Containment Testing to Assess the Efficacy of Closed System Transfer Devices

Joseph Arminger, BS, PharmD1; Alyson Leonard, PharmD, BCPS1; Adam Peele, PharmD, MHA, BCPS, BCOP1; Crystal Peyton, BS, CPhT2
1Pharmacy Department, Cone Health Cancer Center, Greensboro, NC, USA; 2Pharmacy Department, Cone Health Cancer Center

at Alamance Regional, Burlington.

BACKGROUND

  • Hazardous Drugs (HD) are associated with numerous toxicities; including reproductive, teratogenic, carcinogenic, and organ toxicities
  • United States Pharmacopeia Chapter <800> requires nursing usage of closed system transfer devices (CSTDs) for HD administration
  • Two standard classifications of CSTDs available are filter-based and barrier-based 
  • The initial NIOSH protocol suggests the use of the smoke-test and the tracer test, which uses 70% isopropyl alcohol as a surrogate to HDs
  • Filter-based CSTDs have routinely failed simulated smoke tests and 70% isopropyl alcohol tracer tests
  • 70% isopropyl alcohol fails to sufficiently mimic the chemical properties of many HDs

OBJECTIVE

The primary objective was to compare the contamination between barrier and filterbased closed-system transfer devices

METHODS

  • Two barrier-based (Equashield® and PhaSeal) and two filter-based (Tevadapter® and ChemoClave®) CSTDs were used to manipulate ten samples each of ifosfamide, methotrexate, and etoposide
  • Three manipulations performed at approximately 0, 4-6, and s24 hours for each drug-device combination
  • After each manipulation, the vial/vial adapter was disconnected from the syringe/syringeadapter and the membranes were wiped with a ChemoGLO wipe
  • Once all three manipulations had been completed, each bag was opened and wiped using ChemoGLO wipes
  • Before opening a new drug-device combination, the laminar flow hood was wiped using ChemoGLO HDCIean wipes
  • Completed ChemoGLO Wipe Kits were sent to ChemoGLO to be analyzed using LC-MS technology
  • Student’s t-test was used for two-way comparisons and two-way ANOVA for comparison of average contamination among devices

CONCLUSIONS

  • Barrier-based devices are associated with significantly less HD contamination than filterbased devices
  • There was significant contamination when using PhaSeal™ with ifosfamide manipulations
  • Potentially, there are unstudied chemical characteristics of HDs that affect the performance of CSTDs
  • Compared to all other CSTDs, Equashield®
  • had significantly lower contamination than all other CSTDs tested
  • The smoke test and 70% isopropyl alcohol vapor test do not adequately assess the effectiveness in controlling HD contamination
  • Further studies are needed to fully elucidate the effects of various HDs on CSTD performance

DISCLOSURE

The authors of this presentation have the following disclosures concerning possible financial or personal relationships with commercial entities:
  • Joseph Arminger, BS, PharmD- No Disclosures
  • Alyson Leonard, PharmD, BCPS- No Disclosures
  • Adam Peele, PharmD. MHA, BCPS. BCOPNo Disclosures
  • Crystal Peyton, BS, CPhT- No Disclosures Funding provided by Equashield, LLC

REFERENCES

  1. Seth Eisonberb. Hazardous Drugs and USP <800>. Clinical Journal of Oncology Nursing 2017; 21 (2): 179-187. DOI: 10.1188/17.CJON.179-187
  2. NIOSH Report 2016.
  3. Valanis B. Vollmer WM. Steele P. Occupational exposure to antineoplastic agents: self-reported miscarriages and stillbirths among nurses and pharmacists. J Occup Environ Med. 1999;41(8):632-638.
  4. Dranitsaris G. Johnston M. Poirier S, et al. Are health care providers who work with cancer drugs at an increased risk for toxic events? A systematic review and meta-analysis of the literature. Journal of Oncology Pharmacy Practice. 2005; 11(2): 69-78.
  5. USP<800>
  6. Tocco A. The Future Impact of USP 800 in the Health Care Setting www.michiganpharmacists.org/Portals/0faducation/caarticles/usp80O012 015.pdf. Accessed September 2017.
  7. Hirst DVL, Mead KR. Power L, et al. A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs. https://wwwcdc,QOv/nlosh/dockeVr*Mew/docket288/default.html.
    Accessed September 2017.
  8. Michael R. Page. Closed-System Transfer Devices. USP<800>. and the NIOSH Protocol. Pharmacy Timas. 2017: 1-6.

RESULTS

Table 1: Average contamination stratified by device and HD

Table 2: Summary of primary and secondary outcome results

Containment Testing to Assess the Efficacy of Closed System Transfer Devices

Joseph Arminger, BS, PharmD1; Alyson Leonard, PharmD, BCPS1; Adam Peele, PharmD, MHA, BCPS, BCOP1; Crystal Peyton, BS, CPhT2
1Pharmacy Department, Cone Health Cancer Center, Greensboro, NC, USA; 2Pharmacy Department, Cone Health Cancer Center

at Alamance Regional, Burlington.

BACKGROUND

  • Hazardous Drugs (HD) are associated with numerous toxicities; including reproductive, teratogenic, carcinogenic, and organ toxicities
  • United States Pharmacopeia Chapter <800> requires nursing usage of closed system transfer devices (CSTDs) for HD administration
  • Two standard classifications of CSTDs available are filter-based and barrier-based 
  • The initial NIOSH protocol suggests the use of the smoke-test and the tracer test, which uses 70% isopropyl alcohol as a surrogate to HDs
  • Filter-based CSTDs have routinely failed simulated smoke tests and 70% isopropyl alcohol tracer tests
  • 70% isopropyl alcohol fails to sufficiently mimic the chemical properties of many HDs

OBJECTIVE

The primary objective was to compare the contamination between barrier and filterbased closed-system transfer devices

METHODS

  • Two barrier-based (Equashield® and PhaSeal) and two filter-based (Tevadapter® and ChemoClave®) CSTDs were used to manipulate ten samples each of ifosfamide, methotrexate, and etoposide
  • Three manipulations performed at approximately 0, 4-6, and s24 hours for each drug-device combination
  • After each manipulation, the vial/vial adapter was disconnected from the syringe/syringeadapter and the membranes were wiped with a ChemoGLO wipe
  • Once all three manipulations had been completed, each bag was opened and wiped using ChemoGLO wipes
  • Before opening a new drug-device combination, the laminar flow hood was wiped using ChemoGLO HDCIean wipes
  • Completed ChemoGLO Wipe Kits were sent to ChemoGLO to be analyzed using LC-MS technology
  • Student’s t-test was used for two-way comparisons and two-way ANOVA for comparison of average contamination among devices

CONCLUSIONS

  • Barrier-based devices are associated with significantly less HD contamination than filterbased devices
  • There was significant contamination when using PhaSeal™ with ifosfamide manipulations
  • Potentially, there are unstudied chemical characteristics of HDs that affect the performance of CSTDs
  • Compared to all other CSTDs, Equashield®
  • had significantly lower contamination than all other CSTDs tested
  • The smoke test and 70% isopropyl alcohol vapor test do not adequately assess the effectiveness in controlling HD contamination
  • Further studies are needed to fully elucidate the effects of various HDs on CSTD performance

DISCLOSURE

The authors of this presentation have the following disclosures concerning possible financial or personal relationships with commercial entities:
  • Joseph Arminger, BS, PharmD- No Disclosures
  • Alyson Leonard, PharmD, BCPS- No Disclosures
  • Adam Peele, PharmD. MHA, BCPS. BCOPNo Disclosures
  • Crystal Peyton, BS, CPhT- No Disclosures Funding provided by Equashield, LLC

REFERENCES

  1. Seth Eisonberb. Hazardous Drugs and USP <800>. Clinical Journal of Oncology Nursing 2017; 21 (2): 179-187. DOI: 10.1188/17.CJON.179-187
  2. NIOSH Report 2016.
  3. Valanis B. Vollmer WM. Steele P. Occupational exposure to antineoplastic agents: self-reported miscarriages and stillbirths among nurses and pharmacists. J Occup Environ Med. 1999;41(8):632-638.
  4. Dranitsaris G. Johnston M. Poirier S, et al. Are health care providers who work with cancer drugs at an increased risk for toxic events? A systematic review and meta-analysis of the literature. Journal of Oncology Pharmacy Practice. 2005; 11(2): 69-78.
  5. USP<800>
  6. Tocco A. The Future Impact of USP 800 in the Health Care Setting www.michiganpharmacists.org/Portals/0faducation/caarticles/usp80O012 015.pdf. Accessed September 2017.
  7. Hirst DVL, Mead KR. Power L, et al. A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs. https://wwwcdc,QOv/nlosh/dockeVr*Mew/docket288/default.html.
    Accessed September 2017.
  8. Michael R. Page. Closed-System Transfer Devices. USP<800>. and the NIOSH Protocol. Pharmacy Timas. 2017: 1-6.

RESULTS

Table 1: Average contamination stratified by device and HD

Table 2: Summary of primary and secondary outcome results