Medical products and devices are essential in patient care. However if an unsafe products is used on a widespread basis the consequences can be catastrophic. Patients can experience serious injuries and deaths from product malfunctions. For example, the FDA and as well as medical testing companies reported that in 2005 to 2009 there were over 700 recalls of medical products. If the medical community had used these recalled products consistently, there would have been serious health consequences and increased fatalities.

Laws requiring the FDA (Food and Drug Administration) to control medical devices were put into place over thirty years ago. A report prepared in 2010-11 by the Institute of Medicine stated that the FDA must continue to do more to regulate and test medical products. All medical devices and products must be analyzed under set procedures and additional safety and operation information needs to be produced.

Using a unique alphanumeric or numeric code plus a device identifier in all patient and inventory records can facilitate the recall of unsafe products.

Developing Safer Medical Products

To help provide consumers with safer medical products and promote staying healthy initiatives, there are directives and procedures currently being investigated. These include:

– Enabling more efficient recalls on medical products. It is very difficult for healthcare facilities to determine what patients have implanted medical devices that are subject to recall. There are records of what patient has what device implanted, but determining the exact model number can be difficult. Allowing the device to be noted in the electronic health records of patients and tying to those records to an electronic inventory record system can result in the rapid and exact identification of recalled products. This will result in higher safety improvements and patient-follow up to check on implanted devices. This can provide assistance to the FDA when implementing medical device recalls. The device that is subject to a recall or is being recalled could be instantly found in a patient\’s chart, linked to the inventory part and information would include all serial numbers; the patient could be quickly alerted to the recall.

– If a medical device or product has an adverse event or causes patient harm, having availability to adverse event reporting would allow the FDA to engage the public and alert them to a recalled medical product. Currently it is difficult for the FDA to use these reports since they lack specificity about which device is associated with what adverse event. Being able to input and retrieve information on each medical product with labeling will ensure that these problems can be rapidly addressed, the public notified and the patient can return and have their implanted device checked and replaced.

Active surveillance needs to be applied to ensure that safety problems and mistakes can be detected. Using UDI in electronic health records, medical claims and inventory tracking can help register surveillance efforts.

Included should be the FDA\’s Sentinel System, clinic and hospital records, the medical community, patients and manufactures. This will aid in the quick retrieval of information in all records. The appropriate action can then be taken.

For more information, please visit our FDA Reporting for Safer Medical Products website.

For more information, please visit our FDA Reporting for Safer Medical Products website http://www.hipaaexams.com/fda-reporting-for-safer-medical-products.asp

Author Bio: For more information, please visit our FDA Reporting for Safer Medical Products website.

Category: Wellness, Fitness and Diet
Keywords: FDA Reporting for Safer Medical Products