1.
A clear title, with ‘Urgent field safety notice’ followed by the commercial name of the affected product, an FSCA-identifier (e.g., date) and the type of action
2.
Specific details to enable the affected product to be easily identified e.g., type of device, model name and number, batch/lot or serial numbers of affected devices and part or order number
3.
A factual statement explaining the reasons for the FSCA, including description of the device deficiency or malfunction, clarification of the potential hazard associated with the continued use of the device and the associated risk to the patient, user or other person and any possible risks to patients associated with previous use of affected devices
4.
Advice on actions to be taken by the user. Include as appropriate
Identifying and quarantining the device
Method of recovery, disposal or modification of device
Recommended review of patients previous results or patient follow up, e.g., implants, IVD
Timelines
5.
A request to pass the field safety notice to all those who need to be aware of it within the organization and to maintain awareness over an appropriate defined period
6.
If relevant, a request for the details of any affected devices that have been transferred to other organizations, to be given to the manufacturer and for a copy of the field safety notice to be passed on to the organization to which the device has been transferred
7.
If relevant, a request that the recipient of the field safety notice alerts other organizations to which incorrect test results from the use of the devices have been sent. For example failure of diagnostic tests
8.
Confirmation that the relevant National Competent Authorities have been advised of the FSCA
9.
Comments and descriptions should be omitted, which attempt to
(a) Serve to play down the level of risk in an inappropriate manner
(b) Advertise products or services
10.
Contact point for customers how and when to reach the designated person. An acknowledgment form for the receiver might also be included (especially useful for manufacturer’s control purposes)
2 Methods
All notifications on IVD published by the BfArM in 2005–2012 were included in the study, as there is no relevant number of publications of FSCA on the BfArM homepage before 2005. Detailed analysis was made for IVD for infection testing (culture media, reagents, kits, control materials, and culture-based analyzers, e.g., for strain differentiation and susceptibility testing) and their general consumables (e.g., buffers, pipettes, or cleaning reagents). Analyzers based on molecular biological or immunological means were excluded, as they are often used for other analytical parameters (e.g., genetic testing, oncology, or clinical chemistry). The included FSCA were analyzed in respect to the criteria of MEDDEV 2.12-1 rev 8 (Table 1).
3 Results
3.1 Number of Reports and FSCA
BfArM received a total of 3898 reports regarding IVD between 1999 and 2012, from which 3,452 were received since the beginning of 2005. Publication of FSCA and FSN by BfArM started as of the end of 2004, and there were 1,257 FSCA published for IVD within the study period 01. 01. 2005 – 31. 12. 2012. From these, 169 affected culture media, reagents, kits and control materials, and culture-based analyzers and their general consumables for infection diagnostics. The number of annual reports regarding IVD and the corresponding FSCA strongly increased within this time (Table 2).
Year | Number of notifications | FSCA published |
|---|---|---|
1999 | 13 | – |
2000 | 21 | – |
2001 | 33 | – |
2002 | 58 | – |
2003 | 121 | – |
2004 | 200 | – |
2005 | 207 | 135 |
2006 | 235 | 116 |
2007 | 583 | 150 |
2008 | 506 | 143 |
2009 | 392 | 149 |
2010 | 482 | 180 |
2011 | 474 | 194 |
2012 | 573 | 190 |
Sum | 3,898 | 1,257 |
3.2 Fulfilment of MEDDEV Criteria
German and English FSN were found in 157 and 154 cases, respectively. FSN were clearly characterized as FSN in 110 and 134 cases and the names of the affected products were provided in 157 German and 154 English cases. Lot numbers or other information for product characterization was available in 146 and 137 cases, respectively. Detailed information regarding the FSCA was found in 157 and 151 and that regarding product malfunction in 144 and 136 cases, respectively. More detailed analysis was made independent from the language in all FSN. Most frequently product malfunction was due to a fault in the raw material or in the construction of a product (32 cases). Stability issues or a decrease in sensitivity were also a serious problem (27 cases). Impairment or variations in product performance, faulty standardization, or an error in the specification were found in 20 cases, and in 15 cases a contamination was the reason for product malfunction. Erroneous isolation, identification, or a bacterial resistance were found in 13 cases and in 4 cases a slower growth pattern of bacterial strains was identified. Shipping of unsuitable, incorrectly, or mislabeled products played only a minor role (9 cases), and shipping or correction of erroneous and revised package inserts was the problem in 7 cases. There were 12 cases with malfunctions in software and wrongly installed software or data transmission. No precise indication of a product failure was found in 18 cases and in 1 case there was no product failure (change of the package insert to the latest status).
Information on the product related risks with continued use of affected IVD was provided in 116 German and 116 English cases. In most of these cases, manufacturers informed customers only about erroneous results (61 and 58, respectively). A more precise statement whether the result is falsely positive or falsely negative was found in 22 and 23, and 22 and 23 German/English cases, respectively. In further 2 German and 1 English case, manufacturers stated that the results were at the lower or higher end of product specification. In one more case, German and English FSN informed customers about the risk for either lost or mixed-up results between samples sharing bottles with duplicate bar codes. No analytical error, but information concerning the risk of poisoning, contamination, injury, or infection was found in 4 German and 4 English cases. However, in 5 and 3 cases, respectively, the manufacturer informed the affected customers about a low or no risk in continued use of the product.
In 156 German and 152 English cases, manufacturers provided the information for a mitigation of product related risks. These were instructions for risk mitigation (e.g., halt of use, discard of the product, or a request for replacement) in 102 and 102 cases, respectively. In 11 German and 10 English cases, customers were advised to confirm all future results by an alternative analytical method and in 43 and 40 cases, respectively, additional safety or procedural steps were needed to be implemented. Recommendations for a control of previous results or retesting were found in 69 and 75 cases, respectively.
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