An Illinois state lawmaker who at first was bent on stopping hospitals from reusing disposable medical products instead ended up as the hospitals' unlikely protector.
After changing an earlier version of a medical products bill to include a regulatory "safe harbor" for reuse of properly reprocessed devices, legislation proposed by state Sen. Evelyn M. Bowles (D-Edwardsville) sailed unopposed through both legislative houses in Illinois and was sent to Gov. Jim Edgar earlier this month.
Edgar has until mid-August to sign the bill, which he's expected to do. If so, it would take effect on Jan. 1.
Upon signing, Illinois would become the first state to regulate the widespread but hush-hush practice of hospital reuse of disposable medical devices. Those devices include such items as cardiac catheters and arthroscopic surgical equipment.
Almost as tough to estimate as it is pervasive, disposable device reuse has become commonplace as hospitals seek to wring out costs. Some hospitals salvage single-use devices themselves while others enlist specialty companies to do the cleaning and sterilization. But for a combination of public relations and legal reasons, most aren't willing to talk about either practice.
Largely unregulated, device reprocessing has attracted the attention of federal health regulators, but there's no immediate push to take any formal action. Still, the increased awareness of the issue has many hospitals nervous, fearing the practice of reprocessing would be outlawed.
By regulating rather than outlawing device reprocessing and reuse, Bowles' bill would calm many hospitals' fears and may spawn imitation in other states.
Under the Illinois bill that is expected to become law, hospital reuse of single-use devices would be explicitly allowed for products that have been reprocessed by licensed hospitals under state health department oversight. In addition, hospitals would be free to reuse products reprocessed by companies that had registered with the Food and Drug Administration.
That happy outcome for hospitals is a far cry from the scenario painted in Bowles' original bill. Introduced in January, her initial proposal would have banned any reuse of medical surgical devices labeled for single use, fining violators $1,000 for the first and $2,000
for subsequent offenses.
Behind the bill lay an Associated Press story that ran in the St. Louis Post Dispatch in January, said Bowles, who represents a district on the Illinois side of the Mississippi River across from St. Louis.
Outraged by that story's claim that some reprocessed disposable products had sickened patients, Bowles sought to outlaw the practice altogether.
"Are we equating a dollar sign with people's health? That was my position," Bowles said. Her bill passed the state Senate in February without fanfare. By May, however, when a House sponsor was found, the bill had hit the radar screens of reprocessing companies and hospital lobbyists.
Proper reprocessing of so-called single-use devices can save money without sacrificing quality of care, supporters of the practice responded.
Bowles' "heart was good but she had a lack of knowledge," said Chuck Masek, president and chief executive officer of Vanguard Medical Concepts, a device reprocessing company in Lakeland, Fla.
"The headlines make it sound somewhat ominous," added David Harris, a lobbyist for the Illinois Hospital and Health Systems Association. "Original equipment manufacturers label devices for single use not because they're required to but because they choose to."
Avoiding legal liability and selling more products are often the manufacturers' motives, Harris said.
But many products can safely be reused several times, opponents of the bill said. And only 20 years ago, they point out, hospitals routinely reprocessed and resterilized the bulk of devices they used.
After the hospital and reprocessing lobbyists surfaced, Bowles said she came to see that their position might have merit. She then gave them a chance to craft a compromise.
"We'll give you 48 hours to draft something with which you feel you can live but also something we can live with," she said. That opening led to the bill's safe harbor provisions.
For Illinois hospitals, it appears to be a welcome solution.
"I feel real good about it because I'm absolutely convinced it's a safe procedure and able to make a contribution to the hospital," said Catherine Dunnington, who manages the cardiac electrophysiology lab at Illinois Masonic Medical Center in Chicago.
In January, Illinois Masonic began sending certain electrophysiology catheters to an outside company for reprocessing. That big step came after nearly a year of review and analysis, including approval from the hospital's infection-control, risk management, legal and medical affairs departments, Dunnington said.
But the effort was worth it. Illinois Masonic, she said, has seen catheter spending drop more than half-from a range of $17,000 to $25,000 a month to between $6,000 and $10,000.
And even more important, she said, among the 250 or so cases performed with reprocessed catheters, there have been no reports of infection or side effects, equaling the outcomes when the catheters were only used once.