Preventing contamination between injections with multiple-use nozzle needle-free injectors: A safety

[Guest guest]

Preventing contamination between injections with multiple-use nozzle needle-free

injectors: A safety trial

a, , , Anatoly Loskutovb, Darin Zehrunga, Kapaakea Puaaa,

LaBarrea, Mullera, Wang Guiqiangc, Hui-guo Dingd, Darong Hue and

C. Blackwelder1

aPATH, 1455 NW Leary Way, Seattle, WA 98107, United States

bPulse Needle Free Systems, Lenexa, KS, United States

cPeking University First Hospital, Beijing, China

dCapital Medical University Beijing You an Hospital, Beijing, China

eInstitute of Liver Diseases, General Hospital of Beijing Military Region,

Beijing, China

Received 3 October 2007; revised 8 December 2007; accepted 19 December 2007.

Available online 18 January 2008.

Summary

Multiple-use nozzle jet injectors (MUNJIs), a type of needle-free injector, use

a high-pressure stream to penetrate skin and deliver medicament. Concerns for

their potential to transmit blood borne pathogens led to development of a hybrid

MUNJI for use in mass immunizations. The HSI-500®, referred to here as a

protector cap needle-free injector (PCNFI), utilizes a disposable cap as a

shield between the reusable injector nozzle and the skin to reduce the risk of

contamination. This study aimed to determine the presence of hepatitis B virus

(HBV) contamination in post-injection (“next person”) samples immediately

following injection in HBV-carrier adults. Tolerability and pain were also

assessed. The study ended early because the PCNFI failed to prevent

contamination in the first batch tested (8.2% failure rate). The injections were

very well tolerated, with most followed by no bleeding (81.2%) or mild bleeding

(7.8%). 55.2% of participants experienced no pain while 42.3% experienced mild

pain following injection.

Keywords: Multiple-use nozzle jet injectors (MUNJIs); Needle-free injection;

Cross-contamination; Hepatitis B virus (HBV)

Corresponding author. Tel.: +1 206 285 3500; fax: +1 206 285 6619.

1 Independent Consultant.

Vaccine

Volume 26, Issue 10, 4 March 2008, Pages 1344-1352

http://www.sciencedirect.com/science?_ob=ArticleURL & _udi=B6TD4-4RM8827-3 & _user=1\

0 & _coverDate=03%2F04%2F2008 & _rdoc=10 & _fmt=summary & _orig=browse & _srch=doc-info(%2\

3toc%235188%232008%23999739989%23680995%23FLA%23display%23Volume) & _cdi=5188 & _sor\

t=d & _docanchor= & _ct=15 & _acct=C000050221 & _version=1 & _urlVersion=0 & _userid=10 & md5=\

d1070b704d2bd84869cc05f72eaa79c9

_________________________________________________________________

Connect and share in new ways with Windows Live.

http://www.windowslive.com/share.html?ocid=TXT_TAGHM_Wave2_sharelife_012008

[Guest guest]

Preventing contamination between injections with multiple-use nozzle needle-free

injectors: A safety trial

a, , , Anatoly Loskutovb, Darin Zehrunga, Kapaakea Puaaa,

LaBarrea, Mullera, Wang Guiqiangc, Hui-guo Dingd, Darong Hue and

C. Blackwelder1

aPATH, 1455 NW Leary Way, Seattle, WA 98107, United States

bPulse Needle Free Systems, Lenexa, KS, United States

cPeking University First Hospital, Beijing, China

dCapital Medical University Beijing You an Hospital, Beijing, China

eInstitute of Liver Diseases, General Hospital of Beijing Military Region,

Beijing, China

Received 3 October 2007; revised 8 December 2007; accepted 19 December 2007.

Available online 18 January 2008.

Summary

Multiple-use nozzle jet injectors (MUNJIs), a type of needle-free injector, use

a high-pressure stream to penetrate skin and deliver medicament. Concerns for

their potential to transmit blood borne pathogens led to development of a hybrid

MUNJI for use in mass immunizations. The HSI-500®, referred to here as a

protector cap needle-free injector (PCNFI), utilizes a disposable cap as a

shield between the reusable injector nozzle and the skin to reduce the risk of

contamination. This study aimed to determine the presence of hepatitis B virus

(HBV) contamination in post-injection (“next person”) samples immediately

following injection in HBV-carrier adults. Tolerability and pain were also

assessed. The study ended early because the PCNFI failed to prevent

contamination in the first batch tested (8.2% failure rate). The injections were

very well tolerated, with most followed by no bleeding (81.2%) or mild bleeding

(7.8%). 55.2% of participants experienced no pain while 42.3% experienced mild

pain following injection.

Keywords: Multiple-use nozzle jet injectors (MUNJIs); Needle-free injection;

Cross-contamination; Hepatitis B virus (HBV)

Corresponding author. Tel.: +1 206 285 3500; fax: +1 206 285 6619.

1 Independent Consultant.

Vaccine

Volume 26, Issue 10, 4 March 2008, Pages 1344-1352

http://www.sciencedirect.com/science?_ob=ArticleURL & _udi=B6TD4-4RM8827-3 & _user=1\

0 & _coverDate=03%2F04%2F2008 & _rdoc=10 & _fmt=summary & _orig=browse & _srch=doc-info(%2\

3toc%235188%232008%23999739989%23680995%23FLA%23display%23Volume) & _cdi=5188 & _sor\

t=d & _docanchor= & _ct=15 & _acct=C000050221 & _version=1 & _urlVersion=0 & _userid=10 & md5=\

d1070b704d2bd84869cc05f72eaa79c9

_________________________________________________________________

Connect and share in new ways with Windows Live.

http://www.windowslive.com/share.html?ocid=TXT_TAGHM_Wave2_sharelife_012008

[Guest guest]

Preventing contamination between injections with multiple-use nozzle needle-free

injectors: A safety trial

a, , , Anatoly Loskutovb, Darin Zehrunga, Kapaakea Puaaa,

LaBarrea, Mullera, Wang Guiqiangc, Hui-guo Dingd, Darong Hue and

C. Blackwelder1

aPATH, 1455 NW Leary Way, Seattle, WA 98107, United States

bPulse Needle Free Systems, Lenexa, KS, United States

cPeking University First Hospital, Beijing, China

dCapital Medical University Beijing You an Hospital, Beijing, China

eInstitute of Liver Diseases, General Hospital of Beijing Military Region,

Beijing, China

Received 3 October 2007; revised 8 December 2007; accepted 19 December 2007.

Available online 18 January 2008.

Summary

Multiple-use nozzle jet injectors (MUNJIs), a type of needle-free injector, use

a high-pressure stream to penetrate skin and deliver medicament. Concerns for

their potential to transmit blood borne pathogens led to development of a hybrid

MUNJI for use in mass immunizations. The HSI-500®, referred to here as a

protector cap needle-free injector (PCNFI), utilizes a disposable cap as a

shield between the reusable injector nozzle and the skin to reduce the risk of

contamination. This study aimed to determine the presence of hepatitis B virus

(HBV) contamination in post-injection (“next person”) samples immediately

following injection in HBV-carrier adults. Tolerability and pain were also

assessed. The study ended early because the PCNFI failed to prevent

contamination in the first batch tested (8.2% failure rate). The injections were

very well tolerated, with most followed by no bleeding (81.2%) or mild bleeding

(7.8%). 55.2% of participants experienced no pain while 42.3% experienced mild

pain following injection.

Keywords: Multiple-use nozzle jet injectors (MUNJIs); Needle-free injection;

Cross-contamination; Hepatitis B virus (HBV)

Corresponding author. Tel.: +1 206 285 3500; fax: +1 206 285 6619.

1 Independent Consultant.

Vaccine

Volume 26, Issue 10, 4 March 2008, Pages 1344-1352

http://www.sciencedirect.com/science?_ob=ArticleURL & _udi=B6TD4-4RM8827-3 & _user=1\

0 & _coverDate=03%2F04%2F2008 & _rdoc=10 & _fmt=summary & _orig=browse & _srch=doc-info(%2\

3toc%235188%232008%23999739989%23680995%23FLA%23display%23Volume) & _cdi=5188 & _sor\

t=d & _docanchor= & _ct=15 & _acct=C000050221 & _version=1 & _urlVersion=0 & _userid=10 & md5=\

d1070b704d2bd84869cc05f72eaa79c9

_________________________________________________________________

Connect and share in new ways with Windows Live.

http://www.windowslive.com/share.html?ocid=TXT_TAGHM_Wave2_sharelife_012008

[Guest guest]

Preventing contamination between injections with multiple-use nozzle needle-free

injectors: A safety trial

a, , , Anatoly Loskutovb, Darin Zehrunga, Kapaakea Puaaa,

LaBarrea, Mullera, Wang Guiqiangc, Hui-guo Dingd, Darong Hue and

C. Blackwelder1

aPATH, 1455 NW Leary Way, Seattle, WA 98107, United States

bPulse Needle Free Systems, Lenexa, KS, United States

cPeking University First Hospital, Beijing, China

dCapital Medical University Beijing You an Hospital, Beijing, China

eInstitute of Liver Diseases, General Hospital of Beijing Military Region,

Beijing, China

Received 3 October 2007; revised 8 December 2007; accepted 19 December 2007.

Available online 18 January 2008.

Summary

Multiple-use nozzle jet injectors (MUNJIs), a type of needle-free injector, use

a high-pressure stream to penetrate skin and deliver medicament. Concerns for

their potential to transmit blood borne pathogens led to development of a hybrid

MUNJI for use in mass immunizations. The HSI-500®, referred to here as a

protector cap needle-free injector (PCNFI), utilizes a disposable cap as a

shield between the reusable injector nozzle and the skin to reduce the risk of

contamination. This study aimed to determine the presence of hepatitis B virus

(HBV) contamination in post-injection (“next person”) samples immediately

following injection in HBV-carrier adults. Tolerability and pain were also

assessed. The study ended early because the PCNFI failed to prevent

contamination in the first batch tested (8.2% failure rate). The injections were

very well tolerated, with most followed by no bleeding (81.2%) or mild bleeding

(7.8%). 55.2% of participants experienced no pain while 42.3% experienced mild

pain following injection.

Keywords: Multiple-use nozzle jet injectors (MUNJIs); Needle-free injection;

Cross-contamination; Hepatitis B virus (HBV)

Corresponding author. Tel.: +1 206 285 3500; fax: +1 206 285 6619.

1 Independent Consultant.

Vaccine

Volume 26, Issue 10, 4 March 2008, Pages 1344-1352

http://www.sciencedirect.com/science?_ob=ArticleURL & _udi=B6TD4-4RM8827-3 & _user=1\

0 & _coverDate=03%2F04%2F2008 & _rdoc=10 & _fmt=summary & _orig=browse & _srch=doc-info(%2\

3toc%235188%232008%23999739989%23680995%23FLA%23display%23Volume) & _cdi=5188 & _sor\

t=d & _docanchor= & _ct=15 & _acct=C000050221 & _version=1 & _urlVersion=0 & _userid=10 & md5=\

d1070b704d2bd84869cc05f72eaa79c9

_________________________________________________________________

Connect and share in new ways with Windows Live.

http://www.windowslive.com/share.html?ocid=TXT_TAGHM_Wave2_sharelife_012008