Emerging trends in healthcare such as the use of devices at home, and care of aging baby boomers means medical devices must not only be effective and safe, but also easy to use and comfortable. Suppliers of pressure sensitive adhesives (PSA) are developing products in response to these demands.

For instance, medical-grade adhesives are now more versatile, stronger, and gentler, and provide longer wear than previous technologies. Adhesive-coated foams, films, and non-wovens, for example, protect wounds and secure leads to electronics, such as EKG or defibrillator pads, and can provide protection, reinforced strength, and security. Double-coated tapes give design flexibility to devices with differential adhesion requirements. For instance, one side may require high adhesion to bond permanently to a foam and the other side of the tape may require a gentle adhesion for attaching to the skin.

Device trends

Patient safety has always been a consideration in the design of a medical device. It's just more heavily regulated now. To reduce errors and improve overall safety, the FDA recently launched a program to strengthen the way it monitors the safety of medical devices after they reach the market. They want to find ways to improve safety by collaborating with industry and professional organizations.

How easy it is to use a device can also be linked to its safety for the patient. Studies show that more problems are caused by the incorrect use of a medical device than the result of device malfunctions. In 2000, the Institute of Medicine estimated that medical errors cause 44,000 to 98,000 deaths annually in United States hospitals. Although many of these errors are not directly related to the use of medical devices, some are.

This link between ease of use and patient safety becomes even more important as nearly 76 million baby boomers head toward retirement. According to a study conducted by Kaiser Permanente's Medical Care Program, two-thirds of Americans over 62 have at least one chronic disease, such as heart disease, diabetes, and respiratory problems. Therefore many use home-monitoring devices daily.

To compound the problem, nurses, and doctors are expected to be in short supply. The American Association of Critical-Care Nurses projects more than one million nursing positions will be unoccupied by 2008, providing a tremendous opportunity for medical technology. This imbalance between available healthcare workers and people in need of care leads to a demand for home healthcare products that let patients take an active role in their own care.

Consumers can become easily confused using medical devices in the home. Therefore it is crucial that new devices are easily understandable so consumers can use the devices without unintentionally making errors that would compromise their health. As technological developments become more advanced, so do design requirements to ensure safe, effective use of medical products. Fortunately, the performances of PSA tapes also continue to advance and respond to these new requirements.

Design considerations

There are many considerations to make when selecting the right PSA for patient-centric medical devices. These include the chemical qualities of the adhesive and the chemical properties of the materials to be bonded. The entire PSA system — adhesive, carrier, and liner — can help maximize function, efficiency, comfort, and safety.

It is also important to consider ethnicity, gender, age, area of the body, lifestyle, and length of wear when specifying adhesives that touch the skin. Direct skin contact, such as the attachment of electrodes, is critical for accuracy in monitoring, testing, and the performance of procedures needing electrical conductivity. PSAs involving direct skin contact must also meet strict ISO and the FDA's current Good Manufacturing Practice (cGMP) guidelines. These guidelines are important because they give design engineers assurances that a certified material is safe for patients.

An aging population requires skin-friendly products intended for thinner, more sensitive skin. Ultra-Low Adhesives (ULA) are created just for geriatric skin by providing excellent adhesion, a gentle cooling sensation upon contact, and pain-free removal.

Wound care is one of the more common ailments prominent in home care situations, particularly for the treatment of diabetic ulcers. Advances in PSA film breathability, which provide an ideally balanced Moisture Vapor Transmission Rate (MVTR), help facilitate healing. In addition, patients can wear dressings for much longer periods, anywhere from seven to 30 days.

An acrylic adhesive with a high MVTR is ideal for long-term wear to ensure skin is protected from trapped moisture. Patterned coated adhesives are also seeing wider use in the long-term treatment of wounds because the high MVTR that helps wounds breathe consequently speeds the healing process. Understanding how MVTR affects wounds' ability to heal is just one driver for engineers to make positive steps toward assuring patient comfort, safety, and convenience through their products.