The European Medical Device Coordination Group (MDCG) has adopted a guidance document on implant cards, assisting in understanding article 18 of the Medical Devices Regulation (EU) 2017/745 (MDR). Show
According to the guidance, implant cards are intended for patients to be able to identify information about devices that is published elsewhere, for example in Eudamed. It is also intended for the patient to identify themselves in case of field safety corrective action (FSCA) or other issue. Emergency clinical staff or first responders may also use implant cards to obtain information about special care or needs for patients in emergency situations. The implant card must be provided to patients by healthcare professionals, which implies that Member States must draw up specific legislation. Manufacturers are asked to create an informative instruction leaflet to instruct healthcare providers in the use of the implant card, and the effectiveness of these instructions must be verified by a usability study. For ease of use, the implant card should have the same size and shape as a credit card. Information to be providedThe implant card must clearly identify the device and provide any relevant additional information:
In addition, the patient and the healthcare provider must be identified on the implant card:
Symbols are allowed to convey this data. Some new symbols are introduced:
The symbol for the device name is particularly interesting. It looks like the medical device’s version of the IVD symbol, but apparently this is not the case. Implantable systemsIf a patient is implanted with a set of components that are intended to work together, this is considered an implantable system. Some of these components may later be replaced. The exact components to be implanted may not be known to the manufacturer at the moment the device leaves the place where the implant card is added to the package. This means that system cards require a certain flexibility. A suggestion is made of how a system card could look like, but the guidance document encourages parties involved to look into ways to developing implant cards that fit the specific situation for the system in question. UDIArticle 18 of the MDR requires the UDI to be represented on the implant card. In the guidance document this is understood as the UDI-DI of the device, both in machine and human readable format. However, article 27 states that a UDI consists of a UDI-DI (the device identifier), plus the UDI-PI (the production identifier). Annex VI, part C, which contains the UDI-related definitions, confirms this by stating that UDI comprises the UDI-DI and the UDI-PI. However, there is a risk that conformity with the guidance document – only the UDI-DI on the card – results in a non-conformity with the MDR. There is a way to meet both requirements: article 18 requires the UDI plus serial number and/or lot number to be on the implant card. This would imply that if the UDI-PI contains the serial number or lot number, the requirement would be fully met by stating the UDI-DI plus UDI-PI. Summary of Safety and Clinical PerformanceOne of the three reasons for issuing an implant card is that it allows a patient to identify the summary of a device’s safety and clinical performance in Eudamed. That document is required for all implantable devices, without exceptions. However, the implant card is not required for “simple” implants, sutures, staples, dental filling, etc. This means that manufacturers of the “simple” implants need to provide summaries of safety and clinical performance, while their patients will not be able to identify them. It would have made sense using the same exceptions for both cases. Unfortunately MDCG cannot change the MDR, so for now we have to live with this inconsistency. Additional European MDR resources from Emergo by UL:
BMJ. 1998 Apr 18; 316(7139): 1245. Intraocular lens implant cards contain inadequate clinical data E Rom, Senior house officer in ophthalmology A A Castillo, Consultant
ophthalmologist County Hospital, Lincoln LN2 5QY Editor—Purkayastha emphasises the potential of implant cards for patients who have had implants.1 Such schemes will be clinically useful only if the cards contain adequate information about the implant. A future clinician
may need to know about a patient’s implant in order to site a matching one on the contralateral side or to manage the complications of poor fit or biocompatibility. In the case of intraocular lens implants, information is needed about the design and size of the lens, materials and coatings used, dioptric power and “A” constant, and manufacturer’s address or telephone number. Intraocular lens packs already include an implant card for the patient. We looked at lens implants made by four
manufacturers and found that none of the implant cards contained all of the necessary data (table). Information stickers, intended for insertion in the case notes, were similarly lacking in clinically important detail. While all cards and stickers included the manufacturer’s name and model number, most did not state the design, implant materials, or “A” constant. This lack of basic information frequently leads to unnecessary problems when attempts are made to match an unfamiliar implant for
cataract surgery to the second eye. We can foresee only one disadvantage of having full information on implant cards for patients. If late problems are identified with a particular type of implant, publicity could result in unnecessary anxiety among patients who are having no problems and more claims for compensation from those who are having problems. The potential of the system is not being realised, and we urge manufacturers to include all relevant information on both
information stickers and implant cards. Information given on patient implant cards and stickers for case notes
References1998 Apr 18; 316(7139): 1245. Such cards would facilitate recallEditor—I agree with Purkayastha that patients should have implant cards,1-1 but for a slightly different reason—early failure of an implant. At present there are few hip implants that have proved long term results in various age groups,1-2,1-3 and some newer implants seem to fail early.1-4 In addition, many studies have poor follow up, and it is becoming accepted that loss to follow up matters.1-5 The idea of having implant cards is attractive but, given that a patient may have several implants or implants in various combinations (for example, hybrid), then to carry a card for each component may be cumbersome. Alternatives would be to have a data card (incorporating silicon chip technology) that can be updated by “swiping” each time a component is implanted or to have an identification chip implant in a subcutaneous site, which could be scanned and information recalled from an implant register. Such a database could then be used to facilitate adequate follow up and allow early notification of people with implants that might fail, either because of design faults or because of batch failures. References1-1. Purkayastha S. Patients with implants should be given implant cards for reference. BMJ. 1997;315:1377. . (22 November.) [PMC free article] [PubMed] [Google Scholar] 1-2. Alsema R, Deutman R, Mulder TJ. Stanmore total hip replacement. A 15 to 16 year clinical and radiographic follow up. J Bone Joint Surg 1994;76[Br]:240-4. [PubMed] 1-3. Joshi AB, Porter M, Trail IA, Hunt LP, Murphy JC, Hardinge K. Long-term results of Charnley low-friction arthroplasty in young patients. J Bone Joint Surg 1993;75[Br]:616-23. [PubMed] 1-4. Massoud SN, Hunter JB, Holdsworth BJ, Wallace WA, Juliusson R. Early femoral loosening in one design of cemented hip replacement. J Bone Joint Surg 1997;79[Br]:603-8. [PubMed] 1-5. Murray DW, Britton AR, Bulstrode CJK. Loss to follow-up matters. J Bone Joint Surg 1997;79[Br]:254-7. [PubMed] Articles from The BMJ are provided here courtesy of BMJ Publishing Group Why do you need a patient lens implant card?After your operation, your eye doctor should give you a wallet card that shows the type of implant in your eye. You should present this card to any eye doctor who examines your eyes after your surgery. Your eye doctor has a choice of IOLs that may be used to improve your vision.
What is a implant card?What is an Implant card? A patient implant card is a small, portable card intended to be provided to patients following surgery who have received either a permanent implantable medical device or an active implantable medical device.
What is the patient card?Patient cards are a growing library of clinical summaries customized to each physician in your practice and designed to simplify access to common charting elements.
What is considered an implanted medical device?Medical implants are devices or tissues that are placed inside or on the surface of the body. Many implants are prosthetics, intended to replace missing body parts. Other implants deliver medication, monitor body functions, or provide support to organs and tissues.
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Why do I need an implant card?
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