MECA hopes you and your loved ones are staying safe and have been able to navigate the personal challenges all of us face in these trying times. We understand that we’re an important part of your regulatory process and product manufacturing – which is why MECA intends to remain open for as long as possible in order to continue meeting the safety testing needs of the Medical Device Community. 
 
In addition to following the CDC, local and federal guidelines, we have taken the following steps for increased protection:

  • Restricting visitors from entering the building. If necessary, testing can be witnessed remotely.
  • Transitioning nearly all our team to working remotely.
  • Social distancing of all remaining employees in the building.
  • Elimination of employee travel unless deemed essential.
  • Practicing recommended sanitation and cleaning techniques.
  • Quarantining of staff experiencing symptoms.

We have adapted our operations and processes to do our part in “flattening the curve” while also ensuring we are not significantly impacting operations and test program schedules. If you need testing please contact us. We will strive to meet your testing needs in a timely and safe manner.
 

Ventilator Testing & the FDA Emergency Use Authorization

As you may be aware, there is a shortage of Ventilators (as well as other critical supplies) necessary to treat patients suffering from COVID-19.  The FDA has issued an Emergency Use Authorization intended to help increase the supply of Ventilators available for use.

MECA has capability to perform safety testing on Ventilators and similar devices, however we are nearing our capacity to complete these tests in the time-frame we believe is necessary to ensure they can be made available quickly.  We have made the difficult decision at this time to prioritize testing of Ventilators and similar devices related to COVID-19 to existing customers that are established Ventilator Manufacturers.

If you are in need of testing, you can request a quote from our website: https://60601-1.com/get-a-quote/

We will respond as quickly as possible. If we are unable to directly provide services, we have collected a number of resources that may be of use.

COVID-19 Resource List

MECA has partnered with the Association for the Advancement of Medical Instrumentation (AAMI) to collect and share information related to the pandemic.   AAMI has set up a website with a large collection of available resources and information:

https://www.aami.org/news-resources/covid-19-updates

FDA Emergency Use Authorization (EUA): https://www.fda.gov/media/136423/download

FDA Enforcement Policy for Respiratory Devices: https://www.fda.gov/media/136318/download

Access to critical standards:

The American National Standards Institute (ANSI) has opened a free portal to view critical standards (online viewing only): https://www.ansi.org/news_publications/news_story?menuid=7&articleid=634008b9-af6c-4547-b2f9-284d997323b2

AAMI and the American Society for the Testing of Materials (ASTM) have also provided free access to critical standards: https://www.ansi.org/news_publications/news_story?menuid=7&articleid=18b8d9ec-151f-462c-a2c8-d19323dcc449

Testing:

AAMI has established a COVID-19 Response Team consisting of manufacturers, clinicians and FDA representatives to develop guidelines for products being designed/manufactured under the EUA.   The published guidance documents can be found here:  

https://www.aami.org/news-resources/covid-19-updates/covid_cr

These documents reflect the cumulative contributions and deliberations of the experts on the response team.   Additional guidance will be posted as it is developed.

Below is a list of laboratories in the US providing related testing services:

Ventilator Testing:

CSA Group – Irvine
24 Bunsen
Irvine CA 92618
949-733-4300

Intertek Testing Services NA, Inc.
Intertek Lake Forest
25800 Commercentre Drive
Lake Forest, CA 92630
Ph: 949-448-4100 (Charles Parker)

Intertek Testing Services NA, Inc
70 Codman Hill Road
Boxborough, MA 01719
Yaqing.liu@intertek.com
978-263-2662

NEMKO USA Inc (San Diego)
2210 Faraday Ave, Suite 150
Carlsbad, CA 92008
760-444-3500

TUV SUD America
10040 Mesa Rim Road
San Diego, CA 92121
William.elliott@tuvsud.com
858-678-1443

BUREAU VERITAS Consumer Product Services, Inc
One Distribution Center Circle, Suite 1
Littleton, MA 01460
Scott.lambert@us.bureauveritas.com
978-486-8880

PPE Testing:
Nelson Laboratories, LLC
6280 S. Redwood Rd.
Salt Lake City, UT 84123
800-826-2088
dfairbanks@nelsonlabs.com (Douglas Fairbanks
rthoreson@nelsonlabs.com (Robert Thoreson)
www.nelsonlabs.com
(Facemasks, respirators, biocompatibility)

ICS Laboratories, Inc.
1072 Industrial Parkway north
Brunswick, OH 44212
330-220-0515
spfriem@icslabs.com (Steve Pfriem)
www.icslabs.com
(Eye/Face protection, Respirators, PPE)