Clinicians and industry alike are all too familiar with the issue of device reprocessing. Indeed, medlatest’s industry experience extends as far as direct knowledge of processing validation for decontamination and sterilisation of “reusable” devices. It’s pretty clear to us that there remains confusion about the basics, not least the distinction between decontamination and sterilisation and the fog surrounding the subject of how to validate both. The Medical Devices Directive is fairly clear in spelling out the requirements, but less so in providing guidance on how to comply with those requirements.
More recently the thorny subject of reprocessing of “single-use” devices has come to the fore, not least with the publication in 2010 of a report detailing the findings of a working group, the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)on the subject. The document can be found here.
Across the pond, FDA’s position is that it currently requires that reprocessors retain all cleaning, sterilization, and functional performance data to ensure that their reprocessed devices are substantially equivalent to newly manufactured devices. FDA has performed numerous studies on the safety and efficacy of reprocessed SUDs and strictly monitors the practice of reuse. The agency states that SUDs can be reprocessed with reasonable assurance of safety and effectiveness and that reprocessed SUDs that meet its regulatory requirements are as safe and effective as new devices In a January 24, 2006, briefing before the Committee on Government Reform, FDA reported that a search of its MAUDE database for reports of SUD-associated events between October 22, 2003, and December 13, 2005, yielded 176 reports of death, serious injury, and/or device malfunction involving SUDs. However, further analysis of these reports showed that no clear link existed between the reprocessed SUDs and the patient injury or death.
In this context it’s interesting to note parallels between FDA and Eu scientific committee positions, both of which seem pragmatic enough to accept that reprocessing of SUDs will occur, yet both of which also place responsibility for control of devices undergoing such reprocessing on the reprocessor rather than the original manufacturer. It seems like reprocessing will be acknowledged and even allowed on condition that the company or entity doing the job have mechanisms in place to ensure that the device is suitable for reprocessing and in so doing return the single use device to it’s fully assembled ready-for-use state. The Eu position, as recently clarified in a meeting with the UK Chambers of Commerce is that further checks on the practice will mean that while reprocessing can take place, it will only be permitted “in market”, with movement of products consequently restricted. This is a question of “watch this space”, because it looks like a subject ripe for additional legislation.
Source: medlatest staff, European Directorate General for Health and Consumers, www.ecri.org