Standards Provide Safety Within Medical Industry – Are Your Suppliers Compliant?

Being in the Medical Industry, we all understand the importance of a medical device as these both support and save lives and therefore require to meet the relevant quality standards.

Unfortunately, the current situation in South Africa is such that R80.4-billion is spent on Medico-legal claims which now equates to more than half the annual Provincial Budget. These malpractice claims are caused either by the Healthcare Practitioner, or by the Healthcare Facility itself. To curb these expenses, stricter measures will be applied from the insurance provider, as no insurance company will settle any claim if the equipment used is non-compliant.

A condition of Insurance is that the Insured must always “take all reasonable steps and precautions to prevent accidents or losses, included but not limited to, compliance and adherence to laws and regulations which are material to the risk”  The Insured must also “ warrant that all laws, regulations, by-laws and rules that apply to the business or any other matter for which cover is provided” is adhered to at all times.

Even if the Hospital was unaware that the equipment did not comply, it would be their duty to ensure that it did, as all policies exclude cover in respect of non-conformity or disregard of any SANS or legal regulation.

HUTZ products are designed to supply safe electrical power and medical gas within a hospital environment.  These services are required for the connection of other medical electrical equipment such as ventilators, electrocardiograph machines, endoscopes and provide medical gas and vacuum services for use with patients.

As such, these devices are required to be safe for use within the hospital environment, to both the user and the patient. To achieve this, we at HUTZ have implemented and successfully maintained a Quality Management System (QMS) to ISO 13485, a standard particularly for Medical Device manufacturers. This standard ensures control in the design and development, manufacturing and servicing of medical devices.

Additional to this QMS, our products are required to be safe for use by patient, nurse and doctors alike. To achieve this, our products must meet stringent regulations for medical electrical equipment and therefore must comply to the IEC 60601-1 regulation. This regulation requires product safety is ensured by taking the following hazards into consideration;

–              electrical shock;

–              mechanical;

–              radiation;

–              ignition of flammable gases.

 

Furthermore, as our products are used in the same environment as other higher classified medical equipment, our products are tested to IEC 60601-1-2, a regulation ensuring our products do not present any electromagnetic interference of these devices.

As medical devices globally are required to be state-of-the-art, our products must be complaint with standards established internationally. One of these standards is ISO 11197, which specifies the requirements for medical supply units, including the requirements that must be taken into consideration during the design of medical devices to identify the risks associated with the device. In doing so, the risk can be mitigated to an acceptable level, thus providing a safe medical device for the market.

Lastly, as our device may channel gases for the eventual introduction into the body, the pipeline system incorporated within our products must comply with SANS 7396, a South African standard regarding medical gas pipeline systems to ensure patient safety.

This standard is dedicated to, amongst others, the design, installation, performance and testing of medical gas pipeline systems. The requirements cover the followings aspects:

–              Use of medical grade tubing;

–              Use of medical grade terminal units;

–              Cleanliness of system;

–              Cross connections;

–              Earthing of pipeline system.

 

Now ask yourself…Does your supplier act within the set regulation and do the products supplied comply to the set standards so that the medical device can perform as intended?

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