Reprocessing of reuseable medical devices continues to make news. Both the Today Show and MSNBC recently aired segments based on an investigation documented in Filthy surgical instruments: The hidden threat in America’s operating rooms, written by Joe Eaton and published on iWatch News by The Center for Public Integrity. The investigation draws compelling evidence that cleaning and sterilization processes performed in hospitals are wholly inadequate to protect patients from acquiring infections from dirty reusable instruments thought to have been adequately cleaned prior to use. The article points out there is plenty of blame to go around but intense focus has been placed on cleaning personnel and the environment in which they work, in part, through a follow-up article also written by Joe Eaton.
In my view, the patient concern is certainly warranted but to allow the discussion to center on the politically defenseless hospital worker is irresponsible. Based on my over 20 year career in contamination control across various technical industries, nothing short of a systems solution where all stakeholders take responsibility and are held accountable will be successful. To require worker certification through regulation and standardized testing is simply serving the selfish interest of those who politically or financially benefit from such a substantively empty and burdensome requirement, particularly without also regulating and enforcing device design criteria, cleaning instruction clarity and cleaning environments – but these areas aren’t as politically venerably targets. To allow instruments to sit for hours before cleaning, or designing a device with a contaminant trap, or allowing an instruction that does not have an adequate inspection criteria are all more culpable than lack of a certificate. Workers have no influence at all to remedy these deficiencies yet, apparently, they are the first to be scrutinized when something goes wrong.
Cleaning is not rocket, computer, servo or laser science, although it is a critical process in all these industries. Cleaning technicians are not generally certified, and certainly are not required to be by regulation. Training is provided by the employer for no other reason than it is critical to the industry to minimize risk, presumably risk less of concern and less critical than infecting a patient. Granted these industries are not generally concerned with reprocessing used parts or biological contamination – sterilization techniques are not used – but components are just as sophisticated and surface contamination is of major concern with potentially disastrous consequences if not controlled. In these industries, cleaning is not buried in the basement out of mind but is treated as a “critical” process and controlled by a system approach at every relevant stage with high visibility. Designs are reviewed specifically to remove or minimize contaminant traps, prototypes are assessed for cleanability, cleaning process are engineered, highly controlled, quality checked and regularly audited. Contamination control committees are convened to set standards and oversee these processes. Service providers where cleaning is the sole and core capability are often utilized because of their expertise.
Such a system approach is needed in the reusable medical device market as well so stakeholders can’t avoid responsibility by simply saying workers aren’t certified. What a cop out! Such an attitude is a disservice to patients like John Harrison and the others mentioned in the iWatch articles. The industry can do better! We must do better!
[tabs tab1=”Video: NBC Nightly News” tab2=”Video: Today Show” tab3=”Video: FDA”]
[tab id=1]Dirty surgical tools put patients at risk, NBC Nightly News
[tab id=2]Today Show segment: How clean are surgical tools used in the O.R.?
[tab id=3]FDA Studying Cleaning Procedures for Arthroscopic Shavers