The Waiting Game
One of the claims by Medical Device Manufacturers, especially start-ups, is that it takes way to long to bring a new medical device to market and that the regulator process is cumbersome. While the FDA is trying to streamline the process, the FDA takes a cautious approach to new product approval, in large part due to the litigious nature in America. The development from devices to disposables, which are less intrusive forms of treatment, are scrutinized by the FDA’s claim that the devices have to work and they have to be safe.
According to Dr. Herbert Lerner, Deputy Director of the FDA’s Division of Reproductive, Gastro-Renal and Urological Devices, the relationship between the device manufacturers and FDA is getting better as seen in the video below. A great term when talking about medicine and treatments, it is “getting better”. Some of the inventions that are designed to treat us, cure us, prolong life and yes, save lives include: transfusion disposables, infusion pumps and cardiology disposables like catheters/stents and IV sets.
Progress a Long Time Coming
For the sake of discussion, let’s focus our attention on Cardiac Catheterization, which was first performed in 1711, when a long metal tube was inserted into the right and left ventricles of a living horse. We’ve come a long way today with the use of Teflon tubes, self-expanding wall stents, balloon catheters, guide wires, the medical grade plastics and the mass assembly process. Devices are molded, extruded, machined and processed for eventual assembly in a Clean Room. It could become a finished product at the medical device manufacturing facility or at a contract manufacturer site that follows the protocols set by the original device manufacturer.
As mentioned, the concern of the FDA is ensuring a product works and that it is safe. Most medical devices on the disposable side are individually packaged. This means that once the product goes into the package, it is ready for shipment to a hospital, clinic or a supply shop. A growing concern by medical device companies and the FDA is whether the product is clean, meaning that it is free of particles that could end up inside of the human body through veins or other body cavities depending on the actual device. The precautions set forth by the nature of the product and its application is that “it has to be kept clean and free of foreign particles.
FM the Common Denominator
The common denominator for particle attraction is the static electricity that is created by simply handling the components that go into a medical device. The plastic materials used can easily generate the electrostatic forces that pull particles out of the air, even when the work is being performed in a clean room. Room Ionization is gaining in popularity to keep the amount of static electricity at lower levels, but room systems with slow decay rates can’t solve the problem at the assembly workstation. The medical community has to assume that the devices have debris on them and to recognize the need to treat the problem at key points in the assembly process. This is especially true before the parts go into the pouches, blister packs and rigid trays that ship to end users.
Static Clean the Equalizer
In the past year, Static Clean has launched a number of important products to address foreign matter, especially the Particle Trap® line that includes the Particle Trap® Cube, which removes particles from the balloon portion of the catheter and also from any plastic parts that are assembled in the Clean Room. Static Clean welcomes the opportunity to have a partnership approach with our clients old and new, to find the right solution for your process.
As the U2 song ONE say, “Is it getting better, or do you feel the same, will it make it easier on you, now you got someone to blame.
Don’t be the blame for failures, poor yields, rejects, rework and recalls from the field. Let us help.
Image By Matt Skoufalos: http://medicaldealer.com/the-key-to-compliance-cmstjc-guidelines-combine-to-promote-patient-safety/