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January 2018 Newsletter

COMING SOON

Lidocaine HCl, USP, 1%, 5 mL Ampules

We are in the final stages of obtaining FDA approval of an Abbreviated New Drug Application (ANDA), and we expect to have product for sale by late Q1 of 2018. Please contact us for more information.

2018: A YEAR OF INNOVATION

2018 will be an exciting year for Spectra and our customers, as we have a lot lined up. With lidocaine product expected for sale by the end of Q1 and the launch of a sterile product line later this year, make sure to watch out for our monthly newsletters to get the latest updates from Spectra.

NaCl AMPOULES ALSO AVAILABLE

Sodium Chloride Injection USP, 0.9% 5 mL and 10 mL Ampules. This product is currently available in a pharmaceutical and medical device presentation Please contact us for more information and pricing.

SPECTRA’S DEDICATION TO QUALITY REFLECTED IN FDA INSPECTION

Spectra Medical Korea was inspected by the US FDA in August of 2017. It was a very successful inspection. There were no FDA 483 Observations. Quality is priority at Spectra Medical. We take immense pride in providing the products that meet your highest standards.

NRFit® PRODUCTS AVAILABLE NOW

Spectra is here to help you transition to products with NRFit® connectors to reduce the risk of misconnections and improve patient safety. We will be incorporating the NRFit® connectors to our epidural needles, spinal needles and glass LOR syringes product lines. Spectra’s goal is to help our customers be aware about new ISO standards and to facilitate a smooth transition to products with NRFit® connectors.

ISO 80369-6 was developed in 2016 because of several incidents resulting from inappropriate medication being administered neuraxially, resulting in catastrophic consequences. To meet international design standards and prevent future incidences, NRFit® connectors will slowly replace standard small-bore connectors on medical devices used for neuraxial applications.

All healthcare facilities around the world, including the United States, are expected to transition to products with NRFit® connectors. California health facilities have already adopted medical devices with NRFit® connectors as of January 1, 2017.

NONCYTOTOXIC METAL HUBS

As a market leader of the industry, Spectra can certify that all our metal hubs meet cytotoxicity testing requirements. Test results are available upon request.

MEET US IN-PERSON!

9th World Congress of the World Institute of Pain (WIP)

Spectra will be exhibiting at the 9th World Congress of the World Institute of Pain (WIP), which will be held in Dublin, Ireland from the 9th-12th of May. We will be located at booth #38.

The 9th World Congress of the World Institute of Pain (WIP 2018) is a major biennial gathering of pain management specialists. Aimed at physicians, researchers, students and nurses, WIP 2018 will combine participant-friendly educational activities with hands-on courses.

We would love to meet you in-person. To schedule an appointment, please contact us.

International Association for the Study of Pain (IASP)

We will also be exhibiting at the World Congress of Pain® organized by the International Association for the Study of Pain (IASP). It will be held in Boston, Massachusetts, from September 12th to 16th.

The World Congress on Pain® is the preeminent global meeting devoted to sharing new developments in pain research, treatment, and education. The meeting brings together thousands of delegates from more than 100 countries across multiple disciplines.

If you would like to drop by our booth, stay tuned for more specific booth details!

THE NEW FACES OF SPECTRA

Meet the Latest Members of Our Team

We are pleased to introduce the latest additions to our growing team: Robin Cote, Cyndie Yan and Pamela DiNicola.


Robin Cote is a recent addition to the Spectra team who joined us in November 2017. As the Documentation Control Supervisor, Robin is responsible for managing the document control processes, including procedures, drawings, work instructions and labeling.

Robin also helps establish and maintain the documents generated within the quality control systems, including complaint handling, calibration, corrective action, auditing systems and national and international standards. In this role, Robin ensures that Spectra’s customers both internal and external, are provided with the documentation needed to deliver the best quality products on the market.


Cyndie Yan joined Spectra as the new Customer Service and Planner Representative in December 2017. In her new role, Cyndie works with both customers and suppliers on a daily basis.

As our company grows, the demand of tight deadlines and delivery dates, an increasing number of orders and greater customer interaction have made it necessary to expand our customer service capabilities. As a Customer Service Representative, Cyndie corresponds with our customers to ensure superior customer satisfaction. As a Planner Representative, Cyndie collaborates with our factory and suppliers to make sure we plan and buy enough materials for all open customer sale orders.


Pamela DiNicola also came on board with Spectra as a Purchasing Specialist in December 2017. Pamela’s main responsibility is to develop forecasts and interface with Spectra’s manufacturing plant in Korea to ensure timely deliveries.

Her attention to detail and ability to keep pace in a hectic work environment makes her a key player on the Spectra team.

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