The Bug Stops Here: Stricter Environmental Controls Needed

Medical Device & Diagnostic Industry Magazine
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An MD&DI May 1998 Column

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"Many smaller companies are conscientious about sterilization," says Robert Reich, president of Pharmaceutical Systems (Mundelein, IL), "but the methods they're using really aren't appropriate for the contamination." Reich's goal is to educate those companies about the need for more-effective environmental control standards. "This is something we must control, especially in nonsterile environments. Anything to do with microbiological control is of interest to me."

Reich says that it is increasingly important to gain the public's trust that the medical devices they use are safe. The public's concern and interest surrounding microbiological safety is evident in the vast number of consumer newspaper and magazine articles discussing E. coli outbreaks and the rise of nosocomial infections that are becoming more resistant to available antibiotics.

"We have to prove to the public that we can make these products safe, even if strict controls on a particular product are not necessary based on their function," says Reich.

In his article titled "Recovering Viable Environmental Particulates" that begins on page 153 of this issue, Reich describes a case study in which a manufacturer tested its existing environmental control systems against two other control methods and found that the method in use had the worst results. Reich feels that it's not enough to create a control and put it in place; it must constantly be checked and improved. He also believes that better industry or global standards need to be created.

Reich admits that it's feast or famine with the government—at times the industry feels ignored and the people in it are treading water. At other times, like now, people are scrambling to keep abreast of all the changes. Although pleased with the direction FDA has taken of late with the modernization act, Reich wants more to be done in environmental controls, and he'd be more than happy to help.

Reich has been actively involved in setting standards for more than two decades as a member or chairperson on HIMA, AAMI, and ISO committees, covering a wide variety of issues. "You've got to know the rules, because they're constantly changing," he says. "The medical field is a very dynamic industry. The products and issues don't change that quickly but the procedures affecting them can. I like being on the forefront of establishing rules and regulations; I'll always stay involved with regulations."

Harmonizing regulations involves a lot of compromise. "The way to accomplish something is not always the best way or the way everyone else does it," says Reich. "Harmonization is a long, laborious process, but economics will push people into reciprocal arrangements. The trend for harmonization will remain, which is why I like to stay involved; it's too difficult otherwise to keep abreast of what's going on."

Although Reich does a lot of consulting work, using his science degree complemented with some Harvard business courses, he says he's "a scientist first, business person second, rather than a business person with a background in science. I still do a limited amount of R&D."

"I like the balance," Reich says of his various roles. "I didn't want to be strictly a scientist anymore. When I got out of school, I had an idealized version of what it meant to be a scientist, but it's too limiting for me." Although Reich plans to do less consulting and incorporate more proprietary work in his day-to-day job, "the focus of my activities will continue to be in the microbiological control area."

Jennifer M. Sakurai is managing editor of MD&DI.

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