Arguing that reusing single-use medical devices poses threats for patients undergoing surgery and other medical procedures, members of the Massachusetts Medical Device Industry presented photographic evidence of these practices to the Public Health Committee at the State House on Wednesday and encouraged legislators to enforce regulations on the medical industry.
“MassMedic is concerned that the devices could put patients at risk without their knowledge,” said Tom Summer, president of the Massachusetts Medical Device Industry Council. “The primary focus [of the bill] is to make the patients aware the risks of reusing these devices — specifically ones that pierce the skin or enter the bloodstream — hold.”
Summer added that Massachusetts is the second-largest medical device manufacturer in the country.
Phil Coble, a member of MassMedic, also expressed support for the bill and said hospitals do not always follow federal guidelines about reprocessing devices.
“If these devices could be reprocessed and reused, we’d be in the business of reprocessing medical devices, not making them,” Coble said. “Our devices are not designed for reuse or re-sterilization.
“We tested 51 catheters,” he added. “Of these 51, only three were up to standards after being re-sterilized … Based on these results, we can only conclude that reused devices offer a higher risk and patients should be informed.”
Nigel Wilkinson, a MassMedic member, said blades used in [arthroscopic] surgeries are considered medical waste.
“We know from internal studies that use of reprocessed blades poses a higher risk,” Wilkinson said. “The only conclusion we can draw from this is that reprocessed materials do not meet sterilization standards and should not be used.”
Wilkinson offered statistical evidence to support his claims.
“Seventy-five percent of surgeons say that the use of reprocessed devices poses a higher risk of some sort of infection,” he said. “Seventy-one percent of surgeons and 80 percent of nurses say they would feel uncomfortable using reprocessed devices during surgery.”
Wilkinson said many times during a medical procedure, a device is handed to a surgeon without any marking or casing to indicate whether it was reprocessed.
“Hospitals should, at minimum, be required to obtain consent from patients as to whether or not they would want reprocessed devices used on them,” he said.
The panel opposing the bill claimed that the majority of Mass Medic’s evidence was unverifiable.
“The pictures used are en effort to scare hospitals into not using reprocessed devices, said Pamela Carmen, executive director of American Medical Device Reprocessors. “Reprocessing presents a cost-effective solution for single use devices. The single use label is not an FDA requirement. It appears on the package at the discretion of the manufacturer.”
Carmen said “the finest hospitals in the country” would not put their patients at risk to save money. She criticized the Legislature for trying to “force hospitals to report once again to federal standards” and said reprocessed devices “are regulated more strenuously than … new devices.”
According to John Brodding, a member of AMDR, reprocessing medical devices is a safe procedure and costs a fraction of what it would cost to use new devices.
“Reprocessing is an environment-friendly solution because it reduces the amount of medical waste hospitals produce,” Brodding said. “Some of these devices represent thousands of dollars on the hospital’s part and are used externally only.”
This is an account occasionally used by the Daily Free Press editors to post archived posts from previous iterations of the site or otherwise for special circumstance publications. See authorship info on the byline at the top of the page.
