Reason for Medical Device Regulatory Compliance Being a Business Decision

The US Food and Drug Administration noticed frequent complaints of a permanent birth control mechanism called Essure. A medical group from Weill Cornell Medicine in New York registered a 10 times higher occurrence of reoperation during the first year of implantation. In Europe, the PIP breast implant remains a permanent scandal. The question here is why are approved devices causing serious safety concerns in the market? Clearly, strict regulatory oversight does not avoid the rise of malfunctioning medical devices. On the device manufacturer side, following the regulations alone does not assure all safety, quality and effectiveness parameters have to be addressed.

Essure, produced by Bayer, was approved via the 510(k) process. This route excludes medical devices from clinical testing if they are proven to be considerably equal to a similarly marketed instrument. As a result, any clinical data achieved from abbreviated studies would be insufficient to give valid and representative conclusions about safety of devices and performance. Should Bayer have conducted a full randomized, blinded clinical investigation instead? The answer to this should be derived from sensible business based decision-making, and not a general one. Completely understanding the features of the product from both profit and risk perspectives is an important keystone of the value proposition for medical devices. The base customers of medical devices are the end-users and/or patients whose requirements should rightfully take higher priority above regulatory rules.

How To Bring Database Management In Tune With Regulatory Compliance

New regulations regarding financial controls and statements have necessitated an overhauling of collection, retention and management procedures as far as information is concerned.

What is Regulatory Compliance?
Regulatory Compliance Acts make it mandatory for public companies to evaluate, review, restructure and make a detailed report of the internal controls in place for financial statements. The report has to be given a "clean chit" by external auditors. These Acts seek to prevent financial misstatements, and reduce fraud in public companies.

Data Management:
IT is an important tool when it comes to data management to ensure regulatory compliance. IT tools are used for accessing and maintaining records, and protecting the financial systems from misuse. Here are some tips to ensure good data management practices.

1) The appropriate management must be notified of data management ownership and they must understand their responsibilities.

2) Data systems should be listed, their managers notified, and the number of databases, types of information software used, the underlying operating system, access conditions, and other utilities should be listed.

3) Review the potential threats to information stored in databases, and call for periodic reassessments.

4) The data should be properly catalogued, so extraction and tracking become easier.

5) There should be data backup in place.

6) The responsibilities regarding database management must be delegated in a way that it prevents unauthorized access to information, as well as alterations to the data.

Database Management: Database Administrators.
In order to ensure regulatory compliance, database management is broken up into different tasks and each task is delegated to a database administrator, or DBA. The DBA's responsibilities include:

1) Being accountable for the integrity of the data.

2) Authorizing and tracking database modifications and management of security of the system.

3) Ensuring proper backup for database.

4) Ensuring that the database is foolproof against unauthorized access.

5) Maintain a list of all databases, and databases other than their own that they access information from.

6) Keep proper documents in place establishing that they follow legal practices regarding access and privileges.

7) Test database log validation procedures.

8) Rectify the database quickly when unauthorized access and changes to the database are noticed.

9) Ensure that in case of an accidental or premeditated loss of data, it can be recovered in the minimum possible time so that business is not affected.

Database management procedures should satisfy auditors, be legal, and should employ correct auditing methods. There are companies that provide these services. However, they should be aware of their duties and responsibilities and ensure regulatory compliance of their database management processes. Upgrading the database system and putting in proper controls to information access and flow keeps the organization in the good books of auditors, and prevents financial scandals.