New workshops about managing medical technology

25 October 2018- 

The Medical Technology Covenant 9.0

Since the publication of the Medical Technology Covenant, many experiences have been gained in implementing the requirements. The quality of work goes up, says the one. The other person mainly sees an increase in administrative workload. The covenant has lovers and haters.

The purpose of the covenant is to reduce the risk for the patient. But not every healthcare institution appears to implement the core of the covenant properly. Risk-based purchasing, for example. Is that also possible with preventative maintenance, in other words can you ignore the manufacturer's instructions? Other institutions do come a long way, but fail to keep the improvements in business operations alive.

The covenant does not stand alone. It is part of a multitude of laws and regulations, national and international. The new European Medical Device Regulation, for example, the MDR. Applicable as per May 2017 with a transition periode of three years. Primarily, the MDR is intended for manufacturers and suppliers. They have to reinvest in their products and sometimes that is no longer profitable. The consequences of this are already apparent in healthcare institutions. The MDR ensures a better assurance of product safety throughout the entire life cycle. A large part of that life cycle takes place within the walls of hospital and clinic. The MDR therefore means quite a bit for the healthcare institutions.

In the meantime, the world is not standing still: e-health applications are rapidly increasing in number with the associated problems of data protection and cybersecurity. Is e-health also medical technology? And the Netherlands' NIAZ requirements, do they connect to covenant and MDR? Just try to find Software as a Medical Device. Oh, we almost forget the affordability of healthcare. Are we more expensive with the covenant or are we saving costs? And how about the extra administrative workload? That is a matter of flattening, someone said. Of course, but what does that mean? Are we going to stop  storing or cleaning?

NAMCO has put all this in a logical order. Instead of a list with 45 requirements, a limited number of workflows have now been developed that allow you to meet the requirements of the covenant and of the MDR as easily as possible within this strongly changing environment.

Reasons enough to start a new training cycle in the year 2019 on technology in healthcare. Titled: management of the life cycle of medical technology, covenant 9.0.

We prefer to work with small groups up to 10 participants. You can express your interest via: info@namco.nl. You will then be informed about data and locations as quickly as possible.