doctors as much

information as possible about risks of any organ, so they can make an informed

decision about using it.

As to concerns the recommended guidelines may limit organ availability, he says

the aim is the opposite. “The guidelines may actually expand available organs by

providing more confidence in the risks assessment of the donor, which will in

turn improve the chances a patient and doctor will accept the organ,” Kuehnert

says.

Organs that are positive for infections other than HIV can still be

transplanted, “but we just want to make sure we are aware so the recipient can

be treated and we can mitigate complications of infections when they do occur,”

Kuehnert says.

While the federal guidelines are not enforceable, Henry notes that they usually

become mandatory standards of care. Comments can be submitted for sixty days and

his group — along with several others – plans to submit comments protesting

that the CDC did not take its concerns into account and suggesting possible

modifications to the guidelines.

Kuehnert responds that the CDC will take public comments seriously and revise

guidelines where appropriate. “We realize change is difficult and we want to

work with the transplant community to make the guidelines as useable as

possible,” he says.

[Guest guest]

http://blogs.wsj.com/health/2011/09/22/surgeons-object-to-new-cdc-organ-screenin\

g-guidelines/

September 22, 2011, 1:58 PM ET

Surgeons Object to New CDC Organ-Screening Guidelines

By Landro

New guidelines for stricter testing of organ donors are raising concerns among

transplant surgeons, who fear they may limit availability of organs.

The Centers for Disease Control and Prevention yesterday issued new guidelines

recommending that all organ donors be checked for HIV and hepatitis B and C with

the most sensitive screening method, known as nucleic acid testing, the Wall

Street Journal reports today.

Henry, president of the American Society of Transplant Surgeons, and

chief of the transplant center at Ohio State University, tells the Health Blog

the guidelines go too far in the pursuit of safety, and don’t take into

consideration the realities of organ transplantation — which is often performed

in life-and-death situations with little time to spare.

“We support guidelines which help to decrease disease transmission, but we want

them to be evidence-based and balanced by the risks of dying without an organ

transplant,” says Henry.

Guidelines were last updated in 1994, when the more sensitive tests weren’t yet

in use, and covered only HIV.

Nucleic-acid testing, or NAT, can detect an infection acquired seven days before

testing. Standard blood tests, known as serologic testing, measure antibodies to

an infection that may take months to appear. Only about half of procurement labs

in the country voluntary use the newer test, but it can double screening costs.

Moreover, Henry says NAT isn’t always feasible — for example, if an organ has to

be flown to a transplant center from a remote location where no labs are

available.

The proposed guidelines also broaden the types of donors considered to be at

increased risk of spreading an infection. Henry says his group believes they now

classify too many segments of the population as riskier donors even though they

might be good candidates, such as anyone who has had sex with two or more

different partners in the last year. “That could cover three quarters of college

kids in America,” Henry notes.

Kuehnert, who oversees blood and organ safety for the CDC, stresses that

the guidelines are meant to give potential recipients and their doctors as much

information as possible about risks of any organ, so they can make an informed

decision about using it.

As to concerns the recommended guidelines may limit organ availability, he says

the aim is the opposite. “The guidelines may actually expand available organs by

providing more confidence in the risks assessment of the donor, which will in

turn improve the chances a patient and doctor will accept the organ,” Kuehnert

says.

Organs that are positive for infections other than HIV can still be

transplanted, “but we just want to make sure we are aware so the recipient can

be treated and we can mitigate complications of infections when they do occur,”

Kuehnert says.

While the federal guidelines are not enforceable, Henry notes that they usually

become mandatory standards of care. Comments can be submitted for sixty days and

his group — along with several others – plans to submit comments protesting

that the CDC did not take its concerns into account and suggesting possible

modifications to the guidelines.

Kuehnert responds that the CDC will take public comments seriously and revise

guidelines where appropriate. “We realize change is difficult and we want to

work with the transplant community to make the guidelines as useable as

possible,” he says.