New Duodenoscope Design Gets FDA Approval: Will it Prevent Bacterial Infections? | Levin Papantonio Rafferty - Personal Injury Law Firm

New Duodenoscope Design Gets FDA Approval: Will it Prevent Bacterial Infections?

The Olympus Corporation faces growing litigation and possible criminal investigations over the medical scopes that have been implicated in a large number of serious bacterial infections. Meanwhile, competitor Pentax (a division of the Ricoh Imaging Company) has won FDA approval for a new duodenoscope they believe will reduce the risk of infections by making them easier to clean and sterilize. The question is: will it work?

Over the past few years, reusable medical scopes manufactured by Olympus have been infecting patients with antibiotic-resistant bacteria that in some cases have proven fatal. The problem is a design defect that makes such instruments difficult to sterilize after each use, as bacteria can become trapped inside the device, spreading to the next patient.

Last year, Olympus came out with a new design after a voluntary recall of the TJF-Q180V duodenoscope, which had been linked to several bacterial outbreaks across the country. The new device, which was approved in January 2016, was modified in order to make it easier to sterilize. However, in December, five patients examined with the modified scope wound up contracting the same potentially deadly bacteria. One of the patients died as a result, although the FDA report attributed the death to a “pre-existing condition.”

This month, the FDA approved a new duodenoscope from Pentax that features a disposable cap. According to the company, this will facilitate the removal of dangerous bacteria from parts of the instrument that were formerly difficult to clean properly. The company calls this new design “a significant advancement in infection control,” while an FDA official says that the new disposable cap “represents a major step toward lowering the risk of future infections associated with these devices.”

However, some in the medical community have expressed doubts. A number of medical device experts have pointed out that the new Pentax model is only one of many currently in use in hospitals around the world – and that the new design doesn't go far enough toward addressing the problem. Hospital safety consultant Lawrence Muscarella said that the new design “will probably reduce the infection risk, but I’m not sure by how much.”

Muscarella's concern is a valid one. While the tip of the scope has been a problem when it comes to eliminating bacterial contamination, there are numerous other components where such bacteria can hide. Dr. Cori Ofstead, an epidemiologist from St. Paul, Minnesota who has studied this issue, points out that while “it may be a step in the right direction to have single-use components whenever possible...we still have gaps here.”

Dr. Ofstead and others are pushing for regulations that would require stronger sterilization methods involving the use of gas and chemical disinfectants. However, such measures would require scope manufacturers to come up with additional design modifications.

Other manufacturers are designing disposable, single-use scopes as a way of addressing the infection issue. The FDA recently approved two such models, which sale for approximately $250 (compared to conventional scopes, which start at around $40,000). As these disposable scopes become more widely available and patient awareness of the dangers of bacterial infections grows, chances are that market forces and public pressure will cause health care facilities to make the switch to single-use devices.