Despite clean '03 audit, Steris acknowledges it is under federal probe related to hospital sterilizer.

Steris Isomedix Services, Northborough, MA, Stoneham District

An inspection covering corrective and preventive actions (CAPAs) and production and process controls at Steris Isomedix Services, Northborough, MA, resulted in no 483 being issued following a 2003 audit, but on Jan. 4, company parent, Steris Corp., Mentor, OH, acknowledged it is under investigation by FDA and the Justice Department over alleged destruction of evidence involving infections attributed to the failure of its sterilization devices.

A Dec. 24 "Wall Street Journal" article disclosed that Allegheny General Hospital, Pittsburgh, which used Steris' System 1 sterilizer to reprocess endoscopes, wrote 500 patients in 2002 "warning that they might have been exposed to deadly bacteria during a simple test at the hospital."

According to the Journal, "16 patients who had such procedures picked up the bacteria, and nine died ... It didn't attribute the other eight deaths to the infection."

The hospital told FDA that water filters in a device used to sterilize the endoscopes can lead to bacteria in the rinse water, and this was the "probable cause" of the outbreak, the newspaper reported.

Steris, however, denied blame, charging Allegheny did not use proper cleaning and disinfection procedures, but then, a fired Steris executive asserted in Ohio court documents that the firm's "sterilizer failure has led to injuries or death and that Steris 'engaged in a persistent pattern of destroying evidence.'" These allegations led to the FDA/Justice probe.

The Journal reported: "Steris said in a corporate filing for its June 30 quarter that it was being investigated by the FDA and the U.S. Justice Department. Steris says it hasn't been contacted by investigators but will cooperate, and that as far as it knows the investigation is continuing."

Despite all this, the company's Northborough contract sterilization facility passed inspection in 2003 without a 483. George Allen of the agency's Stoneham District Office conducted the investigation, which did not appear to center on the System 1 in-hospital sterilization systems, which is the subject of the FDA/Justice probe.

The EIR noted that Steris Isomedix provides contract gamma and ethylene oxide sterilization services at this facility, according to customer specifications. Jamie Vaillancourt, manager of quality systems and regulatory compliance, stated that process validation, bioburden, sterility testing and other microbiological testing are the responsibility of the manufacturer.

During the inspection, Allen reviewed 12 batch records for each of the device and drug products that were gamma-sterilized. No observations were noted in the EIR.

Allen noted that "incoming material for gamma sterilization is identified with labels marked 'gamma-non-processed.' Processed material is palletized and marked according to customer specifications. These labels may read 'gamma-processed,' 'in quarantine,' or 'gamma-processed--sterility awaiting test results.'" To avoid mix-ups of materials, a chain link fence separates the incoming and processed materials, the EIR noted.

The report stated that CAPA procedures were reviewed with Vaillancourt. "He presented objective evidence to demonstrate that internal audits have resulted in several improvement opportunities. Management reviews are still being conducted on a monthly basis."

The Journal reported that Steris "dominates the market for quick cleaning of endoscopes used in surgery, where full sterility is essential." For routine screening such as colonoscopy, its system is also widely used but not as dominant. In all, Steris says, the System 1 is used 35,000 times a day, by more than 5,000 U.S. medical facilities.

Steris was founded in 1985 by a microbiologist and a mechanical engineer, winning 510(k) clearance for the System 1 in 1988.

After that approval, the company quickly began winning the business of hospitals and clinics, the newspaper reported, noting it has about $1 billion in annual revenue, of which $150 million to $200 million comes from the System 1, by analysts' estimates.

The device, however, has faced criticism from ECRI, a Plymouth Meeting, PA, firm that analyzes device safety, and even the Center for Disease Control and Prevention, the Journal noted

Reports hospitals filed with FDA seem to confirm Steris' contention that many health care personnel do not follow the device's instructions properly, the Journal noted. One such "incident report" to the FDA, for instance, said that hospital workers had "jerry-rigged" parts of these connectors.

According to the Journal, Steris received a 1999 warning letter and one in 2001. It quoted Center for Devices Compliance Director Timothy Ulatowski saying the agency remained confident in the System 1, and that matters that arose in its 1999 and 2001 letters have been resolved. However, an FDA spokeswoman told the newspaper the agency has other issues relating to Steris outstanding, but she did not divulge whether this relates to the Justice probe.

Allegheny Hospital has since stopped using the System 1 in its pulmonary lab, site of the outbreak, which involved a resistant bacterium called pseudomonas aeruginosa. Instead, it's using a system approved by the FDA in the category of high-level disinfection, not sterilization, and is adding an alcohol rinse and air drying, the Journal added.

In addition, the newspaper said Steris last year hired Gerald Faich, M.D., a private consultant and ex-CDER epidemiological chief, to determine if there was a statistical connection between the System 1 and patient infections.

The Journal said Faich concluded it "functions well in practice and reinforces the consistent achievement of sterility by the device." In an interview with the Journal, Faich said that in view of how frequently the System 1 is used--millions of times a year--if it really were defective, hospitals would have more bacterial outbreaks than they do.

Steris did not return calls requesting an update before deadline.

Steris Isomedix Services, Northborough, MA, 3/17/03, Doc. 109658M, $5 plus retrieval.