Did the industry change as a result of the issues it confronted in 2015?
At the start of a new year it is interesting to look back at issues that hit the headlines in 2015 and at the resulting technological and legislative changes.
Among the contamination issues, the poor cleaning of duodensocopes used in surgery hit US headlines when it was linked to cases of transmitted infections. It led to new guidance on the cleaning process and a review of device design, disinfection and adverse effects reporting. In August, the FDA issued Warning Letters to three duodenoscope manufacturers citing violations found during inspections and in October ordered the manufacturers to develop postmarket surveillance studies of how the devices are reprocessed in real world clinical settings.
The pharmacy sector saw changes after a deadly US meningitis outbreak some three years earlier was attributed to unsafe drug compounding practices. The FDA proposed new rules for compounders and increased inspections; many Warning Letters ensued. The latest rules cover when such facilities need to register as outsourcers, how certain products should be repackaged and adverse reactions reporting.
Happily, by the end of 2015 the Ebola outbreak in Africa had reduced to a few sporadic cases. The disease had claimed a total of 11,315 lives. Its infectious nature required an international effort to contain the disease and to equip isolated villages with mechanisms to stem further spread. As a result, there has been a rethink of hospital isolation practices and epidemic preparedness both in Africa and internationally.
Finally, 2015 saw rising concern in hospitals about antibiotic resistance. This issue may well make headlines again in 2016 as people succumb to what were once minor, easily treatable infections. While the pharmaceutical sector looks for new antibiotics, hospital disinfection and good hand hygiene and cleaning will be more relevant than ever in infection prevention. There will be a co-organised Cleanroom Technology/Building Better Healthcare event on this in May.
On this cautious note, I wish everyone an infection free and prosperous New Year.