How traceable is the product you are injecting into your patient? Roseanne Aitken argues the accountability of practitioners in dealing with product traceability
At the heart of the 2013 Keogh report lies the person who chooses to have a cosmetic procedure. While the vast majority of non-surgical treatment providers care deeply for the safety of their patients, are a small minority overlooking an important aspect of patient care? As Dr Patrick Bowler wrote in the Huffington Post, following the release of the Keogh report, “The entire review is about putting the patient at the heart of cosmetic treatments. Every patient has the right to be protected by legislation that makes them feel confident that they will be well looked after and safe.”1 Injectable non-surgical treatments fall under the Medical Devices regulatory product group. To provide guidance, the Medicines and Healthcare products Regulatory Agency (MHRA) recently released Managing Medical Devices (April 2014), and Devices in Practice (June 2014). The latter contains checklists for using medical devices. The Record Keeping checklist emphasises the need for recording where the medical device is from, it’s serial or batch number, and expiry date. This product traceability is a critical requirement for distributors and manufacturers as well. Regular audits by Notified Bodies on ISO certified distributors and manufacturers always include a detailed check on product traceability. Product traceability however, may well be the Achilles heel of the excellent work carried out by bodies and practitioners striving to protect the patient. When your patients give signed consent for their treatment, they do so trusting that their clinician has covered all aspects necessary for their safe care. Reputable practitioners keep accurate records of product LOT or serial numbers injected into patients. This information becomes meaningless if, further back in the chain of supply, there has been a break in traceability. If an adverse event occurs, if a product recall is needed, or if the manufacturer needs to highlight safety aspects of the product, there must be no break in traceability from manufacturer to patients. The patient has no protection if such a break occurs.
How could such a patient-risk situation develop?
It develops hand-in-hand with a so-called ‘grey market’ of product. A grey market (or parallel market) is the trade of a product through distribution channels which, while legal, are unofficial, unauthorised, or unintended by the original manufacturer. The most common type of grey market is the sale of imported goods brought in by small import companies or individuals not authorised by the manufacturer, and who have obtained these goods from third parties. The sale of grey market goods is of concern across diverse industries, ranging from snacks and drinks to clothing and cosmetics. The concern is especially acute with medical devices. Suppliers of grey market goods sold outside authorised distribution channels have no relationship with the producer of the medical device. The manufacturer is completely unaware of where their product has ended up. For the patient, there is no traceability and no protection. The medical device grey market is substantial. Sellers of grey market goods are smart and determined, and substantial money is at stake for them. They often use the EU “free movement” of goods rationale to support their unauthorised sales. Anything that it is legal to sell in the EU can be sold anywhere in the EU. When it comes to injectable medical devices however, this blithe free movement argument shouldn’t be applied in the same way as in the grey market of chocolates, cars and other products. Often grey market suppliers tempt clinicians with an offer of a lower priced product. If clinicians take up this offer, appearing unaware of, or even not caring about the implications of a grey market product for their patients, then who does care? Apart from the patient, it is the authorised country suppliers of the product as well as the manufacturers who care. These suppliers and manufactures ensure that all medical devices they provide to you are fully traceable. Authorised country suppliers have the clinical and sales support of the manufacturer and hold product liability insurance. Grey market suppliers have none of these and are seeking to get a free ride on the manufacturer’s good name and reputation. The waters are further muddied for the clinician by the existence of private labellers. Checking whether traceability exists may not be a simple case of looking for the name of the manufacturer on the product label. How can you, as a reputable clinician or clinic, ensure you are not purchasing grey market products and that all your treatments are fully traceable and supported by the manufacturer? The answer is to ask your local supplier for a supporting letter from the manufacturer. The letter should confirm that the individual or company from whom you are purchasing is indeed the authorised distributor of the product, and that you and your patients can be assured that the product you are using is fully traceable from source. Not only will you have the full sales and clinical support of the manufacturer, but if there is ever any potential risk to your patient you will be the first to know.
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