Medical devices recall

After the system has been released for operation, system maintenance activities take over. The importance of such activities is characterized by recent FDA remarks related to the lack of change control management by regulated organizations. The FDA s analysis of 3140 medical device recalls conducted between 1992 and 1998 reveals that 242 of them (7.7%) are attributable to software failures. Of those software related recalls, 192 (or 79%) were caused by software defects introduced when changes were made to the software, after its initial production and distribution. 

FDA Enforcement Report Index. 1990-. Weekly. URL http // www.fda.gov/opacom/Enforce.html. This database provides access to drug and medical device recalls and product seizures in the United States. A search form incorporated into the opening page enables keyword searches of the entire collection. Simple queries involving only one factor, such as a company or brand name, quickly locate pertinent recall notices, each of which identifies specific product batches, quantities withdrawn from commerce, and their previous geographic distribution. Each entry also describes the reason for recall (contamination,... 

The first and most important point in the development of a medical device is the proper overall design. It is believed that the intrinsic quality, safety, and effectiveness of a device are established during the design phase. FDA statistics show that 30% of all medical device recalls are a result of inadequate design control [1], The design process is the foundation and skeleton that is the basis of a medical device from its inception to the end of its lifetime. The design process is a living and an iterative process it evolves and improves with time. 

Davis, S., Gilbertson, E., GoodaU, S., 2011. EU medical device approval safety assessment a comparative analysis of medical device recalls, 2005-2009. Available at https //www. bcgperspectives.com/content/articles/medical devices technology public sector eu medical device approval safety assessment/ (accessed 05.01.16). 

The pharmacist or physician can report any problems experienced with dmg products and medical devices. In cases where the PDA and/or manufacturer finds that a marketed product constitutes an actual or potential threat to the safety and welfare of the pubhc, that product must be withdrawn from the marketplace, ie, recalled. Several classes of recalls exist, depending on the relative danger that the product exhibits. C/ass I dmgs pose a serious health threat and may require withdrawal at the consumer level C/ass II dmgs pose a possible or potential health problem that usually means withdrawal at the pharmacy or wholesaler levels and C/ass III dmgs may present a remote hazard to health and safety. 

The Safe Medical Devices Act requires reporting of medical devices that probably caused the death, serious filness, or injury of a patient. Postmarket surveillance on permanently implanted devices required with methods for tracing and locating patients depending on such devices. FDA is authorized to recall device product. 

Medical Devices Agency, Guidance on the Recall of Medical Devices, 2000. 

Statements made by, or on behalf of, marketing organizations during promotional audio conferences will also attract regulatory attention if they minimize crucial risk information and promote a drug or device for an unapproved new use. Incorrect, misleading, or incomplete artwork and medical information could lead to the inappropriate use of a drug or medical, device, in which case a recall of that product is usually required. These systems should therefore be validated as they can impact public health. 

There is no licensing or specific approval procedure for medical devices in New Zealand. Section 38 of the Medicines Act 1981, however, places restrictions on the sale of medical devices and details the powers of the Director-General of Health to request evidence on the safety of any device from the importer or manufacturer, and to recall any product from sale if necessary. Regulations 10 and 12 of the Medicines Regulations 1984 control the advertising and labelling of medical devices. 

In addition to reporting of adverse reactions encountered with a medical device distributed in New Zealand, manufacturers should also report to Medsafe any alerts or recalls that have occurred overseas if that device is also distributed in New Zealand. 

Part 5 Uniform Recall Procedure for Medicines cmd Medical Devices, 1995... 

Nursing homes, hospitals, and other facilities that utilize medical devices were required to report to the FDA information arising out of medical devices that contributed to the death or serious injury of a patient. The FDA acquired the authority to order device recalls. Manufacturers of devices were required to conduct post-market surveillance on all permanently implanted devices whose failure might cause serious harm or death. 

Medical device manufacturers are required to report adverse events related to their devices as per 21 CFR 803 under the definition of MDR. Adverse events can be reported directly to device manufacturers or reported to the FDA. The MDR database is searchable and open to the public. In some instances, MDR can provide safety signals for devices that can provoke actions to ensure patient safety such as product recalls. 

Safety of software is equal in importance to that of the hardware elements, as consequences of a software failure in medical devices can be quite serious. For example, a program that is out of control because of a software error can drive a radiation therapy machine gantry into a patient [9]. A Food and Drug Administration (FDA) study conducted over six years (1983-1989) reported that there were 116 problems in software quality that resulted in the recall of medical devices in the United States [3]. Most of the methods and techniques that can be used to improve software safety in medical devices are available in Refs. [10-12]. 

Preservation of Evidence. All equipment and supplies, including but not limited to unused medications, sheets, towels, syringes, samples from the lab, nn-used blood prodncts, and equipment, should be retained after a medical accident. These items can be used in the investigation to ensirre a safe environment. Medical device maliunctions should be tagged per the Medical Device and Product Reporting, Alerts, and Recall Policy, 900.00. 

Medical Device and Product Reporting, Alerts, and Recall... 

In concert with the FDA s QSR, the international device community embraced a similar international standard known as ISO 13485 2003. This version of the standard, and the more current version ISO 13485 2012, like the QSR, put the emphasis on design controls. In both systems, the management of the company is held responsible for reviewing products and ensuring they are made according to a sound quality system. Despite international efforts to harmonize these standards and make their implementation as straightforward as possible, medical device manufacturers continue to recall products due to malfunctions and defects. But because of the system known as CAPA (Corrective and Preventative Actions) most medical devices are clean, safe and perform as intended. 

Notification or safety alert Communication issued by manufacturer to inform the risk of substantial harm from a medical device. These situations can be of the same importance as class I, class n, or class in recall... 

Kuhn D, Wallace D (2000) Failure modes in medical device software an analysis of 15 years of recall data. Nat. Institute of Standards and Technology, Gaithersburg, MD USA. http //csrc. nist.gov/staff/Kuhn/final-rqse.pdf. Accessed 25 August 2010 Littlewood B, Strigini L (1993) Validation of ultrahigh dependability for software-based systems. Comm. ACM 36(11) 69-80... 

Health Canada. MED Effect. Advisories, Warnings Recalls forHealthProfessionals. Medical Devices, http //www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/ index e.html (Accessed 2006/01/27)... 

Requirements for certification and re-certification should be defined. Certification has been regulated with respect to the properties of a medical device before it is allowed onto the market for clinical use, but there are no requirements for feedback based on post-marketing surveillance and retrieval analysis. Only product recall and withdrawal from the market in the case of a serious adverse advent have been regulated. 

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