SISTERS, OR – CONSUMERS' fear of poor-quality healthcare is driving Congress into the debate surrounding the safety of resanitizing and reusing medical devices classified as disposables. Unfortunately, the companies who specialize in such decontamination have found themselves caught between these two groups and are seeing themselves demonized on one side and made scapegoats on the other.
“Our industry is in its infancy and is probably like the generic drug industry 10 years ago,” says D. D. Mac McKibbin, president of Surgical Instrument Service and Savings (SISS) Inc., a reprocessing company in Sisters, OR. “People had the same concerns for safety and quality. However, steps were taken to educate the public and regulate the industry in a manner that allowed it to still do business,” he says.
Hospitals have long practiced single-use medical device reprocessing. They have syringes resanitized, angioplasty balloons resterilized and have surgical instruments cleaned for use in another operation. As healthcare concerns become an ever more prominent American concern, the practice of reprocessing is becoming to many consumers just another example of an uncaring industry that would endanger their lives to save a dollar.
However, reprocessors and others involved in the debate say that healthcare consumers are unaware of the issues and in their zeal, may put a quality industry out of business that saves them a lot of money.
A fresh start
SISS's sterilization conditions meet the ISO 1135 standard, says McKibbin. While the process used to remove contamination from the devices is proprietary, McKibbin explains that each instrument must pass through a 22-step decontamination process where the equipment is tested for bio-burden reduction at each step. “It's superior to what the hospital does,” he says.
The reprocessing company contracts with a hospital to clean and return the equipment. Each instrument is marked and is reprocessed only twice, per McKibbin's policy. McKibbin acknowledges that not all reprocessors are as diligent as he, but he says there is always a bad apple in the bunch – even in the hospital and medical device manufacturing industries.
Both sides of the debate have very clear motivations. Hospitals facing the rising costs of healthcare are seeking to maintain their quality of care while struggling to cut costs and keep staff wherever possible – even going so far as to recycle single-use products. Manufacturers are concerned to see products used in a manner they do not recommend. They also see sales dollars going to a third party rather than to them.
The government became involved in the reprocessing debate many years ago when the FDA first began investigating reports of infection and breakage.
Now Congress may take action. Senator Dick Durbin (D-Ill) and others are seeking to regulate the industry. The regulations are designed to protect Americans from the dangers of improperly reprocessed devices. The proposal states that each type of instrument is to be inspected by the FDA for cleanliness and stability. Each instrument's use can then be tracked and the accuracy of the decontamination process ensured.
The proposal adds much needed regulations to the industry, but not everyone agrees with the specifics. “These regulations will add a minimum of six months to device turnover,” says McKibbin. The delay created to allow the FDA review of the devices would effectively put reprocessors out of business, something that device manufacturers want, he adds.
“Reprocessors need to submit an application and have the products they have cleaned go through the FDA review process, just like the manufacturers have to,” says Mary-Lacy Walsh, deputy director of the Medical Device Manufacturers Association (MDMA) in Washington D.C. Until they do so, the products they are sending back to the hospital have not been proven safe and effective, she says.
The reprocessors believe the manufacturers are not looking for fairness. “The manufacturers have created the need for reprocessing out of their own greed,” Mc Kibbin says. According to McKibbin, when he researched building a reprocessing company overseas he gained new insight into the business of healthcare. “I found that there wasn't a need for a business like mine over there. Medical device manufacturers not only sell their single-use products overseas but they sell them as reusables. In the U.S. they mark up prices 500 to 5000 percent,” he says.
Snyder says the FDA is aware of the pricing discrepancy, but she says the FDA must focus on what is best for the U.S.
The MDMA agrees that what happens overseas is not the issue. “Manufacturers are not required to prove products are for single use. We just have to prove to the FDA that our labeling is accurate,” Walsh says.