On Wednesday, the Senate Judiciary, Law Enforcement and Criminal Justice Committee agreed with the chairman and chief executive of Merit Medical Inc., passing the Medical Device Notification and Liability Act.
Sponsored by Sen. Chris Buttars, R-West Jordan, Senate Bill 110 makes the reprocessor solely liable for the recycled product's safety.
"The reprocessing industry takes Merit Medical's one-use items . . . sterilizes and repackages them" for sale, Buttars told fellow lawmakers. "That casts a shadow that if [the device] fails, after it has had its successful first use, then Merit Medical has liability.
"I find that reprehensible. [The reprocessors] need to accept the responsibility when they take and reprocess that product."
The measure also would require health care providers to notify the Health Data Authority if such reprocessed, single-use medical devices malfunction and cause patient injuries or death.
"SB 110 does not prohibit or otherwise prevent Utah hospitals from purchasing or using reprocessed devices," Lampropoulos said. "It ensures the liability associated with a reprocessed device appropriately rests with the reprocessor."
Merit's chief noted that about 7,600 Utahns are employed in the medical products industry and that his company has a $274 million annual Utah payroll, as well as plans to spend more than $25 million in new facilities on hopes of hiring 200-500 new workers.
"To our knowledge, the reprocessing industry does not employ any Utahns," said Lampropoulos, an unsuccessful 2004 Republican gubernatorial candidate. "SB 110 supports, defends and helps Utah companies employing thousands and thousands of people."
Don Selvey, vice president of regulatory affairs and quality assurance for Alliance Medical Corp. - a Phoenix-based reprocessor - told lawmakers his 18-year-old company has stringent sterilization and testing procedures to assure the quality of reused devices. It has reprocessed millions of devices without being sued by a hospital or patient over device failure, he said.
None of those reprocessed products are made by Merit Medical, Selvey said.
"I have an obligation to provide a much-needed service to hospitals . . . to save substantial amounts of money by using inexpensive devices again and again, if they are high quality," Selvey said. "I am willing and able to assume responsibility and liability for any device failure or malfunction that is the result of my company's failure to properly reprocess the device - but not for a design flaw in the original product."
He and other opponents of the bill argued that existing state law offers companies such as Merit sufficient liability protection.
However, Russell Skousen, executive director of the state Department of Commerce, offered preliminary support for the fuller protections offered by SB 110. Even the legal costs associated with battling liability claims could be enough to hike Merit's and similar companies' insurance premiums, he said.
The committee forwarded the bill with only Sen. Patrice Arent, D-Salt Lake City, opposing it. She argued for more time to discuss the measure's ramifications.
bmims@sltrib.com
