Article 12a, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Reprocessing of Medical Devices.” It is Dr. D’s opinion that one of the most frustrating issues facing device manufacturers is the reprocessing of their devices. Why? Can you say designed, tested, approved, and sold as a single-use device?
I cannot tell you how many times Dr. D has seen user complaints opened against a specific product only to have the product returned to find out the device was manufactured five years ago. Wait just a minute, the shelf-life for the device was 37-months, so why is it now just being used.
Well folks, the doctor would like to inform you there are just two possible scenarios. In scenario number one, it is just a horrible example of poor inventory control by the healthcare provider, a.k.a. the end user. In scenario two, the device was reprocessed and the only discernable marking is that of the original device manufacturer.
Wait a minute, this cannot still be happening in this age of regulation, can it? Ladies and gentlemen, trust the doctor when I say, it happens frequently. Before I dive into the crux of this week’s guidance, let Dr. D leave you with one question. How would you like to have an attending physician use a reprocessed device on you or one of your loved ones when a new device is available? Frankly, it would give me the proverbial “willies” knowing that a device being placed in my body has been used earlier in other patient(s).
One final point, obviously when employing expensive instruments like endoscopes, reprocessing is a cost-driven necessity. Diagnostic catheters used in the field of electrophysiology, not so much. Just to ensure Dr. D is perfectly clear, the reprocessing of medical devices is a widely-accepted practice; however, the doctor questions the validity or reprocessing of devices clearly marketed as single-use, by the manufacturer.
The MDD – 93/42/EEC
Article 12a – Reprocessing of Medical Devices
The Commission shall, no later than 5 September 2010, submit a report to the European Parliament and to the Council on the issue of the reprocessing of medical devices in the Community. In the light of the findings of this report, the Commission shall submit to the European Parliament and to the Council any additional proposal it may deem appropriate in order to ensure a high level of health protection.
What you need to know
You can gather from the doctor’s poignant introduction, I am not a big fan of reprocessing of single-use devices. Not only are there product performance and sterility risks, it deflates the potential earnings of the manufacturers that have designed, validated, placed into expensive clinical trials, and suffered through lengthy regulatory approval cycles at great expense. I would like to see regulators abrogate (look-it up) the reprocessing of single-use devices; however, it is highly unlikely that will occur.
In fact, Dr. D is a staunch believer that reprocessing facilities should be required to complete clinical trials that are identical to the manufacturer in an effort to prove device safety and efficacy, after reprocessing. Regardless, here is what device manufacturers need to know about Article 12a of the MDD.
The reprocessing of medical devices is a reality faced by device manufacturers. There are organizations dedicated to medical device reprocessors. The Association of Medical Device Reprocessors (AMDR) is an organization dedicated to assisting healthcare facilities in the controlling of their skyrocketing costs within the United States. There is a similar organization in Europe, the European Association of Medical Device Processing (EAMDR).
Now Dr. D is not going to debate the virtues of reprocessing; however, device manufacturers need to know that regulations exist, and in some cases no regulations exist, that regulate the practice. In the EU, the acceptance of reprocessed medical devices is extremely diverse with the decision to allow reprocessing premised on decisions made by individual member states.
According to the EAMDR website, the reprocessing of medical devices is broken down into three categories:
- Regulated/accepted under high quality standards;
- Not recommended but performed without quality standards; and
- No legislation but performed without quality structure.
Dr. D strongly recommends visiting the AMDR and EAMDR websites as they are extremely informative and provide the pros and cons (mostly pros) on the topic of reprocessing. Your notified body can guide you through the trials and tribulations of reprocessing for devices marketed in the EU.
What you need to do
Device manufactures need to understand that device reprocessing is becoming more prevalent as the cost of healthcare continues to increase substantially. Reprocessing of devices occurs frequently within the EU. As a device manufacturer, it is important to properly label your devices as single-use, although, that will not stop healthcare providers from reprocessing. Device manufacturers need to continue to lobby regulators and educate healthcare practitioners, to ensure stringent procedures are adhered to in regards to reprocessing. For example, rigorous validation and testing needs to occur in support of device reprocessing.
As stated previously, Dr. D would have reprocessors repeat clinical trials to ensure reprocessed devices are safe and effective. One final thought, the EAMDR website contains an example where reprocessing of devices is actually prohibited within the EU. Spain, although no regulations are in place, believes that prohibiting the practice of reprocessing is the preferred path.
For this week’s edition of DG, there is just one takeaway. Simply put, the reprocessing of medical devices is an acceptable practice within the EU. Healthcare providers pursue the reprocessing of medical devices as a way of controlling costs. Is the practice of reprocessing single-use devices safe and effective? I will leave that answer to the device manufacturers as the responses are probably product specific. Generally speaking, reprocessors believe the practice is safe, device manufacturers, not so much.
Until the next installment of DG, when Dr. D will provide guidance for complying with Article 13 (Decisions with Regard to Classification and Derogation Clause) of Council Directive 93/42/EEC, the MDD – cheers from Dr. D and best wishes for continued professional success.
- Council Directive 93/42/EEC. (1993, June). Council Directive 93/42/EEC concerning medical devices. Retrieved December 21, 2010, from http://eur-lex.europa.eu
- Devine. C. (2009, July). Exploring the effectiveness of defensive-receiving inspection for medical device manufacturers: a mixed method study. Published doctoral dissertation. Northcentral University. Prescott Valley, AZ.
- Safety first: reprocessing of medical devices in Europe. (2011, April). European Association of Medical Device Reprocessing. Retrieved April 1, 2011, from http://www.eamdr.org/
- Third-party medical device reprocessing. (2011, April). Association of Medical Device Reprocessors Website. Retrieved April 1, 2011, from http://www.amdr.org/