Common Manufacturing Errors in Orthopedic Instruments by

Each year, a standard hospital organizes several operations and instruments; therefore, there are chances to make many errors during the processing of orthopedic instruments. The most common mistakes might involve several processes, including manual cleaning of tools, automated washing, manual collection of instrument sets, and finally, the sterilization of surgical instrument sets.

Proper management of surgical instruments reduces the risk of operating room mishaps and instrument malfunctioning. China has established a sterile central department to manage and track recycled orthopedic surgical instruments collectively. Processes like recycling, sterilization, cleaning, inspection, and delivery are centrally based on surgical instrument tracking systems. This system minimizes the risk of errors in surgical instruments’ processing, including missing and mismatched tools.

However, processing errors are still reported occasionally, and the reasons are yet not confirmed. Hence, to increase surgical instrument safety, this article aims to discover the types of surgical instrument processing errors.

Types of Errors

Incomplete Packaging: includes defective packaging materials, including degraded non-woven fabrics, inadequate packaging, missing cushions in the container.

Missing Instrument: Often, the number of instruments is less than stated on the list—several instruments malfunction due to missing pieces, including screws, accessories, tools with wrong specifications, and disordered packaging labels.

Box and cover mismatched: Instruments including boxes and body are usually assigned together with different colors to clarify them for a specific operating room.

Inappropriate packaging material: Manufacturers use different packing materials for tool packages according to the operation’s diverse needs. For example, surgical instruments are used infrequently and packed using a double-layer non-woven cloth. In consideration, medical staff could use that packaging material to prepare a sterile operation bed. CSSD staff might misuse the packing material if they do not strictly follow the instrument list’s introduction.

Indicator card missing: Often, manufacturers do not place chemical indicator cards inside the instrument package.
Wrong count of the instrument: The instrument packages are assembled with a specific number of apparatuses according to each surgical requirement.

Tracking System

The tracking system consists of the quality monitoring system for the tool’s packaging. The model records the detailed information. For example, packaging time, medical staff in charge, name of the malfunctioning instrument, wrong instrument count, and the list goes on.

An audit group regularly records and processing error data in the department. Further, the model performs a weekly audit control on random fifty instrument packages. Another source of packing errors comes from complaints in the operation theater.

Such tracking models can also allow hospital staff to track different surgical devices’ status, make proper use of instrument sets, speed up tools turnaround time, and get manufacturers’ instructions. Firstly, the package label is confirmed while a packaging error is found or dealt with.

In the orthopedic surgical instruments set tracking system, medical can find all detailed information regarding this packaging under the item tracking and disinfection package status.

Results of Tracking System

A study collected data on more than 33,000 surgical instrument packages. A total of 390 errors occurred, that includes incomplete packages (73), missing instrument (77), malfunctioning instrument (30), tools with wrong specification (175), missing or incorrect packaging label (8), box and cover mismatched (15), inappropriate packing material (15), missing indicator card ( 6), and miscount of instruments (6).

Observe the highest rate of errors among the newest nurses and between 16:00–20:00 time. At the same time, the tracking system detected a relatively higher error rate in the Orthopedic Department as well as in the Gynecology and Obstetrics Department. Whereas the research also highlighted the errors in veterinary orthopedic instruments. If not for the tracking system, such errors could take someone’s life.

Conclusion

Wrong instrument specifications are the prime errors in the study. Medical institutes need further effort to standardize the quality assurance for instruments under the same category, and they also need more effort to reduce the error rate during major operations and in the surgery department.

However, apart from China, every country should now go for such tracking systems to keep up with the quality of orthopedic instruments for sale and minimize the count of disinfections and mishaps in hospitals.

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