Concern About Disposable Surgical Gown Recall Prompts HLAC to Reinforce Awareness of Industry Best Practice in Sterility and Safety

February 13, 2020

Hospital and health care professionals have expressed renewed concern about the sterility and safety of disposable surgical gowns following the recent voluntary recall of AAMI Level 3 surgical gowns manufactured at unauthorized sites in China. On January 30, the recall was extended to include procedure packs that contained the gowns and that had been kept on voluntary hold since the announcement of the initial recall.

These events have heightened the industry's awareness of the need for strict risk management in ensuring the safety of operating room gowns and other hospital textiles and sparked calls for increased vigilance in this fundamental of patient health. The Healthcare Laundry Accreditation Council (HLAC) reminds hospitals whose personnel and patients seek reassurance that compliance with its Standards for laundering the gowns and textiles with which they have daily contact contributes to the protection of public health. 

"A site investigation of the unauthorized manufacturer found open windows, a door that was not properly secured, food within the production area, and inadequate facilities for washing hands," notes HLAC president Linda McCurdy. "Each of these conditions introduces the risk of exposure to bacteria or the growth of other organic matter that could become deadly in an operating room. Conversely, reusable gowns that are processed in an HLAC accredited laundry must comply with standards created to eliminate these risks. As a further safeguard that's easily implemented because they are local, these processing facilities are subject to unannounced inspections by infection prevention and other hospital officials. Hospitals and other medical institutions that partner with accredited laundries can offer credible reassurance to their staff and patients that the recent recall is no barometer of healthcare textile safety perils in their operating rooms or on their premises."

The organization reminds healthcare professionals and the public that: 

Reusable surgical gowns are subject to a two-part cleaning process: first, they are laundered to established infection prevention standards, and then they are sterilized in a healthcare laundry's or the surgical center's or hospital's own pack-room. Local processing facilitates inspections that ensure compliance with best practices, fosters open communication with processing staff, and promotes the transparency that is essential to sustained, reliable performance.

The organization notes that in addition to offering the highest caliber of assurance on safety and public health concerns, reusable surgical gowns provide employment to workers in hospitals' and surgical centers' own communities. As a result, those medical facilities play an active role in supporting the local economy.

Their social welfare benefits extend to reducing the waste that is associated with climate change concerns. Single-use gowns must be disposed of as regulated medical waste. A 2015 study published by Lac-Mac reported that adopting reusable rather than disposable textiles "can reduce surgical waste by an average of 65%."

Reusable surgical gowns also outperform disposables as measured by several criteria. In a 2010 study conducted at two large hospitals in Washington, DC, Conrardy et al. found that 86% of surgeons and surgical technologists rated reusable gowns as superior in comfort, and 87% rated them superior in ease of use. Only 6% of participants stated a preference for disposable gowns.

The extensive inspection checklist and additional information are available at HLACnet.org.

 

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