How can we get high quality routine data to monitor the safety of devices and procedures?BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f2782 (Published 07 May 2013) Cite this as: BMJ 2013;346:f2782
All rapid responses
To the Editor,
The robust tracking and tracing of implantable medical devices is well overdue. It is unbelievable that in an age where Toyota can raise a safety issue from its post-production surveillance, and successfully recall thousands of vehicles for correction of the defect before any harm comes to the customer (1), we still put implants into patients without any system to monitor them and keep our patients safe.
Campbell et al. suggest several measures that would allow safety alerts to arise from signals in meta-datasets, and full device traceability to identify affected patients (2). However their proposals distinctly lack a patient perspective. To continue the car analogy, if a customer hears that there is a recall for their type of car, they do not need to wait anxiously by the letterbox to see if their car is to be recalled. Instead they can simply check online by entering their car registration number on the manufacturer’s website.
For patients with a medical device, there is currently no robust way for worried patients to find out if they are affected by a safety alert, and the proposals by Campbell et al. do not go far enough to enable this. Currently, details of implants should be entered into medical records. These are often paper-based and in a proportion, unobtainable, incomplete, lost or destroyed. In the case of the Poly Implant Prosthèse (PIP) implants, although most patients managed to either keep their own records or obtain past records from their original provider, some were lost or destroyed. The Data Protection Act 1998 specifies that records should only be kept for as long as necessary but does not specify a time period (3). British Medical Association guidance suggests that hospitals keep records for 8 years after the conclusion of treatment or death (4). Therefore some medical records may be legitimately destroyed. Medical imaging may be able to characterize site, contour and integrity of some implants, but is rarely capable of obtaining an adequate level of information to identify the exact make, model and batch.
We ran an anonymous survey of patients with PIP implants, advertised through social media. Eighty-three patients responded, of which 59 originally had their surgery in a private UK clinic, 23 outside UK and one in the NHS. Fifty-five (66%) needed to make enquiries to ascertain the make of their breast implants. For 38, this took longer than two weeks, and for 19, longer than six weeks. In response to "how much has the uncertainty regarding implants affected your life?" 70 (84%) rated eight or more (1=not at all, 10=completely).
The human impact of failed medical devices cannot be understated. We conducted a semi-structured interview with a solicitor handling claims for women who have had, or think they have had PIP implants. Commenting about the type of implant he stated, “a significant proportion [of women] don’t know”. This is because women were never told or given a choice of implant. Hundreds of women are affected and some are experiencing high levels of anxiety. “Many are extremely worried. Some women are finding ruptures… and wanting to get them out as soon as possible”.
The Medicines and Healthcare products Regulatory Agency have recently consulted on introducing a unique device identifier (UDI) and it is intended to eventually pass through European legislation (5). This will improve traceability of devices along the supply chain. However, once implanted, the only way to know the UDI of a medical device will be from the medical records. With the unreliability of current record systems as highlighted above, and with the previous failure of expensive central registries (6) (with the exception of the National Joint Registry), there is currently an unsolved need, from the patient’s perspective, to be able to identify the exact details of medical devices whilst still in situ.
In our survey, when asked about their agreement with "all implants should have a readable ID that doesn't require medical records or x-rays", 62 (73%) either agreed or strongly agreed. We believe that technology that would allow this to become a reality should be investigated, so that the safety of medical devices are not only addressed from a systems’ perspective, but also from, and arguably more importantly, the patients’ perspective.
1. Moulds J. Toyota recalls 242,000 Prius cars. The Guardian [Internet]. 2013 Jun 5 [cited 2013 Jul 10]; Available from: http://www.guardian.co.uk/business/2013/jun/05/toyota-recalls-prius-cars...
2. Campbell B, Stainthorpe AC, Longson CM. How can we get high quality routine data to monitor the safety of devices and procedures? BMJ. 2013 May 7;346(may07 3):f2782–f2782.
3. Information Commissioner’s Office. Data Protection Act: Retaining personal data (Principle 5) [Internet]. [cited 2012 Apr 2]. Available from: http://www.ico.gov.uk/for_organisations/data_protection/the_guide/inform...
4. BMA. Retention of health records [Internet]. British Medical Association. 2011 [cited 2012 Mar 5]. Available from: http://www.bma.org.uk/ethics/health_records/retentionrecords.jsp#.T1S-Hn...
5. Medicines and Healthcare Products Regulatory Agency. The revision of European legislation on medical devices. The response to the public consultation. [Internet]. London, UK; 2013 Apr. Available from: http://www.mhra.gov.uk/home/groups/comms-ic/documents/publication/con260...
6. Healthcare Quality Improvement Partnership. HQIP reaction to breast implant debate - registries crucial to identifying risks to patients [Internet]. 2012 [cited 2012 Apr 2]. Available from: http://www.hqip.org.uk/hqip-reaction-to-breast-implant-debate-registries...
Competing interests: No competing interests
Campbell et al, suggest an interesting series of measures that could be used to monitor the safety of devices and procedures . We agree that single measures may mislead but the problem of identifying a problem extends further than considering devices in isolation from the rest of clinical practice.
In 2012, there was a press outcry about the breast histopathology service at King’s Mill Hospital, Mansfield. Many patients were alleged to have been given incorrect treatment because an audit of breast tumour oestrogen-receptor positivity suggested that there was a significant difference between that Trust and others in the region. Consequently, the Care Quality Commission asked for a review of the pathology service to be carried out. This revealed that Kings’ Mill Hospital appeared to be an outlier only because of the small sample size of this service’s throughput. This made statistical evaluation of performance difficult  and the findings of the original audit invalid.
Similar problems were identified in the field of antenatal Down’s syndrome screening. These were resolved by the imposition of a minimum workload threshold for laboratories providing such screening tests. That minimum workload was based on statistical analysis of the volume work needed to provide a robust estimate of performance in a reasonable time period (1 year), and lead to the introduction of Down's Syndrome Screening Quality Assurance Support Service (DQASS) . Definition of minimum workloads forced reconfiguration of screening and has improved National performance.
All sorts of decisions made by departments and individuals can be monitored provided there are sufficient data. This cannot be achieved within the current parochial boundaries that define functional units in the NHS. Some reconfiguration of catchment areas and their volumes of work are needed to ensure sufficient data are available to make desirable and statistically valid interpretations of the quality of that work. It should be possible to identify with confidence that a unit is significantly different from its peers within a short enough timescale for patients to benefit from that knowledge. Thus, workload sizes need to be determined statistically so that the minimum number to give an acceptable confidence interval can be identified.
When a large number of a particular type of examination is carried out, it may also be possible to define a minimum acceptable workload of a clinician. This will allow outliers to be evaluated. This approach has been applied by DQASS with equal success to ultrasonographic measurement of nuchal thickness for first trimester Down’s screening. There is no reason to believe this cannot be applied to other areas of medical practice, whether for an objective numeric result or for a subjective opinion of an observation (interpreted as binary positive / negative) such as with oestrogen-receptor testing. Assessment of devices and procedures is insufficient without such sophisticated analysis.
1) Campbell B, Stainthorpe A, Longson C. How can we get high quality routine data to monitor the safety of devices and procedures? BMJ 2013;346:f2782
2) Royal College of Pathologists. Review of cellular pathology governance, breast reporting and immunohistochemistry at Sherwood Forest Hospitals NHS Foundation Trust: A report prepared for the Care Quality Commission in respect of diagnostic and screening procedure. 20 February 2013.
http://www.cqc.org.uk/sites/default/files/media/documents/20130313_full_... (accessed 13th May 2013).
3) DQASS. Homepage on the NHS Fetal Anomaly Screening Site. http://fetalanomaly.screening.nhs.uk/dqass
Competing interests: No competing interests
This is an important issue worthy of urgent action and debate.
Certainly device tracking is the start. All devices should be bar coded. For inpatients, the bar code should be scanned and added to the procedure (or a new)field in the computerised data. This has a number of benefits:
1. It facilitates recall: centrally held computer records are easy to scan if and when required;
2. The cost of additional data collection is minimised, no new registry to establish, just the cost of adding scanning facilities at relevant locations (ideally decentralised to where devices are inserted but could be done centrally in patient records departments);
3. Data access should eb accorded any researcher who wants to tarck particular types of devices either as a special research project, on a regular basis, or as part of other research;
4. recording specific devices inserted improves costing of procedures as well.
Competing interests: No competing interests