ASH Clinical News ACN_3.13_FULL_ISSUE_DIGITAL | Page 28

The Long and Short of It
System Malfunction
To Infinity and Beyond !

Data Stream

The Long and Short of It

A study of more than 2.6 million siblings in Sweden found that there is at least one advantage to being short : a lower risk for venous thromboembolism ( VTE ). Researchers compared the risks of developing VTE between the tallest and shortest men and women , finding that :

System Malfunction

A study of recalled software-enabled medical equipment , such as pacemakers and painmanagement implants , found that the U . S . Food and Drug Administration ’ s ( FDA ) streamlined review process may put patients ’ safety at risk .
Between 2011 and 2015 :

Compared with men shorter than 5 ’ 3 , men taller than 6 ’ 2 had a

65 % higher risk of VTE ( hazard ratio [ HR ] = 0.35 ; 95 % CI 0.22-0.55 ; p value not reported ).

Compared with women shorter than 5 ’ 1 , women taller than 6 ’ had a

69 % higher risk of VTE ( HR = 0.31 ; 95 % CI 0.22-0.42 ; p value not reported ).

• 627 devices ( totaling 1.4 million units ) were subject to recalls , primarily because of software defects .
• 12 of the devices ( totaling 190,596 units ) were subject to the highest-risk recalls ( i . e ., determined to pose the greatest risk to patient safety ).
• 5 electronic medical record systems ( totaling 9,347 units ) were recalled and classified as posing a moderate risk to patient safety .
When the authors reviewed the devices ’ approval processes , they found that 11 had entered the market through a streamlined review that does not require evidence of safety or effectiveness . One high-risk recalled device was exempt from regulatory review .
“ Software problems in medical devices are not rare ,” the authors reported , adding that “ premarket regulation has not captured all the software issues that could harm patients .”
Sources : STAT News , September 12 , 2017 ; Ronquillo JG , Zuckerman DM . Software-related recalls of health information technology and other medical devices : implications for FDA regulation of digital health . Milbank Quarterly . 2017 ; 95:535-3 .

To Infinity and Beyond !

If you ’ re planning to suit up for an interstellar journey soon , a new study published in BMC Hematology should alleviate your concerns about developing “ space flight anemia ,” a phenomenon in which circulating red blood cells ( RBCs ) are supposedly reduced during time spent in space .
Researchers from NASA ’ s Johnson Space Center compared pre- , mid- , and post-flight hematocrit levels from blood samples collected from 31 astronauts who spent up to six months on the International Space Station .
They found that anemia wasn ’ t a concern , even after the astronauts ’ bodies adapted to microgravity , with hematocrit levels higher than pre-flight levels at all time points :
15 %
10 %
↑12.2 % ↑12.2 % ↑10.0 %
5 %
What explains this association ? “ It could just be that because taller individuals have longer leg veins there is more surface area where problems can occur ,” theorized lead author Bengt Zöller , MD , PhD . “ There is also more gravitational pressure in leg veins of taller persons that can increase the risk of blood flow slowing or temporarily stopping .”
Source : Zöller B , Jianguang J , Sundquist J , Sundquist K . Body height and incident risk of venous thromboembolism : a cosibling design . Circ Cardiovasc Genet . 2017 ; 10 : e001651 .
0 %
2 weeks
3 months
6 months
After the astronauts returned to Earth , all blood parameters reverted to pre-flight levels within 30 days .
Source : Kunz H , Quiriarte H , Simpson RJ , et al . Alterations in hematologic indices during long-duration spaceflight . BMC Hematol . 2017 ; 17:12 .
26 ASH Clinical News November 2017