On 6 May, Medical Procurement of Ukraine held a webinar dedicated to ensuring the quality and safety of medical devices after their procurement and transfer to healthcare institutions. The event was supported by the USAID project “Safe, Affordable and Effective Medicines for Ukrainians”, SAFEMed, and brought together representatives of Medical Procurement of Ukraine, the State Service of Ukraine on Medicines and Drugs Control, and experts in the fields of quality, conformity assessment and post-market surveillance of medical devices.
As part of the event, Maksym Bagrieiev, Managing Partner of Cratia and Chair of the Medical Devices Working Group of the American Chamber of Commerce in Ukraine, delivered a presentation focused on the practical actions healthcare institutions should take when an incident, quality issue, suspected non-compliance or adverse reaction occurs during the use of a medical device.
The presentation focused on the lifecycle of a medical device after procurement: what happens to a device after it is supplied to a hospital, how healthcare professionals should act when a problem is identified, whom they should notify, and why even a single case in a healthcare institution may be important for the entire medical device safety system.
During his presentation, Maksym Bagrieiev emphasized that reporting an incident or a problem with a medical device is not a mere formality or “complaint for the sake of complaining.” It is the first signal from the place where the medical device is actually used. Hospitals and healthcare professionals are the first to encounter situations where a device does not work as expected, has a defect, creates an additional risk for the patient or complicates a medical procedure.
Such situations may include, among others, damage to sterile packaging, deformation of a device during use, increased resistance when using a syringe or catheter, missing components in a kit, unclear or contradictory labelling, malfunction of electromedical equipment, irritation or another unusual reaction after use of a device, as well as unstable or clinically unconfirmed results of diagnostic tests.
Special attention was paid to the fact that such cases should not automatically be treated as isolated incidents or explained solely by staff error. A single incident in a hospital may be the first indication of a broader problem — for example, a defect affecting a specific batch, series, model or even a systemic error in the instructions for use, labelling, design or manufacturing process.
The speaker underlined the importance of proper documentation of the problem. If a defect or suspected non-compliance is identified, it is advisable to preserve the device itself, its packaging, labelling, instructions for use, batch number or serial number, and, where possible, to make photo or video records. These details may be critically important for further analysis by the manufacturer, authorised representative, supplier, conformity assessment body or market surveillance authority.
An important part of the presentation addressed the role of the manufacturer and its authorised representative in Ukraine. Maksym Bagrieiev explained that notifying the manufacturer or the authorised representative is not merely a claim concerning a specific product. It is the transfer of information into the manufacturer’s quality management system. Having received such notification, the manufacturer may check the specific batch or series, assess whether the problem is isolated or systemic, conduct root cause analysis, review the risk assessment, clarify the instructions for use or labelling, change the manufacturing process or quality control, provide users with additional explanations or initiate corrective actions.
Such actions may have practical consequences not only for one healthcare institution, but also for other users of the medical device. In certain cases, the manufacturer may arrange repair or replacement of the device, issue an urgent safety notice, update the instructions for use, change the packaging or labelling, strengthen quality control, restrict the supply of a particular batch or initiate a product recall.
The webinar also addressed the role of the State Service of Ukraine on Medicines and Drugs Control as the state market surveillance authority for medical devices. Submitting a notification to the State Service in cases where a product may pose a risk to patients or has defects that may cause harm is not a “complaint against the manufacturer”, but a mechanism for protecting the right of users and patients to safe products.
After receiving a notification, the market surveillance authority may assess the information, verify the product characteristics, request documents and explanations from economic operators, assess the level of risk and determine whether restrictive or corrective measures are required. If risks are confirmed, such measures may include warning users, temporary restriction of the product being made available on the market, withdrawal from the market or recall.
The presentation also highlighted typical mistakes that healthcare institutions should avoid. These include failing to report a problem because of an assumption that it is an “isolated case”; attributing the situation to staff error without proper analysis; disposing of the device before the investigation is completed; failing to record the batch number or serial number; failing to preserve packaging or other materials necessary for product identification; and failing to inform the manufacturer, authorised representative or competent authorities.
It was separately emphasized that an effective medical device safety system is impossible without the active participation of users. Healthcare institutions are not only recipients of products, but also important participants in post-market surveillance. Their notifications make it possible to identify problems in a timely manner, collect information on the real-life use of medical devices, prevent recurrence of incidents and improve patient safety.
To simplify the reporting of incidents and problems related to medical devices, practical forms that may be used by hospitals and other healthcare institutions were presented during the session.
Forms and useful links for healthcare institutions:
- Notification to the manufacturer or the manufacturer’s authorised representative in Ukraine regarding an incident / problem with a medical device: https://cratia.ua/Incident_notification_AR.docx
- Notification to the State Service of Ukraine on Medicines and Drugs Control regarding medical devices that have caused harm to public interests or have defects that may cause such harm: https://lnk.ua/MeJhQBlf3
- Notification of a non-occupational accident in accordance with Resolution of the Cabinet of Ministers of Ukraine No. 270: https://lnk.ua/wtN9xqgRb
Video of the webinar: https://www.youtube.com/watch?v=ruuQf7tGHVI
Cratia supports the development of a systematic approach to medical device safety in Ukraine and the consistent implementation of post-market surveillance practices that enable timely identification of risks and ensure proper interaction between healthcare institutions, manufacturers, authorised representatives, suppliers and state market surveillance authorities.
Reporting incidents, quality issues and adverse reactions is an important element of responsible use of medical devices. It helps not only to resolve a specific situation in an individual hospital, but also to prevent similar cases from recurring in other healthcare institutions, improve the quality of products available on the market and strengthen patient protection.
