Savvy hospitals that use reprocessing strategically as a major savings initiative are seeing the impact of commoditization with single-use device reprocessors.

The emergence of the “part-charge” model in South Africa has seen some hospitals enjoy a rise in patient numbers. These patients, in some cases have been informed about the re-use of the devices without understanding the implications related to the “part-charge” model.

In essence :

Part-charge is the term used when the cost of a single medical device is directly divided between multiple patients, on which the device is to be used. Part-charge requires the device to be reprocessed between each patient use, in order to ensure the device meets original manufacturer (OM) specifications.

At first glances, the explanation above is perceived to be harmless but with a better understanding the consequences are dire.

Some medical aids have agreements with OM’s. The OM provides a set of instructions for cleaning. It’s important to note that the practice of reprocessing is a highly regulated science and cannot be carried out by ill-equipped facilities. This does not mean that hospitals are ill-equipped to deal with patients but rather ill-equipped to assume the role of a manufacturer.

Assuming this role, requires various permits, licenses, validations,certifications and above all, some very sophisticated equipment and testing methods.The license and certifications are limited to manufacturers, meaning that when these devices are cleaned at hospital level, the necessary equipment and validations are absent. This would mean that there is no liability or responsibility assumed, should the device cause harm to the patient. What is even more disturbing is that the staff who are co-erced into this practice are not suitably qualified or properly trained according to international standards and in some cases, required to sign disclaimers.

The rate of secondary infections are increasing and is the topic of discussion at conferences all over the country.

Is overloading CSSD ( central sterilization services department ) staff with work outside of their job description, merely to cut costs, worth risking the lives of patients?

If the patient has a better understanding of this practice, lawsuits would be directed at this.

It is important to note, that a local reading this article would assume that all of this is relative to public hospitals. Most would like that to be the case but the malfeasance is more evident in the private sector.

all is not lost…

When suitably equipped validated reprocessors, who comply with international and local standards, offer a safer alternative…this alternative is met with great resistance.

Four decades of advanced reprocessing in nearly 40 countries have proved device efficacy and safety. So why has this not been allowed to develop in South Africa? What makes South Africa different from a technological perspective?

The Association of Medical Device Reprocessors Association (AMDR ) is the global trade association consisting of members of the commercial single-use device reprocessing and remanufacturing industry. AMDR represents regulated, commercial reprocessing, promotes reprocessing as an important healthcare strategy that helps hospitals and healthcare providers increase quality, reduce costs and improve patient care, and protects the interests of its members in regulation, legislation and standard-setting world-wide.

OM in South Africa surely do have a presence in other countries where reprocessing is flourishing. So these OM’s encourage and promote reprocessing in other countries and in South Africa form part of a trade body who is apposed to reprocessing…whether it is being conducted by a professional organisation or not; this is not evident from their position statement.

One thing is certain, whether it is just being apposed to something for no valid reason or just employing tactics to divert attention…the benefits of licensed reprocessing are not being promoted.

The three most commonly lauded benefits :

Environmental: medical waste is diverted from landfills

Financial: the savings enjoyed by users and patients and in most cases removes the need for a co-payment

Safety: when reprocessing is conducted by a licensed reprocessor, quality systems and evidence based practices ensure that a substantially equivalent device, with respect to performance and safety, where quality is not compromised is delivered to a patient

So where did all this start?

Ignac Semmelweis, battled his peers about 200 years ago to accept what was decades later accepted as the germ theory of disease.

The self-estimation of doctors was very high back then and of course they did not like the idea that they were guilty of causing a terribly high mortality rate ( the maternal mortality rate stood at 10% and at times increased to almost 40% as a result of poor infection prevention).

The FDA took the first step to advancing US healthcare by regulating medical device reprocessing about 160 years later as a result of OM pressure. This ensured that the practice lead to hospitals abandoning illegal in-house reprocessing and then referring products to the OM or Licenced reprocessors.

These licensed reprocessors employ the same standards as OM’s and ultimately carry the same liability insurance for its products – two vital steps which hospitals or unlicensed facilities could not employ, setting up the doctor or hospital for litigation and more importantly playing with the lives of patients.

South Africa has recently paved the way for licensed reprocessing ensuring that the patient receives a device which is not compromised.

In countries where unlicensed reprocessing is prevalent, it becomes the responsibility of the patient to ask these hard questions…

Is the device safe?

Has it been reprocessed by a licensed organization?

Would the co-payment be reduced or removed? – this depends on whether NHI achieves its objectives

So wouldn’t it just be easier to avoid all of this by purchasing a brand new device every time?

Some of these devices are prohibitively expensive. First world countries experience cost pressures and employ these responsible steps (licensed reprocessing) to curb costs.

Why should South African patients be subjected to illegal practices when licensed and validated solutions

exist?