Blood draws with­out the nee­dle

Modern Healthcare - - INNOVATIONS - By El­iz­a­beth Whit­man

Pa­tients at Sacra­mento, Calif.-based Sut­ter Health’s hospi­tals and clin­ics across North­ern Cal­i­for­nia could soon have their blood drawn a lit­tle dif­fer­ently. In­stead of stick­ing a pa­tient with a nee­dle, nurses will tap into ex­ist­ing pe­riph­eral IV lines us­ing a de­vice called a PIVO.

Sut­ter has be­gun us­ing the de­vice on one floor of its Alta Bates Sum­mit Med­i­cal Cen­ter in Berke­ley, Calif. The pace and ex­tent of its use on other floors and in other hospi­tals de­pends on the re­sults of Sut­ter’s eval­u­a­tion of the de­vice.

“I’m op­ti­mistic,” said Eric Stone, co-founder and CEO of Ve­lano Vas­cu­lar, the San Fran­cis­cobased med­i­cal de­vice com­pany that de­vel­oped the PIVO. A hand­ful of health sys­tems be­sides Sut­ter are us­ing the PIVO, in­clud­ing Salt Lake City-based In­ter­moun­tain Healthcare, or plan­ning to use it. Brigham and Women’s Hos­pi­tal Bos­ton is study­ing the de­vice.

The PIVO, a sin­gle-use, Class II de­vice cleared by the FDA, draws blood through a pe­riph­eral IV line al­ready in­serted into the pa­tient. Once at­tached to the IV catheter, a plunger is drawn back, pulling blood into a vac­uum tube or sy­ringe.

Blood draws are one of the most com­mon and fre­quent pro­ce­dures in hospi­tals. Pa­tients have blood drawn wher­ever they get care: hospi­tals, doc­tor’s of­fices, skilled-nurs­ing fa­cil­i­ties and else­where. But the con­ven­tional method is im­per­fect.

Ac­cord­ing to Ve­lano, the cur­rent method of draw­ing blood leads to 200 “nee­dle-re­lated in­juries” daily among healthcare providers. Among adult pa­tients, 28% have to be stuck at least twice to draw blood suc­cess­fully; among chil­dren, it’s 44%.

Nurses also con­tend with dif­fi­cult in­tra­venous ac­cess in pa­tients, depend­ing on their med­i­cal con­di­tions. Obe­sity, chronic ill­nesses, chemo­ther­apy and other is­sues, such as in­tra­venous drug use, can ren­der it dif­fi­cult for providers to ac­cess a pa­tient’s veins. That trans­lates to re­peated at­tempts to in­sert nee­dles into veins and treat­ment de­lays that can hurt pa­tient sat­is­fac­tion rates and in­crease the costs of care.

Pa­tients typ­i­cally have their blood drawn at least once per day, said Anna Kiger, chief nurs­ing of­fi­cer for Sut­ter. Dur­ing ex­tended hospi­tals stays, these fre­quent needle­sticks add up, and not all pa­tients have veins that tol­er­ate re­peated punc­tur­ing. Us­ing the PIVO, how­ever, elim­i­nates bruis­ing and other ef­fects of re­peated blood draws with a nee­dle. The process also doesn’t wake the pa­tient.

Train­ing nurses to use the PIVO took about 20 min­utes, Kiger added, and those who have used the de­vice for sev­eral days said they would rather not re­turn to us­ing nee­dles. They’re not the only ones.

“It’s a def­i­nite wow fac­tor for pa­tients,” Kiger said. A few groups in par­tic­u­lar stand to gain from PIVO use, in­clud­ing geri­atric, on­col­ogy and ma­jor surgery pa­tients. And it would be a wel­come change for pe­di­atric pa­tients be­cause it al­le­vi­ates nee­dle anx­i­ety, she said.

From Stone’s per­spec­tive, if a nurse has trou­ble find­ing a pa­tient’s vein in the first place, why sub­ject them to be­ing jabbed a sec­ond, third or fourth time if a pe­riph­eral IV is al­ready embed­ded in the pa­tient?

The idea vi­o­lates every hos­pi­tal pol­icy and con­ven­tion, Stone ad­mit­ted.

In its guide­lines for best prac­tices in draw­ing blood, for in­stance, the World Health Or­ga­ni­za­tion warns against draw­ing blood through IV lines, at least in hos­pi­tal­ized pa­tients, say­ing that draw­ing blood in this way “may give false re­sults.”

But with the soft poly­mers that are used in catheters to­day, draw­ing blood through an IV line doesn’t ac­tu­ally re­sult in hemol­y­sis, the dam­age and sub­se­quent break­down of red blood cells, Stone said, cit­ing stud­ies and analy­ses from hospi­tals that have used the PIVO.

Sut­ter’s labs mon­i­tor the qual­ity of blood drawn through a nee­dle and via the PIVO, and they have not detected a dif­fer­ence. Blood drawn with the PIVO has not been hemolyzed or clot­ted. Kiger also said she did not have con­cerns about safety, in­clud­ing the risk of in­fec­tion.

The PIVO’s first FDA clear­ance came in Jan­uary 2015. The FDA also cleared a tweaked ver­sion of the sys­tem in Jan­uary 2016.

But even as more hospi­tals adopt the de­vice, pub­lished clin­i­cal data are lim­ited. There are no data, for in­stance, com­par­ing rates of blood­stream in­fec­tions from the PIVO with that of the stan­dard nee­dle draw. “To date, we have not seen any blood­stream in­fec­tions that have been di­rected to­ward our tech­nol­ogy,” Stone said.

Stone also said more re­search is un­der­way. In a clin­i­cal trial spon­sored by Ve­lano, Brigham and Women’s Hos­pi­tal is eval­u­at­ing the PIVO’s abil­ity to pro­duce qual­ity blood sam­ples. The prospec­tive, ran­dom­ized study in­volves an es­ti­mated 150 pa­tients and will in part an­a­lyze sam­ples for hemol­y­sis.

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