How can Surgical Saw manufacturers and users benefit from product recall investigations?

Product Recall; It is a voluntary withdrawal or recall from the market by the manufacturer of the device for technical and medical reasons, depending on the features and performance of the medical device.

According to Article 2-62 of the Product Recall (EU) 2017/745 Medical Device Regulation; A recall is any measure aimed at ensuring the return (to the manufacturer) of a device that has already been made available to the end user.

When performing a Product Recall or investigation; Countries have official sites that they prepare according to their own laws and make available to the public. Some of these are as follows;

Although product recall is used to recall the manufacturer’s own products from the market, it provides great opportunities for risk assessment of events that have not yet occurred to the manufacturer. Quality Assurance is a unit that serves to catch errors before they occur and prevent risks before they are experienced. What is often confusing is; is to predict events that have not occurred during production and use.

What methods can be followed to ensure that these predictions are close to reality?

  • With equivalent device work, we can clarify our competitors who produce products similar to the product we produce,
  • Monitor competitors’ product recalls on a quarterly basis,
  • We can compare the data we obtain as a result of monitoring with our own risks,
  • When a new risk arises, we can evaluate the risk in detail with our risk management team,
  • By updating our risk analysis, we can activate the measures, warnings and alarms decided to be taken.

As Surgical Saw manufacturers, we are obliged to monitor the performance and safety of our risks at a clinical level, as products that support surgery and cannot be monitored clinically. If the framework for evaluating performance and security risks is limited to what has been experienced so far, we will be unaware of the problems that may arise at any time. If the product causes problems, we may already run out of time to take possible precautions.

Users; The actual evaluation data of the surgical saws they use cannot be accessed as easily as Class 3 products. Therefore, even if they think they have to rely on hearsay, recall investigations can give them an idea of what problems are being experienced with the products of the brands they use. (worldwide, if not in their own region)

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