Medical device companies manufacture equipment that must meet certain criteria for use in the healthcare industry. All devices must work properly, be reliable, produce accurate data and meet specific standards. In this article, we will take a closer look at a few of the manufacturing best practices medical device companies are expected to follow.
Use Quality Materials
The success of any manufactured product in part comes down to the quality of the materials in the item. Materials used to construct medical devices must be of the best quality. This may sound obvious, but it is still required as a best practice to ensure it happens. Since some of these devices are inserted into the human body, stainless steel and other non-allergenic metals are required as part of the building process. In short, the cheapest materials available are not necessarily what you would expect to find in medical devices.
Properly Trained Staff
Even in an assembly line setting, each person who comes in contact with a medical device during the manufacturing process should know what they are doing. Having staff and workers who are properly trained and who participate in training upgrades when needed ensures that the manufacturing process moves smoothly. The staff who know their job well can assist with unusual circumstances that may arise and be attentive to reduce potential risk factors that could affect processing. Qualified staff can prove to be an asset to reducing the time needed to train new staff following a turnover. Well-trained workers are generally more likely to stay with the company.
A Safe Work Environment
Factories tend to be busy places. Serious injuries can occur if the worksite is not kept clean and tidy with all safety standards observed. When making products, such as medical devices, it is important to have the manufacturing system laid out in a fashion that makes efficient use of time and labor. This reduces the downtime and the accompanying cost to the manufacturing company due to lost time. Workers who feel safe on the job will perform better and experience better overall morale.
A Thorough Software Validation Process
Software validation occurs when programs are evaluated to verify that the software meets pre-defined requirements. Two methods are used to perform software validation: internal and external. Internal validation is concerned with the contents of the software and ensuring that all included software meets the goals of stakeholders. External validation tests use of the software to determine whether it functions in a manner that meets the expectations of the stakeholders. When both tests have been successfully conducted, the software is said to have been validated. As this Dickson article notes, software validation is actually required by law within the medical device industry.
Continuous Environmental Monitoring
Continuous environmental monitoring requires the use of equipment that can be programmed to sample various conditions at regular intervals. Concerning facilities used to manufacture medical devices, Temperature and humidity are conditions frequently monitored at plants that manufacture medical devices. Certain materials react differently under cold, hot, humid, or dry conditions. These reactions can weaken some materials and, in turn, harm any device containing them. Several types of specialized sampling tools are used to record, track, and document conditions. The most common of these is a data logger. With data loggers, information collected can be downloaded to a handheld device or computer for review. Data loggers are programmed for specific condition ranges. When conditions near a level considered dangerous, the data logger sends an alert to initiate human intervention. These monitoring devices can be used in adverse conditions or where human monitoring would be difficult.
Regular Recalibration of Sensors
The appropriate calibration of sensors helps ensure proper operation and the best possible performance. As with any mechanical measuring tool, the accuracy of the sensors that collect data can drift over time. The fact that the accuracy may alter over time does not render the apparatus useless. Instead, the device, such as a data logger or any other measuring gauge, just requires recalibration to keep it operating at its best. Some of the reasons to calibrate sensors include:
As a Precautionary Measure
Sensors are unlikely to work perfectly every time they are used. To make sure they operate consistently and at the highest levels of accuracy, regular recalibration at stated intervals will prevent data from being adversely affected. Sensors may differ from one manufacturer to another and there is no guarantee that a replacement sensor will have the same sensitivity as the one it is replacing. Calibration compensates for this possibility.
The Environment They Work In
Sensors have primarily replaced humans in the collection of certain environmental sources of data. However, the harsh conditions they endure can sometimes lower their accuracy. Imagine a data logger in a freezing cold storage locker for an extended period. Or think of the same measuring device in a humid location for the same duration. To keep sensors working properly in those conditions, regular calibration is required.
Medical device companies are under strict guidelines to supply products that not only meet but surpass certain criteria. For this to happen, a series of best practices are implemented to ensure compliance. These practices include such logical steps as using high quality materials, maintaining qualified staff, and giving those workers a safe work environment. Probably one of the most important best practices in the manufacture of medical devices is the software validation process that proves the device is properly made to do a certain job and that it can accurately and reliably perform the work. It is comforting to know that such quality control measures are in place and being used.