Clinical Evaluation
Rationale (ref: MDD 93/42/EEC consolidated 2007, Annex X):
深圳新东方英语培训1.1. As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of u of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be bad on clinical data. The evaluation of this data, hereinafter referred to as "clinical evaluation", where appropriate taking account of any relevant harmonid standards, must follow a defined and methodologically sound procedure bad on:
1.1.1. Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpo of the device, where: – there is demonstration of equivalence of the device to the device to which the data relates, and
– the data adequately demonstrate compliance with the relevant esntial requirements.
1.1.
2. Or a critical evaluation of the results of all clinical investigations made.
1.1.3. Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2
venthheavenCritical Evaluation
a. Device Description, function and u
Electrical portable nasal suction units (and jars) supply a controllable vacuum source for medical suction/drainage of nasal fluids. Typically they will be ud where no piped suction is available and rely on battery for their operation (also can be ud/charged via the mains), and as such are suitable for field or transport u. Etc短裙配什么上衣
b. Clinical Evaluation
XXX Company have had demonstration portable nasal pump models evaluated (or are still under evaluation) at a number of NHS Trusts and similar clinical environments. Becau of the variety of environments / us / flexibility a formal protocol has not been ud for the evaluations. The parame
dic etc is supplied with the unit, instructions and feedback form - and allowed to u as per their training with similar devices/suction systems (i.e. as would normally be the ca). The specific XYZ feedback form includes an evaluation of the
'Instructions'. Forty evaluations have now been returned. The feedback data is overall very positive, especially with respect to ea of operation. The feedback form has 14 questions, plus additional ctions for comment and comparison to other units (such as the Acme device), where previously ud. A scoring system of 1 (least positive) – 10 (most positive) is ud. A typical question ud is “How clear was it to understand the vacuum lection and level indicator?” Out of a possible maximum 10 mean score, a curr ent mean of 8.41 is reported. For tho who have made a comparison, 65.5% have indicated that XYZ is …better‟ or …much better‟ than units currently ud (normally Acme or Vogon). If tho who indicated a match (…same‟) are included, this figure goes up to 96.5%. Etc.
c. Analysis of and references to the literature
An extensive review of available published literature has been conducted. There have only been very limited citing found of a XXX Company product ud in a clinical study, not one relating to a portable nasal suction unit. Etc.
Literature referencesguei
1. …The u of nasal drainage pumps in post-operative events‟; B. Conk et at; Ear,
No & Throat Weekly; Vol II; Number 13; 2009.
2. …Nasal Suction‟; J. Smith; 2007; Page 312; Pub. Amazon Inc.
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Etc
Their general u of nasal suction units in a clinical environment is very commonplace around the world, as indicated by the literature, and their safety is generally excellent. In the UK individual NHS Trusts cover the u and the training associated with such devices in their procedures. Etc
chanel是什么意思d. Hazards
As with any electrical item there is the risk of shock due to faulty units or incorrect u. The units the
mlves have been tested and conform to the appropriate Standards with respect to medical electrical equipment (BS EN ISO 10079-1 and BS EN 60601-1). Testing to meet the esntial requirements and relevant Standards were conducted by an independent Test Hou, and as well as the Standards above, comply with BS EN 1789, BS EN 60601-1-2 (EMC) and VCA requirements Other hazards of u relate to applying incorrect suction and biological contamination, which is a possibility with all such devices (Note as part of the Risk Management ction of the Technical File, a risk asssment has been conducted). Etc
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e. Conclusion
A number of the literature references cited are from textbooks, since the design, principles of operation and u of medical nasal suction units is so well established. In one paper9, an Acme Suction Unit is referenced, which was the basis of original design intent comparator for the portable nasal suction unit.
It should be noted that XXX Company customers re-order nasal suction units and jars; as such clinical function of the items acceptably can be indicated by default. All marketed XXX Company products are supplied with a generic feedback form; that can be ud for clinical or other comments.
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Post market surveillance via complaint analysis for a 5 year period up to now shows only 4 complaints for all types of XXX Company nasal suction units. The were investigated and evaluated in-hou. Two complaints are for the same device and relate to possible misu or transit issues, another relates to transit damage and the final one is believed to be customer related. The nasal suction unit has been on the market since November 2006 with no issues reported. No other negative feedback has been reported. From our records no XXX Company nasal suction unit/jar has been involved with any product alert or recall.
string什么意思The data that is now available adequately demonstrates compliance with the relevant esntial requirements. As indicated in this Clinical Evaluation ction, the current feedback for the nasal suction unit is very positive and further formal feedback data is envisaged. There are no contra-indications such that the XXX Company nasal suction unit cannot be on the market as a Class IIa medical device. Etc.
Reviewer: Joe Bloggs (Quality Manager) Date : 8.5.09
