The care of pressure ulcer patients is becoming increasingly challenging as fewer and fewer nursing staff are faced with a growing number of people in need of care, which is why more effective anti-pressure ulcer products are urgently needed.
Pressure Ulcer Care in Germany – An Overview
The problem of pressure ulcers poses challenges for nursing staff, doctors, service providers (medical supply stores) and scientists, as well as therapists, but of course especially for patients.
A pressure ulcer is a wound that occurs when, under unfavourable conditions, permanent pressure and shear forces act on a specific area of skin, hindering or interrupting its blood supply. Pressure ulcers often manifest as chronic, extremely painful wounds, which can lead to a significant reduction in quality of life, especially for people with limited mobility.
Internationally recognised risk assessment scales, such as the Braden, Norten or Medley scales, are helpful assessments for determining the risk of pressure ulcers developing under certain conditions.
In Germany, the data on patients affected by pressure ulcers is unfortunately increasingly incomplete. The National Association of Statutory Health Insurance Funds (GKV-SV) reported 65,000 cases of pressure ulcers in hospitals in 2021. In a study conducted by the Charité University Hospital in Berlin, the authors estimated that around ten percent of all patients with limited mobility in nursing homes in Germany suffer from pressure ulcers.
Ultimately, the data available for both outpatient and inpatient care is unreliable. However, even based on a conservative estimate, it can be assumed that over 600,000 people in Germany suffer from pressure ulcers.
Supply Situation
There is a wide range of aids available to prevent pressure ulcers. Seat cushions, mattresses and positioning aids are offered by a large number of manufacturers. These aids provide urgently needed pressure relief for many people affected by pressure ulcers.
However, the best remedy for pressure ulcers remains regular movement and repositioning of the body. For many immobile patients, however, this requires the support of nursing staff, which is a dwindling resource in our times.
A report of the DAK-health insurance (article only available in German) shows that
- almost 250,000 care workers (article only available in German) will retire in the next ten years.
- the number of people in need of care will continue to grow.
Due to the age-related retirement of the baby boomer generation, experts estimate that by 2035, over 20 percent of nursing staff will need to be replaced in almost every federal state – a requirement that cannot be met with current training and immigration figures.
This means that the most important resource in pressure ulcer treatment and prevention – nursing staff – will be reduced. The hope is that innovative, effective products will be able to alleviate the problem.
Hope Among Aid Manufacturers
If nursing care declines in the coming years, while at the same time the burden of care increases due to an ageing population, part of the solution will certainly lie in aids that support and enable nursing care.
Effective anti-decubitus systems are needed to improve the quality of life for millions of people in the coming years. Thanks to the reimbursement system of the German Medical Technical Aids Register (Hilfsmittelverzeichnis – HMV) appropriate aids can be made available to those affected quickly and affordably. This is crucial, because only when products are readily available can their effects actually be felt in everyday care.
However, getting listed in the HMV is a complex matter that can easily trip up those who are inexperienced. Manufacturers must be equally familiar with technical requirements, legal regulations and medical evidence – a demanding challenge that requires experience and detailed knowledge. Our article provides a concise overview of the fundamentals and special features of HMV, particularly for international manufacturers. „The German Medical Technical Aids Register – a Guideline for International Manufacturers“.
Working Together for Success: Partnership with BEO BERLIN
The requirements of SGB V are added to the usual requirements of the EU-Medical Device Regulation . Without the right documentation, studies and statements, it is virtually impossible to successfully list an anti-decubitus product in the HMV. This is precisely where BEO BERLIN comes in.
We have more than 25 years of experience in the approval of medical devices and in supporting manufacturers in complying with regulatory requirements. Our experts guide you step by step through the process – pragmatically, cooperatively and professionally.
Thanks to our established network of recognised testing facilities and medical experts, we prepare a listing application that is not only formally correct but also convincing in terms of content. In this way, we work together to lay the foundation for better care and a higher quality of life for pressure ulcer patients.
If you have any questions or would like our assistance in listing your product, please send us an email!
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