February 12, 2020

Trusted Mounting Solutions – Criteria for a medical-grade product



Trusted Mounting Solutions – Criteria for a medical-grade product

READ AND LIKE THE ARTICLE AT LINKEDIN

Clinical standards and medical requirements relating to equipment such as implants, instruments and medical devices directly linked to patients (e.g. vital sign monitors) are rigorously applied. However, peripheral and supporting device equipment such as mounting solutions in critical areas often escape such scrutiny, yet they are installed at the same time as the devices they hold and remain there for many years. The question is: „What are the criteria when selecting the mounting solution for your hospital and should the same medical requirements not apply to those?“

EN 60601-1, 3rd edition compliancy must form the basis of everything medical suppliers do, to ensure that you and your customer get the safest, most beneficial solutions available in the world today. At CIM med we are solely committed to the medical market. Our medical mounting solutions are designed and tested to the most exacting of standards, CE marked, adhere to the regulations MDD 93/42 ECC and are FDA registered.

Load tests must be carried out both statically and dynamically. With a 4-fold or 6-fold safety factor depending on the tensile factor we at CIM med go beyond the required standards. Lifecycle tests ensure trouble-free operation, backed up by a 5 year standard warranty, zero maintenance guarantee with no extraordinary T&C’s. Automated testing equipment puts our products through 40’150 cycles in all possible directions of movement for all arms. In my experience this is what it takes to be the best in the market.

The benefit of internal cable integration is obvious when it comes to effective wipe disinfection and hospitals can choose from a variety of manufacturers offering this feature. However, mounting arms with integrated cable management must be equipped with component grounding. This is a crucial requirement to ensure electrical safety at all times. Always check before you buy any solutions.

Height adjustable arms of numerous manufacturers offer best flexibility and optimal positioning of your monitor. Most brands in the market are easy to move and maneuver when the medical device is mounted using an internal gas spring. But what happens when the monitor is taken off without engaging the locking lever? CIM med® height adjustable arms are equipped with the unique safety feature of a slow-release gas spring. Should anybody try to remove the monitor before locking the arm in position, the arm will only rise at a slow and even tempo. A technical detail to protect your staff and property from potential harm.

There is no compromise when offering mounting solutions for anesthesia applications. Any manufacturer of medical mounting solutions for anesthesia applications should take the time and effort to carry out all safety testing such as static and dynamic load testing as well as threshold testing in combination with the anesthesia cart. This is an essential part of medical compliance. I consider it the manufacturer’s responsibility to ensure that any configuration offered to the market, is tested, stable, safe and compliant. Again, there must be no room for small print and compromise in an environment where it is about the health and life of people.

All equipment in critical care areas are frequently cleaned. Repeated wipe disinfection has a wearing effect on surface and materials and thus may reduce the lifecycle of a product. CIM med® mounting solutions withstand the long-term use of disinfectants and resist against multi-resistant pathogens (MRSA, MRGN, Klebstelle pneumoniae, ESBL, Clostridium difficile) which is backed up by a material resistance certificate according to DIN EN 60068-2-74 (Contamination by Liquids) and DIN EN ISO 2409:2013 (Coating Materials – Cross-Cut Adhesion Test).

Another major aspect to consider when choosing a mounting solution: How easy can hygienic measures be conducted? Infection control routines are vital in the clinical environment in order to prevent Hospital Acquired Infections in critical care areas. Clinicians’ hands touch contaminated surfaces of medical equipment, devices and monitors during patient care. Hygiene regimes and cleaning processes are often not consistent during a clinical day. As a result microbial contamination of those surfaces causes microbial colonization and transmit pathogens. A comparative investigation by Dr. Brünke shows that the construction of mounting arms is a critical factor when it comes to microbial control in hygiene-sensitive environments. The independent data proves that an elaborated constructional design is a crucial aspect to avoid and/or reduce microbial contamination in a clinical environment, especially in highly sensitive areas and to lower the risk of microbial transmission during handling. See Dr. Brünke’s white paper.

Decision makers, product managers and clinical staff put a huge amount of time and effort into choosing the best state-of the-art medical equipment for their hospital. Not surprising because they know what matters when it comes to restoring and safeguarding health. This attention to detail should continue when selecting supportive or peripheral devices. At CIM med we have all the supporting data to help you reach a qualified decision.

Manuela Deverill, CEO CIM med GmbH

Media Center
Configurator CIM med charity