An interesting observation on safety issues raised in returning contaminated items such as jewelry to clients, as voiced by this medical professional’s concerns for their patients. It is evident that infection control measures should be carefully considered when previously worn jewelry or other contaminated personal items are to be returned to a customer.
Please regard the discussion in the comments below
Question
I am an OR nurse and recently started a new job in a prestigious orthopedic hospital. At the request of a surgeon or patient when implants are removed we have been cleaning and flashing them and returning them to the patient in a plastic bag.
[NOTE: Flashing is an outdated term for sterilizing items unwrapped for immediate use]
https://brnskll.com/shares/flash-faq/
At my previous hospital we never would do this as it was considered unsafe and a possible infection hazard. I questioned the peri-operative educator about this practice and she stated there was nothing wrong with doing this and there was no regulation against returning explants to patients. Frankly, I am appalled at this practice. Can you tell me if there is any professional standard on this or if this is an acceptable practice?
Answer
There is no universal standard or regulation on this practice. In my experience the decision and process is left to each hospital to decide and to develop a hospital policy.
In developing a policy on the return of explants to patients there are many concerns and issues that need to be considered and addressed. It is suggested that a task force or committee be established, bringing together the required expertise to develop a sound and rational policy. Representation on the committee may include surgeons, peri-operative staff, infection control, epidemiology, risk management, legal affairs, manufacturer, sterile processing, pathology and materials management. Each committee representative or grouping of representatives will investigate issues related to their area expertise. The following is a list of some of the concerns and issues to address.
- Reprocessing of implants
- Method of cleaning, decontamination and sterilization for each type of explants
- Personal safety, injury risk assessment associated with explants to be processed and returned to patient
- Identify which explants can and cannot be returned to patients
- QA of reprocessing efficacy
- Packaging and labeling of device for sterilization and return to patient
- Adherence to any biohazard handling or labeling in accordance with federal, state and local regulations
- Who rightfully has ownership rights to the explant
- Issues involving past, current or future implant recalls — and compliance to FDA regulations — e.g. tracking, ownership, reporting, return to manufacturer
- Compliance with FDA and/or other regulatory mandates relating to disbursement and distribution of such devices
- Maintenance of required documents and manifestos for tracing purposes
- What other records will hospital create and maintain
- Who, when, where and how will explants be returned to patient
Reference: February 2012+AORN Journal Vol. 95, Issue 2, Pages 288-296 Returning Explants to Patients AORN 2012 PDF
From Healthcare Purchasing News
Ray Taurasi is Eastern Regional Director of Clinical Sales and Services for Healthmark Industries. His healthcare career spans over three decades as an Administrator, Educator, Technologist and Consultant. He is a member of AORN, AHA, SGNA, AAMI and a past president of IAHCSMM and has served on and contributed to many national committees with a myriad of professional organizations, manufacturers, corporations and prestigious healthcare networks. Taurasi has been a faculty member of numerous colleges teaching in the divisions of business administration and health sciences. In addition to this column he has authored several articles and has been a featured speaker on the international scene.
Recommendations by the Quality Task Group (91)
Implants for Orthopaedics and Traumatology
Recommendations by the Quality Task Group (93)
Reprocessing implants, supplied in an unsterile state, for orthopaedics and traumatology – Part 2
To avoid contamination with particles, implants must not be cleaned or disinfected together with other used medical devices. Ideally, a dedicated washer/disinfector should be available for implants.
My position is that reprocessing should and eventually may be possible, and the standards are in the works for over a decade. The caveat is at this point, to do it correctly, and to prove the safety is beyond the means of economy for most jewelry items. It would have to costs less in time and validation than the wholesale cost of the items. I’ve been studying this with the ASTM committee F04 on Medical and Surgical Devices and Committee F04 on Medical and Surgical Materials and Devices and Subcommittee F04.15 on Material Test Methods on the subject of “how clean is clean enough?”
For the time being, I strongly suggest that you have a no returns except defects policy. Any returns for defects are treated as a loss in terms of tax deduction, to recycle the gold by remelting it, and discard items such as stones that can not withstand high temperatures for cleaning and depyrogenation. At some point, cold plasma technology will be available to avoid breakage, and cleaning validation services will come down in cost.
Essentially, the technology for repeatedly, effectively and reliably reprocessing personal wear items that might come in contact with an initial or healing piercing are not currently available on a small scale, and may be damaging to your jewelry, especially in terms of breakage. The Hydrim was not designed for that. For your purposes, I’ve looked into contract a company that specializes in medical prosthetic or orthodontic appliances reprocessing. Otherwise, the legal issues get very complicated and potentially very expensive, such as if you have to register with the FDA for a 510(k) and as an ISO 9001:2015 and ISO 13485:2016 device reprocessor and have a clinical microbiology staff for validation.
I contacted SciCan about this specifically again, and the word is Hydrim is not for jewelry, as medical and dental are not allowed to use them for implants or orthodontic brackets and bands. Additionally, any cleaning equipment that is also used to reprocess contaminated instruments would pose further issues.
Previously worn items present cleaning problems and liabilities beyond our current processing capabilities. This has held true with surgical implants, and the risks are applicable to our field. What we can’t see, and most of us will not have the means to measure are the residues that remain post processing. The health hazards are significant, and are much more so when a reprocessed item is left in place in contact with healing tissues.
My above post mentioned malformed proteins such as prions, which are among the more difficult remaining residues to detect, along with mycobacterium, biofilm and cysts among many other pathogens are known to survive our cleaning and sterilization methods.
It is not worth the risk, as there is not yet an approved reliable method for reprocessing surgical implants, and the reuse of orthodontic brackets and buttons is not advised as it may impair the performance and increase the risk of patient injury. The main issues after recycling have not been due to documented clinical issues, rather from the limitations in the high temperature cleaning process which damages or destroys some materials, causes changes in the metallurgic microstructure which suggest susceptibility to metallic intergranular corrosion which would lead to breakage.
A colleague quoted me and made this little sticker to inform clients.
smartsexyscientist:
I am not a piercer, but as a microbiologist, I have a few questions about this. If you’re using the autoclave correctly, everything should be killed. Nothing is going to ‘grow back’ after a proper autoclave session. (There are a very few microbes that are resistant to normal autoclave settings, but these are rare and highly controlled in the labs they’re studied in, the chances of them appearing on a average person’s jewelry is extremely low). And I’m not quite sure how ‘protein residues’ could possibly cause a bacterial/fungal/viral infection? Perhaps leftover toxins that are produced by certain microbes (i.e. S. aureus, a common skin microbe, can produce a toxin) could cause damage but it wouldn’t be an actual infection. And the vast majority of those toxin proteins (including the S. aureus toxin) are destroyed by the heat and pressure of the autoclave.
The only one of these that kind of makes sense is prions since as far as I know those are extremely difficult or impossible to decontaminate. But prions (the causative factor of ‘mad cow disease’, among others) are only spread through contaminated brain tissue, so I would think the likelihood of them appearing on a piercing would be extremely low. Not that I’m saying buying used body jewelry is a good idea. I personally would never want to buy used jewelry. But the scientific inaccuracies here don’t really inspire confidence in the piercer. If I saw this at a studio I went to get pierced at, I would turn around and walk right back out the door.
Hello microbiologist friend smartsexyscientist :)
These points were reduced from a much more involved conversation in the context of describing why sales of used body jewelry is an untenable business practice, and to discourage professionals from considering their autoclaves infallible. At a piercing studio, you wouldn’t want to have to question if someone had previously worn your jewelry or if it was new and safely handled prior to cleaning and sterilization.If it is not clean, it can’t be sterilized.
A colleague cherry picked quips to keep it simple for a lay person to understand . As easy as it may be to pick it apart, it is clear that you got the message, and as a person who describes some understanding of steam sterilization, you already understand that an autoclave process should be effective against most pathogens. Prions are one harmful known protein type that are not destroyed by steam sterilization, and require more harsh means for removal from a surface. They are most often spread through contaminated brain and spinal tissue, but also through other kinds of nervous tissue, such as the tongue.
Another part of the problem when it comes to body jewelry is that the autoclave operator most likely does not have a background in clinical microbiology and infection prevention, and may not have optimal equipment to clean and sterilize jewelry. Most of the autoclaves used in North American piercing studios do not have dynamic air removal such as a vacuum or pressure pulsing system. They rely on gravity displacement and can not adequately sterilize hollow, porous or wrapped loads, which results in regrowth.I do not condone appeal to authority, even when I’m the alleged authority. I am a person very interested in the specifics of “how clean is clean enough,” and to this end continue to study and participate in the related workgroups in the ASTM F04.15 subcommittee on on Material Test Methods. We’ve been working on the problem of reliable validation for surgical implant reuse for philanthropic purposes for over a decade. For example, pacemakers can be still functional for years after explanted from a deceased individual. The concerns for failure are due to both infectious material (protein, bacterial, fungal and viral) that resists autoclave processes inside crevices and hollow or porous spaces, and endotoxin and pyrogen residues that can cause rejection, even without infection.
Biofilm and denatured proteins that can prevent effective decontamination are known problems with body jewelry. More on this subject here.
References of interest:
ASTM F2847 – 10 Standard Practice for Reporting and Assessment of Residues on Single Use Implants
WK32535 New Practice for Establishing Limit Values for Residues on Single use Implants
WK33439 New Guide for Standard test soils for validation of cleaning methods for reusable medical devices
I support the establishing evidence based standards for decontamination and sterilization of medical device and other surgical implants for reuse, if it can be done safely and consistently. Once that sort of process is standardized in medicine, then it might be applied to body jewelry. This shouldn’t be impossible, and may be forthcoming. A promising note is that there are processes to clean bone and tissue for allograft and implant from exogenous sources, such as cadavers, into patients in need. These sorts of things under clinical investigation may result in the standards we need for reprocessing body jewelry.
Until implants can be safely reused under routine conditions, we should not reprocess previously worn body jewelry for anyone but the original wearer’s own personal reuse.
Thank you for your detailed answer Brian Skellie! I did not know that prions could be transmitted via tongue tissue, or that the autoclaves used in piercing studios weren’t quite the same as the ones I’m used to in lab. This makes much more sense now.
smartsexyscientist, I agree that the subject certainly deserves a more in depth discussion, and that the image alone is not enough. I’m glad it piqued your interest and that you were interested in more information.
As an expert in both biomaterials for body jewelry and infection control, I can assure you that when reprocessing worn items is involved there is virtually no chance in achieving 100% sterilization. The risk of some pathogens such as bacterial and viral agents can be reduced, but not removed from surgical implants, this is why they can not be safely reused from person to person.
Surgical instruments are exposed in contact with the body for far less time than implants ergo jewelry. The extended exposure time allows protein adhesion and biofilm formation in areas that will not be removed by cleaning and sterilizing processes.
I would strongly recommend not ever reprocessing some unknown person's jewelry to wear for a second user. Even with a clean bill of health, the residues can guard pathogens, endotoxins and pyrogens.