A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs

Required Elements for Initial Public Posting:

Title: A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs

Anticipated Date of Dissemination: January 2017

Subject: test protocol for evaluating the combined liquid, aerosol, and vapor containment performance of CSTDs in which a physical barrier prevents all drug mass from crossing the system boundary

Purpose: for use by manufacturers and their customers to conduct meaningful comparisons between CSTD products

Timing of Review: December 2014-January 2015

Primary Disciplines or Expertise Needed for Review: industrial hygiene, occupational and environmental medicine, engineering, oncology, clinical practices

Type of Review: Panel

Number of Reviewers: 3

Reviewers Selected by: NIOSH

Public Nominations Requested for Review Panel: Yes, 09/08/2015

Opportunities for the Public to Comment: None

Peer Reviewers Provided with Public Comments Before Their Review: No

Charge to Peer Reviewers:

Closed-system transfer devices (CSTD) have been shown to be an effective way to reduce surface contamination during the handling of hazardous drugs in the healthcare setting. This proposed protocol is not testing whether CSTDs are effective in reducing environmental contamination, but rather it is testing the closed-system performance of devices that claim to operate as closed systems. Thus, it tests a device’s ability to meet the definition of not allowing the transfer of mass (liquid, particulate or vapor) in/out of the system. Several key decisions were made in the development of this protocol and we would like specific comment on these matters. Reviewers should evaluate the document for completeness, to identify gaps and issues or concerns, and to assess whether the document is written in a clear and understandable manner.

In addition, specific questions about the protocol are given below.

1. Isopropyl alcohol was used as a challenge agent to test the closed-system performance of the CSTDs. This selection was based on a number of factors including its liquid state when contained at room temperature, its high vapor pressure, and its ease of detection using common direct-reading instruments. Is isopropyl alcohol an appropriate challenge agent for the closed system containment test? If not, is there another challenge agent that should be considered to test the containment performance of CSTDs? Hazardous drugs have very different molecular structure and formulations, are unsafe, and limited measurement methods are available. Should drug formulations be considered challenge agents to test the performance of CSTDs?
2. Several pharmacy manipulation procedures are specified for use during the conduct of the CSTD containment test protocol. Do these procedures appear adequate for the intent of the protocol? Should any of the procedures be removed or additional procedures added?
3. NIOSH used the proposed CSTD containment test protocol to evaluate five CSTDs. In this evaluation, since a leakage of true zero cannot be measured, a limit of 1 ppm was identified to determine acceptable containment performance. This limit was based on a manipulation of the limit of detection of the instrument used to measure the isopropyl alcohol concentration. Was the NIOSH evaluation an appropriate use for the containment test protocol? Is it helpful to have the evaluation discussion in the protocol document? Was the selection of the 1.0 ppm performance threshold appropriate for this evaluation, given the instrumentation and measurement data?
4. Is the use of the factor (3.3) x the limit of detection that NIOSH uses in development of analytical methods appropriate in this instance for determination of the containment performance threshold? Are there other methods that should be considered to set a performance threshold?
5. Currently, the containment test protocol itself does not include a recommended performance threshold. Would the protocol be more useful if a performance threshold was recommended?

Peer Reviewers:

1. Nurtan A. Esmen
   Academic and Professional Credentials: PhD
   Organizational Affiliation: University of Illinois at Chicago
   Areas of Expertise, Discipline, or Relevant Experience: chemical and air engineering, industrial hygiene, occupational and environmental medicine
   Recommended by: NIOSH
2. Martha Polovich
   Academic and Professional Credentials: PhD, RN, AOCN
   Organizational Affiliation: Georgia State University
   Areas of Expertise, Discipline, or Relevant Experience: oncology, clinical practice, nursing research and education, safe handling of hazardous drugs
   Recommended by: NIOSH
3. Melissa A. McDiarmid
   Academic and Professional Credentials: MD, MPH
   Organizational Affiliation: University of Maryland
   Areas of Expertise, Discipline, or Relevant Experience: occupational and environmental medicine, oncology
   Recommended by: NIOSH