In response to criticism to its initial draft test protocol, NIOSH recently published a revised protocol for public comment.

BACKGROUND
There has been concern over the effectiveness of Closed System Transfer Devices’s ability to effectively contain drug and drug vapor and prevent exposure during the compounding and administration process. Manufacturers use a variety of mechanical and air cleaning mechanisms in CSTDs and there is currently no recognized testing standard. This is a problem for both existing devices as well as new versions of existing devices.

NIOSH PROTOCOL REVISED
An initial draft test protocol to determine vial protector effectiveness to contain drug and drug vapor using isopropyl alcohol as a surrogate marker for chemotherapy was published, but received criticism for failure to include air-cleaning devices and using a surrogate with a high vapor pressure. Tests conducted on five CSTDs demonstrated performance variability with two products providing significantly superior results.

As a result, NIOSH is working on a revised protocol intended to compare all CSTDs and is asking for public comment. The protocol and posted comments can be accessed here.

INDUSTRY INPUT IS IMPERATIVE
It’s in the profession’s best interest to provide robust comments for NIOSH consideration since these devices can significantly impact the safe handling of hazardous medications and are NOT a requirement for administration under the proposed USP Chapter 800. The revised NIOSH approach involves using a surrogate with less volatility.

HERE’S HOW TO COMMENT:
1. Click here
2. In the search box, enter the ID number:  288-A, CDC-2016-0090
3. Click on “Comment Now”
4. Comments must include:
Agency Name: CDC-2016-0090 and
Docket Number: NIOSH-288-A

Note: Comments will be accepted until 11:59 PM ET on February 28, 2018.

We compiled a list of important considerations for you as you evaluate the proposed NIOSH protocol:

  • Should the test be something that all facilities can perform at their own site or should it be something that manufacturers have to complete via an independent third-party laboratory testing facility?
  • Should the test be merely a “snapshot in time” of performance or should it be more longitudinal looking at how CSTDs perform over a more extended period of time, which represents a situation more akin to “real practice” patterns?
  • Under what conditions should each CSTD be tested? Should testing be to the letter of the FDA cleared package insert or should there be variations in temperature and pressure included in the testing, which more actually represents clinical practice? For example, facilities in Denver or Salt Lake City are essentially practicing a mile above sea level. Vials filled at sea level and then punctured at altitude will have a much higher-pressure gradient to consider than those punctured at sea level.
  • Should isopropyl alcohol be abandoned as the surrogate test standard? With small molecules and high vapor pressure, isopropyl alcohol represents a “worst case scenario” for CSTDs. If a CSTD can contain a “worst case” surrogate that is perhaps the ultimate test since no one knows what the physical characteristics of future hazardous medications will look like. With the ultimate goal of healthcare worker safety, should the protocol be reduced in rigor or should it be as robust as possible in terms of a surrogate, which raises the performance bar for all of these products rather than lowering it to a standard that more products can potentially meet?
  • If a device cannot pass with IPA, which was identified as a worst-case scenario or another surrogate, should the manufacturer be required to test on all hazardous drugs or a select sample of hazardous drugs that are commonly used and found to be highly volatile or all hazardous drugs in which the device will be utilized?
  • Should the actual drug be used for testing instead of a surrogate? If the actual drug is used which drugs should be tested? Drugs that could be considered for testing at a minimum might include cyclophosphamide, 5-Fluorouracil, mitomycin, paclitaxel, thiotepa, and methotrexate. These drugs are easily sampled and represent a wide spectrum of drugs on the market that are known to produce vapors.
  • Should NIOSH also include a companion test to establish the performance of CSTDs in maintaining “dry connections” during the administration phase that more accurately simulates the process of chemotherapy compounding? Since this step is currently a “must” for administration of cytotoxic agents in the proposed USP 800 chapter this would seem to be as important at the pharmacy-compounding step. As previously noted should this also use an actual drug such as cyclophosphamide, 5-Fluorouracil, mitomycin, paclitaxel, and methotrexate to assess drug residue at critical connection points?

We look forward to updating you further on this important issue. If you have additional comments or concerns, please connect with us at info@visanteinc.com.

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