Karen Gunning – The Compliance Expert

Karen Gunning – The Compliance Expert

Karen is Polyco Healthline’s Quality Assurance and Regulatory Affairs Manager. An expert in medical devices and barrier technology, she’s been in the industry for 28 years, overseeing product compliance and regulations.

A self-confessed anorak, she enjoys helping customers and suppliers with any regulations question. In doing so, she believes her role is vital within the global supply chain of PPE equipment and medical devices.

Within that broad category, her speciality is products marked as Medical Devices. She knows the ins and outs of the qualities necessary to sell these to the European market and is always happy to advise about compliance.

So Karen, what questions are you asked most frequently?

Mostly about different glove materials – which material would be best to prevent specific risks and meet customer requirements. From chemical and mechanical resistance to medical use and food contact.

What questions do you wish were asked more frequently?

To be honest, all questions are always welcome. And these vary across different sectors and products, including gloves, coveralls, pulp and polythene. So keep them coming! It helps us to understand customer needs.

What do you feel is the biggest problem within the health and safety industry?

Although standards compliance has become more prevalent, there isn’t always the support available for customers to make an informed choice. Sometimes we find that documentation for using certain chemicals can be a little light on detail. We need more than just stating, ‘wear gloves and protective clothing’. For example, you may think that wearing a disposable glove would provide enough protection, but it is all dependent on the material resistance (including thickness) and the concentration of the chemical being handled. For instance pure acetone will permeate a disposable nitrile glove almost immediately, which is why we have a reusable range for longer contact..

How do Polyco Healthline’s products and/or services address that problem?

We’re able to provide deeper knowledge and the support in a way that’s understandable to customers. We do this in a number of ways:

  1. Our lab technicians test and communicate products’ chemical and physical resistance.
  2. Our technical officers research and support customer queries.
  3. Our team in China and Malaysia ensures consistent high quality at the factory before shipping.
  4. The Quality Control team audit and inspect product deliveries on receipt into the UK distribution centres.

Ultimately, this means that customers can have total confidence to use our products safely, and to have all the supporting knowledge that they need.

What is your favourite product and why?

These days Polyco Healthline really has a superb range, so it’s tricky to choose one. Can I pick three?

For disposable gloves, what stands out for me is SafeDon™. Not just the glove, but the whole technology is such an innovation beyond standard dispensing methods.

Then on the reusable side, the Dyflex® Air has good cut resistance but is still lightweight with excellent tactility. And then there is the Tremor-Low™ which is great at reducing the effect of vibrations.

What future development will have the greatest impact on your industry specialism? What will change?

The Medical Device Directive and the PPE Device Directive have changed to regulations. That’s going to have a huge impact – and a really positive one for us. As directives, these principles from the European Parliament were still open to interpretation as to how they were transposed into law and applied by member states. Now that they are regulations, they have a binding legal force. Manufacturers and suppliers across the EU will have to apply the regulation in its entirety.

Why are you proud to sell and represent Polyco Healthline products and services?

Our team works really well together as a close-knit group inside a big family, providing support, knowledge and product safety assurance to all departments and outwards to our customers. We’re always looking to innovate and be part of new ideas. The ethos is spot on because our interests are always the customer and how to ensure the best quality safety products are served to the end user.

How are you able to provide the greatest value to Polyco Healthline customers?

As I said, I’m happy to help with any question regarding regulations. But we’re also heavily involved in social responsibility and the ethical trades initiative. For instance we work closely with factories and suppliers to ensure that the principles of the ETI base code are recognised and integrated into the ethics of the business.