About medical gowns
Gowns are examples of personal protective equipment used in health care settings. They are used to protect the wearer from the spread of infection or illness if the wearer comes in contact with potentially infectious liquid and solid material. They may also be used to help prevent the gown wearer from contaminating vulnerable patients, such as those with weakened immune systems. Gowns are one part of an infection-control strategy.
A few of the many terms that have been used to refer to gowns intended for use in health care settings, include surgical gowns, isolation gowns, surgical isolation gowns, nonsurgical gowns, procedural gowns, and operating room gowns.
In 2004, the FDA recognized the consensus standard American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70:2003, “Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.” New terminology in the standard describes the barrier protection levels of gowns and other protective apparel intended for use in health care facilities and specifies test methods and performance results necessary to verify and validate the newly defined levels of protection:
- Level 1: Minimal risk, to be use used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit
- Level 2: Low risk, to be use used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab
- Level 3: Moderate risk, to be use used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases
- Level 4: High risk, to be use used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne)
A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. A surgical gown is a personal protective garment intended to be worn by health care personnel during surgical procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate matter. Because of the controlled nature of surgical procedures, critical zones of protection have been described by national standards. the critical zones include the chest from scapula to knees and sleeves from cuff to above the elbow. Surgical gowns can be used for any risk level (Levels 1-4). All surgical gowns must be labeled as a surgical gown.
Surgical Isolation Gowns
Surgical isolation gowns are used when there is a medium to high risk of contamination and a need for larger critical zones than traditional surgical gowns. Surgical isolation gowns, like surgical gowns, are regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. all areas of the surgical isolation gown except bindings, cuffs, and hems are considered critical zones of protection and must meet the highest liquid barrier protection level for which the gown is rated. All seams must have the same liquid barrier protection as the rest of the gown. Additionally, the fabric of the surgical isolation gown should cover as much of the body as is appropriate for the intended use.
Product names may include but are not limited to isolation gown, procedure gown, or protective gown. Since names are not standardized, product labeling that describes its intended use for isolation precautions or liquid barrier protection in moderate or high risk situations fall into this category.
From couture gowns to handbags, and now to surgical gowns, there’s no telling what Michael Kors will do next.
The plain paper or fabric surgical gown has been an untouched staple since it’s beginning. No one has dared to change what is meant to be a protective sterile function, and turn it into artful fashion.
In an interview with Kors, he explains his desire to reach out to the everyday person with his designs. His peer designers have historically done this by developing a ready to wear line for Target, but Kors desired to explore an untouched market. He describes this line as “fresh, playful, chic, and of course, FABULOUS.” Since the line was designed for spring, the colors are upbeat and refreshing shades of blue.
Cleverly named ‘Dr. Kors,’ this spring line brings the latest trends to the OR. Many surgeons and surgical techs can’t wait to get into these gowns and enjoy an opportunity to express themselves. “Clothing changes the way we feel and therefore the way we interact with each other,” explains Kors. He believes the OR can be a more artistic and positive place.
Orders for the new gowns have skyrocketed, as surgeons, ICU staff, PAs, nurses, and surgical techs everywhere press the hospital to make these gowns available to them. Dr. Katie Jackson, an ENT surgeon in New York, has added the gowns to her preference card as something she requires for every case. “I’m so excited!” squealed Dr. Jackson. “I really hope he has one with a peplum!”
Surgical tech, Anita Willers, is already fantasizing of the day she can scrub in with a Kors’ gown. “Ah, it will make those 12-hour liver cases so much more bearable knowing that I at least look good. Although now I will be even more upset when Dr. Winston splashes blood all over me. He better step up his game.”
Dr. Kors’ line of gowns is set to hit hospitals in March of 2015. In the meantime, Kors has already started work on his first fall line for Dr. Kors, and he assures us both lines will knock your Danskos off.