News | May 26, 1999

Report Outlines Sterilization Challenges

By: Adam Ezra Segal-Isaacson


•Don't Guess, Ask
•Lessons Learned
•Offshore Dangers

Are your sterilization procedures sufficient? Are you doing everything you can to control the risk of infection in your facility?

A new 500-page market research survey, Sterilizing Equipment, Sterilants, Disinfectants, Reuse & Infection Control 1999 can help you answer those queries. The report, from publisher BMN, Inc. (Costa Mesa, CA), examines infection control and sterilization issues in detail. The report gathers the coverage of these issues in the firm's Biomedical Market Newsletter together with extensive unpublished reports.

"One key lesson of this study is that each sterilization methodology has its own strengths and weaknesses," says publisher David Anast. "When manufacturers' instructions are followed precisely, each methodology can be effective. Facilities that don't follow processes completely do so at their own risk." For this reason, "strong anecdotal evidence suggests that offsite sterilization is better," as offsite sterilizers provide consistently higher levels of sterilization.

However, there are risks to using offsite providers. Outsourcing sterilization procedures may increase the legal risks resulting from an incident involving reused or reprocessed materials. The correct balance between in-house sterilization and its risks and outsourcing and its risks will be different for each facility.

Anast notes that over 150 incidents reported to the Food and Drug Administration (FDA) over the past decade have involved sterilization processes. While an incident can be as serious as a patient death, many incidents are much more minor, on the order of "thumb slammed in door."

In his opinion, most incidents are reported; there is no lurking iceberg of incidents beneath the reported number. Over the last 25 years, in his opinion, the possibility of individual incidents has decreased as the sterilization industry has matured and progressed, but the possibility of large-scale incidents is still substantial.


"Don't guess, ask"

Most incidents involve the misuse of equipment. When dealing with sterilization equipment and routines, he stresses the rule "Don't guess, ask." Because sterilization equipment must go through rigorous testing to gain FDA approval, it is more than likely that the problem faced at any particular time by hospital staff has been addressed by the manufacturer. When in doubt, he advises, call the manufacturer.

One major incident involved AbTox Inc. (Mundelein, IL) in 1998. A manufacturer of gas-plasma sterilizers, AbTox has since declared bankruptcy. Ten patients were injured, and over 150 sterilizers were recalled as a result of situations allegedly arising from ophthalmology instruments being sterilized in AbTox equipment.

Although the cause of sterilization failure is under investigation, it seems most likely that there were chemical reactions between metals in the instruments and the sterilization equipment. AbTox claims that the FDA had approved the devices in question, but the FDA claims that modifications made to the model in question hadn't been tested and approved by the FDA.

Some people in the industry "just don't get it," says Anast, about what changes call for re-approval. "It's an excellent lesson for manufacturers that some minor changes still do merit 510(k) approval." [Biomedical Market Newsletter has published Deciding When to Submit a 510(k)—1999, which provides further guidance on this topic.]


Lessons learned

A lesson from this for hospitals, says Anast, is that "you can claim what you want, that the manufacturer is responsible, but the ultimate responsibility is with the hospital." Additionally, "it's important for the hospital to be very clear to its staff on the need for them to educate themselves about outsourcers and their equipment." He adds that "hospitals should absolutely not be getting involved in sterilization if their staff doesn't have the skills."

In a column for Medical Design Technology, Anast amplified this issue: "One has to wonder how many young, inexperienced, ill-supervised, minimum-wage, untrained, unskilled, uneducated staffs may be playing Russian Roulette with patient safety." As health care facilities move toward lower paid workers (health aides replacing nurses, for example, and "med techs" replacing them), the effect on safety could be substantial. The desire to cut costs ultimately leads, Anast says, to reuse of equipment and the remanufacturing and reprocessing industry. He "strongly suspects that HMOs will be forced to protect themselves" by requiring separate informed consents from patients when reused equipment is used.


Offshore dangers

One danger in the rush to cut costs is outsourcing sterilization and remanufacturing overseas. "I'd be real uncomfortable with exporting remanufacturing overseas," says Anast. "I don't know of incidents, but it makes me nervous."

A U.S. site is visited on the average of every six to 12 months by an FDA inspector, while no comparable oversight applies overseas. There is often criticism of this FDA oversight, and even Anast comments that at times the FDA has been "lackadaisical" in its enforcement.

On the other hand, "People can throw stones at the FDA all they want," he says, "but they need to understand that the FDA is the best that's out there. Because the FDA is good, U.S. products have a sterling reputation overseas."

While in the past, FDA interactions with manufacturers has been confrontational, today the FDA has a more collegial, educational, and constructive approach. The result, he says, is that instead of doing only the minimum, manufacturers often are more inclined "to do the right thing to create a better, safer product."

Unfortunately, the entire sterilization issue is often below the level of awareness for the general public. Anast has had hospital administrators tell him to "make sure you're the first patient of the day" if you're undergoing endoscopy, as the equipment will likely not be properly cleaned and sterilized for later patients. "No doubt," he says, "the true source of many nosocomial infections will be traced to endoscopic instruments." Although scary, his warning clearly underlines the significance of sterilization and related issues.


Adam Ezra Segal-Isaacson is a New York City-based health care reporter.