Test Labs Newsletter October 2024

Test Labs 2024 USA Marathon

My recent journey across the United States, which I dubbed the “2024 USA Marathon,” offered a rare and direct glimpse into the world of the U.S. medical device industry. With stops in key cities like Boston, Philadelphia, Salt Lake City, Irvine, Minneapolis, and Atlanta, I aimed to connect personally with industry leaders, listen to their pressing concerns, and gather insights that would help align Test Labs with the specific needs and opportunities of this critical market.

Expert Spotlight

Introducing Holly Scott:?Our Executive Account Manager

What do you do at Test Labs??

My main role is as an Executive Assistant to the Managing Director; scheduling and notetaking meetings, making travel arrangements and a wide variety of other organisational tasks. I do however, wear many hats, so, alongside being an EA, I am also the Archivist for our studies, as well as helping to integrate new systems to elevate our current processes, such as a new CRM system, Capacity Scheduling Tool and KPI Dashboards. One of my main focuses however is being an Accounts Manager, being a link between Test Labs and our current clients, assessing their needs and helping to facilitate any testing requirements they may have.

Where did your interest in Executive Account Management stem from? ?

I think it just evolved over time, having worked in a customer service based industry nearly my whole career, it was something that just came naturally after a while, at 17 I don't think I understood how important customer service was, I just wanted to earn some money, but as I got older and had more experience working and interacting with customers, my mindset changed and I understood more about how business worked and the main base of the industry is customers, without them, most businesses don't function.

What would your advice be for someone thinking of becoming a Executive?Account Manager?

I would always advise someone coming into customer service to keep calm and level headed, dealing with people, whether it is face to face, via a video call or even on the phone can be difficult, each person is an individual and won't be a copy of another customer you have dealt with, you always need to be adaptable and flexible to give your customers the best and the most effective way to do this is keeping calm and level headed.

What is your top tip to manufacturers to keep them compliant?

When looking for a testing partner, remember to check their NPS score. It is a great way to understand how the industry sees a business and whether they would refer them to other people.

What do you love most about your job?

The variability, my day to day isn't a set routine, one day I could be booking and scheduling travel for conferences, others I could be with our customers discussing their testing needs, then I could be with the Operations Team working on capacity scheduling or archiving studies.

What do you get up to when you’re not doing Executive?Account Management?

When not helping customers, I tend to be at my PC gaming, at my desk drawing or setting up my sessions for my Dungeons and Dragons campaigns.

Cleaning Validation

Cleaning Validation is the first step for ensuring the utmost safety and efficacy of reusable Medical Devices. Our system goes above and beyond to assure that every instrument meets the highest standards of cleanliness.

Applicable Standards

• BS EN ISO 17664-1:2021 - Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Critical and semi-critical medical devices
• BS EN ISO 15883-1:2009+A1:2014 - Washer-disinfectors. General requirements, terms and definitions and tests
• BS EN 15883-5:2021 - Washer-disinfectors. Performance requirements and test method criteria for demonstrating cleaning efficacy
• ANSI/AAMI ST98:2022 - Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
• ASTM F3208-20 - Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

Test Soils

• Edinburgh soil - For use with instruments used in general surgery, orthopaedic and upper respiratory.
• Dental soil - For use with instruments used in dentistry.
• Ophthalmic soil - For use with instruments used in eye procedures.
• Artificial Test Soil - For use with instruments used in gastrointestinal procedures.
• Blood soil - For use with instruments used in general surgery.

This is not an exhaustive list, depending on your medical device application, alternative test soils can be selected.

Relevant Endpoints

As per standards, two analytes must be picked for the cleaning validation study. The minimum requirement is Protein and one of the following residual analytes: Haemoglobin; ATP; Carbohydrates; TOC; Endotoxin

Testing Laboratory Net Promoter Score

Holly Scott

NPS is a great measure of our customers perception of our brand, our business and our people, it helps businesses like ourselves to effectively understand any improvements that could be made to our management and quality systems, testing activities and our customer services, it also serves as an amazing way to give glowing feedback to your staff, especially if our customers have taken to the time to write a review.

Good Laboratory Practice & Safe Medical Device Reuse

Toni Carlton

Writing a Biological Evaluation Plan (BEP) is not something that just anyone can do. It requires deep knowledge, experience, and a thorough understanding of the medical device regulatory landscape, especially if you want it to be accepted by the Regulators. Under ISO 10993, competent and qualified professionals must be involved in the planning and documentation of biological evaluations.?