Medical Laboratory Management and Emergency Preparedness: Legal Requirements and Quality Assurance in Türkiye

What is an Adverse Event in Medical Laboratories?

Adverse events are caused by a malfunction in a device's performance, an unexpected situation during use, or user error. harm to the patient, healthcare worker or a third partyThese are events that could result in such outcomes.

What does the legislation in Türkiye say?

In Türkiye Medical Devices Warning System Circular, This mandates the detection, reporting, and monitoring of adverse events occurring after the placing of laboratory equipment on the market. Laboratories:

• The events should be documented.
• The device must document its make, model, and lot numbers.
• To the Ministry Between 2 and 30 days notifications must be made at varying intervals.
• They should prepare risk analysis and corrective action reports.

Reporting Adverse Events: Who, When, How?

According to legal regulations, not only manufacturers, laboratory managers and users as well They are obligated to report the incidents. Delay or incomplete reporting may lead to legal penalties.

Risk Management for Laboratories and ISO 14971

ISO 14971 standard, This is the international reference for managing risks related to medical devices. According to this standard, incident analyses and corrective action planning are required.

How can the process be strengthened through consulting?

With our specialized consulting services for medical laboratories:

• We establish and document your incident management processes.
• We empower your staff with awareness training.
• We develop risk assessment forms and procedures.

In this way, not only the legislation, You also fully comply with international quality standards..

Take action today to be prepared.

Adverse events can have significant consequences if preventative measures are not taken. To secure your institution, raise staff awareness, and strengthen a patient safety culture... Contact us immediately..

Notes:

All kits used for analysis/testing/examination are classified as medical devices. in vitro diagnostic (IVD) medical devices or It is referred to as an in vitro medical device.

“All software classified as "software as a medical device" is also considered a medical device. Detailed information about this software can be found at the following websites: "https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd" and "https://health.ec.europa.eu/system/files/2021-03/md_mdcg_2021_mdsw_en_0.pdf".