The Importance of Strict Standards for Medical Equipment Manufacturing

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Healthcare providers in Pennsylvania and elsewhere have to trust the equipment they use to perform a wide array of medical procedures. From simple examinations to complex surgery, medical equipment must be manufactured to strict specifications in order for doctors, nurses, and other personnel to properly treat their patients. Simply put, lives are at stake.

With this in mind, it’s important for medical professionals to understand and appreciate the importance of precise and reliable medical equipment manufacturing. Whether being assembled in the Keystone State, down in one of Mexico’s maquiladora plants, or somewhere overseas, the instruments and devices used by doctors and nurses to perform essential medical services have an exceptionally high bar to reach and an incredibly low tolerance for failure.

Sterile Conditions

One of the key aspects of safe and reliable medical equipment manufacturing is the assurance that products used for healthcare purposes are sterile upon arrival. While hospitals and other medical facilities are responsible for maintaining the sterility of their equipment, healthcare professionals can’t afford to have products arrive which are tainted with prepackaged pathogens. The results for their patients can be disastrous.

The factors which contribute to properly sterilizing medical equipment during the manufacturing process include things like air and water filtration as well as adherence to biological safety laws. For instance, a facility manufacturing surgical tools is expected to meet or surpass Class 7 for air cleanliness as defined by ISO Standards. This means there are no more than 10,000 particles larger than 0.5 microns for every cubic foot within the confines of the assembly area.

Low Tolerance

Another key issue related to medical equipment manufacturing is the low tolerances involved. Precision machining and temperature control are essential for the production of reliable instruments and devices. This is especially true when it comes to the equipment used for surgeries and related procedures. The delicate tissue and minuscule parts of the human anatomy require the utmost in accuracy when being operated upon.

One-tenth of a millimeter might not sound like much of a size difference to the average person, but to those familiar with surgical instruments, the variation is enormous. Surgeons have to be able to count on their tools to be a specific size and design. This can only be achieved via strict and uncompromising standards at the manufacturing stage.

High Stakes

Medical science is unlike any other industry in that it holds the key to life itself. Business executives, judges, airline pilots, teachers, police officers, shopkeepers, and general laborers are all beholden to the skills and insights of doctors and other medical professionals. In order for society to successfully function, reliable forms of healthcare must be in place.

It’s for this reason that medical equipment manufacturing is so tightly regulated. We cannot afford to let the instruments and devices used by doctors and other medical personnel to be made without strict specifications. 

The ability to trust healthcare experts to get the job done right is something people typically take for granted. While skills, experience, and intelligence play fundamental roles in establishing this trust, the foundation rests upon the reliability and quality of the equipment being used.