My son's foot

I do not usually visit hospitals. In fact, whenever possible I try to avoid them. However, a month ago, my son Douglas decided upon elective surgery to have one of his one of his toes straightened. Being twenty-five years old and having parachuted from an aircraft the previous year, Douglas showed no trepidation whatsoever as we drove to the hospital. After he was admitted into the pre-operative department, I was asked to meet the surgeon and the anesthesiologist.

Being an inquisitive kind of fellow, I asked the doctor what type of anesthetic would be used before the surgery was performed. I was informed that the short-acting, hypnotic agent known as Propofol would be intravenously administered. Always the wit, I turned to my son and said, "Good luck then, Michael." The anesthesiologist was not amused and immediately went into a rant about how Mr. Michael Jackson's lack of success with the drug was due to improper administration. I felt three inches tall.

Thanks to the professionalism of the surgeon, my son's operation was a complete success—although he has to wear a very large shoe that looks as if it were designed by engineers at NASA.

Having not visited a hospital in about ten years, it was interesting to note the changes—and especially the new products—that the doctors and nurses now use in their everyday tasks. However, it was not the high-tech flat-screen display used to monitor heart rate and blood pressure that impressed me most of all. Nor was it the precision-made cannula-over-needle device used to administer Lactated Ringer's solution into my son's bloodstream. It was the Novaplus ice bag—manufactured in China—that the hospital supplied to keep the anticipated swelling at a minimum. Fabricated of just five parts (including the manufacturer's label), the product could keep ice in a frozen state for up to six hours.

However, even the most simple products, like these, demand some serious design, manufacturing, and testing techniques. While the systems used to manufacture such products may incorporate vision, it is rare to read many case studies that describe how the systems are deployed.

Perhaps the main reason for this is the legal ramifications that might occur should such details be revealed. In the development of automated manufacturing systems to build medical devices, vision plays just a small but vital role.
Compliance or consequences

Because manufacturers must comply with standards such as TS 13485 and ISO 9001 as well as FDA requirements, their systems most often employ secure electronic signature and document control, allowing a complete audit trail of the manufacturing process, and providing lot and serial tracking, traceability, and a device history record. With the development of every new medical device, new methods must be implemented to ensure they are tested and manufactured to the highest quality requirements.

To guarantee that these products meet FDA standards has proved challenging when products—such as my son's ice bag—are not manufactured domestically. Indeed, according to a recent report, the FDA conducts relatively few inspections of foreign establishments.

Officials estimate that the agency inspects foreign manufacturers of high-risk devices (such as pacemakers) every six years and foreign manufacturers of medium-risk devices (such as hearing aids) every twenty years. Finally, inspections of foreign manufacturing operations pose unique challenges to the FDA, such as difficulties in recruiting investigators to travel to certain countries and in extending trips if the inspections uncover problems.