PPE Testing Resources

PPE Testing Resources

OVERVIEW

Last Updated: 06-09-2020

AFFOA is leading a centralized collaboration to rapidly characterize materials and products critical for combating the COVID-19 Public Health Emergency, to support the Massachusetts Manufacturing Emergency Response Team (M-ERT) initiative as well as additional similar national efforts.

We have partnered with Massachusetts Institute of Technology (MIT), MIT Lincoln Laboratory, University of Massachusetts Lowell (UML) and the US Army Combat Capabilities Development Command-Soldier Center (CCDC-SC) to characterize materials and hardware using existing and newly procured equipment located at the participating institutions.

Our goals:

  1. Coordination of testing efforts to ensure testing resource availability for hospitals, first responders, government institutions, commercial product and material manufacturers, academic initiatives, innovators and entrepreneurs. 
  2. Evaluation of internationally sourced products with regulatory designation (e.g. KN95, FFP2) to inform procurement and distribution efforts at the National, State and hospital levels.
  3. Testing of key metrics to inform ongoing R&D efforts on product sterilization and re-use.
  4. Rapid testing of preliminary performance of regulated raw materials and product prototypes proposed by new and existing manufacturers of PPE, such that these devices have a faster pathway for appropriate regulatory certification through NIOSH and FDA. 
  5. Rapid testing of preliminary performance of novel filtration media being evaluated by organizations and manufacturing partnerships with innovative solutions and organizations with strong clinical expertise.

If you are interested in testing your materials and products, please fill out the following questionnaire and we will be in touch with you as soon as possible:

https://bit.ly/AFFOA_PPE_testing

TESTING CAPABILITIES

At this stage we are able to provide testing of materials and products that are intended to address the shortage of:

  • N95 respirators and masks
  • Surgical masks and masks intended to provide liquid barrier protection
  • Isolation gowns (Level 1-3)

Currently, the following tests can be performed:

We are working on adding testing capabilities according to product demand and shortages identified by the Commonwealth of Massachusetts and Massachusetts hospitals. 

INTERPRETATION OF TEST RESULTS

These tests do not provide certification or pre-certification. When possible, the required, standardized instrumentation is used to perform the test procedures. However, some organizations use custom built instruments and perform testing as close as possible to the guidelines in ASTM, NIOSH and AATCC standards. 

We provide testing results in an interpretable format for recipients of test data, and it is the responsibility of the requester to interpret the results for their purposes. We provide no guarantees on the implications of the tests, nor recommend materials or products for a specific use. We can, however, provide some unofficial guidance and connection to appropriate resources at NIOSH and the FDA, on a case by case basis.

COST AND LEAD TIME

Due to high-demand, lead-time for test results may vary depending on the nature of tests requested, the origination of the test request, and the number of other requesters. Though we are unable to provide a specific turnaround time, these testing services are aimed at providing much faster results than the >2 week lead times that others have reported at commercial testing facilities.

The financial model for these testing services is still being configured. At the moment, all tests are performed free-of-charge for the requesting organization. Consequently, we are dynamically prioritizing which tests are performed based on their viability to provide immediate relief during the COVID19 Public Health Emergency.

SAMPLE PREPARATION

Depending on the test requested, we will provide specific instructions on the preparation of your samples. However, we note here that no samples which may have been previously exposed to biological materials are acceptable for testing. Unused and, preferably, unopened (if previously commercially packaged) samples are preferred. It is also preferred that materials have an accompanying MSDS that can be shared prior to the performance of testing.

TESTING RESULTS

AFFOA and our testing partners have conducted performance assessment of some internationally accredited respirators including KN95 respirators.

AFFOA makes no representation as to the authenticity of the samples received and assessed. Validation of the claims that any product meets a particular international standard cannot be made using the published results. The results of these tests are for the sample tested and may or may not be representative of a larger lot or population of similar respirators. No conclusions can be made regarding equivalency to N95 products. The results cannot be used as a proof of performance or certification of any kind. While filter efficiency and resistance to airflow shows how well the filter media performs, users must ensure a proper fit is achieved. These results are not to be used by manufacturers, distributors, suppliers, and importers to make claims about their products and/or to influence purchasers.

Please follow the following link to obtain access to the testing results:

https://forms.gle/cyYpxKwQAcddM9SM8

CONTACT

If you are interested in testing your materials and products, please fill out the following questionnaire and we will be in touch with you as soon as possible:

https://bit.ly/AFFOA_PPE_testing

If you have any questions or have relevant testing capabilities and would like to partner with us, please reach out to Michael Rein, testing_PPE@affoa.org