How Fusion Digital Paper™ Solved Electromed Inc.’s Labeling Issue

About Electromed, Inc.:

Electromed, Inc. manufacturers the SmartVest® Airway Clearance System medical device, which delivers high frequency chest wall oscillation (HFCWO) therapy to people with compromised airway clearance who are unable to adequately clear mucus from their airways by other techniques.

People with comprised airway clearance are typically prescribed a combination of drug therapies, chest physical therapy, special coughing positions and techniques, and one or more of several coughing assist accessories. If these regimens fail to provide adequate relief, or a patient continues to experience infections and other complications caused by an inability to clear mucus from the airways, the treating physician may prescribe a more powerful therapy: a medical device that delivers HFCWO.

HFCWO technology consists of a wearable vest that surrounds an inflatable air bladder, a programmable air compressor, and a hose connecting the two. The patient puts on the vest and turns on the air compressor, which delivers a rapidly repeating pulse of air, alternately squeezing and releasing the upper body. Each squeeze simulates a “mini-cough”, which acts to loosen mucus from the walls of lung airways, reduce the thickness of mucus, and propel mucus toward larger airways, where it can be expectorated or suctioned.

Suitable for patients of all ages, from full-term newborns to senior citizens, HFCWO typically becomes a vitally important part of a patient’s daily long-term treatment routine. Patients usually self-administer two 15 to 30 minute HFCWO sessions daily, with the system programmed to deliver five to 20 compressions per second, as directed by their doctor’s prescription. HFCWO is used to treat both chronic conditions and acute in-patient cases. It has been prescribed to treat more than 400 diseases and conditions, among the most common being cystic fibrosis, cerebral palsy, bronchiectasis, neuromuscular conditions, and the combination of emphysema and chronic bronchitis commonly known as chronic obstructive pulmonary disease (COPD).

The Issue:

The 2.5” x 3.25” label that is sewn to the inside of each SmartVest garment has on it printed information that includes the vest size and color, plus government regulatory and manufacturer information that is required for medical devices. These labels were previously purchased from an outside company and this vendor had a minimum order quantity for each item. With eight different sizes and six different colors, Electromed had to purchase 1,000 labels to cover each combination of size and color. These labels were expensive, but the even larger problem was that due to frequent changes in government regulations and medical information, the labels were often obsolete before the initial inventory purchase could be used. In fact, two subsequent audits mandated changes to these labels. This meant that thousands of labels had to be dispositioned, with a substantial dollar impact each time.

The need to have printed labels that are in compliance with all current regulations, coupled with the significant cost of obsolete labels, prompted Ron Taylor, Electromed’s Materials Manager, to explore other labeling options that would allow Electromed to react quicker and minimize the inventory impact. One possible option was purchasing a stand-alone sublimation printer, but this would have required significant capital investment and added several steps to the overall manufacturing process. Ron also investigated various materials for the tag itself and found that a cloth-like material was much preferred for patient comfort due to the “pulsing” action of the SmartVest® device and the label could potentially be “pulsing” against the patient’s skin. Ron searched for a cloth that was suitable for a medical device, but could also be printed on Electromed’s Konica Minolta C360 Series PCL color copier, so he could bring the label printing in-house and print only the number of labels needed.

The Solution:

Ron discovered Fusion Digital Paper™ and the RF510W product, which reliably feeds and prints on Electromed’s Konica Minolta C360 Series PCL color copier, while also meeting all the requirements of a medical device label. A 12” x 18” sheet of RF510W is imaged with 20 labels at a time and then the sheet is cut into individual labels before sewing into each SmartVest® garment.

Fusion Digital Paper™ is a family of unique synthetic products specifically engineered for digital imaging. They are made to withstand the rigors of fusing temperatures up to the 400⁰F level. Durable, tear resistant, and waterproof, Fusion products run great on high heat toner production digital equipment. They also provide beautiful image fidelity and have excellent toner adhesion.

Since the SmartVest garment is generally worn twice a day by patients, it is normal to expect it will be washed, and the label must retain all the relevant information and be readable after washing. The washing cycle test involves cutting a printed label in half, washing one half of the label, and comparing the washed and non-washed control label images side by side.

Also, because Electromed’s SmartVest home-care system has a lifetime guarantee and patients can exchange their vest for a larger size or replace a vest, it is imperative that the label image remain clear and toner adhesion is excellent for the life of the garment.

Ron stated that “Fusion Digital Paper™ RF510W is suitable for medical garment labeling use. The cloth tag is comfortable for the patient and the printed image is clear and readable. Also, the toner adhesion withstands the washing cycle test.”

According to Ron, “The new system of printing labels in-house on Fusion Digital Paper™ RF510W is much less expensive. We print only the number of each type of label we need at the time we need them, so it saves Electromed money not only in the cost of the labels, but also in the wasted obsolete labels. Also, we don’t have thousands of labels in inventory that could become obsolete as soon as a new regulation is passed, which also threatens our compliance with ISO quality requirements.”