The Danger of Non-Sterile Medical Devices

In 1992, the CDC published a warning simultaneously to the medical community as well as the public: Use of non-sterile manufactured medical devices is risky business. The report, Postsurgical Infections Associated with Non-sterile Implantable Devices, covered the potential risk and ultimate irresponsible nature of producing delicate and critical devices from non-sterile manufacturers. The CDC stated that ultimately, it was then the responsibility for of the hospital to sterilize the device and that if there were any adverse reactions or consequences experienced due to the use of one of these devices, the problems should be immediately reported to the manufacturer who in turn is responsible for reporting the problem to the FDA.

And this is where things get messy.

While the CDC article might attempt to offer some sense of order and oversight in the manufacturing and use of medical devices, the reality is less reassuring. In actuality, the majority of medical devices sold in the United States do not need approval from the FDA. Nearly 25 years after the CDC article, very little has changed in the regulation of nonsterile medical equipment – and people are dying because of it.

During a time when the healthcare debate rages on and politicians battle over the rising medical costs, very little attention has been paid by governmental organizations to the shocking number of illness and death caused by infection as a result of nonsterile medical equipment. The World Health Organization (WHO) produced the findings of their study on the economic effects of illness and injury in 2009, and from personal household damages, to inflated healthcare costs, to the microeconomic impact experienced, illness and injury is costing this world trillions of dollars every year. With 1 in 25 patients contracting a hospital-acquired infection according to the CDC, the financial cost of nonsterile medical equipment is staggering. According to the Health Grades Hospital Quality in America Study conducted in 2011, however, that number could be much higher. Of the estimated 722,000 patients in the United States who acquired an infection in the hospital, 75,000 individuals died as a result.

Nonsterile medical equipment and poor regulation of the industry has been the subject of several studies and journals in the last five years, in particular after several outbreaks of infection resulted in the illness and deaths of several individuals.

Most recently, an outbreak of carbapenem-resistant enterobacteriaceae (CRE) occurred at Ronald Reagan UCLA Medical Center in Los Angeles, and brought into focus the current failings in regulatory oversight and the inherent dangers of nonsterile medical device manufacturing and the lax FDA approval process.

During the UCLA Medical Center CRE breakout of 2015, two patients died and nearly 180 patients were exposed to the drug resistant “superbug”. The culprit? The Olympus Scope. A device that was manufactured, produced, and marketed without any formal study or FDA approval prior to being sold and used in a medical setting. The Olympus Scope, as it turned out, was a nonsterile medical device that was manufactured and used on patients before being tested, examined, or approved by any medical professionals or health regulatory organization. As it turns out, of the medical devices sold and used in the United States, only 10% require FDA premarket approval or any significant testing. In other words: There is little required testing and minimal quality assurance between the time a medical device is devised and when it is being used on a live human being.

Once on the market, the lack of oversight and the worries continue. With little data or testing being administered before the equipment is put on the market, one would expect that the regulation over these nonsterile devices would be kept a close eye on in order to identify any potential problems with the devices. Unfortunately, this is not the case. Manufacturers are required to report any deaths related to their nonsterile medical device, as well as any malfunctions the device might be experiencing within 30 days. This information is entered into an online database that is searchable by the public. While this sounds promising, the FDA redacts and eliminates several of the details pertaining to the death, illness, or malfunction. Critics of the MAUDE database argue that these redactions can have major health and safety implications, as well as protect the manufacturers and does not hold them accountable for rushed or poorly executed equipment.

As to the facilities in which the manufacturers produce the equipment, the FDA imposes minimal oversight as well and even less reporting to the public regarding their findings. In the event the FDA discovers what would be considered “serious problems” in the facility, a standard form is issued, however, the information held within that form that outlies the “serious problems” is not accessible to the public without filing a public information request. In other words, if a manufacturer of a medical device is discovered as having an unsafe work environment, nonsterile manufacturing, or dangerous methodology, it is the burden of the public to discover this information. The FDA will not release the information to the public willingly.

The reality is that nonsterile medical equipment, the manufacturers who produce it, and the Federal government that is supposed to oversee it are taking an astronomical toll on the physical and financial wellbeing of The United States. Expecting the producers and manufacturers of medical devices to create well tested, safely produced, and fully vetted products designed to save and improve the lives of those who use them is not too much to want. However, expecting the government to be responsible for providing adequate oversight and open communication with the public regarding potentially unsafe devices is without any question something that we deserve, and if we are not getting it, demand. There are too many lives at stake, and the next one could