Regular safety and technical inspection (BTK) of medical devices is not just a legal obligation. For gastroenterology, obesity medicine and pulmonology departments it is a cornerstone of patient safety, protection of healthcare staff and smooth day-to-day operation of the entire department.
When an endoscopy tower or an automated endoscope washer fails in the middle of a busy operating day, it means postponed procedures, stress for staff and financial losses for the hospital. How can such situations be prevented, what exactly does the legislation say, and why should you entrust BTK to certified experts?
What is BTK and what is its legislative framework?
Safety and technical inspection (BTK) is a comprehensive check of the technical condition of a medical device. In the Czech Republic it is strictly regulated by the Act on Medical Devices (No. 375/2022 Coll.). Its aim is to verify that the device retains the properties and intended purpose declared by the manufacturer and that its use is safe.
If you neglect the inspection, you expose yourself not only to the risk of sanctions from the State Institute for Drug Control (SÚKL), but above all you bear full legal liability should a technical defect harm a patient’s health. Neglecting BTK also invalidates insurance contracts when claims are settled and may lead to the loss of the device warranty.
How often is BTK performed on endoscopes and other equipment?
The basic rule is: the frequency and scope of BTK are always determined by the manufacturer of the medical device in its instructions for use. If the manufacturer does not explicitly specify the interval, the legislation requires an inspection at least once a year.
- Flexible endoscopes and endoscopy towers (e.g. FUJIFILM systems): For these highly sophisticated optical and electronic devices, an inspection at least once a year is the standard. It checks leak tightness, angulation condition, the quality of optical fibres or sensors, and the function of working channels.
- Endoscope cleaning and disinfection equipment (e.g. WASSENBURG): Automated washers require strict adherence to service intervals, usually including not only the annual BTK but also regular validation of the washing processes. Endoscope cleanliness is the dividing line between a successful procedure and the risk of nosocomial infection.
- Electrosurgical units (e.g. BOWA): Power calibration, safety circuits and leakage currents are verified, usually at 12-month intervals.
Why not entrust service to “generalists” but to authorised experts?
In medicine, time saves lives. We at SuppMed s.r.o. fully appreciate this. We are not just distributors; we are partners of your department. Why entrust BTK and device service to our team?
- Authorised service with certification: Our service team undergoes regular, rigorous training directly at the manufacturers’ centres. We are exclusive or authorised representatives for brands such as FUJIFILM, WASSENBURG, BOWA and Broncus Medical Inc. We use only original spare parts.
- Speed that keeps your operation running: We understand that a device in service earns nothing and blocks patient care. Our service intervention is fast and economically sensible.
- Proactive diagnostics: During BTK we do not merely “tick items off the protocol”. Our technician can detect microscopic damage to an endoscope (e.g. wear of the bending rubber) before a massive ingress of liquid destroys the expensive electronics of the device. This saves you hundreds of thousands of crowns.
- Complete documentation in case of an audit: After every inspection you receive a detailed and legally flawless BTK report, with which you can calmly pass any SÚKL inspection or accreditation procedure.
Don’t wait for a breakdown in the operating theatre
Operational blindness and staff workload often cause inspection deadlines to be forgotten. Do not leave the technical condition of your equipment to chance. Regular BTK extends the service life of your investments and gives physicians the certainty that they can fully concentrate on what matters most – an accurate diagnosis and patient treatment.
Is the expiry date of your last inspection approaching? Submit your request for a safety and technical inspection to our specialists.
Interested in a demonstration of one of our devices?
Fill in the form and our specialist will contact you within 24 hours to arrange a professional consultation.
Suppmed s.r.o.
U nákladového nádraží 1949/2,
130 00, Prague 3, Žižkov
Czech Republic
Company ID: 24170674, VAT ID: CZ24170674
Bank account: 6540917001/5500
Email: info@suppmed.cz
The company is registered at the Municipal Court in Prague, file no. C185220
