CE marking of medical devices and protective equipment is a requirement. OneMed has also assessed the function of the products.
– We have evaluated both certificates and products, says Catharina Persson who is Category Director in Sweden, which means that she is responsible for the product assortment offered to customers. Sometimes the documentation on products offered to us have been inadequate and we have been forced to reject those products and other times we have contacted an organization that verifies that the product meets the requirements with regard to safety, a so-called Notified Body.
The letters CE are an abbreviation for “Conformité Européenne”, which means “in accordance with EC directives”. The presence of a CE mark on a product signifies that the manufacturer or importer certifies that it meets EU health, safety and environmental requirements. There are two regulations to take into account - PPE, the regulation for personal protective equipment, when the equipment is intended to protect the wearer and MDD, the Medical Devices Directive, when protecting the patient. The standards include, among other things, respiratory protection, mouth protection, eye protection, medical gloves, protective gloves, surgical clothing and protective clothing.
– We have spent an enormous amount of time on quality assurance because it is so important that healthcare staff are protected. They must be protected from infections and that is why it is so important that we know what we are doing. Many of us are nurses with both nursing experience and solid knowledge of the product assortment. Now the task is to purchase and deliver quality-assured products. It is a teamwork and we notice an increased awareness that healthcare staff have access to, and instructions for, the protective equipment that is used.
OneMed's suppliers are located in Asia, but also in Europe where closed borders has been, and to some extent still is, a problem. Local suppliers have been able to contribute with certain products, but when the demand exceeded the supply, OneMed cooperated with customers to avoid hoarding of certain sought after products.
Another aspect when it comes to purchasing is conditions in the production. OneMed's suppliers sign and work according to a code of conduct, which regulates that products are manufactured under good working conditions. Regular visits are made to ensure that the code is complied with, especially in countries deemed “high risk”. In addition to products from many different suppliers, OneMed has two own brands (evercare and SELEFA). The production of the own brands is also regularly inspected by certified auditors.
– The tender requirements are increasing, says Catharina Persson. This applies to environmental aspects as well as conditions in production, which is important to us in the dialogue with our suppliers.
Catharina also emphasizes the importance of investing in innovative and high-quality products and aids, and spreading knowledge to achieve improved care results. One such area is to - with the help of education and the right products - shorten the healing time for difficult-to-heal wounds, which also leads to lower total cost.