Manufacturer sentenced for selling unsterilized surgical instruments

FDA Consumer, Jan-Feb, 1998 by Dixie Farley

A manufacturer of gynecological

surgical devices was sentenced to a

15-month prison term after pleading guilty

to intentionally selling unsterilized

instruments labeled as "sterile" and

providing FDA false information.

The manufacturer and the company

also were ordered to pay $37,004 each

to the hospitals and clinics that had

returned the instruments. All the unsafe

devices were recalled, seized and

destroyed under FDA supervision.

After hearing testimony at the Sept.

17, 1997, presentencing hearing, Judge

Frederick Scullin, of the U.S. District

Court for the Northern District of New

York, also placed International Medical

Technologies Group Inc. (IMTG) on

five years' organizational probation and

ordered its president, John Sturgeon, to

withdraw his device marketing clearances

and avoid involvement in the

manufacture of drugs and devices for

one year after serving his sentence.

IMTG sold syringes, aspiration catheters,

surgical tubing, cervical dilators,

curettes for sampling tissue, and tissue

collection sets for use in surgical

gynecological procedures such as abortion,

treatment of abnormal uterine bleeding,

and uterine sampling for diagnosing

cancer. These are considered sterile

surgical procedures, and doctors have

traditionally demanded sterile instruments

for performing them. The risk of infection

is one of the major hazards of these

procedures because infection may lead

to blood poisoning, infertility and death.

At the hearing, Eugene Williams,

M.D., an obstetrician-gynecologist now

retired from FDA's Center for Devices

and Radiological Health, testified that

the unsterilized devices created a serious

risk of harm from infection and that data

gathered by the agency's Buffalo, N.Y.,

district office indicated that a fourfold

increase in infections at one clinic was

likely due to the use of unsterilized

IMTG devices the clinic had received.

The company's poor practices came

to FDA's attention in January 1993,

when three former IMTG employees

complained to the agency's Albany,

N.Y., resident post that the company

was shipping unsterilized products

labeled as "sterile."

Early in 1993, Nancy Saxenian and

Michael Sinkevich, investigators with

FDA's Buffalo district office, inspected

IMTG.

Initially, Sturgeon gave the investigators

company records showing that surgical

devices labeled as sterile and

distributed to hospitals and clinics had

been sterilized by Medical Device

Sterilization Inc., of Saratoga, N.Y. But

when Saxenian and Sinkevich tried to

locate the company, they could find no

evidence of its existence. Confronted

with this finding, Sturgeon admitted

that he'd fabricated the records,

intentionally giving false information and

knowingly labeling the unsterilized

devices as sterile. FDA's approvals of the

devices called for them to be sterilized

with ethylene oxide, but Sturgeon said

sterilization was too costly.

The investigators examined

Sturgeon's records, noting that one load

of curettes had been sent to a

Northborough, Mass., company for

sterilization. But the records also showed

that, of a batch of 1,825 curettes, only

1,500 had been sterilized. When FDA

asked Sturgeon to identify which instruments

had been sterilized and which

were in commercial distribution,

Sturgeon was unable to do so. As a result,

FDA urged Sturgeon to recall from the

market all curettes made by the company.

As the inspection progressed, the

investigators found other problems, including:

* no records of production, quality

control, packaging, and labeling specifications

* inadequate records of product specification

testing and dates and number of products made

* no written procedures for inspecting

finished devices

* failure to receive FDA marketing

clearance for tissue collection and uterine

injector sets.

Sinkevich recalls that Sturgeon

appeared "vague, evasive, inconsistent and

uncertain" in answering questions and

providing records. Eventually, Sturgeon

admitted that the company had distributed

other unsterilized products labeled

as sterile. At FDA's urging, he recalled

from the market all remaining products

made by the company.

At the end of the inspection, the

investigators reported their findings to

Sturgeon, who gave them copies of written

manufacturing procedures he said he

intended to put in place to meet FDA

requirements.

However, FDA found the procedures to

be inadequate and decided to take further

action.

"In light of the extensive manufacturing

problems and Sturgeon's history of

falsifying records and shipping

potentially hazardous unsterilized devices as

sterile, particularly when faced with

economic incentives, we decided to go for

seizure," says James Kewley, a compliance

officer with FDA's Buffalo district

office.

Accompanied by Saxenian and

Sinkevich, a U.S. deputy marshal seized

the devices in August 1993. Saxenian

witnessed destruction of the devices,

valued at $100,000, in February 1994.

FDA continued to investigate

Sturgeon and IMTG through a federal grand

jury in New York. "We interviewed

many current and former employees,"

says John Thompson, a team leader in

FDA's Buffalo district. "From the interviews,

we learned that Sturgeon had engaged